TPSAC: Proposed Requirements for Tobacco Products Manufacturing Practice (TPMP) Rule Meeting5/18/23

good morning everyone I'm Christine donavo chair of the tobacco product scientific advisory committee I want to thank you all for joining us today I want to make a few statements and then we will introduce the committee for topics such as those being discussed at today's meeting there are often a variety of opinions some of which are held quite strongly our goal is that today's meeting will

be a fair and open forum for discussion of these issues and individuals can express their views without interruption thus as a gentle reminder individuals will be allowed to speak into the record only if recognized by the chair we look forward to a productive meeting in the spirit of the federal advisory committee Act and the government in the sunshine act we ask that the advisory committee members

take care that their conversations about the topics at hand take place in the open form of the meeting we are aware that members of the media are anxious to speak with the FDA about these proceedings however FDA will refrain from discussing the details of this meeting with the media until its conclusion also the committee is reminded to please refrain from discussing the meeting topics during breaks

thank you I would now like to invite the members of the committee to introduce themselves their institutional affiliation and expertise we will start on this side with Dr Bailey all right thank you Andy Bailey University of Kentucky tobacco extension specialist at the University representative on this committee and I represent over 3 000 tobacco Growers here in the U.S I've been with University of Kentucky for about

21 years in this capacity as tobacco extension Specialists thank you I Am David Johnson I am with tobacco technology I've been working in tobacco for approximately 30 years I've worked for small tobacco companies and medium-sized tobacco companies I'm representing the small tobacco manufacturers here today good morning my name is from Altria I'm a vice president of scientific officers at Altria but today I'm here as a

normal team member representing large tobacco manufacturers good morning my name is Alberta Vicente and I work with the Indie Health Service good morning I'm Deirdre Lawrence kittner I'm the director for the office of smoking and health at the Center for Disease Control hi I'm Lisa Postell I'm at the national heart lung and Blood Institute at NIH Adam Leventhal with the University of Southern California good morning

I'm Lucy papova at the school of Public Health Georgia State University my expertise is in communication marketing and behavior related to the products good morning I'm minion guy from Virginia Commonwealth University Center for the study of tobacco products and my expertise is in health and health excuse me tobacco-related Health disparities morning Dr um docology I'm director of respiratory Technologies lab also at RIT on my training

and expertise is in aerosol mechanics lung deposition product characteristics and reverse engineering and monitoring topography in the National environment good morning my name is Scout I'm the executive director of the national LGBT cancer Network and my expertise it's an implied mathematics sociology sociomedical Sciences but I would definitely say related tobacco it's Health disparities thank you technologically impaired I'm Donna Upson I'm a pulmonary physician uh professor

of medicine at the University of New Mexico and staff physician at the VA in New Mexico I've been working in prevention and treatment of tobacco dependence for about 25 or 30 years especially with the American thoracic Society thank you I believe we also have Dr George joining us remotely Dr George could introduce himself good morning my name is Sven yard I'm faculty at Duke University School

of Medicine in the department of anesthesiology and the toxicology and environmental health program my expertise is in flavor additives of tobacco products including their behavioral physiological and toxicological effects thank you I would like now to ask Serena to introduce herself and read the conflict of interest statement and housekeeping um before we have Serena read the housekeeping I'd like to just proceed down the line with uh

Dr King uh yes Brian King director of the center for tobacco products Emil Wang uh senior regulatory Council and Senior advisor for manufacturing and Regulatory policy at ctp's office of compliance and enforcement May Nelson director officer Office directions good morning everyone before I begin some keys were lost we want to check and make sure that it's no one's keys in this room and hearing none okay

good morning everyone my name is Captain Serena Hunter Thomas and it is my pleasure to serve as the designated Federal Officer for this tobacco science Pro tobacco products scientific advisory committee meeting first I would like to thank the many hands that were involved in the planning support and preparation of this meeting leading up to today it truly took a village and I thank you all including

Dana bambemo Janice O'Connor Emil Wang Matthew Brenner Robert Schwartz hey you are Patel Nicola Staples and her team Andrea takash and her team Monique Hill and the collective FDA DFO community today's session will cover one topic that is open to the public in its entirety the meeting topic is described in the Federal Register notice that is published that was published on Friday March 10 2023. the

FDA press media representative for today's meeting is Miss Abigail capobianco Miss capobianco if you're present if you could please raise your hand okay the transcriptionist for the meeting today is Mr Toby Walters I would like to remind everyone to please speak please check your pagers and cell phones and make sure that they are either turned off or in silent mode when making your comment please first

state your name and speak loudly and clearly please keep in mind that one Committee Member Dr Sven George is joining us remotely we would like everyone to be heard for the benefit of all committee members FDA staff and public attendees here in the room as well as those listening via webcast in addition speaking loudly and clearly will ensure that your comments are accurately recorded for transcription

I will now proceed to read the conflict of interest statement for this meeting the center for tobacco products of Food and Drug Administration is convening today May 18 2023 for a meeting of the tobacco product scientific advisory committee under the authority of the federal advisory committee Act of 1972 and the family smoking prevention and Tobacco Control Act of 2009 the committee is composed of scientists Healthcare

professionals a representative of a state government a representative of the general public ex-officio participants from other agencies and three industry Representatives the following information on the status of this advisory committee's compliance with applicable federal conflict of interest laws and regulations is being provided to participants in today's meeting as well as to the public and is available for viewing at the registration table the purpose of today's

meeting which is being held in Open session in its entirety is to discuss the proposed requirements for tobacco products manufacturing practice tpmp rule accordingly this meeting is categorized as involving a particular matter of general applicability or pmga with the exception of the industry Representatives all committee members are either special government employees or regular government employees from other agencies and are subject to Federal conflict of interest

laws and regulations based on the categorization of this meeting and the matters to be disc considered by the committee all meeting participants with the exception of the three industry Representatives have been screened for potential conflicts of interest FDA has determined that the screened participants are in compliance with applicable federal conflict of interest laws and regulations with respect to the committee's industry Representatives we would like to

disclose that doctors Maria gagova William Andy Bailey and David Johnson are participating in this meeting as non-voting Representatives Dr gagova is representing the tobacco manufacturing industry Dr Bailey is representing the tobacco Growers industry and Dr Johnson is representing the tobacco small business pool industry their role at this meeting is to represent these industries in general and not any particular company Dr gagova is employed with Altria

Client Services Dr Bailey is employed with the University of Kentucky research and education center and Dr Johnson is employed with tobacco technology this concludes my reading of the conflict of interest statement for the public record and at this time I would like to hand the meeting back over to the chair Dr Del nivo thank you thank you Serena we're going to now move into our presentation

I'd like to introduce rear Admiral Emil Wang from the FDA thank you Dr donivo and welcome members of the tobacco product scientific advisory committee and guests I am here to provide an overview of the tobacco product manufacturing practice tpmp proposed rule to assist the committee's discussion and support your recommendations to FDA uh before I get started with the presentation I'd like to cover um some disclaimers

the presentation and the attached briefing documents contain information prepared by the FDA for the panel members of tipsac on the proposed tpmp regulation this presentation and the briefing package may not include all issues relevant to tip sack's consideration of the proposed regulation it is intended to focus on issues identified for FDA for discussion by tipsac the information in these materials is not a formal dissemination of

information by FDA and does not represent agency position or policy the information is provided to tips act to Aid the committee in its evaluation of the proposed regulation the agenda for today is a quick overview of the proposed tpmp regulation its objectives namely to protect the public health and assure that tobacco products are in compliance with the food drug and cosmetic Act the scope of the

proposed regulation the framework and an overview of the provisions of the proposed rule as well as the topics that FDA has identified for tips act discussion the proposed tpmp rule is a foundational role of CTP that will help protect the public health and assist in implementing ctp's statutory and Regulatory authorities tpmp's activities and Records will help ensure that commercially marketed tobacco products comply with the requirements

of the statute such as pre-market review and tobacco product standards it's important to underscore that compliance with the final tpmp regulation does not mean that a tobacco product is safe CTP recognizes that tobacco products are inherently dangerous with significant risk while all tobacco products have inherent risks to the public health the proposed tpmp regulation is focused on minimizing and preventing product problems and health issues not

normally associated with the use of a tobacco product that is additional risks associated with these products as set forth in section 906e of the food drug and cosmetic Act the statutory objectives are to protect the public health and to assure that tobacco products are in compliance with uh chapter 9 of the food truck and cosmetic act for example the proposed tpmp regulation is intended to protect

Public Health to address minimize and prevent design and Manufacturing issues and product contamination also as an example to assure that tobacco products are in compliance with the statute cpmp's proposed requirements can enable FDA to identify modifications to a tobacco product and determine if tobacco products are adulterated and misbranded some more detail on how the proposed tpmp regulation is intended to protect the public health bpmp's proposed

requirements are all interrelated and necessary to assure that the public health is protected the proposed requirements will assist tobacco product manufacturers and enable FDA to protect the Public Health by among other things minimizing or preventing product problems and health issues not normally associated with the use of tobacco products for example exploding ends batteries and physical chemical and biological hazards these issues have been experienced by FDA

and have also been reported to FDA the proposed requirements will Aid in investigations of potential problems related to tobacco products from design and Manufacturing issues that can cause illness injury or death for example tpmp can assist with investigations of adverse experiences such as e-cigarette or vaping product use Associated lung injuries evoli so FDA can take appropriate action if it is determined that such problems are attributable

to tobacco products the proposed requirements would require manufacturers to take measures to prevent product contamination that can result in injuries and adverse experiences such as metal plastic or chemical contaminants again these have been reported to FDA safety reporting portal and have resulted in manufacturer voluntary recalls the proposed requirements would require that manufactured and distributed tobacco products consistently conform to the specifications described in pre-market applications and

notices committed to and authorized by FDA or comply with a tobacco product standard in effect a key proposed requirement is for manufacturers to establish and maintain a master manufacturing record MMR and a production record the MMR is in essence the recipe for a tobacco product that includes specifications established by the manufacturer and any requirements of applicable tobacco product standards specifications also include those for the identity

and amount of components and parts ingredients additives and materials and the product design the MMR will also include all manufacturing methods and procedures and all packaging labeling and labels approved for use with the finished or bulk tobacco product a production record will then be prepared for each batch of finished or bulk tobacco product to demonstrate Conformity with the requirements established under the MMR the proposed requirements

would also require manufacturers to identify and investigate the scope and cause of complaints and non-conforming products to take appropriate corrective actions such as recalls the proposed tpmp regulation would also help assure that tobacco products are in compliance with chapter 9 of the food drug and cosmetic Act ppmp is a primary regulatory tool that enables CTP to verify what is reported and filed to and authorized by

FDA for example the proposed requirements would enable CTP to determine if commercially marketed tobacco products including pre-existing tobacco products are modified rendering them new and requiring a new pre-market application or notice other provisions of the act that tpmp can help assure compliance include helping FDA verify that the ingredients and additives used in tobacco products are consistent with what is listed tested and reported to FDA the

proposed tpmp requirements for labels labeling and packaging would enable CTP to determine if they are in compliance with the requirements of the act and regulations ppmp's proposed procedures and Records would provide for tracing of all components or parts ingredients additives and materials as well as each batch of manufactured and distributed finished or bulk tobacco products so manufacturers and FDA can take corrective actions for non-conforming products

such as recalls regulation would also help to determine if tobacco products are adulterated or misbranded failure to comply with any final tpmp requirements would render the tobacco product adulterated tpmp would enable CTP to determine if commercially marketed tobacco products are adulterated or misbranded for example if a manufacturer um manufacturers a tobacco product that is inconsistent with the specifications identified in the pre-market application under which it

has received marketing authorization or required by a tobacco product standard these products would be adulterated or misbranded and subject to CTP enforcement action very quickly the scope of the proposed tpmp regulation covers finished tobacco product manufacturers and bulk tobacco product manufacturers CTP considered a broader scope to include manufacturers of components and parts but determines that the proposed regulation should cover these entities that have the most

direct impact on public health finished tobacco products are those tobacco products sealed in final Packaging Finnish tobacco product manufacturers have the burden of ensuring that suppliers of components and parts meet their established specifications the proposed regulation also covers bulk tobacco product manufacturers that is those tobacco products that are not sealed in final packaging but otherwise suitable for Consumer use as a tobacco product without requiring further

processing other than packaging or labeling bulk tobacco products can be simply packaged labeled and sold to Consumers and these include for example bulk tobacco that is bagged for sale such as roll your own tobacco or cigarette tobacco bulky liquids or batteries that are then packaged and labeled by a manufacturer or vape shop for sale to Consumers CP determined that it is necessary to cover bulk tobacco

