`Case 1:20-cv-00393-LO-TCB Document 1007-10 Filed 02/11/22 Page 1 of 13 PagelD# 28202
`
`EXHIBIT J
`EXHIBIT J
`
`
`
`9/16/2020
`
`Case 1:20-cv-00393-LO-TCB Document 1007-10 Filed 02/11/22 Page 2 of 13 PageID# 28203
`Perspective: FDA's Preparations for the September 9 Submission Deadline I FDA
`
`Perspective: FDA's Preparations for the September 9 Submission Deadline
`
`By Mitch Zeller, Director of the FDA's Center for Tobacco Products (CTP)
`August 31, 2020
`
`On Sept. 9, premarket review applications for many new tobacco products, including e-cigarettes, certain cigars, and hookah
`products, currently on the market are due to FDA for review. FDA staff have been working tirelessly on preparations to meet this
`challenge in an efficient, reliable and transparent manner.
`
`The Deeming Rule and FDA's Premarket Review Requirement for Deemed Tobacco Products
`
`Prior to Aug. 8, 2016, e-cigarettes, cigars and hookah products were not regulated by FDA. That's because the original grant of
`authority from Congress in 2009 only covered cigarettes, smokeless tobacco, cigarette tobacco, and roll-your-own tobacco.
`
`That all changed with FDA's historic "Deeming Rule" that helps implement the Tobacco Control Act and allows FDA to protect the
`public health and protect future generations from the dangers of tobacco use. On Aug. 8, 2016, when the deeming rule took effect,
`many of the regulatory and statutory requirements that had been in place for manufacturers of cigarettes, smokeless tobacco,
`cigarette tobacco, and roll-your-own tobacco since 2009, became applicable to e-cigarettes and all other electronic nicotine delivery
`systems (ENDS), cigars, pipe tobacco, nicotine gels, hookah tobacco, and any future tobacco products.
`
`Before the deeming rule, there were no federal protections on, among other things, retailers selling these tobacco products to youth.
`The deeming rule changed that and its continued implementation has allowed FDA to make great strides in protecting public health
`through tobacco regulation—for example, manufacturers of these tobacco products must register their establishments and list their
`products with FDA, products may not be marketed with direct or indirect claims of reduced risk unless substantiated by FDA and
`they receive FDA authorization to do so, and retailers are prohibited from selling these tobacco products to youth.
`
`Importantly deemed tobacco products are now subject to the requirements in the Tobacco Control Act that already apply to
`cigarettes and smokeless tobacco products. This includes the requirement that a "new tobacco product" (/tobacco-
`products/products-guidance-regulations/market-and-distribute-tobacco-product)must receive premarket authorization from the
`
`https://www.fda.gov/tobacco-products/ctp-newsroom/perspective-fdas-preparations-september-9-submission-deadline
`
`1/12
`
`1 199_RESP00016448
`
`
`
`9/16/2020
`
`Case 1:20-cv-00393-LO-TCB Document 1007-10 Filed 02/11/22 Page 3 of 13 PageID# 28204
`Perspective: FDA's Preparations for the September 9 Submission Deadline I FDA
`
`L.
`
`FDA prior to marketing.
`
`For deemed products that met the definition of a new tobacco product and were on the market as of Aug. 8, 2016 (when the deeming
`rule took effect), FDA issued a compliance policy; this, in effect, provided more time for manufacturers of these products to submit
`their applications for authorization. The deadline for the submission of applications for these products is now approaching. As the
`result of a court order (and a subsequent extension due to the unique circumstances of the COVID-19 pandemic), applications for
`deemed new tobacco products on the market at that time are due to FDA by Sept. 9, 2020 1. The court order also provided a
`one-year period during which products with timely filed applications might remain on the market pending FDA review.
