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Vapor Technology Association Amicus Brief In Support Of Fifth Circuit Rehearing En Banc

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New Orleans, LA – September 9, 2022  – The Fifth Circuit granted the Vapor Technology Association’s (VTA) unopposed motion to file an amicus brief in support of Petitioners’ Petition for a Rehearing En Banc in the case Wages & White Lion Investments, a/k/a/ Triton Distribution v. FDA.

Recently, a panel of Fifth Circuit judges denied Triton Distribution’s appeal of the FDA’s market denial order (MDO) for its flavored e-liquid products in a 2-1 decision.  Thereafter, Triton filed a Petition for en banc review, asking the entire Fifth Circuit to reconsider the ruling. 

VTA’s amicus brief supports Triton’s request by explaining that it involves issues of “exceptional importance” necessitating review by the entire Fifth Circuit Court of Appeals.   VTA’s amicus brief highlights three key points:

  1. Economist John Dunham & Associates’ evaluation of the adverse economic impact that the ruling would have if it lead to the removal of all flavored open-system vaping products from the states comprising the 5th Circuit (Louisiana, Mississippi, and Texas);
  2. The leading tobacco-control scientists who have warned that removing flavors will deter adult smokers from quitting and have recommended limiting the sale of flavored vaping products to adult-only stores; and
  3. The results of VTA analysis of FDA’s compliance data between 1/1/20 and 6/30/22 which reveals:
    1. The rate of illegal youth sales of cigarettes and cigars are twice the rate of vaping products;
    2. Of all violations for youth vaping sales, only 3.61% occurred in true brick and mortar vape shops with nearly 80% occuring in non-age-restricted facilities; and
    3. 60% of all youth vaping sales violations involved traditional tobacco flavors (tobacco, mint, menthol) with less than 40% involving other flavors which the 5th Circuit’s ruling would adversely limit.

VTA’s full amicus brief + the economic impact report is available HERE.

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Bloomberg Law Calls VTA Unlikely FDA Ally

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DEEP DIVE

The FDA has gained an unlikely ally in its plans to ban menthol cigarettes—a leading vaping trade group that wants to see smokers switch to e-cigarette products.

The agency received hundreds of thousands of comments on its effort to target menthol and other flavored tobacco products that can make smoking harder to quit. The Vapor Technology Association, which represents an industry typically known for its combative relationship with the Food and Drug Administration’s Center for Tobacco Products, says it wants to see the proposal go through, so long as the FDA authorizes more e-cigarettes as an alternative.

“Removing menthol cigarettes from the marketplace is an important step forward, presuming that the agency does what it needs to do in terms of securing and providing alternative products that are legal and authorized and getting them introduced into the marketplace,” VTA Executive Director Tony Abboud said in an interview.

One proposed rule (RIN 0910-AI60) would prohibit tobacco manufacturers and retailers from making, distributing, and selling cigarettes containing menthol as a flavor. The second (RIN 0910-AI28) would ban all characterizing flavors, including menthol, in cigars.

Public health and anti-tobacco groups say the proposals would go far in the FDA’s efforts to reduce negative health outcomes and disparities fueled by products disproportionately used by Black Americans and other minority groups. The FDA has warned that menthol can make smoking more addictive and appealing, especially among youth.

The vaping industry has long framed its products as a way for smokers to transition away from combustible tobacco. But health groups say that offering products as an off-ramp for traditional cigarette and cigar users isn’t part of the FDA’s mandate, and that there’s not enough evidence for the agency to take an official stance on e-cigarettes as a reduced-harm alternative.

The FDA has said it likely won’t be able to complete its review of tobacco-based e-cigarette marketing applications until June 30, 2023—nearly two years after a court-imposed deadline of Sept. 9, 2021. It’s so far authorized 23 electronic nicotine products and recently ordered Juul Labs Inc. to remove its products from the US market, but subsequently stayed that order pending further review.

The agency said in an email that it couldn’t comment on a specific timeline for reviewing public input on the menthol proposals, but added that it plans to “move carefully and quickly in considering all public comments received and determining next steps to protect public health.”

