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FDA’s Formal Position on Enforcement Discretion Revealed

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VTA presses CTP on clarifying enforcement discretion policy

The “million dollar” question: CTP has historically allowed all tobacco products with pending pre-market tobacco applications (PMTAs) to remain on the market, subject to FDA’s enforcement discretion, but in the past few months has been making confusing statements particularly with respect to non-tobacco nicotine (NTN) products, also known as synthetic nicotine products. Following up on VTA correspondence from early November 2022, we asked Director King directly during our January 10, 2023 meeting: “Has CTP had changed its well-established enforcement discretion policy for non-tobacco nicotine products only?”

What we said: It’s extremely important that we get clarity on this question so all market participants understand CTP’s position and so that companies are not able to misrepresent CTP’s position for their own benefit.

  • For years, CTP has used enforcement discretion to allow all tobacco products with pending PMTAs to remain on the market and that policy should be consistently applied to tobacco-derived and non-tobacco derived nicotine products alike.
  • CTP has exercised enforcement discretion for years. CTP has asked courts not to limit its enforcement discretion. CTP has explained its actions or inactions based on enforcement discretion.
  • Some companies have been attempting to confuse retailers and dissuade them from carrying synthetic nicotine products by claiming that CTP uses enforcement discretion only for tobacco-derived nicotine products and not for synthetic nicotine products.
  • Nothing in the new law limited CTP’s enforcement discretion – in fact, CTP has been exercising that discretion – and CTP would never unilaterally limit its own discretion.

What FDA said: During the January 10 meeting Director King indicated that had been no policy change with respect to CTP’s use of enforcement discretion.  Director King promised a formal letter soon from CTP in response to VTA’s questions to clarify CTP’s position.

King to VTA: FDA has no enforcement discretion policy for TDN or NTN products!

VTA received a letter from Director King on February 2, 2023 outlining CTP’s formal position on enforcement discretion regarding tobacco-derived nicotine (TDN) and non-tobacco/synthetic nicotine (NTN) products.

About Face: The formal response letter promised from Director King stated, among other things, that:

  • TDN products are not being treated differently than NTN products.
  • CTP has not been using enforcement discretion for tobacco-derived nicotine products or synthetic nicotine products.
  • All products, regardless of whether they include tobacco-derived nicotine or synthetic nicotine, are illegal and cannot be sold unless and until their PMTAs have been authorized.

Go deeper: While CTP has always acknowledged that FDA was using its enforcement discretion, that has changed. Here is how CTP recasts its historical and current position:

“Accordingly, your letter’s assertion that FDA is “us[ing] its enforcement discretion to allow…products to remain on the market” while they undergo review is not correct. On the contrary, as the guidance reiterates, all illegally marketed TDN e-cigarette products are subject to FDA enforcement. The same principle applies to NTN products; specifically, all illegally marketed NTN products are subject to enforcement.”

“FDA cannot affirmatively allow or permit the unlawful marketing of tobacco products, including TDN and NTN e-cigarette products; as the above statements reflect, all illegally marketed products are subject to FDA enforcement, such a seizure, civil money penalty, or injunction. Moreover, FDA has not adopted a broad policy of enforcement discretion with respect to TDN or NTN e-cigarette products that lack the required premarket authorization.”

Why Now?

  • Sure, VTA has been pressing CTP on clarifying the question of enforcement discretion for months.
  • But, it is worth noting that CTP’s letter (three months in the making) was received just one day after Sen. Richard Durbin (D-IL) and other Senators issued another yet another press release and sent a letter to HHS Secretary Xavier Becerra blasting CTP for its, yes, “exercise [of] enforcement discretion,” and demanding “This enforcement discretion should have ended years ago. It must end today.”
  • According to CTP’s letter, they have never been using and are not using enforcement discretion for any nicotine-containing product.

Takeaway. As far as the FDA is concerned, every nicotine product that is on the market without having already received a PMTA authorization (even if that PMTA is still being reviewed by FDA) cannot be marketed. And, there is no enforcement discretion preference for tobacco-derived nicotine products as compared with non-tobacco/synthetic nicotine products. They are all in the same boat from FDA’s perspective.