`
`https://www.fda.gov/tobacco-products/ctp-newsroom/perspective-fdas-preparations-september-9-submission-deadline
`
`2/12
`
`1 199_RESP00016449
`
`
`
`9/16/2020
`
`Case 1:20-cv-00393-LO-TCB Document 1007-10 Filed 02/11/22 Page 4 of 13 PageID# 28205
`Perspective: FDA's Preparations for the September 9 Submission Deadline I FDA
`Since the deeming rule took effect, FDA has been taking measures to prepare for the large volume of applications the agency
`anticipates receiving, particularly from manufacturers of e-liquids, e-cigarettes and other ENDS products.
`
`Expectations for Applications Coming in by Sept. 9
`
`All new tobacco products are required to obtain premarket authorization through one of three pathways: (/tobacco-
`products/products-guidance-regulations/market-and-distribute-tobacco-product) Premarket Tobacco Product Applications
`(PMTA), Substantial Equivalence (SE) Reports, or Requests for Exemption from Demonstrating Substantial Equivalence (EX REQ).
`Those deemed new tobacco products still on the market that do not have premarket applications submitted by Sept. 9, 2020, will be
`subject to FDA compliance and enforcement actions.
`
`However, there may be some deemed tobacco products that are eligible for "grandfathered status" because they were commercially
`marketed in the United States as of Feb. 15, 2007. These deemed tobacco products are not "new tobacco products" and therefore do
`not need to submit premarket applications (unless the products were since modified). We expect that many cigar, hookah tobacco,
`and pipe tobacco products may fall in this category, and we encourage manufacturers to request a determination from FDA
`(/tobacco-products/market-and-distribute-tobacco-product/grandfathered-tobacco-products)on their products' grandfathered
`status. For deemed tobacco products that are not eligible for grandfathered status, (/tobacco-products/market-and-distribute-
`tobacco-product/grandfathered-tobacco-products) manufacturers may decide that their product is sufficiently similar to a
`previously authorized or grandfathered product and find that the SE or EX REQ pathway is the most appropriate pathway for their
`applications.
`
`To date, no ENDS product has received marketing authorization from the FDA and FDA has not issued a grandfathered status
`determination for an ENDS product. All premarket applications for ENDS products accepted by the FDA have been submitted
`through the PMTA pathway, and we expect most applications for ENDS products submitted on or before Sept. 9 to be submitted
`through the PMTA pathway.
`
`Although we do not know how many applications will be submitted by the September deadline, we do know that there are over 41313
`million deemed products listed with FDA.
`(https://ctpocerlida.gov/rlapp/home.html;jsessionid=6NouTk7SupBTUcBdML705bwgjnNti4sWQ6ouORBeqpjiQPYtordq!827333740)
`Even if applications are submitted for only a portion of those products, the likelihood of FDA reviewing all of these applications
`during the one-year review period is low, given that this would be an unprecedented number of applications and several orders of
`
`https://www.fda.gov/tobacco-products/ctp-newsroom/perspective-fdas-preparations-september-9-submission-deadline
`
`3/12
`
`1 199_RESP00016450
`
`
`
`9/16/2020
`
`Case 1:20-cv-00393-LO-TCB Document 1007-10 Filed 02/11/22 Page 5 of 13 PageID# 28206
`Perspective: FDA's Preparations for the September 9 Submission Deadline I FDA
`magnitude greater than anything the Agency has experienced. However, FDA has been planning and preparing to receive the
`expected influx of applications for years. Our preparations are intended to help ensure that our approach to product review protects
`public health and is fair, consistent, efficient, and as transparent as possible.
`
`We have been encouraging companies to submit their applications as early as possible. To date, FDA has received applications for
`around 2,000 deemed products — of which around 40 percent have already been resolved.
`
`Preparations to Receive Premarket Review Applications
`
`FDA has been working tirelessly to ensure that we are as prepared as possible to receive, process, and review the applications in a
`timely manner. To help accomplish this, we have been laying the groundwork for many years.
`
`Since Congress authorized FDA to regulate tobacco products in 2009, CTP's staff has increased from just a handful to over 950
`today. During that time, we have built product review expertise and refined our premarket review processes, enhanced our technical
`capabilities, issued rules and guidances, met with stakeholders to get a better understanding of tobacco products and applicants'
`needs for information about the process, invested in tobacco product research, and provided resources to help industry prepare and
`submit premarket applications.