products because they are suitable for use by consumers and a person who merely packages and labels the bulk products may not be able to determine if these products are contaminated or non-conforming or may not be able to conduct adequate investigations for issues related to product design or product production process issues the proposed regulation also will cover specification developers that is those entities that initiate or create

the design specifications of a tobacco product CTP is aware that some manufacturers including small tobacco product manufacturers May contract out the design and development activities to a specification developer for example many ends products are designed by specification developers in foreign countries such as China the design of an end product can be critical to its performance poor design can result in fires and explosions a contract or

physical manufacturer of the tobacco product may not know the complete design and specifications of the tobacco products they are manufacturing and would not be in the best position to take appropriate corrective actions or investigate non-conforming products that contain design defects also CTP is aware that some members of the tobacco industry have organized their corporate structures to separate the design specification functions from manufacturing making it difficult

for FDA to access the design and specification records the proposed regulation would also cover repackages and relay blers of finished and bulk tobacco products dtp um wrote the proposed tpmp regulation based on a framework utilizing an umbrella approach that is it contains a flexible requirements that can accommodate different types of tobacco products because this regulation would apply to all regulated tobacco products and the many different

types of tobacco products the proposed regulation does not dictate in detail how manufacturers must produce a specific tobacco product the proposed requirements are written in general terms to allow manufacturers to establish procedures appropriate for their specific products and operations the proposed approach allows finished and bulk tobacco product manufacturers the flexibility to establish procedures that are appropriate to the manufacturer's facilities and operations and appropriate for a

given tobacco product tobacco product manufacturers who have large and complex manufacturing processes would likely need to establish more detailed procedures to comply with the proposed regulation while tobacco product manufacturers who have less complex manufacturing processes may need less extensive procedures also of important notes is that the proposed rule provides that manufacturers would need to comply only with the requirements applicable to its manufacturing operations this means

that if a tobacco product engages in some operations subject to the proposed requirements but not others the manufacturer need only comply with those requirements applicable to the operations in which it is engaged therefore smaller tobacco product manufacturers would be able to tailor their procedures to suit their operations while still complying with the proposed tpmp requirements but tpmp proposes a two-year effective date for non-small tobacco product

manufacturers the statute requires that small tobacco product manufacturers have at least four years following the effective date to comply this means that the proposed regulation establishes a compliance date of a total of six years for small tobacco product manufacturers to comply the statutes also provides a requirement for petitions for exemptions and variances manufacturers including small tobacco product manufacturers May submit a petition for exemptions or variances

if they are not able to comply with all or some of the proposed tpmp requirements or if they elect to take an alternative approach a petition would need to include a detailed explanation of how the manufacturer's methods facilities and controls meet the statutory objectives this slide provides a summary of the proposed Provisions by subpart and sections as mentioned the proposed regulation utilizes an umbrella approach with

flexible requirements that would apply to the wide variety of tobacco products offered for sale and distribution as mentioned manufacturers would only need to comply with the requirements applicable to their operations for example a manufacturer of finished e-liquids would not need to comply with the proposed warning plan requirements because e-liquids are only required to Bear a single warning also a finished cigarette manufacturer who does not engage

in repackaging or re-labeling operations would not need to comply with the proposed repackaging and re-labeling requirements also a specification developer who only designs and creates the MMR for another manufacturer's tobacco product and does not engage in any physical manufacturing would not be subject to for example the proposed requirements in subpart C buildings facilities and equipment support e production processes and controls and subpart G handling storage

and distribution in summary manufacturers should establish procedures for their operations follow their plans and maintain records of their activities as covered in the background materials FDA has identified the following topics for tips act discussion and recommendation the proposed scope of the tpmp regulation covers finished and bulk tobacco product manufacturers including specification Developers does the committee have any recommendations on the scope including potentially expanding the scope

does the committee have any recommendations or comments on the umbrella approach that proposes requirements in flexible terms to enable manufacturers who are subject to the rule to establish procedures that are appropriate for their specific products and operations does the committee have any recommendations on the product specifications that FDA proposes to be required and documented in the MMR does the committee have any recommendations on the proposed

design and development activities and risk management processes to control risks associated with the finished and bulk tobacco product and its production processes packing and Storage and finally FDA welcomes any additional recommendations on the requirements of the proposed regulation CTP looks forward to tip sacks discussions and recommendations to help the agency strengthen the proposed tpmp regulation we look forward to supporting your discussion thank you Emil y

I will we're going to now enter into the open public hearing phase first I will read the open public hearing statement welcome to the open public hearing session please note that both the FDA and public believe in a transparent process for information gathering and decision making to ensure such transparency at the open public hearing session of the advisory committee meeting FDA believes that it is important

to understand the context of an individual's presentation for this reason FDA encourages you the open public hearing speaker at the beginning of your written or oral statement to advise the committee of any Financial relationships that you may have with the sponsor its products and if known its direct competitors for example this financial information may include the sponsor's payment of your travel lodging or other expenses in

connection with your attendance at this meeting likewise FDA encourages you at the beginning of your statement to advise the committee if you do not have any such Financial relationships if you choose not to address the issue of financial relationships at the beginning of your statement it will not preclude you from speaking with that I would like to ask our first Speaker Lauren lempert from ucss Center

for tobacco control research and education are my slides available there we go can you hear me so good morning I'm Lauren leppert a researcher at ucsft course our t-core has submitted public comment on April 13th that includes many citations to the published literature that support recommendations which I'll briefly discuss today in general we support fda's proposed requirements to the extent that they will help minimize some

of the risks inherent in um in tobacco products that said these requirements should be seen as a floor not a ceiling and manufacturers should be explicitly prohibited from using their compliance with these minimum requirements to promote either implicitly or explicitly that their products are safer higher quality or endorsed by FDA because of our t-core's particular expertise in protecting the health of priority populations and youth I'd

like to focus on two of the recommendations detailed in our written comments first we strongly support the section requiring manufacturers to establish and maintain procedures to control packaging and labeling to ensure that they comply with FDA regulations as well as the manufacturer's established specifications this is especially important to ensure that the nicotine concentration labels on e-liquids and e-cigs accurately describe the nicotine concentration labels that are

actually contained in those products we cite substantial evidence that the actual nicotine concentrations in e-liquids frequently vary considerably from the labeled concentrations for example in one study nicotine was detected in 91 percent of the example samples analyzed despite their labels which indicated they contained zero nicotine and many products whose labels indicated zero nicotine actually contain nicotine concentrations ranging upwards of 23.9 milligrams per milliliter also many

studies show that young e-cigarette users frequently misunderstand the strength of nicotine and e-cigarettes and many don't realize that e-liquids even contain nicotine there's considerable evidence which we cite that adolescents and young adults have difficulty understanding what is meant by the nicotine concentrations on labeling described in the confusing but common metrics milligrams per milliliter or percent nicotine as you can see in these packs young users often

rate concentrations presented as milligrams per milliliter as stronger more addictive and more harmful than equivalent concentrations presented as percent nicotine but even worse adolescents and nicotines all often and young adults often underestimate nicotine strengths which could lead to inadvertent exposure to high nicotine levels adults who use e-cigarettes also have difficulty understanding nicotine concentrations presented as either milligrams per milliliter or percent nicotine and these difficulties are

expected to be worse among people with minimal education language barriers or among other priority populations oops what happened um our written common cites several studies that finding that e-liquids is inaccurate and ineffective labels lead to misunderstanding confusion and possibly disregard about the amount of nicotine and cigarette products this in turn may lead to inadvertent exposure to high nicotine levels continued use and addiction for these reasons

we strongly support fda's proposed requirements to help ensure that E-liquid and e-cig labels accurately reflect the nicotine concentrations actually contain the products along these lines FDA should mandate an easy to understand labeling metric that clearly consistently and accurately conveys nicotine strengths next okay here we go next we urge FDA to strengthen requirements about product storage and shelf life there's significant evidence that e-cigarettes have finite shelf

lives and can become contaminated with bacteria and fungus that grow while the E-Cigarettes still on the shelf and they become more toxic over time therefore we recommend that this section be strengthened to require manufacturers to set explicit specifications addressing shelf life to clearly State the expiration date on product labels and to require expired or adulterated products to be removed from store shelves in summary and whoops

well I can't find the summary um fda's final rule should protect the health of Youth and other priority property populations by requiring that nicotine concentrations on labels accurately reflect the actual contents nicotine strengths on labels are presented in clear and consistent metrics that youth and adults understand and expiration dates are clearly stated on labels and expired products are removed from store shelves in addition to these

points thank you for considering all of UCSF Q Corps recommendations found in our written public comments that was submitted in time for your consideration thank you I'd like to ask our next speaker Connor Fuchs thank you good morning I'm Connor Fuchs from the campaign for tobacco-free kids and I have no Financial relationships to disclose thank you for the opportunity to speak today before turning to specifics

of the proposed rule I want to begin by recognizing the proposal's importance but also some of its limitations as FDA recognizes in the proposed rule tobacco product manufacturing requirements have the potential to help mitigate the risk of health issues that are not normally associated with the use of a tobacco product that includes for example requirements aimed at preventing the manufacturing distribution of adulterated tobacco products products

contaminated with foreign substances such as metal glass Nails dirt and hair all of which FDA says have been found in Finnish tobacco products however it's also necessary to recognize the limits of the proposed rule compliance with these manufacturing practices will certainly not make a tobacco product safe nor will it mean that the product benefits of Public Health in any way is FDA and all of us

know these manufacturing practice requirements once finalized will not address the many serious and Grave health issues that are normally associated with the use of a tobacco product such as the fact that smoking causes ninety percent of all lung cancer deaths eighty percent of all deaths from COPD and leads to stroke and coronary heart diseases all tobacco products present inherent risk to the public health and no

tobacco product even if manufacturing full compliance with this proposed rule is safe for the individual nor will compliance with this rule establish that a product is beneficial to Public Health in any way therefore it's important for FDA and tipsac to be careful about how it describes the impact of this rule the agency must avoid any any implication that products manufactured in compliance with this rule are

thereby safe or benefit the public health turning to some of the specifics FDA FDA proposes to require all tobacco products to have a unique identifier code that would establish traceability for that product's components Parts ingredients and additives which would Aid in investigations related to complaints and non-conforming products I want to take this opportunity to remind FDA that section 920b of the federal Food Drug and cosmetic

act creates a statutory obligation for the agency to implement a track and Trace system to help prevent and enforce the get the enforce the law against the illegal market and tobacco products as detailed in a 2013 citizen petition submitted by various Public Health officials and organizations urging FDA to adopt such a system track and Trace would help the agency to identify Contraband products including those not

in compliance with tobacco product standards that would also help establish at what point in the distribution chain legal tobacco products are unlawfully diverted into the legal Market if is the proposed rule provides FDA will require products to have these unique identifier codes the agency should consider designing and implementing the codes in a manner that could also accommodate a track and Trace system that gives the government

meaningful and ready access to information needed to detect and investigate illegal diversion next I want to touch on the implementation period under the proposed rule manufacturers would not have to comply with the rule for the first two years after it's finalized and small manufacturers would receive four additional years for a total of six years to comply with the rule proposing two full years until the final

rule becomes effective is too long at the very most FDA should give most manufacturers one year from when the rule is finalized to comply and five years for small manufacturers that would reasonably align with the one-year default implementation period the Tobacco Control Act establishes for product standards and indeed compliance with the proposed manufacturing requirements should be less burdened some of them compliance with the product standard

particularly because as FDA notes inspections have demonstrated that a number of Manufacturers have already implemented many of the measures proposed here additionally many of the requirements FDA proposes here based on industry recommendations thus manufacturers should not need two and in some cases six years to comply with the requirements proposed here finally enforcement will be critical to ensure that the public benefits from the standards set out

in the proposed role in certain critical ways FDA has failed to vigorously enforce the Tobacco Control Act and that lack of enforcement has undermined the public health benefits of the statute and of fda's tobacco regulations for example a plethora of products including youth appealing flavored e-cigarettes remain readily available at stores across the country even though they lack the pre-market authorization orders that are required under the