VTA Letter to King
King Letter to VTA

VTA Presents to Reagan-Udall Foundation Reviewing CTP

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Comments of the Vapor Technology Association

Presented by Tony Abboud, Executive Director

INTRODUCTION

Good morning.  The Reagan-Udall Foundation’s mission[1] of “modernization,… accelerating innovation and enhancing product safety” could not be better applied to any other product category within the FDA’s ambit of authority than less harmful nicotine products.

This review couldn’t have come at a more important time and Commissioner Califf should be applauded for calling for it and Director King should be applauded for embracing it. FDA’s new leaders have an historic opportunity to dramatically change public health in the U.S. by boldly correcting errors of the past, eliminating political interference in the scientific process, providing a clear roadmap for the approval of less harmful nicotine products, and accelerating innovation away from the deadliest product on the market – the combustible cigarette.

But, this will not happen, if at all, at a fast enough pace to save the lives of millions of Americans who still smoke cigarettes unless serious process changes are made.

What has the Agency done well?  

You have asked us to address three components and I will start with what the FDA has done well.

  1. In 2017, Commissioner Gottlieb announced a Comprehensive Plan for addressing tobacco and nicotine issues.  Foreseeing the challenges of PMTA compliance, Gottlieb extended the deadline for filing from 2018 to 2022 since the agency still needed to “issue foundational rules to make the product review process more efficient, predictable, and transparent for manufacturers.” The comprehensive plan also expressly acknowledged the continuum frisk and that ENDS products fall at the lower end of the risk continuum when compared to cigarettes.
  2. CTP issued an ANPRM on the important issue of flavors to examine their impact on initiation and on smoking cessation.
  3. CTP has effectively administered its Substantial Equivalence application process for reviewing new tobacco products.  

What has the Agency not done well?

Unfortunately, these positive steps have not led to the successful execution of CTP’s mission.

Since January 2020, CTP’s efficient management of the SE process has bizarrely resulted in the authorization of 600 new combustible tobacco products, 250 of which are new cigarettes. In contrast, FDA’s management of the PMTA process has authorized only 6 less harmful ENDS devices, some of which are antiquated technologies and/or have virtually no market presence.  How did this happen?

First, the FDA abandoned its Comprehensive Plan and did everything but create the “efficient, predictable, and transparent” process Gottlieb said was necessary. 

CTP never finalized the “foundational rule” for PMTAs before applications were filed and it acquiesced to a 2-year acceleration of the filing deadline notwithstanding the unavailability of that final rule. This forced companies to rely on non-binding guidance, rush scientific research and data collection, submit redundant applications, and conduct unnecessary testing. 

Second, CTP failed to apply the continuum of risk in its comparative assessment of ENDS to cigarettes and also failed to distinguish between open and closed ENDS products.

Third, CTP abandoned its ANPRM on flavors in 2018, ignoring the enormous body of science presented by all stakeholders, including VTA’s substantive review of all flavor studies.

Fourth, CTP altered its review process and standards AFTER applications had been accepted for substantive review, using those changes to deny countless PMTAs all without conducting that substantive review, and failed to balance all the prongs of the APPH test, choosing instead to use single alleged deficiencies to deny applications.

These actions plunged the entire category into chaos and CTP’s decisions into protracted litigation.

This was all driven by an exclusive focus on youth and flavors which has been directly criticized by the 15 past presidents of SRNT, the most esteemed group of tobacco-control scientists, as threatening the chances of adult smokers to quit. I’ll briefly explain one example of how the Agency’s prior interim leadership allowed outside influences to subvert the PMTA scientific process on this issue alone.  

Flavor Example

In August 2020, CTP’s Office of Science documented its process for reviewing applications for flavored ENDS products and explained that it anticipated approving such products as APPH.  At a June 11, 2021 public meeting, the Office of Science transparently explained the process and priorities it was using to review PMTAs.

Two weeks later, when FDA’s Acting Commissioner Woodcock testified before a Congressional committee on June 23, committee members demanded that Woodcock deny JUUL’s PMTAs and deny any flavored e-liquid PMTAs claiming thatwas her responsibility regardless of the science.