`
`BUILDING EXPERTISE AND REFINING THE PREMARKET REVIEW PROCESSES
`
`Although the applications received in response to the Sept. 9 deadline will generally be for deemed products, FDA has been
`successfully conducting premarket review of cigarettes, smokeless tobacco and roll-your-own tobacco for many years. Since 2009,
`we have received over 600 PMTAs, more than 7,700 SE Reports and over 800 EX REQs—and have closed out a large majority of
`these applications. Shaped by the experiences, challenges and lessons learned over the last decade, we have made several
`refinements to our processes to ensure that we are able to receive and review these applications properly and efficiently.
`
`We've also greatly increased the number of staff that we have conducting premarket reviews. Since 2011, CTP's staff in the Office of
`Science has increased ten-fold, from around 40 to over 400 full-time employees today — and the majority of these staff spend most
`of their time on product review. CTP continues to hire and train more staff to conduct product review in anticipation of the influx of
`applications. These improvements put us in a much better position to handle the applications than we were in 2011, when the agency
`received a large influx of over 3,600 SE Reports within a week of the "provisional SE" application deadline 2.
`
`https://www.fda.gov/tobacco-products/ctp-newsroom/perspective-fdas-preparations-september-9-submission-deadline
`
`4/12
`
`1 199_RESP00016451
`
`
`
`9/16/2020
`
`Case 1:20-cv-00393-LO-TCB Document 1007-10 Filed 02/11/22 Page 6 of 13 PageID# 28207
`Perspective: FDA's Preparations for the September 9 Submission Deadline I FDA
`
`IMPROVING
`SYSTEMS TO
`RECEIVE AND
`PROCESS
`APPLICATIONS
`
`One very
`important update
`we have made is
`the ability to
`receive tobacco
`product
`application
`submissions
`electronically
`through the CTP
`Portal (/tobacco-
`
`products/manufacturing/submit-documents-ctp-portal) or Electronic Submissions Gateway (/medical-devices/emdr-electronic-
`medical-device-reporting/fda-electronic-submissions-gateway-esg)on any day and/or time. Prior to putting these systems in place,
`applications could be received only in-person and during business hours. Moving to an electronic system has allowed us to receive,
`process, and load submissions for review quickly and efficiently. We have been encouraging applicants to use our electronic
`submissions systems as they substantially cut down on the processing time. We have recently updated and tested our systems to be
`able to handle more submissions simultaneously and allow more concurrent users. The improvements were made to address the
`stability and performance of the applications.
`
`https://www.fda.gov/tobacco-products/ctp-newsroom/perspective-fdas-preparations-september-9-submission-deadline
`
`5/12
`
`1 199_RESP00016452
`
`
`
`9/16/2020
`
`Case 1:20-cv-00393-LO-TCB Document 1007-10 Filed 02/11/22 Page 7 of 13 PageID# 28208
`Perspective: FDA's Preparations for the September 9 Submission Deadline I FDA
`Additionally, FDA recently sought comment on a proposed form
`(https://www.regulations.gov/document?D=FDA-2019-N-2854-
`1145&utm campaign=CTP+News%3A+PMTA+Subsmissions+-
`+3920&utm medium=email&utm source=Eloqua) that could
`reatly assist both FDA and industry in identifying the products of
`submissions where an applicant groups multiple PMTAs into a
`single submission (grouped submission). The agency believes that
`he draft form could assist applicants in providing the information
`or each individual product in a grouped submission. By having
`roduct information more clearly organized, FDA would be able to
`ore efficiently process and review the applications contained in a
`grouped submission.
`
`To help users successfully use the CTP Portal, technical specifications for submitting electronically (/tobacco-
`products/manufacturing/electronic-submissions-tobacco-products) are available on the website. In addition, to help with any
`technical issues, information on troubleshooting is available on the website, and users may contact our fully staffed Help Desk.
`(/tobacco-products/manufacturing/submit-documents-ctp-portal)
`
`The Agency continues to strongly encourage applicants who plan on submitting applications for a large number of products to
`contact the Agency as soon as possible to discuss their plans and method of submission.