Tobacco Control Act FDA must avoid making the same mistakes here and must actively enforce these manufacturing practice requirements from day one and before I conclude my remarks I will mention that we um the campaign for tobacco-free kids also submitted written comments on May 11th to the docket for your consideration so with that I will stop and thank you to tip sack and FDA for the opportunity

to speak today thank you our next speaker is Andrew Pearl hi can you hear me yes great hi uh my name is Andrew Perot I'm representing cigar rights of America we appreciate the opportunity to make these comments to tip sack as you review fda's proposed tobacco product manufacturing rule CRA is a national advocacy organization dedicated to protecting the interests of consumers retail tobacconist suppliers Distributors importers

and manufacturers of premium cigars the proposed rule would establish requirements that the FDA asserts are necessary to protect the public health while the rule claims not to press prescribes specific mitigations the text of the Preamble makes clear that FDA expects all manufacturers to adopt water soil pest temperature and humidity controls and mitigations these implied requirements are simply not supported by the scientific literature cited by the

agency fda's scientific analysis suffers from numerous flaws that fatally compromise the rule the agency fails to adequately analyze the potential hazards and risks that manufacturers should consider it completes product categories strong inappropriate inferences about fundamentally different products and it fails to demonstrate that there are population level risks from premium cigar manufacturing to Public Health further FDA bases its standards on pharmaceutical regulations and fails to provide

a scientific rationale for why this is more appropriate than agricultural mitigations that it has adopted in the recent past CRA believes the proposed rule fails to demonstrate that the majority of the described risks are applicable to premium cigars nor that the proposed mitigations will meaningfully protect the public health as such we ask that premium cigars be specifically Exempted from the requirements of the rule unless the

agency can demonstrate that they would result in improvements to human health tips act should determine whether FDA has provided adequate Hazard and risk identification for issues that the agency would require premium cigar manufacturers to address in its experience with produce safety FDA clearly identified links to human illness caused by microbial contamination both numerically and through extensive qualitative risk analysis these analyzes identified the specific pathogens that

result in illness routes of contamination and methods of control all these were supported by scientific analysis fds made made no comparable effort to support or justify its proposed requirements for premium cigar manufacturers it cites no cases of illnesses linked to the category and any suggested links are tenuous at best for instance the proposal extensively discusses aflatoxin as a potential Hazard that cigar manufacturers are expected to

mitigate through water temperature and humidity controls the supporting scientific document documentation for the agency's assertion is a single study conducted on chewing tobacco in India but does not link to actual illness and ignores significant difference in in patterns of use and risk exposure between tobacco chewers and premium cigar smokers similarly although fda's proposal would nominally allow manufacturers to assess their own risks the Preamble makes clear

that some Provisions such as potable water quality standards would apply to all manufacturing practices generally in the case of potable water requirement FDA cites potential contamination with E coli bacteria as the hazard that's being controlled but provides no evidence of illness resulting from this contaminant on premium cigars or otherwise even the foundational documents on Tobacco regulation that FDA cites such as who's white paper on the

scientific basis of tobacco regulation provide little support for the agency's proposal it does not specifically examine premium cigars as category nor does it identify manufacturing hazards that premium cigar manufacturers could usefully mitigate we also note that premium cigars have fundamental characteristics of manufacturing that may mitigate many of the hazards potentially identified by FDA by definition premium cigars don't contain additives and are composed solely of holy

whole leaves fundamentally this is unlike other tobacco products that ensure consistency by pulverizing and mixing multiple batches of leaves together which might spread potential contaminants in a way that would not be possible with premium cigars premium cigars also rely on extensive aging and drying of the leaves as well as an extended fermentation process typically these processes last from 6 to 18 months and while we're currently

seeking more data both of these processes likely significantly reduce potential impacts on human health because of these unique characteristics we believe that any requirements imposed by FDA on the category should be scientifically demonstrated um with available evidence recently the Reagan Udall Center was asked by FDA commissioner Robert Calif to review CT peace operations the center's independent review found that ctp's transparency on sporting science was insufficient

and in response FDA is recommitted to transparency on scientific matters this proposed rule however does not demonstrate that commitment to putting science first and we asked tip sack to review our full comments and to make appropriate recommendations on supporting fda's requirements with sound science thank you are there any unscheduled uh speakers for the open public hearing session foreign okay everyone if um we can uh return

to our seats we're going to resume the meeting at this time thank you gonna move into discussion amongst the committee and we're actually going to start um by allowing the committee to ask any clarifying questions um of FDA and so if you have a question please raise your hand Donna thank you Donna Austin um so my understanding is that this rule the proposed rule applies to

manufacturers and not to retailers and so my question is on some of the um the storage provisions do those end at the time when the the product goes to the retail Market uh yeah thank you for that question Dr Upton uh yes correct uh the storage requirements would only apply to manufacturers and any distribution of the products under the manufacturer's control so once it leads the

manufacturer's control then the proposed tpmp requirements for storage would then not apply to other entities such as retailers Adam Levin ball question I have a question the 350 employee threshold to determine small business what was the rationale for that particular number and why focus on employees uh instead of other potential metrics like number of units sold thank you for that question Dr Leventhal the food truck

and cosmetic act defines what is considered a small tobacco product manufacturer so the statute defines that criteria as being 350 employees or less the FDA notes that that number includes all entities under the control of a manufacturer so if there are kind of multiple facilities or subsidiaries under a manufacturer those employees would be counted under to determine whether that manufacturer is considered a small tobacco product

manufacturer thank you so Adam levable with a follow-up question um is there any requirements um with this rule to use that particular definition um of small manufacturers uh that criteria for small tobacco product manufacturers as defined by the statute would determine the the other statutory requirement for the additional four years for a small tobacco product manufacturer to comply with a regulation uh with a proposed tpmp

regulation that that takes into effect does that answer your question it doesn't my question wasn't about the rule but um you mentioned that the definition of small manufacturer came from I think you're saying the either Tobacco Control Act and so my question is I is there flexibility in terms of maybe using alternate definitions for this particular role or not necessarily even using I guess small versus

large business when thinking about implications for the uh the timing of requirement for compliance FDA welcomes a tip sacks recommendations about about the the size of Manufacturers and we can take that into account to determine if there is a way for us to consider that in in that line um you know the question I think is tied to the extra four years and so um I

have a question in that can um can all manufacturers fall under the the same rollout period with small businesses applying for an extension through a variance instead of universally allowing all small businesses automatically to to get the extra four years um Dr donivo if I understand your question uh is whether all manufacturers can uh whether they can be taken into account for the extra four years

that the statute provides for small tobacco product manufacturers is that correct I guess I'm trying to figure out is is the is the carve out for small business required to have a different timeline and if it's not required can there be the flexibility that the proposed rule has in so many ways be offered to small businesses to apply for extensions through variants uh yes um the

the statute does require that small tobacco product manufacturers be afforded an additional four years to comply beyond the effective date of the final regulation with respect to your second question um the statutory requirement for petitions for exemptions and variances is afforded to all manufacturers subject to the uh the proposed regulation when it becomes final so that would apply to both small tobacco product manufacturers and non-small

tobacco product manufacturers Lucy papova a few questions but let me start with this easy one in the describing the risk assessment there's three determinations where you talk about acceptable tolerable and unacceptable but then in the text there's also not tolerable it's not tolerable and unacceptable essentially the same thing or those are different uh thank you for that question ma'am so the proposed design and development controls

would require a risk assessment and and to address risks that either the manufacturer determines to be unacceptable or that rises to to the level where it would be a reasonable probability of of um author review the specific language but it's a tie to the mandatory recall provisions of 906 excuse me 908c and so um uh and so if if the proposed terminology of uh not tolerable

or unacceptable uh is not uh clear then we would uh welcome any recommendations that the committee has on on that term yeah my I was just thinking it wasn't clear I just you just use unacceptable consistently in in the rule okay thank you and can I do another one um since we're on the design verification and validation could you clarify whether it would apply to the

products on the market that have been on the market prior to February 2007 or it exempts those products uh yes the proposed requirement for the design and development activities for verification and validation if if I recall uh FDA proposes that that not apply to tobacco products currently marketed so it would only be a Ford looking requirement once the once the tpmp regulation becomes final and effective

Matthew Brenner are you online can you hear me yes we can okay I'll just chime in then if I'm going to answer a question moving forward I just want to go back to the previous question about the date and the prior um the products that would be applicable to this rule so can you provide the justification for accepting the products prior to the February date 2007

sorry um are you referring to the last question uh relating to design and development and the verification invalid yes I am I'm sorry okay thank you so uh so that requirement would uh the proposed requirement would apply to tobacco products uh that undergo design and development activities um after the effective date of the final Rule and so it's FDA is not proposing to tie that to

um the February 15 2007 date just to make sure that I'm clear so what I what I think I hear you're saying is it's products moving forward correct but my question becomes what is the justification of the rationale because these products are still being manufactured the ones that were prior to the state right so what is the justification of the rationale for accepting the products before

the date um among the considerations uh was uh was to not require manufacturers through retro respectively recreate or or create their verification validation activities that may not be in existence and so the uh the thinking was that once the tpmp rule becomes effective then any design and development activities that uh that occur uh would have to comply with those requirements including verification and validation thank you

minion guy so should this proposed rule occur right um how does FDA intend to communicate to the public the differences between the products you see to say the dates the differences between the products posts I'm sorry I'm horrible States Post February 2017 correct um 2007 see I'm bad with Dave my husband won't tell you that and and free can you please tell me how they would

actually communicate the differences between these what what products are falling under this umbrella and and not or has there been any kind of consideration about how we communicate that to the public so the February 15 2007 uh date um uh any products before that would be considered pre-existing tobacco products and uh the Tobacco Control acts pre-market authorities um would would apply to those products that are

commercially marketed after those dates however all tobacco products that are commercially marketed uh including pre-existing tobacco products would be subject to the tpmp regulation once it becomes final so if I can make a clarifying point so the the questions regarding this have to do with the design and development and that is not applied here to the pre-existing products because they have not gone through a pathway

to Market with FDA is that correct Also to clarify uh the uh these pre-existing tobacco products that were on the market prior to February 15 2007. uh they would not be required to um to document their verification validation activities under the design and development uh proposed requirements however after the effective date of the final tpmp rule uh if they undergo for example modifications uh to their

product then moving forward they would they would have to comply with the uh but with the design and development activities including verification and validation Dr Johnson the Scout so I'm trying to understand what labeling would look like under this and since there's so many references to other uh rules within it I think it gets a little confusing but I'm very interested in trying to make sure

that there's some level of uniform uh and well understood by people with low levels of Education indication of nicotine levels so can you first of all also tell me has FDA done research on what is easily understandable as far as a nicotine level considering some of the comments that we've gotten about the confusion related to some of the ways that it's currently displayed and then describe

what we would be seeing if this goes into effect related to nicotine strength labeling on the different types of products and is it up to each of the different manufacturers how they display that or would it all be uniform be proposed tpmp regulation does require that all approved labels labeling and packaging that are that can be used on a tobacco product be maintained in the master

manufacturing record uh and the other records such as the packaging and labeling controls and the production record will help FDA to verify that what is actually uh the labels actually used on the uh commercially marketed tobacco product uh is in fact what what has been approved by the manufacturer for use but with respect to your specific question about whether how these for example nicotine levels are

displayed and how labels are understandable the proposed tpmp regulation does not require any specific format or display of those materials and as mentioned tpmp is intended to Implement other ctps authorities and so those labels for example may be reviewed in a pre-market application or notice answer that could be a consideration taken into account under ctp's pre-market review so just to clarify then that means that for

example the types of labeling that has already been brought up that has been proven to be confusing to Consumers uh could be perpetuated if anything even potentially you know um maximize if it's mislabeled or if it's confusing and that would be up to the specific product manufacturer in all those cases which which type of labeling they use uh yes the uh proposed tpmp regulation uh does

not propose to define or require the specific format or display of labels but we certainly welcome tips acts recommendations on that particular issue so if that is a is a public health concern we welcome your input we have a question from or a comment from Dr George online um thank you uh I would like to return to the Dr uh upson's question about the applicability of

these rules to a manufacturers or retailers um that's not still but not very clear to me um especially since the rules in several sections State expiration date some for uh components of tobacco products used during manufacturing but also for finished products like at ends that need to be specified and determined by the manufacturers I would assume that these expiration dates actually apply to the retailers otherwise

it would be possible if these are just internal for manufacturers that a manufacturer could wait until the end of their internal expiration date and send them is soon to be expired product to the retailer because there the expiration date does not apply I would appreciate clarification there um the second thing I would like to uh uh second uh Scouts comment about the labeling um I would

urge FDA to implement more stringent standards specifically also since nicotine levels in ens products often are not reflected on the labels or they are very strongly Divergent um and uh the question of labeling for synthetic nicotine is is not being indicated mentioned here at all thank you uh so let me first address the the second question about the labeling uh if uh if the committee has

any recommendations on any specific requirements for labeling uh then a CTP would certainly welcome those recommendations with respect to the first question about expiration date and my understanding the question uh being whether an expiration date is required or should be required um I mean throughout the rulemaking document the term expiration date is mentioned um that uh these should be considered for components during manufacturing but in

in other sections um they are mentioned in the context of finished products for example here additional requirement for stability tests to determine appropriate storage conditions and expiration dates for finished ends products uh right so um this this then refers to a finished product in contrast to expiration dates let's say for flavor chemical or a batch of tobacco being used so I I would assume the the

first for the finished product really applies also to an expiration date for the uh on yeah for the retailer not not just for the manufacturer am I correct this is Matt Brenner if you can hear me online um to answer your question on scope the the proposed requirements uh applied to Tobacco product manufacturers not retailers so um and that includes your comment on expiration date I