Immediately after the hearing, I learned from those inside the FDA that Woodcock injected herself on the  flavor issue. Two weeks thereafter, CTP documented Woodcock’s interjection in a now infamous July 9 “fatal flaw” memorandum, explaining that the Office of Science was “tasked” by the Acting Commissioner to implement a “new plan” to “take final action” on as many flavored ENDS applications as possible – a complete reversal of both the process and priorities they announced less than one month earlier.

The memorandum articulated a review process which imposed a new testing prerequisite, 11 months after the applications were filed. CTP created a new “presumption” that all flavored products are attractive to youth to justify the new requirement for long-term product specific studies on cessation and a heightened standard for flavored ENDS.  CTP’s scientists were forced to alter their process to ensure the blanket rejection of virtually all flavored applications and did so without even reviewing the applications and science submitted.  The process change effectuated a de facto policy change and as it was unfolding in September 2021, I heard from people inside FDA who were stunned that the Agency had changed its position “without any scientific support.”

This leads me to recommendations.

RECOMMENDATIONS

  1. CTP must implement safeguards to ensure that the review process is free of external pressures. I have only highlighted one of many examples. Unless the process is insulated, CTP will never be allowed to execute its mission.
  2. Unapologetically follow the science and announce approvals.  The Office of Science must be allowed to complete its reviews and when it authorizes applications, those decisions should immediately and loudly be announced to the marketplace. 
  3. Immediately reverse the fatal flaw memo and actually review the science presented.  This means not imposing a non-product-specific presumption regarding initiation (i.e. that ALL flavored products are attractive to youth) while demanding “product specific” data regarding cessation.
  4. Restore the primacy of APPH balancing test. This means treating the cessation and population benefits prong equally to the initiation prong.  This means conducting a holistic review and not singling out one set of data on which it justifies denials.
  5. Use CTP’s enforcement discretion to work companies through the PMTA process.  Virtually all PMTAs have been submitted on grossly accelerated timeframe. Working with companies that can comply with the requirements and providing them the time necessary to complete the required science ensures a stronger process. This particularly applies to FDA’s recently acquired non-tobacco nicotine authority. This also applies to smaller manufacturers who don’t have large scientific staff or resources.
  6. Avoid rejections based on administrative or technical failings.  CTP has refused to accept certain otherwise robust applications because of technicalities. In these cases, reviewers should be authorized to pick up the phone and get those technicalities cured, rather than plunge the agency into protracted and wasteful litigation
  7. Establish defined testing methods.  This should be done for HPHC testing and while ensuring those methods are consistent with normal human use.
  8. Eliminate redundant and unnecessary testing.  For example, biomarker studies and inhalation studies are irrelevant when companies have presented data showing a dramatic reduction (or absence) of toxins.
  9. Use the full scope of its post-marketing order authority. In balancing the APPH, CTP should rely on post-market surveillance and post-market consumer studies to monitor its authorizations and suspend or withdraw a marketing order if it finds new evidence would so justify it.
  10. Equally fund research proposals.  FDA funded research is critical to the review process. To date, the agency has only funded research purporting to identify problems, i.e., youth initiation. CTP should equally fund research on smoking cessation.

CONCLUSION

In conclusion, today, CTP is stuck, trapped if you will, managing a monstrous rule of its own creation.  It needs direction from this Foundation to impose a transparent set of requirements and to ensure strict and fair adherence to science-based decisions.  As a final note, CTP needs to appreciate that the entire application approval process is being made virtually irrelevant due to the Agency’s inability to stop the flow of products into this country from companies ignoring the regulatory process. It is our hope that the Reagan-Udall Foundation’s review will ultimately create an “efficient, predictable, and transparent” process and, in so doing, make real the promise of less harmful nicotine products.

[1] Mission of R/U and mission of the FDA: “The Reagan-Udall Foundation for the Food and Drug Administration is an independent 501(c)(3) organization created by Congress “to advance the mission of the FDA to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety.”

VTA Amicus Brief In Support of 5th 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.

Bloomberg Law Calls VTA Unlikely FDA Ally Copy

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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

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. 

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.
  • 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!
CHOOSE YOUR OPTION BELOW TO ENGAGE!