`
`ISSUING RULES AND GUIDANCES
`
`To assist manufacturers and importers preparing applications, FDA has published several foundational rules and guidances related
`to the application processes.
`
`FDA's final rules, including Refuse to Accept Procedures for Premarket Tobacco Product Submissions,
`(https://www.federalregister.gov/documents/2o16/12/29/2o16-3137o/refuse-to-accept-procedures-for-premarket-tobacco-
`product-submissions) Exemptions From Substantial Equivalence Requirements
`(https://www.federalregister.gov/documents/2on/o7/o5/2on-16766/tobacco-products-exemptions-from-substantial-
`equivalence-requirements)and National Environmental Policy Act; Environmental Assessments for Tobacco Products; Categorical
`
`https://www.fda.gov/tobacco-products/ctp-newsroom/perspective-fdas-preparations-september-9-submission-deadline
`
`6/12
`
`1 199_RESP00016453
`
`
`
`9/16/2020
`
`Case 1:20-cv-00393-LO-TCB Document 1007-10 Filed 02/11/22 Page 8 of 13 PageID# 28209
`Perspective: FDA's Preparations for the September 9 Submission Deadline I FDA
`
`Exclusions,
`(https://www.federalregister.gov/documents/2o15/o9/24/ 2015-
`24219/national-environmental-policy-act-environmental-
`assessments-for-tobacco-products-categorical) provide clarity on
`processes and requirements related to these pathways and actions.
`
`FDA has issued several guidance documents, such as Demonstrating
`the Substantial Equivalence of a New Tobacco Product: Responses to
`Frequently Asked Questions (https://www.fda.gov/regulatory-
`information/search-fda-guidance-documents/demonstrating-
`substantial-equivalence-new-tobacco-product-responses-frequently-
`asked-questions), Establishing That a Tobacco Product Was
`Commercially Marketed in the United States as of February 15, 2007
`Uregulatory-information/search-fda-guidance-documents/establishing-tobacco-product-was-commercially-marketed-united-
`states-february-15-2007) and the Premarket Tobacco Product Applications for Electronic (/regulatory-information/search-fda-
`guidance-documents/premarket-tobacco-product-applications-electronic-nicotine-delivery-systems-ends)Nicotine Delivery
`Systems (ENDS)
`
`
`nicotine-delivery-systems-ends) among among others, to help industry navigate through the application process.
`
`Additionally, FDA has proposed rules on Content and Format of Substantial Equivalence Reports; Food and Drug Administration
`Actions on Substantial Equivalence Reports (https://www.federalregister.gov/documents/2019/04/02/2019-o5787/content-and-
`format-of-substantial-equivalence-reports-food-and-drug-administration-actions-on) and Premarket Tobacco Applications and
`Recordkeeping Requirements, (https://www.federalregister.gov/documents/2o19/o9/25/2o19-2o315/premarket-tobacco-product-
`applications-and-recordkeeping-requirements)which when finalized, will set forth the content and format requirements for these
`applications.
`
`ENGAGING WITH STAKEHOLDERS
`
`To further facilitate the application submission and review process, we held multiple meetings with manufacturers to hear about
`their products, held scientific seminars to discuss the details and constituents of certain tobacco products (such as ENDS and e-
`liquids), and engaged in research to fill knowledge gaps about certain tobacco products. We also made visits to farms and primary
`and secondary manufacturing sites to learn more about how these companies make their products.