The FDA said it may ultimately “decide to end the rulemaking process, to issue a new proposed rule, or to issue a final rule.”

Harm Reduction

The VTA said in comments to the FDA that it supports the menthol ban in cigarettes, but that it should do more to help adult smokers.

“VTA promotes regulation that can hasten the reduction in smoking cigarettes and that focuses on the critical importance of tobacco harm reduction as an essential public policy objective,” the group said in its letter.

In addition to the proposed ban, the FDA should “simultaneously accelerate the review and approval of menthol vaping products and other flavored vaping products,” Abboud said in an interview.

“If you’re going to take away cigarettes from a large population of consumers that are addicted to those products, you must provide them alternatives,” Abboud argued.

“Otherwise, we fear the worst happens,” he added, noting 2021 research cited by the FDA that estimates nearly 46% of menthol smokers ages 35 to 54 would become non-menthol tobacco cigarette smokers after a ban.

“That is not the best public health outcome that we can have,” Abboud said. “When you think about how popular menthol cigarettes are, the goal is to get them off of cigarettes altogether.”

Youth Risks

Tobacco policy analysts say there isn’t clear evidence that e-cigarettes is a less harmful alternative, and that such benefit must be balanced with the risks that youth will become smokers through vaping.

In 2021, roughly 39% of middle- and high-school smokers in the US reported frequently using e-cigarettes, compared to 19% for cigarettes and nearly 21% for cigars, according to the Centers for Disease Control and Prevention’s annual National Youth Tobacco Survey.

The only people likely to benefit from flavored e-cigarettes as a reduced-harm alternative are current cigarette smokers, Joanna Cohen, director of Johns Hopkins University’s Institute for Global Tobacco Control, said.

“It’s not reduced harm when you’re not using any tobacco product,” said Cohen, who recently served as a voting member on the FDA’s Tobacco Product Scientific Advisory Committee.

Joelle Lester, director of Commercial Tobacco Control Programs at Mitchell Hamline School of Law’s Public Health Law Center, said that while e-cigarette companies have argued the “potential” for their products as a “harm reduction strategy or cessation strategy, they haven’t demonstrated it to the FDA.”

“We don’t have to wonder about the harm for youth initiation or the role that menthol plays, because we know a lot about that already,” Lester said. “I don’t think that those should hold equal weight.”

Health Disparities

Public health groups say that the FDA should move ahead quickly with the menthol and flavor bans as a pivotal step forward to address health disparities.

“FDA’s public health mission requires it to finalize the proposed rule to permit its life-saving benefits to be realized as quickly as possible,” the Campaign for Tobacco-Free Kids and the American Lung Association said in a joint letter to the FDA along with more than 100 other patient advocacy and medical groups.

They added that the tobacco industry “has targeted Black Americans with marketing for menthol cigarettes for decades,” and that “Black Americans suffer a disproportionate toll of the disease and death caused by menthol cigarettes.”

“By increasing cessation in these communities, the proposed rule will reduce smoking-related health disparities and increase health equity,” they added.

In a separate letter on the proposed flavored cigar ban, the groups said that these products use flavors to “help mask the harshness of cigars,” making them especially attractive among youth. They added that the tobacco industry “targets Black youth with cheap, flavored cigars,” resulting in a “disproportionate impact on underserved populations.”

Nearly 85% of non-Hispanic Black smokers report using menthol cigarettes, compared with just 30% of non-Hispanic White smokers, according to the FDA. The agency has also said that in 2020, the 30-day cigar smoking levels for non-Hispanic Black high school students were twice as high as White students.

Cohen said it’s “long overdue to get menthol cigarettes banned in this country,” as places like Canada and the European Union have already instituted similar policies.

Lester said that the FDA should also be “directing additional cessation support for whom this is an opportunity to quit smoking altogether,” especially communities of color that tobacco companies have historically targeted in their product marketing.

“It’s the FDA’s responsibility to deliver sufficient support in the same sort of targeted careful way,” Lester added. “We want to make sure we’re reaching the most affected communities.”

Michael Bloomberg has campaigned and given money in support of a ban on flavored e-cigarettes and tobacco. Bloomberg Law is operated by entities controlled by Michael Bloomberg.