I would also like to add that for your question about expiration date for components for manufacturing uh tpmp's proposed requirements uh for purchasing controls and for acceptance activities uh that that would be something that manufacturers would have to assess and establish any requirements that may include expiration dates for the components that they receive for further manufacturing so that's how tpmp would address that aspect of the

question um a tpmp the proposed tpmp requirements does not specifically require an expiration date but certainly for example if that is a specification that is what uh CTP authorizes in a pre-market application or notice then then that should also be established as a specification under the master manufacturing record requirement as well so also if they manufacturer establishes their own specification for an expiration date or shelf

life then that also should be taken into account in the tpmp proposed MMR requirement thank you I want to add Adam Adam 11th Paul so uh going back to the question about the products that were on the market prior to February 15 2007 and that the the the draft of the rule that we're discussing today um would exempt those products from the proposed requirements for design

verification validation design approval and design transfer um does the FDA already have information on each of those products that are consistent with the type of information [Music] that would be required for new products um in terms of pmtas mrtps and the rationale behind that question is because if the FDA doesn't have important information about these pre-existing products in relation to design verification validation design approval design

transfer and other aspects related to the manufacturing process how will the FDA confirm that they meet these standards that are outlined here for the protection of Public Health and also how will the FDA confirm whether a product may be varying from those specifications and be considered a non-compliant product and in relation to that question if not should that part of the rule be removed to remove

that exemption thank you so are you presented quite a few uh aspects to your question um FDA um does currently inspect manufacturers particularly domestic tobacco product manufacturers and as part of fda's inspections the agency does collect records of manufacturing any available manufacturing procedures and documentation that manufacturers currently maintain however the agency has observed that there may not be consistency and certain manufacturers may not maintain all

of the procedures and records that the proposed tpmp regulation covers and so to the extent that those records are available FDA does um evaluate those to determine for example whether there have been uh any modifications to those products um but to the extent uh that tip Sac has any uh concerns and recommendations about uh about the proposed requirements and any potential public health concerns about whether

certain records that the proposed tpmp um requirements don't cover for example uh your your point about a pre-existing tobacco products and um and their verification and validation activities as an example then CTP welcomes your recommendations as to whether the agency should reconsider um not having those uh verification and uh the design uh verification and validation records to not apply to to those products before the effective

date of the proposed excuse me of the final regulation thank you for the clarification Adam levinfall that appears based on the information I have that I would recommend that that exemption be dropped for the pre-existing products prior to 2007 February 15th I have a question regarding Dr York's a question about expiration dates um and it was in the registry it mentions that that actually the industry

recommended stability testing to determine storage conditions and expiration dates for finished ends products and we've heard testimony that there's increased contamination over time of e-liquids and that the nicotine levels vary over time and so I'm wondering what the fda's rationale is for not including expiration dates uh one consideration was the umbrella approach that FDA took with this regulation uh to propose requirements that would apply to

all tobacco products and all different types and categories of tobacco products uh and so that was one consideration for for not including the industry Industries proposed GMP requirements that included um expiration dates and stability testing however if if the committee feels that this requirement is important and is relevant to all uh tobacco products then we welcome your input and recommendation on that thank you Risa Robinson

so the proposed rule defines a component as software or part of as a sen or as an assembly of materials and my question is referring to the software is that are you talking about computer code you're talking about source code um simple algorithm or or what what is that referring to the software uh that's the definition that CTP defined in the deeming regulation and and um

and I don't believe that the definition uh specifically addresses uh your question about whether it goes down to the source code of the software but if the committee feels that that is a relevant and important for the proposed tpmp regulation to cover with respect to components and parts we welcome your uh your input on that tobacco products understanding that the way it's currently written it's the

um the design and development components that that is being Exempted is that right um I want to actually add a question about the labels themselves um for the pre-existing products because these are products that manufacturers use as their predicate presumably for substantial equivalence applications and so with respect to the labeling um what if anything would would that be included in the MMR and if there were

changes made to the label would that result in a pre-existing product being adulterated or misbranded so I would say that the proposed tpmp regulation and the requirements for example for the MMR to contain all copies of approved label labels and packaging to be maintained uh that that is is a forward-looking requirement once the tpmp regulation becomes final and so the situation that you described uh can

be would not necessarily be addressed by by tpmp and the labels labels labeling and packaging that a pre-existing tobacco product has used and whether that changes over time ctp's other authorities may be able to address that for example uh registration and listing specimens of of label label labeling and packaging are required to be submitted to FDA answer the agency may have information or copies of of

the labels for pre-existing tobacco products but um but the proposed tpmp requirement would not require that manufacturers uh would not necessarily require documentation of of of the pre-existing tobacco products labels that have been historically used so for products that were introduced after 2007 right those that are not pre-existing that have received um marketing authorizations if those labels change are those products then considered misbranded or adulterated

uh that is uh something that the proposed tpmp requirements itself doesn't address um but but if uh CTP becomes aware of um of any labels that a pre-existing tobacco product uses either through registration and listing or through what's collected on inspections if those are adulterated or misbranded then then CTP can take enforcement action as appropriate Alberta Alberta bicente um I have a question and then followed

by two comments one question is um will the manufacturers be required to have a Tracker and tracing system so in case um there's a recall be easily identifiable identifiable to recall for recall and then the second is the I'm in favor of having labels with expiration date and then a standardized language for consumers so they'll understand because it's really hard for you know it's just the

the labeling is very confusing especially the content the concentration of nicotine products so it'll be important to include that as well [Music] so with respect to your question uh PM the proposed TPMT does propose to require that manufacturers establish a unique identifier for all components and parts that they that they receive and that are used to manufacture a finished in both tobacco product and that unique

identifier would also be maintained in the production record and so the the intention is to be able to trace all incoming components and parts as well as the uh the distribution of the finished and bulk tobacco product from the manufacturer however the proposed tpmp requirements does not establish a specific system for for track and Trace so so it's really something that is maintained through the proposed

records under tpmp Johnson yes I'd like to go back for one second to the issue of labeling and specifically the concentration of nicotine and e-liquids what is the fda's proposed process for reviewing and authorizing variances and tolerances for those because obviously no manufacturing no manufacturing process produces exactly the same material at any given time so there has to be a process by which you define what

is an acceptable level and have that has that been considered at this time this is Matt Brenner from the FDA I just I appreciate your question I at this time I I believe that that question is outside the scope of the proposed tpmp rule um we don't discuss concentration of nicotine on labels uh when we talk about the packaging and labeling section of this proposed rule

um and while we appreciate the question uh and and understand the concerns around nicotine levels um we believe that it's outside the scope for this discussion I'll add that um while I uh concur with Matthew's response that the proposed tpmp requirement uh does require that the manufacturer establish specifications for their tobacco product in the MMR and the specifications would also include any acceptance criteria for that

and and in turn through the other records such as acceptance activities and the production record that if the product does not meet the established specifications and acceptance criteria that would be considered a non-conforming tobacco product just as a follow-up to that so basically what you're saying is is that during the production of the master manufacturing record the process will be evaluated by the manufacturer they will

establish the specification the tolerances and the variances associated with their process and that is what the agency will use to base their decision upon uh yes uh and and that is uh and let me also clarify uh that that as tpmp is intended to implement uh ctp's other authorities such as pre-market review that is expected that uh the product specifications um that is documented in the

MMR and reflected in the other manufacturing records are consistent with what is submitted and authorized by FDA in its pre-market review um yes if I may go back to the records it's could you clarify for us how can public if ever will be able to access this information so throughout the rule it says manufacturers will be required to keep records of all activities related for each

provision so the records will be there does could you explain will FDA have to proactively request those records and will the public then have to go to the FDA for the records or just in general like how can the public be informed uh yeah tpmps proposed uh Records uh the those records uh must be uh readily accessible for FDA uh to uh to evaluate um and

and uh FDA will evaluate those records during inspections um but uh the proposed tpmp regulation uh does not propose that those records uh be uh be otherwise reported to FDA or otherwise disclosed this is Matthew Brenner out and also add that if the community has any recommendations on the maintenance of Records around this proposed rule well we certainly would encourage um any information that you want

to provide around around that as well is it fair to say that the agency would apply the same rules for protection of trade secret and confidential information around this rule that it does around everything else uh yes the uh the FDA does have uh requirements and obligations uh to protect to protect commercial confidential information and that would also apply to uh the tpmp proposed requirements and

Records Donna Upson does the proposed regulation cover all products with synthetic nicotine when I was reading it it said tobacco products containing synthetic nicotine or non-tobacco nicotine would be included but I want to clarify that all products containing synthetic nicotine would be covered unless of course there are some FDA approved pharmacotherapeutic agents that contain synthetic nicotine uh yes uh the proposed tpmp regulation would apply to

all FDA regulated tobacco products including non-tobacco nicotine synthetic nicotine that are currently under cpp's jurisdiction so just because I know that FDA has the authority to to regulate synthetic nicotine but when you say tobacco products containing nicotine synthetic nicotine is that everything containing synthetic nicotine or does it have to have some tobacco component to it uh yes the recent legislation did provide CTP the authority to

regulate all tobacco products that contain tobacco derives from any source so that would include non-tobacco nicotine synthetic nicotine and so the synthetic nicotine does not necessarily have to contain tobacco derived nicotine Adam Levin ball so a couple of comments to get some reaction to the FDA and the other tipsac members so so first off um it's worth reconsidering the staged rollout with that four year [Music]

um additional allowance and the cutoff of the small business being 350 uh as a definition and the reason why is that it's it's understandable that you know a smaller businesses may need more time to establish the practices to comply with with this regulation at the same time the idea of having a uh a deadline for compliance is is to protect the public health and so it

may be that companies that meet this definition of a small business May in fact have the capacity to widely distribute products and um in that case those companies May be manufacturing products that would be non-compliant and potentially have many of the different types of health risks that are described here so um it's recommended to reconsider that and to consider maybe even a different process there may

not need to be a binary between small businesses and um non-small businesses there could be multiple stage dates that would be dependent on the protection of Public Health and the likely number of different types the number of tobacco product units sold and the potential population health impact it was a long comment but I want to explain the rationale and then one additional comment um is there

was some discussion about the specific parameters I think about nicotine um it's understood that the umbrella process was utilized this framework right because every different type of tobacco product may not fit the same type of manufacturing um um the production uh criteria and needs um it may be worthwhile to consider putting a guidance for manufacturers afterwards um to provide um recommendations about certain components that the

manufacturing process so just for an example I think nicotine concentration is mentioned pH is mentioned as examples I think and it places like quite a bit of burden on the manufacturers to have the scientific knowledge and people on staff to be able to determine what scientifically valid not only tasks but also I guess metrics you know would be needed to for the manufacturers to even look

at quality control and whether there is a a deviation from their intended product so so in addition to the types of information that would be needed which would differ across different products I think another related component of this uh issue is the idea of the statistics required to identify what is a trend um where there may be a unacceptable number of products that are being manufactured

and that are not compliant with the intended um characteristics of the products and it's understood that you know clear numbers could not be provided here in this umbrella rule but to follow up in in terms of a guidance it may be helpful again especially for manufacturers that may not have scientists available on staff who can review the scientific literature and apply those types of principles thank

you uh thank you for that comment um uh an important aspect of ctps uh regulation is education and Outreach and CTP is committed to uh to providing the resources for manufacturers to understand how to comply with the final regulation and so uh the center uh is considering and will plan to have education and Outreach materials including for example a small entity compliance guide to provide guidance

to manufacturers on how to comply with the final regulation if there are specific issues and topics that the committee feels that guidance or other education and Outreach materials which may include webinars for the agency to address we welcome those recommendations this is Matt Brenner again and following up Dr Leventhal thank you for your two comments um if there are specific recommendations that you have around uh

the small manufacturers and the additional compliance time uh we or I I recommend [Music] that you um submit them I also would would add that section 906 E1 B Roman at 5 requires an additional four years for small manufacturers following the effective date of the of the final rule so around any of those recommendations I would just also keep in mind that requirement that FDA has