Negative Economic Impacts of Omnibus Synthetic Nicotine Language – STATE BY STATE

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NEGATIVE ECONOMIC IMPACTS OF THE
PROPOSED SYNTHETIC NICOTINE LANGUAGE 

IN THE FEDERAL OMNIBUS BILL

This morning it was revealed that Congressional leaders are planning to include language in the federal Omnibus spending legislation that would effectively ban synthetic nicotine.  This would occur because the proposed bill would impose a Pre-Market Tobacco Application (PMTA) filing deadline of just 90 days after passage for any product containing synthetic nicotine.  Everyone who understands anything about PMTAs knows that no such application can be filed within that short timeframe, particularly because FDA requires at least 6 months of scientific data for such an application.

Our economist, John Dunham & Associates, evaluated the negative economic impacts that this legislation would reap for the U.S. and for each state.  Here are the findings for the United States:

LOST JOBS:                                   16,100

LOST WAGES:                               $ 802,216,700

LOST ECONOMIC OUTPUT:        $ 2.5 billion

—————————————

LOST FEDERAL & STATE TAXES:   $328,188,500

LOST CONSUMPTION TAXES:       $198,930,000

TOTAL LOST TAXES:                       $527,118,500

You can find the details on the negative impact on the U.S. economy here.

Also, you can find the negative impact on YOUR state below.

STATE BY STATE BREAKDOWN OF LOST JOBS, WAGES, TAXES AND ECONOMIC OUTPUT

Alabama

Alaska

Arizona

Arkansas

California

Colorado

Connecticut

Delaware

Florida

Georgia

Hawaii

Idaho

Illinois

Indiana

Iowa

Kansas

Kentucky

Louisiana

Maine

Maryland

Massachusetts

Michigan

Minnesota

Mississippi

Missouri

Montana

Nebraska

Nevada

New Hampshire

New Jersey

New Mexico

New York

North Carolina

North Dakota

Ohio

Oklahoma

Oregon

Pennsylvania

Rhode Island

South Carolina

South Dakota

Tennessee

Texas

Utah

Vermont

Virginia

Washington

West Virginia

Wisconsin

Wyoming

The Negative Economic Impacts of the New Nicotine Tax Imposed Only on Vapor Products In the Reconciliation Bill (HR 5376)

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Prepared by John Dunham & Associates


for the Vapor Technology Association

December 2021

THE NEGATIVE ECONOMIC IMPACTS OF THE
NEW NICOTINE TAX IMPOSED ONLY ON VAPOR PRODUCTS

IN THE RECONCILIATION BILL (HR 5376)

Executive Summary

Background

  • The vapor product industry is an important part of the US economy.  About $8.1 billion in vapor sales lead to 133,600 jobs and $22.1 billion in economic activity. 
  • About 35,000 of these jobs are held by people working for the over 9,850 independent adult-only, retail vape shops located across the country.  Even so, the number of independent adult-only, vape shops has fallen by 27 percent since 2018 as a result of new state and federal taxes and regulations. 
  • Congress is currently deciding whether to impose a new tax only on vapor products of 2.78-cents per milligram of nicotine, believing that such a tax would “equalize” or create “parity” with cigarette taxes.
  • Conclusions
  • Our analysis finds that the bill would not create anything close to parity with cigarette taxes but, rather, would tax vapor products at a much higher rate – up to nine times higher – than the tax on a pack of cigarettes.
  • Our analysis also finds that, if passed, the proposed nicotine tax in the Reconciliation Bill:
  • Would lead to a net price increase on vapor products at retail of about 53 percent (21.2 percent for a standard two-pack of closed-system pod products and 73.5% for a standard 60 milliliter bottle of open system e-liquid), while the price of cigarettes and other tobacco products would remain unchanged as they would not be subject to any additional federal tax.
  • Would lead to a reduction of nearly 42,800 full-time equivalent jobs and the loss of $2.2 billion in wages and benefits.
  • Would negatively impact the size of the overall economy which would fall by about $7.0 billion.
  • Would result in states and their localities losing $620.1 million in taxes while the federal government attempts to generate revenues.
  • Would lead to a loss of about 31.9 percent of vapor product sales or 3.7 million milliliters of e-liquid consumed.  Of this loss, 61.2 percent would be the result of consumers switching to other tobacco products, including combustible cigarettes.  An additional 18.5 percent of these lost sales would move to the black market.