(Updated with comments on the proposed cigar ban in the 26th paragraph.)

To contact the reporter on this story: Celine Castronuovo at ccastronuovo@bloombergindustry.com

To contact the editors responsible for this story: Alexis Kramer at akramer@bloomberglaw.com; Cheryl Saenz at csaenz@bloombergindustry.com

Celine Castronuovo

Reporter

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VTA Meets with FDA Again on Synthetic Nicotine PMTAs

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VTA MEETS WITH FDA FOR SECOND TIME IN
30 DAYS ON SYNTHETIC NICOTINE PMTAS

Washington, D.C. – May 3, 2022 –  As we reported on April 13, immediately after the new law governing synthetic nicotine was signed by President Biden, the Vapor Technology Association (VTA) knew that it had to engage with the U.S. Food & Drug Administration’s Center for Tobacco Products (CTP) on the issue of synthetic nicotine and we did so in early April.  During that meeting with dozens of CTP regulators from seven different offices inside CTP, we presented a thoughtful case for synthetic nicotine products that, to our knowledge, had not yet been made to any policy maker.  As we previously explained, we were encouraged by CTP’s level of engagement, but also knew that urgent follow up would be necessary given the arbitrarily short deadline imposed by Congress for the filing of synthetic nicotine pre-market tobacco applications (PMTAs).
To that end, yesterday, VTA’s Board of Directors and members conducted their second meeting in less than 30 days with CTP, this time with CTP’s Office of Science.  The meeting organized by our executive director ensured that the most relevant and accurate scientific picture of synthetic nicotine was presented through experts who have deep experience in tobacco and nicotine science and regulation, including Dr. Bill Jackson, PhD (Organic Chemistry), Dr. David Johnson, PhD (Physical Analytical Chemistry), Dr. Ray McCague, PhD (Organic Chemistry), and Dr. Willie McKinney, PhD (Inhalation Toxicology).  Importantly, Dr. Johnson and Dr. McKinney also have extensive experience with the FDA having, among other things, previously served on FDA’s Tobacco Products Scientific Advisory Council.
During the meeting, our experts were able to dig in on the science of synthetic nicotine explaining the processes by which synthetic nicotine is manufactured, the scientific purity of certain forms of synthetic nicotine, the similarities and differences between synthetic nicotine and tobacco-derived nicotine, the differences between synthetic nicotine products and cigarettes, and the numerous unique benefits that would be realized by the successful introduction of products containing synthetic nicotine into the marketplace.  Most importantly, we were able to discuss how science can and must be the driver of this PMTA process.
As with our first meeting, we are encouraged by the level of engagment by the Office of Science on this issue.  And, we greatly appreciate the participation of numerous FDA scientists from the various responsible divisions within the office with whom we were able to share our scientific knowledge and advanced thinking on the key issues.
But, our work is not done.  These meetings, and the additional meetings that we are working on, are just part of VTA’s multi-pronged strategy to ensure the proper and full assessment of synthetic nicotine PMTAs.  If your company is manufacturing products containing synthetic nicotine and is serious about regulatory compliance, or if your retail operation wants the ability to continue to diversify its retail offerings with synthetic nicotine products, or if you want to have continued access to innovative products containing synthetic nicotine, you should strongly consider being engaged in our strategic efforts.
To learn more about what you can do, please reach out to us. 
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VTA Meets with FDA; Makes Case for Synthetic Nicotine