hi Risa Robinson this question is related to the workflow process when different companies are involved in the life cycle of the product and the proposed rule refers to specification developers and my question is does the responsibility lie with the contractor or with the small ends company you had referred to that in your presentation that in some cases you had small companies who are developing ends and

they would contract out so I'm wondering does the responsibility lie with the small company or does it rely with the contractor foreign it would depend on on the contractual uh relationship and what the uh in your example the small manufacturer is um is tasking the specification developer uh to do but certainly so for example uh that would be covered under tpmp's proposed requirements for purchasing controls

and and how a manufacturer deals with their with their suppliers and so and so to the extent that a manufacturer establishes certain requirements or parameters for the specification developer to meet then that would be something that would be the um the responsibility of that manufacturer and thank you um I would like to refer to the issue of uh pesticides that are being mentioned here as as

potential contaminants of uh tobacco products uh due to exposure from uh the manufacturing side where these are used to combat paths also sanitizing agents are are included I'm strongly supportive of this because um this this can lead to significant exposures and it's it's not much known about what happens when these are actually combusted I would like to add a few other components that might be introduced

accidentally uh in in into tobacco during manufacturing for manufacturing and this this includes lubricant lubricants that are used in in the equipment some of them are are quite toxic then they are adhesives Plus sticks that are used in packaging or um even yeah for the raw product and plasticizers contained within plastic and and also metals that can be introduced during Manufacturing um that's my recommendation thank

you uh thank you for for that recommendation uh I do note that uh the proposed tpmp requirements uh do cover manufacturing materials uh and uh and so the manufacturer does have to consider and make sure that manufacturing materials which may include for example lubricants don't otherwise contaminate the tobacco product that's being manufactured and also under packaging and labeling controls that that the manufacturer does have to

consider packaging materials that that that that those packaging materials don't contaminate or otherwise adulterate the tobacco product manufacturing record so is it true to say that you know at some point FDA is input into the master manufacturing record through primax sorry so uh my questions are about manufacturing records is it true to say that FDA has input into a manufacturing records through pre-market tobacco product applications

because basically all the information which is containing in a master manufacturing versus something which FDA is using to review the applications it shows you know how the product is manufactured whether we have the right processes and controls in place and therefore you know if there are some kind of uh question from FDA and FDA reviewers and they might be having input into Mass manufacturing records and

only after the product is authorized the manufacturer can consider the master manufacturer to be finalized uh so as as mentioned uh the product specifications that a manufacturer needs to document in the master manufacturing record FDA expects that that those specifications are consistent with what is submitted to FDA and reviewed and ultimately authorized in a pre-market application or notice um also as you know manufacturing information for

example is required to be submitted in a pre-market tobacco product application pmta and certain manufacturing information May otherwise be a part of ctp's pre-market review and so there is that interrelationship between what FDA reviews and what needs to be documented under tpmp's proposed records so in case the FDA see some kind of issues with for example process qualification or validation verifications they would be uh asking

manufacturers during the pre-market review process and through for example deficiency letters to address those kind of inconsistencies before the product is authorized uh yes and uh but if the committee has any other thoughts or recommendations to to make sure that what is reviewed and authorized that that information is accurately and comprehensively addressed and documented under tpmp's proposed requirements we would welcome your thoughts on that to

the point of of Flyers the proposed regulation mentions under process controls that manufactures you know would be responsible for for the suppliers and it mentions that the tobacco products are from qualified suppliers um who who determines those qualifications and and how do they determine if they're met especially as you mentioned that some contractors are you know for example um for ends coming in China uh yeah

so uh tpmp does require through purchasing controls a process for the manufacturer to evaluate and qualify the suppliers and part of that is to ultimately that's to make sure that suppliers provide the components and parts that meets the requirements and specifications established by by manufacturers and so that is really the ultimate responsibility of Manufacturers because if suppliers provide components and parts that don't meet specifications uh

that may result in a non-conforming tobacco product under the proposed cpmp regulation and the other proposed requirements for example acceptance activities also provide additional processes for manufacturers to to to ensure that what they actually receive and use in the manufacturing of their tobacco products meets their established specifications hi uh D kitner from CDC I wanted to ask a question about the effective date I heard that

there was I heard that you all said that there's a four-year requirement for the small manufacturers but for the two-year effective date is there any legal or legislative reason why you can't diminish the two years to one year I would recommend that it be one year in the interest of Public Health thank you for your comment Dr kittner yes the compliance date is set in statute

that small tobacco product manufacturers have an additional four years after the effective date to comply with the final tpmp regulation uh CTP proposes a two-year effective date but that is not required by Statute Adam Leventhal um some I have a comment and set of questions about um consumer complaints um so one uh comment is the FDA may consider making either as a guidance or maybe amending

this rule if a when a complaint is um provided to a manufacturer that the manufacturer receiving the complaint um provides the consumer with information to either the safety hotline at FDA or some other mechanism to ensure that the consumers are educated and that if they wish they can take the information directly to the FDA number the second comment and um point is the when a complaint

um is provided by either a consumer or by a health professional or some other individual [Music] information and guidance to the manufacturers about whether a complaint indicates an adverse event or some sort of Public Health concern that meets a threshold that would require the manufacturer to automatically notify FDA and the and I don't know exactly what that would be and I know that we'll have time

for the committee to discuss what those might be but um certainly if there is some sort of a um an unexpected health risk associated with a product being used and um that information does not get transmitted to the FDA immediately then of course that puts the population Health at risk and so allowing whatever standard types of the timing of reporting and accessing those types of Records

is required to be reported to FDA under a regulation that FDA has to promulgate under Section 909a those uh complaints need to be investigated and so uh FDA this has not yet promulgated a regulation to Define uh which adverse experiences are required to be reported to FDA however the proposed tpmp requirement would require that any adverse experiences that relate to a non-conforming tobacco product or any

complaints that relate to any product design issues those do need to be investigated I'll also point out uh and and we certainly kind of welcome your comment and recommendation on this that FDA does have a safety reporting portal where any member whether it's industry the public or public health professionals can submit any adverse experience is to FDA through the safety reporting portal also CTP has a

potential tobacco violation reporting mechanism as well and so all of uh any adverse experiences that a a user a member of the public or public health professionals that they become aware of can also be reported to FDA through those mechanisms and um uh and uh uh we can certainly uh consider addressing that in guidance that the agency expects to develop and publish uh after the final

rule to help industry and the public understand uh the requirements of the final tpmp regulation I have a few more questions first Lucy then Risa and Andy Bailey and then we're going to move into formal discussion I think a lot of topics have already been brought up in the Q a and if there are questions that remain during the formal discussion those can still happen but

we do need to kind of go through what we've been charged for today to get to get through so Lucy mine is more a recommendation regarding the language throughout the tpmp there's language saying not risks not normally associated with the use of tobacco products and it's defined as those not inherent to risk my recommendation is rather than using normally everywhere that implies to people who read

that this is oh it's normal to have those negative outcomes so rather than doing this I would recommend using language that doesn't have the word normal so something that risks that are not inherent to tobacco use because you don't want to normalize those risks and throughout addressing the concern that has been raised about that this regulation doesn't mean that the products are safe every time the

risks are mentioned that are as Adam refer to them maybe unexpected health risk always bring up that those that are not and not just risk but repeating illness death and disease that are not inherently associated with tobacco use so just using the word normal potentially replace with inherent or some other wording even The Limited resource forcement in in the need to get in handle on the

electronic cigarettes I'm I'm curious um about the reasoning for including premium cigars in the proposed ruling giving them the several comments that we've that we've heard so the proposed tpmp regulation uh would cover all tobacco products that are regulated um by CTP but if the committee has any recommendations around the scope we would welcome your input on that yeah I just had one comment um in

the documentation it it mentions exemptions and if you can provide some clarity about the process for exemptions and the time frame allowed for applying for exemptions uh yes uh so exemptions and variances is a statutory provision that the uh dpmp regulation once it becomes final needs to incorporate those are those uh proposed requirements are covered under subpart J of the proposed regulation and that does establish

the proposed process criteria and timelines so for example it does provide tip sac and an opportunity to report its recommendations on any petitions for exemptions and variances there is a time frame that is included in the proposed requirements namely that tipsac has 60 days after the petition's referral to tip Sac to provide its recommendations and there are also proposed time frames for FDA to make a

decision to Grant or deny the petition which is proposed to be 60 days and there are also proposed criteria that the petition must include for tipsac and FDA to consider in making its decision on that petition for exemption or variance but if the committee has any recommendations or um or or additional thoughts on on the process the criteria in the timeline we would welcome that input

now we're gonna move are going to start with number four um regarding the committee having any recommendations on the proposed design and development activities and risk management process to control risks associated with finished and both tobacco products and its production processes packaging and Storage I think some of your questions I think Adam your questions about pre the the pre-existing products might might fall under this but

sure um so just as I mentioned that's that's fine thank you so Adam Leventhal um yeah as I mentioned previously [Music] for the protection of Public Health it does not appear that allowing an exemption for the products that were on the market prior to 2007 February 15th [Music] um is uh beneficial and so uh is recommended that that exemption for that component of the rule be

dropped and that be applied widely across all um tobacco products being marketed under the purview of the FDA and CTP I would support that as well and it sounds like this might be the section where we would also talk about a suggestion to have an expiration date on the products as well and another piece that we haven't brought up yet but was brought up in the

comments is uh the idea of the potential degradation of the products it's a little bit obviously more complicated to control Refrigeration or temperature or things like that but it seems like it wouldn't be as complicated to control the ideas they should not be made in transparent models for ends so that exposure to sunlight at least minimizes the risk of things like uh Benzene precursors so I

I would certainly suggest we add the expiration date sunlight exposure as well and I think maybe under one we would talk about the scope where maybe we could think about expanding it to some of the actual retailers I just want to add briefly to with expiration date we're talking we've been talking primarily about ends but there are also other products um smokeless tobacco as it sits

on the Shelf my understanding is tobacco-specific nitrosamines increase over time and so um I think expiration date is is relevant there as well and there are some manufacturers that are ready put a expiration date on their product this just follows up on the expiration date Scout mignon guy um so I I think that the question of expiration dates is important right but I think that equally

important is providing a providing guidelines or some parameters about the labeling and packaging specifically for these products right so my recommendation would be that FDA continue to work in in sort of the direction of providing very clear guidelines and parameters for the manufacturers that will include the expiration dates but in terms of packaging labeling and packaging and the information that needs to be provided to Consumers

because that that seems to be a part that's unless I'm missing it is missing um from this discussion but we're getting down to the level of detail when we're talking about specific um expiration dates this is Matthew Brenner I just want to ask a clarifying question to the committee members um for those of you that are proposing a required expiration date um do you have uh

recommendations around products um excuse me around the umbrella approach that FDA has taken and the proposed Rule and how the proposal would mesh with those products um that or those manufacturers that feel that their products do not need an expiration date um and how they would mesh together and then who would also determine um the expiration date and you know the criteria around it and any

sort of extra information would be helpful for FDA um in addition to your comments that you provided thank you I mean there's been a lot of discussion about ends specifically and so um that certainly would be one product that would be um that that could fall with an expiration date and I would say smokeless tobacco as well but not not my area for the other products

and what happens over time with those products but welcome yeah I was actually going to make the same point this is Lucy papova make the same point um Dr Brandon did um that if we do use the umbrella approach and allow at this stage all the manufacturers to do their own risk assessment and put those things in versus FDA coming up with the specifics for expiration

date or for clear plastic versus not clear plastic bottles that that gets us to the points like which way do we want to go and the question would be is there enough evidence currently to establish all those rules and I'm I don't know but in terms of the what is in currently in the in the policy would be in a proposed policy is to let the

manufacturers figure it out and then they were supposed to keep assessing that and if there is but I don't know if we need to so this is more of a question to everybody how we should think about it Maria yeah I think I would agree with agree with you know if you're trying to apply the umbrella Pro if you're trying to apply umbrella approach uh for

regulating uh through the tpmp all tobacco products they cannot try to be very specific for certain uh tobacco products you know there are definitely differences between across tobacco products with this traditional debacle products which are more agriculture have high variability compared to product which are more uh engineered and only using nicotine in tobacco products or devices you know so saying that now we can establish that

they shall fly across all products may not be necessary because for example device may not need to have a shelf life but at the same time know how manufacturers determines whether there is necessary having a show five or sell by date on on the packages will be through reinvestment if we are going to be seeing that you know the product is aging and changing over time