`
`https://www.fda.gov/tobacco-products/ctp-newsroom/perspective-fdas-preparations-september-9-submission-deadline
`
`7/12
`
`1 199_RESP00016454
`
`
`
`9/16/2020
`
`Case 1:20-cv-00393-LO-TCB Document 1007-10 Filed 02/11/22 Page 9 of 13 PageID# 28210
`Perspective: FDA's Preparations for the September 9 Submission Deadline I FDA
`In 2018 and 2019, FDA held public meetings on the application review processes and, specifically, deemed tobacco product
`applications. The 21318 meeting focused on improving public understanding and to seek feedback on the policies and processes for
`the submission and review of tobacco product marketing applications, including the general scientific principles relevant to various
`application pathways. The 2019 meeting aimed to outline existing product review policies, procedures, helpful tips, and general
`scientific principles that specifically apply to the manufacturers submitting applications. These meetings were widely attended by a
`variety of stakeholders in person and online, and all materials shared during the meetings are available on the FDA website and have
`been (/tobacco-products/products-guidance-regulations/market-and-distribute-tobacco-product)frequently promoted on FDA's
`communication channels. (/tobacco-products/products-guidance-regulations/market-and-distribute-tobacco-product)
`
`Additionally, throughout 2019 and 2020, FDA held numerous listening sessions with a variety of stakeholders to hear their
`questions, concerns, and suggestions regarding the PMTA process. Stakeholders—including public health professionals, trade
`associations, and manufacturers and distributors of e-cigarettes, e-liquids, and packaging systems—participated in these listening
`sessions and provided valuable input.
`
`INVESTING IN RESEARCH
`
`To expand the scientific knowledge base around tobacco products and topics related to tobacco products, FDA has been investing in
`research (/tobacco-products/tobacco-science-research/tobacco-regulatory-science-research-program) for many years, including
`collaborating with Centers for Disease Control and Prevention (CDC) on the annual National Youth Tobacco Survey (NYTS),
`(/tobacco-products/youth-and-tobacco/youth-tobacco-use-results-national-youth-tobacco-survey) funding the Tobacco Centers of
`Regulatory Science (TCORS), (/tobacco-products/research/tobacco-centers-regulatory-science-tcors) and collaborating with
`National Institutes of Health (NIH) and National Institute on Drug Abuse (NIDA) on the Population Assessment of Tobacco and
`Health (PATH) Study. (/tobacco-products/research/fda-and-nih-study-population-assessment-tobacco-and-health) Studies
`generated from these research ventures have helped ground the FDA's regulatory actions in science, inform FDA's review process
`and can generally help inform tobacco product applications.
`
`PROVIDING AND PROMOTING RESOURCES
`
`To assist those involved in submitting applications, FDA has created a dedicated web page for manufacturers and importers where a
`consolidated set of resources and information (/tobacco-products/manufacturing/submit-tobacco-product-applications-deemed-
`tobacco-products) about tobacco product applications may be found (/tobacco-products/manufacturing/submit-tobacco-product-
`applications-deemed-tobacco-products).
`
`https://www.fda.gov/tobacco-products/ctp-newsroom/perspective-fdas-preparations-september-9-submission-deadline
`
`8/12
`
`1 199_RESP00016455
`
`
`
`9/16/2020
`
`Case 1:20-cv-00393-LO-TCB Document 1007-10 Filed 02/11/22 Page 10 of 13 PageID#
`Perspective: FDA's Preparations for the September 9 Submission Deadline I FDA
`28211
`(/tobacco-products/manufacturing/submit-tobacco-product-applications-deemed-tobacco-products)
`This page houses pertinent information for manufacturers preparing for the Sept. 9
`deadline, including information on the different premarket pathways and how to submit
`an application. The page also highlights key resources, such as tobacco product master
`iles to submit applications more efficiently.
`
`0 FDA Tolmcco 0 - -441CIINICCID
`FDATobacto Applicatiod Tips
`Appkaliar1s. for prorrarkel rovieny far leerriel rgvo tobacco peadtKils. on tho rnr•
`.V5 Cr Aqg .za
`.1'0101,19 e
`-ore retivatC1 90 I:* tilt.1 by WI. 5. 2020
`
`FDA has also been regularly sharing helpful tips for applicants as part of our "FDA
`obacco Application Tips" efforts on social media and through email.
`
`All of the previously shared social media tips and emails are available at our Twitter
`"moment" (https://twitter.com/i/events/1285265549661003776)
`(http://www.fda.gov/about-fda/website-policies/website-disclaimer) and on our website.