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VTA Meets with FDA on New Federal Synthetic Nicotine Law
 Washington, D.C. – April 13, 2022 – After passage of the new law governing synthetic nicotine last month, VTA had to adjust its prior strategy and immediately began working on a strategy to ensure a viable path for companies which are selling products containing synthetic nicotine and which are serious about regulatory compliance.  A serious strategy for companies intending to file substantive applications would require at least two critical elements.
First, we knew that it would be critical to engage with FDA to give the Agency reasons to take seriously the PMTAs that will be filed.  We knew that we had to present to FDA the scientific and public health benefits to the consumer and the Agency of encouraging the development and marketing of products containing synthetic nicotine.   We knew that we had to counteract the narrative the synthetic nicotine products exist only to circumvent FDA regulation – a point that has been made by FDA and Members of Congress.  We knew that we had to give FDA new reasons to use its enforcement discretion to engage in a full scientific analysis of synthetic nicotine PMTAs.  And, we knew that we had to immediately act given the short time frames imposed by the new law.
To that end, last week, VTA’s Board of Directors and members met with the FDA Center for Tobacco Products (CTP) on the issue of synthetic nicotine.  In attendance was a large group of FDA personnel (35+), including senior leaders, representing seven different offices inside CTP dedicated to addressing the issue of synthetic nicotine.  Our team included presentations by three Ph.D’s in Organic Chemistry and Physical Analytical Chemistry, enabling us to frame critical scientific and public policy issues that we believe had not previously been presented to or considered by the FDA.  We are encouraged by the meeting and are now working on the necessary follow-up.
Second, we knew that it would be critical to educate Members of Congress on synthetic nicotine who have been fed a negative and narrow narrative that synthetic nicotine products are merely an attempt at circumventing regulation. It is clear that Members of Congress know little to nothing about how and why synthetic nicotine was invented or what synthetic nicotine products offer by way of benefits to the public.  To that end, VTA’s lobbying team – which has been working to defend the industry and promote a consistent message on harm reduction since 2015 – has developed a strategic plan for taking the same message we shared with FDA to Congress and for that we are going to need your help.
How You Can Help.  As with every other major challenge, we know that a sound and strategic approach can reap benefits but only if approached in a thoughtful manner and if supported with adequate resources.  VTA is the trade association that has had a continuous seven-year lobbying presence on Capitol Hill.  We have been at the center of every major fight on vaping.  While we have not won every fight, we played a pivotal role in every victory and, in so doing, dramatically extended the time our harm reduction industry had to grow.  Here are a few examples:
• getting the PMTA deadline extended from 2018 to 2022 (before it was snapped back to 2020),
• stopping multiple federal and state flavor ban bills,
• stopping Cuomo’s flavor ban executive order in court,
• convincing President Trump to reverse the flavor ban he announced in 2019,
• stopping the PACT Act bill three times before it finally passed, and
• defeating last year’s huge vape tax bill that would have imposed the first federal tax on vaping products which would have been 9 times higher than the cigarette tax.
If your company is manufacturing products containing synthetic nicotine and is serious about regulatory compliance, or if your retail operation wants the ability to continue to diversify its retail offerings with synthetic nicotine products, or if you want to have continued access to innovative products containing synthetic nicotine, we need your help and you need to be plugged into our campaign.  
So, please join our team and support our efforts today.  Your support has made everything we have done (and are doing) possible and will be critical to future success. 

SUPPORT OUR WORK ON SYNTHETIC NICOTINE!
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PMTA Deadline Arrives: Industry Steps Up

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PMTA DEADLINE ARRIVES:
VAPOR INDUSTRY RESPONDS

This is a BIG DAY for the vapor technology industry. The day that so many said could not come has arrived. And, just like with every other deadline imposed by the FDA, the vapor industry has stepped up to the task.

Once thought impossible, already reports are coming in of many manufacturers filing their Pre-Market Tobacco Applications (PMTAs) covering what is sure to be thousands of products. Congratulations to all those companies who dug in, did the hard work, gathered the science and submitted their PMTAs by the deadline. Yes, companies had to make some tough decisions along the way, but that was always expected as we headed into the final phase of the Deeming Regulation.

Last week, the FDA confirmed it will take each applicant’s individual circumstances into account during the review process. To be sure, FDA already has been quickly replying to early applicants and issuing initial acceptance letters accepting applications for a variety of products.

While this may feel like a finish line, it is really only the beginning of an ongoing process with FDA as CTP reviews each application submitted and engages with further questions of the applicants.

VTA will continue our existing dialogue with FDA to strongly advocate for our members participating in the process.  To that end, the process rolls out as follows:

Phase 1:  Administrative Review.  FDA initially reviews the application to make sure that basic requirements are in the application, it is in English, it includes required contact information and that it contains product identifying information. If these basic elements are included, a company should receive a letter from FDA accepting their application for further action. If not, FDA will send a “refuse to accept” letter.