beyond the specification of the product that potentially could be triggering if again indeed is going to be increasing the houses of the product beyond the inherent risk of the product maybe there is requirement for establishing shelf life photo products but I think it should be a fit for purpose fit for the product which uh we are trying to manufacture NSL and also at the authorize I

like also to open it up to comments and discussion about question three regarding recommendations on the product specification that FDA proposes to require in the MMR well it kind of I guess overlaps three and four but I also would strongly concur with mignon around um the idea that we need to have a more consistent labeling across products which I'd really love to see is that uh

a that there's some research done and what kind of labeling is easily understood by low literacy and um you know priority populations and things like that but as well that we just see the same equivalency whether it's a cigar or an ends product or a carton of cigarettes that we get one visual clear label as far as how much of this addictive substance this product contains

um another Point related to that too is we haven't brought it up yet and I think it would be falling under these areas but um you know there's not a lot of uh danger of a child accidentally ingesting 12 cigars but there certainly is a danger of a child actually ingesting one amount of liquid that has the equivalent amount of nicotine and then going to poison

control and it was certainly one of the things brought up in the hearing as well so that being the case I would also strongly encourage the idea of child proof packaging on products that have high nicotine unengineered products that have a potentially toxic level of nicotine almost exactly what I was going to say so thank you yes um so right regarding the units of nicotine I

agree some kind of standardized units across all products which is like including a typical unit per typical use and I'm not sure what like where that's going to land yet but as well as total amount of nicotine contained in the in either in the bottle or in the package of cigarettes or whatever in case of accidental poisoning including um child proof packaging as Scout mentions warning

and warning labels that are shown and demonstrated not to wear off over time would you along with that I'm hearing uh a lot of comments about the the how much nicotine are in the are in the products and um a call for that to be clearly included in the labeling which may or may not be within the purview of this product standard um but along those

lines do folks have comments about whether or not those nicotine levels should be reported and required in the MMR I don't know if it's within the purview or not but it seems like we should be able to regulate how much nicotine can be sold in one container or manufactured and put in one container this is um Matt Brenner from FDA I'll just note that if a

um the agency establishes uh a tobacco product standard under 907. of the fdnc ACT then that would be required under um manufacturers established MMR so I think some of the comments are are on point and I think some some of it um would would depend if a tobacco product standard uh is is in effect Chris you just said something that just I thought that the MMR

included the nicotine levels right now did I get that incorrect oh oh yeah right exactly oh yeah exactly okay great is it varying into product standard language which is not Maria first and then then Lucy again I just would like to make sure you know we take into account have a colleague trying to establish labeling right now there is no label of nicotine content in a

pack of commercial cigarettes you know it would be very difficult to establish it and with the agricultural variability you will see uh by the variety and then the question would be what is the how does this information is helping to the consumers when you basically cannot put one number and you will have a quite wide range compared to products such as uh you know highly engineered

tabaconic coating containing product where you have full control of uh what you're putting it in the correct and therefore the specifications can be more narrower and those do usually uh show uh nicotine content on a on a peg so I just would like to make sure you know we take into account variability of the product and what is the intent of the label to communicate um

so I understand that there's like some question about like the scope of this Rule and the intention of the rule and um uh regardless of the idea of [Music] um putting in the rule recommendations or requirements about these different parameters we're discussing um um including you know like the the bottle and uh and whatnot uh I just want to reiterate that and I understand that new

products uh that go through pmtas or mrtps the FDA can establish those requirements at a product by product basis however for the products that were on the market prior to 2007 February 15th the FDA may not have that level of detailed information and I recommend that the FDA require the design verification and validation design approval design transfer and uh to those products so that way the

FDA can have a benchmark to understand whether a product is deviating from the intended the intended manufactured product and therefore maybe a non-compliant product and maybe a compliant that therefore I mean a product that therefore adds additional risk to the consumer above and beyond what is authorized by the FDA to be sold going back to the labeling for nicotine um actually we should be careful because

we don't want to go back to labeling of harmful constituents where people then go shopping for essentially you know all cigarettes are equally harmful but one might have less nicotine and people would go for this thinking or even comparing cigarettes to e-cigarettes and they're like oh you cigarettes has more nicotine so I would be cautious about uniformly labeling just the nicotine content and pasta research shows

like you don't want this comparative harm information in terms of grams and milligrams when it doesn't actually reflect the relative risks of the product but for I agree that for ethic for e-liquids and and products the the numbers of nicotine should be very clearly communicated in a consistent manner so people can make those judgments and I feel like milligram per milliliter might be the better way

because it kind of allows for bigger scale for them to look at yeah in terms of yeah sorry this is Lisa Posner from nhlbi um in terms of labeling the nicotine concentration especially for e-liquids I think um it's important to keep in mind whether the goal of that is um to know the risks of accidentally swallowing the nicotine for a child or et cetera Etc or

if the goal is to communicate to the user what kind of nicotine they are exposing themselves to because as we know the heat of the um the liquid is is heated to and the the the chemical you know whether it's nicotine salt or base these all factor into what you're actually exposing yourself to so I think they're both important things to keep in mind but we

we need to keep in mind what the goal is Donaldson thank you for that comment and I would recommend that our research be supported to find out more about the nicotine delivery of different devices we know that with when nicotine levels were altered with cigarettes that smokers Topography of smoking you know how frequently they inhaled How Deeply they inhaled how long they held their breath all

affected the amount of nicotine they were they were getting and it's much more complicated with ends so I would ask that there'd be more research supported to determine how that how that's affected thank you I would like to go back to to the design of validation verification for the product which room in the market before February 15 2000. seven uh so I just want to make

it very clear that the current tpmp although they don't require to recreate a design validation verification they still hold they still hold tobacco manufacturers to the assurance that you know manufacturers are developing product uh within uh specifications you know so they need to be still establishing all uh quality control and Quality Management Systems to ensure that all the incoming materials is appropriately uh processed uh the

the have a control over manufacturing processes and then the battery release criteria can demonstrate that the products are manufactured to the specifications so I think it's only the first piece where for the manufacturers when some of those products were designed decades even hundred years ago would be very difficult to recreate uh retrospectively but uh actual process and Manufacturing process of those products is definitely uh fully

would be definitely fully controlled and the products are developed to do specifications we're going to move to question two um regarding the umbrella approach that proposes requirements and flexible terms opening that up for discussion people getting hungry um you know I'll I'll start I mean I I think that um I think this was a hard document to put together and recognizing that there is a wide

variety of tobacco products on the market and that a one size fits-all approach doesn't um work um and so the flexibility in this document I think will um enable both the manufacturers and FDA to monitor good good business practices good good manufacturing practices down the line but I think to I think to Lucy or Adam before who made a comment about guidance to to the industry

and so you um and and so with with regards to that like if they're in in line with that um if there are any ways to also provide maybe um best practices or kind of model examples um of specific manufacturers that have put their um their practices together within within the required timeline um and along those lines also um I lost it it's gone it just

went um you know so I also made a comment about guidelines Chris but the question that I have related to the scope I I didn't quite understand the person who was on the call that asked something about the the umbrella approach and how it meshed with what we're doing I wasn't clear on what they were asking Matt Matthew Brenner yeah yeah I'm here I'm not sure

in what we were talking about in reference to the umbrella approach okay um oh I think it was just if you have more direct recommendations uh it was in sorry I have it in my notes here it's on regarding expiration date if there are particular recommendations that the committee has in regard to keeping in mind that we are using an umbrella we've proposed an umbrella approach

uh to to this for in this proposed rule um and we're covering all tobacco you know you know finished in bulk tobacco products under the scope if the committee has recommendations on how to incorporate both the umbrella approach and any recommendations they have around requiring uh an expiration date we would certainly welcome that you know just keeping in mind that we do have we are proposing

an umbrella approach around the rule so I think that's what I was you know my request was okay mignon um so uh Matt just to make sure that I'm clear because I I don't unders I don't see how an umbrella approach or the scope um precludes requesting or providing additional guidance for specific products or or categories of products or families or products so unless I'm missing

something I don't I don't see how that would how they would I think at one point you said how they mesh um I'm not I'm not sure how they how asking for these additional got this additional guidance or providing additional guidance would not mesh with this with this umbrella approach sure um well guidance I guess would be separate right from from requirements um so if we

are requiring something uh to all tobacco product manufacturers right um if there is you know additional information that you know that we have I think it would be helpful uh when making our requirements around a particular uh you know uh set of information like like expiration date right I know some um people uh on the committee have brought up uh uh different products that you know

warrant an expiration date and I think it would be helpful for us um to have more information around what products um you recommend to have one it's more like any information that you all can provide would be really helpful that that's all thank you yeah I'll also uh confirm that uh while um CTP took this umbrella approach uh there is nothing to uh preclude uh CTP

from considering requirements that may differ depending upon the type of tobacco product yes that's exactly what I was trying to get at thank you Emil y oh sorry I didn't understand um yeah I uh I'm glad to hear that there's this flexibility uh within this umbrella approach that that's good to know um I I was in in the queue for quite some time so I I

actually wanted to respond to some of the the earlier questions um especially also the labeling um so I have certain recommendations for labeling synthetic nicotine products um there there is a concerns and some of these products contain racemic nicotine such as S and R in equal amounts that consumers become confused about what the actual nicotine content is and and what effects this might have so so

this this should be really uh there should be a standard developer to label these types of products since they might be very confusing to the consumer um I also want to refer now to the risk assessment in in product design what I really appreciated was that that FDA mentioned that this even extends to the design of the shape of the products or varieties such as lozenges

that might be considered candy by young children and they they could poison themselves yeah using uh ingesting ingesting them by accident if they are just lying around so I I would ex like to that that these criteria are being extended to product design for example also of of ends um all many of these new especially the Disposable products they they resemble brightly colored toys or biting

and chewing aids for babies and toddlers or computer parts or any other household products and uh there is in my opinion a much higher risk associated with these for being used by young children and and resulting in poisoning so I think these type of uh risk assessments should also be done for ens thank you Johnson yes with regard to the synthetic nicotine I think it's important

to realize that a racemic product is very different than a bioequivalent product which would be an S nicotine and there are synthetic excess nicotines that do exist that are chemically physically and biologically equivalent to tobacco-derived nicotine and should be treated as such racemic there is some question because the high levels of R does not have the substantial database to be able to make an assessment and

so additional studies probably be required for those types of products I would think sure um so uh with regards to the overall umbrella approach one concern is that if the rule were to be amended so that it were product specific the amount of time that would take in order to make the rule final um that that could potentially put um you know the population at risk

so I know it may not be able to be um I guess uh um I don't know I know like a date probably could not come out for uh expected or required for an amended Rule and so therefore um given that you know the umbrella approach may work um and then accompanied with specific guidances that could be product specific and so I know there were some

questions about what what would the guidances say what types of um uh chemicals or tests would the guidance say that manufacturers should test for in order to ensure that the products being manufactured were meeting their intended and um I think it's too difficult for us in one meeting to provide a comprehensive list um and so I think that a follow-up to this meeting that includes you

know the scientists from the FDA and other potential scientists to provide more information but it seems that as already stated in the rule we have uh considerable data on ph nicotine concentration Chris had mentioned uh tsnas right and so there are some that um I would assume that the FDA scientific staff would be able to you know immediately put out in a guidance um and uh

the other issue I wanted to raise is that um you know we get new scientific information all the time about about risks that we otherwise wouldn't know and so that um a um a general procedure of the FDA to look at that guidance and update it on a uh a regular basis based on how the science accumulates and we identify new constituents that could be hazardous

that are being seen in these products would be important so therefore of course the manufacturers can test the products for those types of constituents we're going to move into now the first question um some of this we might have already captured in um earlier discussion in the Q a but I want to reopen it up about any recommendations on scope including expanding the scope the one

kind of consistent comment that I've heard thus far is that the pre-existing tobacco products should not be excluded so if folks have any comments beyond that particular one um let's let's hear it um just going back to the retailers are currently not included but I think something should be said if there is expiration date that is put either by the FDA or the manufacturers then and

that might cover under somewhere else but if not there might be just a piece about how that applies to retailers absolutely going to say the same thing yeah we need to make sure that if if there is an expiration date that there is a full cycle of compliance with making sure that expired products are not offered for public consumption which would pretty much mean that we

have to have the retailers engaged and then you know purview and checking on the retailers I also want to do someone have a question I was just going to also just open it up to question five um which are just additional um recommendations so any comments that individuals have about either expanding the scope or additional recommendations um I just I want to reiterate these comments about

changing the um length of duration for compliance to a um minimum of one year for all businesses and then um I'm a little confused about the requirements and for this four-year but assuming that there is no law that would prevent the rule from being amended perhaps a lower threshold like 50 employees might be considered and giving them a three-year timeline or something like that whereas all

other companies and manufacturers would have to meet the one-year um deadline for being compliant with the rule just a clarifying question I think for for a meal and that is the small business requirement that is in the Tobacco Control Act not this proposed Rule and you're bound by the Tobacco Control Acts definition of small businesses and the four year is that is that correct uh yes