`(/tobacco-products/manufacturing/fda-tobacco-application-tips-email-series)
`
`Looking Forward
`
`Consistent with the court order (/news-events/press-announcements/coronavirus-covid-19-update-court-grants-fdas-request-
`extension-premarket-review-submission-deadline) that set the Sept. 9, 2020 application deadline, for products with timely
`applications, FDA may continue to defer enforcement of the premarket requirements for up to one year through Sept. 9, 2021
`(unless a negative action is issued by the FDA on an application during that time). Examples of negative actions include Refusal to
`Accept (RTA), Refusal to File (RTF), and a No Marketing Order (NMO).
`
`FDA strives to review as many applications as possible during this one-year period and we have been developing a review process
`aimed at maximizing the number of products reviewed while ensuring the greatest public health impact. Although CTP has greatly
`expanded its reviewing capacity and is developing well-defined, consistent and transparent review processes for all phases of
`premarket review, there are limits to these resources considering we may receive applications for several millions of products.
`Further, although we expect high quality and complete applications to come in by Sept. 9, if we do find deficiencies, it is likely FDA
`will issue a Deficiency Letter with a 90-day deadline for companies to respond.
`
`FDA plans to update the public and release information regularly as we refine plans for allocating product review resources and the
`process by which products would move into scientific review. Although these details will be regularly evolving and will depend on
`several factors—such as the number and types of applications that are received—overall, the decisions will be guided by the
`
`https://www.fda.gov/tobacco-products/ctp-newsroom/perspective-fdas-preparations-september-9-submission-deadline
`
`9/12
`
`1 199_RESP00016456
`
`
`
`9/16/2020
`
`Case 1:20-cv-00393-LO-TCB Document 1007-10 Filed 02/11/22 Page 11 of 13 PageID#
`Perspective: FDA's Preparations for the September 9 Submission Deadline I FDA
`28212
`
`principles outlined below.
`
`To ensure the greatest public health impact, transforming the current tobacco landscape into a fully regulated marketplace is
`our foremost priority. This means providing adequate review resources for reviewing those products currently on the market that
`have the greatest chance, either positively or negatively, of impacting public health. For example, for several years we have been
`discussing how ENDS products—which come in a wide range of varieties, flavors and nicotine strengths—should never be initiated
`by youth, but there may be potential benefits to an adult cigarette smoker switching completely to ENDS products. This will be the
`
`https://www.fda.gov/tobacco-products/ctp-newsroom/perspective-fdas-preparations-september-9-submission-deadline
`
`10/12
`
`1 199_RESP00016457
`
`
`
`9/16/2020
`
`Case 1:20-cv-00393-LO-TCB Document 1007-10 Filed 02/11/22 Page 12 of 13 PageID#
`Perspective: FDA's Preparations for the September 9 Submission Deadline I FDA
`28213
`first time we apply the public health standards provided by Congress to a large group of these relatively new products. Through our
`science-based premarket review process, we will ensure that the most widely-used products get the opportunity to be tested by these
`standards.
`
`As always, FDA intends to be fair in allocating FDA resources to review applications from both small and large manufacturers
`and importers, and from applications received through different pathways. And although the applications for certain products
`currently on the market are under a time constraint (i.e. the one-year review period referenced by the court), FDA also intends to
`ensure that resources are devoted to reviewing applications for products that are not currently marketed.
`
`Additionally, we intend to maximize the resources that we have to review the most products in the shortest timeframe—with
`the above guiding principles in mind. To help with this, we are refining our review processes to shorten the overall review time.
`Depending on the number of new applications we receive by the deadline—which could be anywhere from a few hundreds of
`thousands to millions—as a matter of practicality we may not be able to fully complete review of all tobacco product applications that
`we receive by Sept. 9, 2020 within the year. Scientific review of a PMTA, for example, includes a multi-disciplinary review that may
`include engineering, toxicology, behavioral and clinical pharmacology, microbiology, individual health impact and population health
`impact. However, we are taking a number of steps to enable us to complete as many reviews as we can, while not sacrificing the
`integrity of the premarket review process.