Phase 2:Filing.  FDA engages in a preliminary scientific review to make sure that everything required by the statute is included, such as health risk data, HPHC studies, descriptions of components, ingredients, additives, and principles of operation, description of facility controls, manufacturing, etc.  If FDA finds these elements, a company will receive a letter accepting the application for filing.  If not, FDA will send a “refuse to file” letter.

Phase 3:  Substantive Review:  This is FDA’s full-blown evaluation of all the science and data presented in each application.  FDA will take recommendations from TPSAC and will engage with the applicant with questions.  This process could take up to 12 months and during this time FDA may send the applicant a deficiency letter, giving them 90 days to provide missing or deficient information.  If FDA has made a scientific decision to issue a marketing order, FDA will send an environmental information request letter before it can issue a final marketing order. Otherwise, FDA will send a “no marketing order” letter.

Phase 4:  Post Marketing Reporting.  As part of its approval process, FDA may require that the sale and distribution of your product is restricted (i.e., to protect kids).  Or FDA may require the applicant to establish and maintain certain records and make certain reports available to FDA.  Post market reports will vary based on submission and may include a requirement that the applicant engages in serious or unexpected adverse experience reporting or any manufacturing deviations.

VTA’s full, in-depth analysis summarizing the important developments for those impacted by the PMTA deadline, particularly as it relates to FDA’s enforcement now that the PMTA deadline has been reached, can be found here. 

Gov. DeSantis Vetoes Flavor Ban SB 810!

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VAPOR TECHNOLOGY ASSOCIATION APPLAUDS GOVERNOR DESANTIS FOR DECISION TO VETO ADULT FLAVOR BAN BILL

Governor DeSantis is the First Governor to Veto A Flavor Ban

Washington, D.C. – September 9, 2020 – The Vapor Technology Association (VTA) applauds Florida Governor Ron DeSantis (R) for his decision to veto SB 810, a flavor ban. SB 810 was passed by the legislature in March of this year under the mistaken belief that it would raise the age to purchase vapor products to 21. But, due to federal legislation passed in December 2019, the legal age to purchase vapor products was already 21 in Florida making that portion of the bill “superfluous” in the Governor’s words.

“Governor DeSantis has shown true leadership and understanding in his decision to veto SB 810,” said Tony Abboud, Executive Director of the Vapor Technology Association. “On behalf of all the vapor companies, large and small, and the more than one million vapers in the state of Florida, VTA thanks Governor DeSantis for his bold decision to protect Florida’s public health and economy, which comes at a time of great uncertainty for many. This is the positive reinforcement the industry and the people of Florida need.”

The Vapor Technology Association worked closely with the Florida Smoke Free Association, a VTA member association, to educate legislators throughout the legislative session and had moved a meaningful regulatory bill that would have provided real solutions to the core issue of youth access and/or appeal. However, that effort was tossed in favor of an unnecessary and last minute flavor ban, disguised as a bill that would merely raise the age to 21.

Immediately after the bill’s passage in March, VTA went to work on a multi-media veto campaign strategy that involved:

  • the VapersSayVeto call to action site,
  • the industry’s only television advertisement directed at the Governor,
  • a social media drumbeat, and
  • professional economic analysis from VTA economist John Dunham & Associates

The statewide campaign educating the Governor and his advisors on the negative public health and economic impacts of SB 810 was deployed in cooperation with the Florida Smoke Free Association, which also delivered sophisticated and passionate messages of their own to the Governor.

Moreover, VTA’s economists prepared a report and were deployed to explain that, if enacted, this bill would have removed $605.6 million from Florida’s economy, cost $41.3 million in state and local tax revenue, and put more than 4,500 Floridians out of work. In addition, VTA’s economist testified before the Florida Office of Economic Development Review Committee and was asked to provide additional data for consideration leading to the commission announcing that SB 810 would have serious adverse tax implications for Florida’s economy.