Dr Don Evo uh the Tobacco Control Act has a definition for small tobacco product manufacturers which is the 350 employees including all entities under is control and section 906e which provides CTP the authority to promulgate this tpmp regulation also contains a statutory requirement to afford small tobacco product manufacturers an additional four years beyond the effective date but certainly your comment about the proposed two-year effective date

we welcome that that recommendation for clarification this is Matt Brenner on the phone again for clarification there's just a difference between the effective date of a final Rule and the compliance time frame to to comply with those requirements so right now we are proposing a two-year effective date for all manufacturers uh with a an additional two years for tobacco product manufacturers to comply with the rule

and four years from the uh effective date for small tobacco product manufacturers yeah can you restate that Matt please sure and Emil you can jump in on the phone excuse me anytime so there is a two-year effective date for all manufacturers so every well the effective date is the same for all manufacturers and then there is a two-year time frame where manufacturers non-small manufacturers would have

to be in compliance and a four years from the end of the effective date for small tobacco product manufacturer so any money under that 350 or the first two sequential or overlapping so it's four years before anybody would have to comply with this from today I mean not from from whatever uh yeah so to uh to clarify any uh confusion uh so the the effective date

uh would apply to um to all uh manufacturers uh however uh for any manufacturers that meet the definition of a small tobacco product manufacturer uh the statute requires that they have an additional four years beyond the effective date and so um how that applies in practice is that non-spall tobacco product manufacturers would have to comply with the final rule after the effective date which is currently

proposed to be two years but we do hear Tiff sacks recommendation to potentially shorten that two-year effective date but after that effective date uh small tobacco product manufacturers have an additional four years to comply there's two piece two pieces right there's to become effective and then manufacturers not small businesses will then have two years from there to comply so and the committee make recommendations on both

the effective date and the compliance timeline yes uh yes and so uh the the the compliance date that we're referring to uh is the compliance State uh for small tobacco product manufacturers that takes into account the additional four years that the statute affords them answer that is a statutory requirement but the effective date that FDA is proposing two years that is not set in statute I

think where there's confusion not about the small exception there's confusion about whether that two-year effective date is also the compliance state for large manufacturers or if there is an additional two years past the effective date that the large manufacturers have still to comply uh so uh no uh large manufacturers are non-small tobacco product manufacturers have to comply um after the effective date of the final regulation

so uh so if that if the final regulation uh has the um two-year effective date that's currently being proposed then it's two years uh after publication of the final rule that large manufacturers have to comply but that um but we welcome tips acts recommendation on whether that two-year effective date is um is appropriate for uh to achieve the statutory objectives I'd like to Echo Dr Leventhal's

comment that um we're all very concerned when this is going to take effect and so I would recommend that you know better than we do how long things could be delayed so I would recommend it as few delays as possible you know beyond what's necessary be done that would if postpone this and enable more youth to get addicted to nicotine um and then just a couple

comments more minor ones I would recommend deleting uh regarding synthetic nicotine you talk about tobacco products containing non-tobacco nicotine I would recommend getting rid of that first word tobacco and just say all products containing non-tobacco nicotine you know except those at the April for therapeutic reasons just because there's seems like there's some room for a hedging there not that I'm a lawyer and then one one

last recommendation is that um you mentioned that record-keeping ingredients and processed are important to go back and see where there might have been risks such as either alley a valley is no longer a reported disease reportable disease to CDC so I would recommend that evali and other health problems that come up be looked at immediately and and um and and that the public and the health

and medical professions be informed right away that's what worked with the valley people got the word out pretty quickly we don't know how much evaluate there still is the valley we don't know how much so I would recommend making a valley a reportable disease again in addition to anything else that comes up you know going forward thank you I want to recommend um making recommendations regarding

the records and availability of theirs to the public and I understand the desire to keep the trade secrets and those can be redacted how they normally are but I think it would be particularly useful to have that risk assessment results and to be available to the public so the public is aware of what to what the manufacturers have considered and what they deemed acceptable or tolerable

versus unacceptable and so I would recommend making those records public and either by again this is something where right now in the rule the companies just have to have the records and then either implementing something where the records should be made available on the company's own websites or somewhere or available by request or if we could then just tell the public to request them from the

FDA when the FDA gets them so but something should be made available where the public needs to be aware of those the risk Assessments in particular minion guy so this this may go back to number four I think that you moved us on to number five but I just want to go back to number four really quickly um which is back to the idea of initially

you stated that that some manufacturers would have unique identifiers or some some manufacturers would be required to have unique identifiers on some products is that correct am I understand that correctly uh yes uh the proposed tpmp requirements uh would require that all manufacturers um establish a unique identifier for all of the components and parts that they receive such that that can be ultimately traced for the

products that they manufacture beautiful okay and just a quick follow-up so what I would recommend is is the establishment or and um the establishment of in compliance with a track and tracing system either on behalf behalf of the manufacturers or the FDA or both particularly probably on behalf of FDA simply because it would put an additional burden on those small smaller manufacturers or small employers to

be able to comply with this so that the FDA pick up on that um specifically because it would have it would it would help I'd quickly identify and assess products that cause Adverse Events um as opposed to I believe you heard I heard you say if we find them so as opposed to the agency happening upon them um and it'll also able to it'll help facilitate

communication to the public when necessary in order to circumvent you know sort of widespread Adverse Events with any particular product yeah I said a general comment really about number one the scope of the rule and my expertise is from a raw tobacco side not so much manufacturing but the raw tobacco has been delivered uh to the manufacturers and and based on what I see manufacturers impose

require from Growers I think you'll find a lot of these tpmp requirements are already in place by Major manufacturers things like foreign material there's some major things major requirements for Growers to reduce non-tobacco-related material as it comes into the manufacturer a lot of things about Conformity there's I guess an incredible level of detail devoted to uh how these manufacturers Source Products of the consistency Conformity you

know how they deliver how they get those products delivered in and the timing of that and the scheduling there's been a lot of time in that to make these products conform also I think somewhere I saw in the documentation pesticide residues as it relates to pesticides applied in the field which we do a lot of work with that in my area there's a lot of emphasis

for manufacturers on maximum residue levels in raw leaf mrls and also guidance residue levels grls that we hear about very very frequently for manufacturers about about what those levels are if they're high and we're doing a lot of work trying to limit those in the field before the product ever gets to the manufacturers there's a lot of emphasis placed on a lot of points uh with

tpmp right now that I think will find that are already in place by manufacturers yeah I just wanted to comment on the risk assessment procedures you know and uh transparency with the FDA you know via the industry are guilty by FDA and as a part of the new double product application we do need to share with FDA everything about a product including the results men and

having basically potentially identified it and mitigating any kind of risk so FDA uh exactly knows uh what went to the development of the product and I have the informations to demo for us to demonstrate that potentially is appropriate for production of Public Health you know so they will have uh they both know everything including Adverse Events even right now for any kind of serious adverse event

we need to be reporting a data a resident within the certain period of time and then even the master product is in post Market uh in in the marketplace we have uh post Market surveillance reporting requirements where we again need to be basically sharing with FDA you know whether we receive any kind of Adverse Events it's also part of the manufacturing inspections where if they can

be asking again information assessment potential non-compliance of the product or even at residents literally experience throughout the time they've been there last time so I think there is a lot of information exchange between the manufacturers and the FDA to fully be transparent about what's happening in manufacturing but also in Marketplace after George um thank you um I would like to address the the issue of ends

batteries that's mentioned in several sections of of the rule proposal uh I think it's a great idea to implement standard or yeah restrictive manufacturing practices that can avoid explosions and and fires um however without involvement of retailers and consumers this problem cannot be solved because most of the fires they originate when these are discarded by the consumer so um I think manufacturing rules should also include

recycling programs where products used by the consumers are taken back by the manufacturers and disassembled and and discarded accordingly so they cannot cause any explosions and all the methods and other other toxic components can be reprocessed or uh yeah discarded in an environmentally friendly manner thank you I'm trying to identify the person that was speaking prior to Sven Dr Cordova thank you for all of the

young guys sorry thank you for all the information about um um the the exchange of communications and information between the FDA and and the industry it's very useful to have that information and I think that it actually it bolsters my point in which it should be easy to facilitate this tracking this track and Trace system as a result of that because you have this communication and

we can actually have the FDA sort of compile that information that's usable and accessible to the consumers which are in the end the ones that we're trying to to focus on in particular so thank you for supporting that um yeah Adam Leventhal in relation to that too um it's it's kind of understood that uh there are some practices that are already established by the industry um

but those are not uniformly practiced um especially amongst newer companies and um maybe potentially smaller manufacturers so it makes sense to provide a little bit more clear information that will be applied across the board to the entire industry and one particular issue would be some sort of a clear information about when a complaint comes in what is considered a adverse event that would require immediate notification

to the FDA and number two what immediate means and so providing a specific timeline that protects the public health but also kind of understands that the company would need to do some investigation but there needs to be a timeline because the internal investigation by the manufacturer if that drags on and on and on and on the public continues to be at risk so it's important for

the FDA to be notified immediately when an adverse event comes up and then the company can follow up as they do their own investigation and that will allow the FDA to determine whether it needs to also immediately do an investigation thank you we're going to break for lunch now for 30 minutes we're going to take a 30 minute break for lunch so now we're going to

move into the final comment um portion of the meeting where we're going to go around the table and have each member of the committee provide their final comments to be entered into the record for this meeting so oh excuse me Dr donibel can I make a clarifying point to the committee please uh hello good afternoon all I wanted to clarify our discussion about pre-existing tobacco products

and what is Exempted uh and so the proposed tpmp regulation would only not apply the design and development activities to pre-existing tobacco products of the thought being that we we did not want pre-existing tobacco manufacturers to recreate or create design and development activities and records that they don't have and may not have the historical knowledge to to create but all other proposed requirements of tpmp would

apply to pre-existing tobacco products thank you thank you can we start um yeah are we comfortable starting with you at your end Andy your final comment right uh I didn't really have any further comments I just want to reiterate what we was talking about regarding uh discussion point one with a scope I do feel like a lot of these tnp uh points are already in place

I think at least with large manufacturers uh you'll find that a lot of these have been have been going on for a long time yeah thank you I think this is a step in the right direction where we're looking at trying to make sure that we have the quality consistency a lack of contamination and no adulteration of these products and I think this will get us

there I think it needs to be applied consistent with the statutes and consistent with the scope that allows for individual categories to have varying company sizes that can fit within the guidelines and meet the requirements um so we do appreciate the efforts uh in proposing um a tpmp for manufacturers uh we believe that you know it's in the also in terms of Manufacturers to make sure

that you know we have our procedures and quality controls in place to manufacture a product to the specification and really avoid our minimizing likelihood of consumer being exposed to non-conforming products Authority or mislabeled because you know I think uh we we also want to protect public health and making sure that you know the consonants are not exposed to the higher increase of the risk which is

beyond that inherent tobacco products we also appreciate the approach with the umbrella approach for tpmp regulations because we believe uh it's critical to assure flexibility in complying with the proposed dpmp uh requirements to take into account both different kind of manufacturing processes but also depending on tobacco products which are currently out there whether it's uh the traditional tobacco products or new Innovative products and potentially even

a future product so then we don't stifle The Innovation so overall you know I think we are in a support of a tpmp Alberta basanti um thank you for the invitation to attend this meeting and I just wanted to reiterate that um to include the um when it comes to label to include the expiration date and then also a standardized labelings for the consumer to be

able to understand the information the hi uh Deirdre kitner and I'd like to recommend uh reducing the uh effective date to one year as opposed to two years and uh do as much as possible to diminish the confusion and maximize comprehension of the nicotine content on the labeling and make it as standardized as possible thank you Lisa pastel so I really appreciate the opportunity to be

here um I think this is incredibly important um especially in in light of what we just experienced with e-valley and I think it's going to require some thought to to decide um whose burden it is and on what kind of schedule compliance of the um the design components are going to be followed so how frequently are products going to be looked at to make sure that

no modifications have been made in terms of the umbrella flexibility I think it's going to be really critical to have clear guidance on who is required to offer what documentation because anytime there's flexibility in the government that engenders some uh some panic and uncertainty in the in the population so I think clear guidance that doesn't require every uh organization to have its own separate conversation with