`
`Throughout the review process, we will strive to be as transparent
`as possible, while meeting all necessary requirements for non-
`disclosure of industry trade secrets and confidential commercial
`nformation. In the coming months, we plan to release data on the
`monthly progress (/tobacco-products/market-and-distribute-
`obacco-product/tobacco-product-marketing-orders) we've made in
`our review process, including metrics such as number of
`applications accepted and filed, in addition to metrics we already
`report on — such as the number of applications that we have taken
`final actions on (refuse-to accept, refuse-to-file, positive and
`"
`negative marketing orders, withdrawals) and the total applications
`received on a monthly basis. Although there may be some delays in
`the release of this information in the first few months, we will
`
`release information as quickly as possible.
`
`https://www.fda.gov/tobacco-products/ctp-newsroom/perspective-fdas-preparations-september-9-submission-deadline
`
`11/12
`
`1 199_RESP00016458
`
`
`
`9/16/2020
`
`Case 1:20-cv-00393-LO-TCB Document 1007-10 Filed 02/11/22 Page 13 of 13 PageID#
`Perspective: FDA's Preparations for the September 9 Submission Deadline I FDA
`28214
`In addition, we plan to make publicly available a list of the deemed new tobacco products that are subject to the Sept. 9 deadline,
`were on the market as of Aug. 8, 2016, and for which a premarket application is submitted by Sept. 9, 2020. However, before doing
`so, we will need to ensure that the publishing of any such information complies with federal disclosure laws and regulations as only
`certain types of product information from applications can be lawfully disclosed. We request your patience as we work through the
`appropriate processes to ensure the posted information is accurate and compliant with federal laws. In the interim, we encourage
`retailers and other interested parties to refer to the public statements made by the companies or contact the companies directly to
`get information about applications they may have submitted.
`
`Ensuring new tobacco products undergo a robust premarket evaluation by FDA is a critical part of our mission to protect the public
`health, particularly youth, and to reduce tobacco-related disease and death. While the authorization of a new tobacco product
`doesn't mean they are safe, through the premarket review process, FDA conducts a science-based evaluation to determine whether a
`new tobacco product meets the applicable statutory standard for marketing authorization—for example, whether the product is
`appropriate for the protection of public health with respect to the risks and benefits to the population as a whole, including users and
`nonusers, and taking into account, among other things, the likelihood that those who do not use tobacco products will start using
`them.
`
`Although there is much work ahead, conducting these premarket reviews is an essential part of the FDA's public health mission. Our
`staff has been working tirelessly for many years to make these processes as smooth as possible. As we approach Sept. 9 and beyond,
`FDA will continue to take meaningful steps to ensure we are protecting the public health from the harms associated with tobacco
`use.
`
`On Aug. 19, 2020, the U.S. District Court for the District of Columbia issued a ruling, in part, to prohibit FDA enforcement of the Tobacco Control Act's premarket authorization
`requirement for premium cigars until after the agency considers developing a streamlined substantial equivalence process specifically for premium cigars. Accordingly, FDA will not
`enforce the premarket review requirement against manufacturers of premium cigars that do not submit premarket applications for these products by the Sept. 9, 2020 deadline.
`Read the web statement (https://www.fda.govitobacco-products/ctp-newsroomictp-statement-premarket-authorization-requirements-premium-cigars).
`
`2. The Tobacco Control Act stated that tobacco products introduced into commercial distribution after February 15, 2007 — but before March 22, 2011 — could remain on the market if
`they were the subject of an SE Report submitted no later than March 22, 2011. A new tobacco product that meets both of these criteria can be legally marketed unless FDA issues a
`not substantially equivalent (NSE) order. By March 22, 2011, FDA had received nearly 3,600 applications that were classified as "provisional SE Reports" — nearly all of which were
`submitted within the final few days before the deadline. Read More (ht 1ps://www.fda.gov/tobacco-products/clp-newsroom/fda-updale-provisional-substanlial-equivalence-se-
`review-process)
`
`https://www.fda.gov/tobacco-products/ctp-newsroom/perspective-fdas-preparations-september-9-submission-deadline
`
`12/12
`
`1 199_RESP00016459
`
`