Governor DeSantis took the time to learn about the industry’s impact in the state and understand the legislation’s negative consequences, as seen in his veto transmission letter to Florida’s Secretary of State Laurel Lee. He also recognized that this bill would not achieve its goal of reducing youth vaping. We are pleased that the Governor’s thoughtful veto message clearly reflected the same core issues that we presented in VTA’s request for a veto.

VTA has led national efforts to address underage use of e-cigarettes. Our comprehensive plan announced last year, ensures controlled distribution of all tobacco products, including e-cigarettes, and to impose real limits on access and appeal of all tobacco products to youth. Flavor bans like SB 810 are not effective, rather they eliminate adult alternatives to dangerous cigarettes for adult smokers and devastate small businesses. VTA commends Governor DeSantis for listening to his constituents and understanding the real public health policy implications at stake, specifically, that flavor bans will lead to an unregulated black market and will drive adults back to smoking dangerous cigarettes.

About the Vapor Technology Association

The Vapor Technology Association is the U.S. non-profit industry trade association whose 1000+ members are dedicated to innovating and selling high quality vapor products that provide adult consumers with a better alternative to traditional combustible cigarettes. VTA represents the industry-leading manufacturers of vapor devices, e-liquids, flavorings, and components, as well as the largest wholesalers, distributors, importers, and e-commerce retailers, in addition to hundreds of hard-working American brick-and-mortar retail store owners throughout the United States. Follow us on Twitter.

For Manufacturers and Retailers

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PMTA UPDATE FOR MANUFACTURERS & RETAILERS
August 31, 2020

As the September 9, 2020, Pre-Market Tobacco Application (PMTA) deadline is rapidly approaching, VTA members are working feverishly on finalizing their applications for submission to FDA. This update summarizes some important developments that will impact everyone involved. Specifically, we first address manufacturer-related updates and then retailer-related updates. 

MANUFACTURER UPDATE

FDA Says It Will NOT Extend September 9 Deadline: Late on Friday afternoon, we received an e-mail from FDA, responding to our request for an extension of the PMTA deadline, saying that FDA will not extend the September 9 deadline. The FDA wrote, in part:

“Dear Mr. Abbound [sic]: Thank you for contacting the U.S. Food and Drug Administration’s (FDA’s or the Agency) Center for Tobacco Products (CTP) to request an additional extension of the premarket application deadline on behalf of your members with deemed new tobacco products.  […]

FDA has received many individual requests for a further extension of the September 9, 2020, premarket application deadline. After considering your request, FDA has determined that it will not grant a further extension of the September 9, 2020, premarket application deadline set by the Court for members’ products. Any additional delay would impede FDA’s critical public health priority to promptly require submission of premarket tobacco applications.”

Important Guidance for Companies Filing Applications: In the email, FDA went on to explain that it “intends to prioritize enforcement decisions on a case-by-case basis such as prioritizing enforcement based on the likelihood of youth use or initiation. However, FDA intends to take individual circumstances into account as it considers your members’ premarket tobacco product applications that are submitted by the September 9, 2020, deadline.” 

Because FDA is making decisions on a case-by-case basis, it is imperative that you make your specific case if, for example, there are certain elements that may be incomplete in your application. Specifically, FDA said:  “FDA encourages your members to explicitly identify any content that may be missing from an application and clearly explain how COVID-19, a recent natural disaster, or other unforeseen circumstance has affected ability to provide such information.”

Also, FDA has said that it will work with companies to get their applications through the process during the 12-month review period under certain circumstances: FDA wrote: “If an application is sufficient to be accepted, filed, and proceed to scientific review and, during such review, your member would subsequently provide the needed information and make substantial progress toward addressing deficiencies in an application, we intend to take that into account in deciding whether to initiate enforcement action against products for being on the market without premarket authorization, even where FDA is reviewing applications after September 9, 2021. The decision as to whether to enforce after the one-year review period may take into account responsiveness to our requests, the particular nature and extent of scientific evidence that is lacking, and evidence of demonstrated hardship due to the COVID-19 pandemic, recent natural disasters, or other unforeseen circumstance in obtaining such evidence.”