the FDA I think would be really important thank you Adam Leventhal um I'd like to commend the FDA for putting together this rule they they put a lot of thought and energy into it and um I think that the umbrella approach is a good start on moving um with the additional guidance provided that may be product specific and maybe updated as new science comes out that

would help the manufacturers optimize their manufacturing process to protect the public health I did hear Dr or Mr Brenner's mention about the exemption for the products on the market before 2007 February 15th and it's uh the rationale as to why the requirements for the for the design verification validation and approval and design transfer would not apply however I think the reasons those [Music] parts of the

rule are in place in the proposed rule is to protect the public health and so it seems to me that whether it's via um you know reverse engineering or whatever process is required all tobacco products are dangerous including those on the market prior to 2007 February 15th so they should all be put forth the same standard to protect the public health in addition I concur with

these recommendation of reducing the timeline for compliance perhaps one year would be a a date to consider and I also believe that additional guidance on what would be a good tracking Trace system would be useful in addition to guidance on statistics and the types of testing that would be um needed in order to maintain quality assurance and prevent deviations from the products being manufactured from their

intended specifications to protect the public health thanks Lucy papova um going back to the design and development requirements I feel they include a lot more than just coming back up with the design plan it also includes all the risk assessment and it does at least according to the FDA presentation the master manufacturing record is also underneath that I feel that including them rather than exempting them

is the right way of doing it and if there's given the umbrella approach and the flexibility the companies have they can just say we don't have the design at products have been like this for a long time here's what they are but they still would need to go through the risk assessment all of those specified and I feel that the way it's written right now they

might it might be interpreted as they are also exempt from all the other things so I would concur with how they're saying that we should apply the same standard to everybody else but given the flexibility already inherently in the Pro in them proposed rule it could be companies have that ability to deal with that without much burden and this also will reassure that the small manufacturers

that they're not that FDA is not being preferentially treating the big companies by exempting all their products um reiterating I concur with labeling requirements it would be good to just reiterate that Clarity in particularly for the liquids with and my preference would be four milligrams per milliliters including the retailers at least for the expiration date as we were talking about we need to have the full

um the tobacco products need to be covered by this manufacturing requirement kind of from the start and this is where we have it like at the beginning they already have all the whoever's producing the original elements they're covered but then also going through all the way through retailers as I mentioned earlier the language substituting not natural the risks not naturally associated with tobacca use to not

normally or naturally I mean well all of those imply kind of normalization of those risks so if using something like inherent would be better um including the records given that there's already so much communication between the FDA and the manufacturers making those records public or at least providing the public an easy way to assess and access that information would be good I also concur with shortening

that and um the distance the time between the rule and the effective date to one year um especially given that a lot of companies already have all those procedures in place it should be easy to do for them and for the small manufacturers the four years will still be in place and finally I think umbrella approach is a good way and I feel like it gives

enough flexibility and for us all to continue working on that and potentially come back with some better recommendations or guidances but like keeping it flexible at this point seems appropriate minion guy um so first I want to applaud the FDA for taking this very rigorous and comprehensive approach and using this umbrella approach to implementing this proposal to drafting this proposed rule um I'm heartened to learn

that some of these products um that are that were on the market prior to February 2020 uh February 15 20 2007 we'll adhere to some elements of The Proposal however I do agree that we we need to ensure that we have a standard approach across all so perhaps one means could all manufacturers so perhaps one one way to do this could be to allow some room

for smaller manufacturers of those individuals that don't have the appropriate information to apply for exemptions with some sections as opposed to you know exempting complete groups of of this rule um I want to reiterate the importance of requiring the the effective date to begin in one year and in addition I want to reiterate the importance of FDA providing guidance and specifications to here to the sections

of the proposed rule that we've identified as needed and that FDA Institute the track and tracing system that not only captures Adverse Events but it could also help us establish a record of best practices for manufacturers that we can use in the future as we Endeavor to minimize the risks associated with tobacco use and to protect the health of the public thank you Risa Robinson I

would like to thank the FDA for drafting the proposed rule which is which in my mind takes a giant step forward to protecting Public Health um I have a few recommendations here um for the record I'd like um recommend eliminating the exemption for products prior to exemption date as stated by my colleagues previously and reduce the effective date to one year second Implement consistent labeling for

nicotine content per standard unit of measure and by total nicotine contained in the container or package and to consider both the need to inform users of the contents as well as to protect non-users from Poison I recommend the MMR requirements should include guidance on preferred units of measure which are specific for the component and be stated in such a way as to be able to compare

components across products for the software can controller is a key aspect of nicotine delivery and e-cigs and should be a key component in product regulation and transparency software controls heating element feedback um such as maximum coil temperature and Power on off criteria so I'd like to recommend that this be considered in the proposed rule five MMR documentation should be made available to the public and for

the purposes of independent researchers six MMR should consider the reality that constituents in the unpuffed and unheated product can be quite different than the constituents in the emissions and finally I recommend that the FDA reconsider the an exemption for premium cigars in the spirit of allocating resources to maximize the impact on public health thank you and I'm Scout I as a public health expert would much

rather be here trying to talk about how to get rid of these products but that said I understand that a lot of work has gone into this it is certainly past due that we get some of this regulation in place and so I am substantively very pleased to see the proposed rule as it's put forward my suggestions to continue to enhance it would be as follows

first of all absolutely uh go with the minimum time which is allowed it sounds like it's probably one years for one year for the effective date and maybe we're stuck at four for the smaller uh producers but if we're if we have any variability there I would also encourage that four to be shorter that there is uniform labeling across all products and that labeling takes very

much into account audience comprehension and probably introduces a graphic component to more easily be able to compare the apples to the oranges that particularly for products that have high concentration of nicotine that are in a position where they could be accidentally ingested that child proof containers be considered for those products and also as well for the products which are engineered and have problems with exposure to

sunlight according to available research so far that it's an opaque product packaging and then also that FDA strongly considers the concept of how enticing packaging is to youth for example by mimicking things like gum packages things like that as a way to minimize the exposure unintended exposure to people who can be poisoned by it um I also think that it was brought up a few different

times that we do not want the tobacco industry to be saying that their adherence to this uh rule in any way constitutes a healthier necessarily um product so I would encourage FDA to create some language around that just saying something along the lines of you know this product conforms to fda's manufacturing specifications or something like that or regulations something that does not allow it to come

across as being healthy I I think with the note with the pre-2000 exemption that we're talking about I think there's a way to skin the cat between what you're talking about you don't want them to post-hop create documents that weren't really a part of their you know development plan but we do want to make sure that we have the specs so that you understand what current

products should be kept to and tested to so in that way I'd suspect it could be just a small modification that if it's pre-2007 that you submit the final product specifications to make sure that you're not creating documents that didn't exist but we still have a baseline by which to figure out if a document is in or out of compliance I think for some of the

things we're talking about related to new nicotine products that might be of uh different potency different efficacy different you know that we should always presume that they're at least as hazardous as the ones on the market because there's a lot of science out there until new science proves that they diverge from that in some way so I just want to be careful that if there's a

new nicotine product that we do not presume it's safe as a starting point but we at least presume it's at the Baseline that we see for existing products um I definitely support having expiration dates and as a result expanding it to retailers so that that can be fully complied with I also think that FDA should really consider how to make sure compliance costs are not dependent

upon Congressional allocations of budget to the FDA because that means that they could really vary and also means the tobacco industry could have a strong say in them so might want to figure out ways that compliance costs related to this whole thing can actually be directly connected to the manufacturers um I do think that when we're talking about unintended exposure there's several different categories of it

like for example it could be with poison control reporting that people are getting access to something or that the batteries are um you know causing problems for people so I do think that as FDA considers compliance related to this they should consider the different areas where reporting might exist that need to be monitored in order to understand the full public impact I support the records being

public um with you know Trade Secrets being redacted I support there being the development of a track and Trace program I also support recycling as being a piece of this equation to make sure we minimize the risks related to batteries one thing we didn't talk about here but that was brought up in the public comment was also that there are right now higher criteria for warning

labels on things like nicotine gum when it's therapeutic pharmacological then there is a nicotine gum when it is being sold for continued consumption we should definitely make those even to minimize the chance that people can get access to you know chewed nicotine gum and and poison themselves in that way I do think that this idea of small companies we we brought up an interesting point that

the number of units they sell may be more relevant to their impact on the market than the number of employees they have so that should be considered as to whether that's a better measure of a small company and then the last thing is really that we understand that if there's one thing that this world has taught us is that there will be new products and new

ways to consider to consume nicotine that the tobacco industry will create in the very near future and so that said I think that FDA should strongly consider what level of uh potential rapid response they have those new products particularly if they fall outside the specific regulations here if there's any way that they might somehow exempt or jump around some of the categories here so that that

response can be much faster than this proposed rule has come in response to all of the ends which have flooded the market thus far thank you Donna Upson and I also want to thank FCA for addressing this topic um and I agree with the most of the comments here that it's the benefit of going near the end um I agree that there should be standardization of

nicotine both by manufacturers so that it doesn't levels don't vary even Within products and that there are easily understood labels of the nicotine content um I agree with the decreasing the time to one year and and I would also recommend that the premium cigars not be Exempted I think that this proposed rule should apply to all tobacco products and uh including the synthetic nicotine products and

there are lots of reasons for that premium cigars have health risks and there are the entry point for many youth to become dependent on nicotine especially African-American youth um and in the past premium cigars or cigars have been modified sorry to meet whatever the criteria are to make them premium cigars and that included adding things to make them heavier and different things the the rules are

more strict now but I would not accept any any tobacco products and I would ask that FDA be able to enforce the rules um and again mentioned that I think getting getting the final rule out as soon as possible A good rule is important because every day that we lose and this may not affect how many people become addicted to nicotine um but I think we

need to to keep moving thank you I'd like to ask Dr George for his final comment you I'm I congratulate FDA for proposing these generally reasonable requirements for tobacco product manufacturers which establish controls for the manufacturer specific specification packaging storage and labeling of tobacco products while these rules will not prevent tobacco products from continuing to kill almost half a million Americans per year they will help

to protect Public Health from outsized harms due to poor manufacturing practices and errors I advise FDA to expand risk risk assessment criteria for manufacturers to protect children from accidentally ingesting tobacco products such as the NDS designed by colorful toys or candy and also assess risks for youth that are enticed by these products to start vaping at a young age FDA should Implement labeling standards for nicotine

in ends and modern nicotine pouch products with special consideration given to forms of synthetic nicotine products containing mixtures of synthetic and tobacco derived nicotine together should not be permitted since they may confuse the consumers even more recycling of the NDS needs to be an integrated part of the manufacturing rule since the unds cause pollution and are a fire hazard FDA should consider requiring expiration dates on

certain tobacco products to protect consumers it is understood that the umbrella approach does not exclude the implementation of rules specific to Tobacco product categories the rules should become effective in one year keeping the exception for small manufacturers thank you I want to thank the FDA for their efforts on this proposed rule as well as the committee members for for this robust discussion if we had had

the tpmp in place at the time of a volley you might have had a more effective and efficient epidemiological investigation which got at the root cause of a volley in a more expedient fashion today there are still misperceptions that persist about what was the root cause of the epidemic to that extent I recommend that track and Trace be included in the proposed rule with regards to

scope to include pre-existing products where appropriate and allowable under the Tobacco Control Act importantly because many of the pre-existing product service predicates for substantial equivalence applications and it would also facilitate the identification of misbranded or unauthorized products on the market the tpmp reflects Sound business and Manufacturing practices that we have heard from our industry representatives are compatible with their existing business practices to that effect I

recommend that the timeline be compressed along with the majority of our members here today effective within one year with regards to the umbrella approach it provides needed flexibility for the diversity of tobacco products on the market and the proposed tpmp will serve as a living document that will grow and will apply to Future product standards lastly with with regards to the request for premium cigars to

be Exempted there is a process in the tpma in the TM tpmp um for that and so if the cigar associations and cigar industry wishes to seek an exemption there is a process laid out in the proposed rule where they can come forward and make more clearly their arguments and articulations for that particular exemption and with that I would like to invite the FDA if they

have any final comments uh Dr Del nivo and tipsac committee members the agency greatly appreciates your engagement and a thoughtful recommendations we hear your uh your thoughts and we'll take that into consideration we believe that your recommendations will help to make tpmp stronger in order to advance our mutual mission to protect Americans from tobacco-related death and disease so thank you very much for uh for your

contributions today I would like to thank everyone for attending today including those that participated in the open public presentation and with that the meeting is adjourned