In addition to extending the deadline, VTA has encouraged FDA to work with companies as they navigate the process. Last Friday’s email sends the message that, while they are not moving the deadline further, they are planning to take into account each companies’ special circumstances. 

Today, FDA published another statement regarding upcoming PMTA submissions. The “Perspectives” piece published today by FDA today covers a number of topics. Here are the most relevant:

FDA Expects a Large Number of Applications and the One Year Review Timeline May Be Exceeded.  FDA acknowledged “there are over 400 million deemed products listed with FDA. 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 magnitude greater than anything the Agency has experienced.” […]  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.”

FDA Will Work With Companies By Sending Deficiency Letters:  “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.” Giving companies an opportunity to cure deficiencies in their applications, rather than simply rejecting the application, is something we have encouraged FDA to do.

FDA Says It Will Devote Resources to Expedite Review for both Small and Large Manufacturer Applications: Director Zeller wrote, “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.  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.”

RETAILER & DISTRIBUTOR UPDATE

Many of our retailers are asking about what they can expect and what they should do regarding the upcoming PMTA deadline. Here’s a quick update on FDA planned actions that affect retailers.

Will There Be a Sell-Through Period After September 9, 2020?  No. Unlike with prior regulations for which FDA has permitted a “sell-through” period allowing the continued sale of non-compliant products (i.e., non-compliant labels), there will be no sell-through period allowed for non-compliant products after September 9, 2020.  In other words, if a product SKU is not covered by a PMTA that has been accepted for review by the FDA, or if a manufacturer has simply failed to file any PMTA, those products cannot continue to be legally sold after September 9, 2020.

So What Happens on September 10, 2020? In the past, FDA has focused its initial enforcement activity around manufacturers and importers rather than at the distributor and retail levels of the supply chain as this is the most efficient use of its limited enforcement resources. Importantly, it will take FDA some time to compile a list of those products for which it has received PMTAs in order to begin its enforcement activity. 

FDA to Publish PMTA List: Last month, VTA made a specific request to the FDA that it change its prior practice and publish a list of the products covered by PMTAs so that retailers and distributors have a clear understanding of the specific products (not just brands or manufacturers) for which FDA has received an application. Today, FDA announced, “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.”  FDA will do this while also respecting the confidentiality requirements under the Federal Food, Drug and Cosmetic Act.  FDA also noted that while the deadline is on September 9, 2020, it will take FDA some time for them to compile and confirm that their list is accurate before publication. The fact that FDA will be publishing such a list is dramatic change from their prior practice. In the meantime, we will do our best to inform you of VTA members which are participating in the process.

FDA Has Suspended In-Person Inspections:  In March, due to COVID-19, FDA issued a partial stop-work order instructing all of the agencies with which it contracts at the state level to stop doing compliance checks and vape shop inspections.  This suspension of in-person retail enforcement activity is likely to continue until COVID-19 restrictions begin to lift, but FDA has stated it plans to continue its monitoring of social media, websites and publications and will issue warning letters when needed.

FDA Will Continue Its Enforcement Priorities: In February 2020, and more recently the FDA outlined and reiterated its enforcement priorities.  FDA will continue to focus its enforcement efforts on:

  1. Flavored cartridge-based ENDS products.
  2. All other ENDS products for which the manufacturer has failed/fails to take adequate measures to prevent access or use by minors.
  3. Any ENDS products that are targeted to minors or which are likely to promote use by minors.
  4. Manufacturers which have not filed PMTAs on or by September 9, 2020.

What Can Retailers Do Now?  Beginning on September 9, 2020, retailers can ask manufacturers for specific information on whether their products are covered by a PMTA.   Each manufacturer may have a different method of providing you with evidence that it has filed PMTAs for its products, including, for example, a redacted version of its Cover Letter or proof of submission through the electronic filing portal.  While FDA is not currently performing in-person inspections, they will likely resume soon after COVID-19 restrictions are lifted. So, if inspections resume before FDA publishes the list of products for which PMTAs have been filed, you can insulate yourself from potential exposure by having on hand documentation from your manufacturers regarding the product that you have on the shelves.

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