Table 1
Economic Impact of Proposed Nicotine Vapor Product Tax Increase

 DirectSupplierInducedTotal
Jobs-21,331-8,974-12,470-42,776
Wages-$869,866,251-$636,356,853-$707,328,020-$2,213,551,124
Economic Output-$2,562,607,363-$2,205,386,235-$2,255,024,480-$7,023,018,078
State and Local Taxes   -$620,087,422

Background on the Proposed Nicotine Tax Increase in HR 5376

The U.S. Senate is currently considering the Reconciliation Bill, known as HR 5376, which was recently passed by the U.S. House of Representatives.  As passed by the House, HR 5376 would impose a new tax only on e-cigarettes or vapor products containing nicotine that are manufactured in or imported into the United States in the amount of $50.33 per 1,810 milligrams of nicotine.  The nicotine tax rate would be $0.0278 for each milligram of nicotine in a vapor product ($50.33 / 1810 milligrams of nicotine = 2.78-cents/mg). In HR 5376, taxes on existing tobacco products, including combustible cigarettes, would remain unchanged.[1]


The proposal claims to equalize the tax on e-cigarettes at the same rate as cigarettes, at least at the Federal level, in an effort to create parity between the products.  However, our analysis finds that the bill would not create anything close to parity with cigarette taxes but, rather, would tax vapor products at a much higher rate – up to nine times higher – than the tax on a pack of cigarettes.

The current federal tax on cigarettes is $50.33 for every 1000 cigarettes, which amounts to a federal tax of $1.01 for a pack of cigarettes ($50.33 / 1000 = $0.05033 x 20 cigarettes per pack).  

A pack of cigarettes contains approximately 204 milligrams of nicotine (10.2 mg/cigarette x 20 cigarettes per pack).  Applying the proposed nicotine tax of 2.78-cents per milligram to cigarettes, means that the tax on a pack of cigarettes should be $5.41, not $1.01. 

Viewed another way, the federal tax on cigarettes, if applied to their nicotine content, would only amount to less than half a penny per milligram, not the 2.78-cents Congress seeks to impose on e-cigarettes ($1.01 per pack / 204 mg of nicotine per pack).

As defined in the bill, the proposed tax would be equal to about $2.22 on the standard closed system nicotine vapor product (such as a two pack of JUUL pods), and an astonishing $10.01 on the standard average 60 milliliter bottle of nicotine containing e-liquid used in an open system vapor device. The following table shows the significant tax differential on a per unit and as a percentage of the retail price for each of these products and demonstrates that HR 5376 fails to create any parity, but significantly overtaxes e-cigarettes, making cigarettes more financially attractive.

Table 2
Comparison of Proposed Nicotine Tax to Actual Cigarette Taxes in the United States

 Cigarettes(pack)Closed-System Vape (2-pods)Open-System Vape (60ml)Cigarette Tax < Closed-SystemCigarette Tax < Open-System
Tax Per Unit$1.01$2.22$10.01-120.3%-891.1%
Tax as Percent of US Retail $14.4%21.2%73.5%-47.1%-410.2%
Tax Per Mg of Nicotine0.5-cents2.8-cents2.8-cents-461.6%-461.6%

The Negative Effect of Recent Taxes and Restrictions on the Vaping Industry

The nicotine vapor industry is an important segment of the American economy; however, a range of new laws including a ban on most flavored nicotine vapor products, increased age-of-use, and the imposition of taxes and bans at the state and local levels have already led to significant losses in jobs and tax revenues from the sector.

The first comprehensive analysis of the economic impact of the industry in the country was completed in 2018.[2] At that time, over 166,000 jobs depended on the production and sale of vapor and electronic cigarette products. Those holding these jobs received nearly $7.9 billion in wages and benefits, while generating almost $24.5 billion for the US economy.  (Table 3)

In 2018, the Federal government received about $1.9 billion in various tax revenues from the industry’s businesses and employees. State and local governments received about $1.5 billion in tax revenues from the industry and its employees, and an additional $909.0 million in state excise and sales tax revenues from adult consumers who purchased nicotine vapor products during that year. (Table 3)

Table 3

Economic Impact of Nicotine Vapor Industry in the United States (2018)

 DirectSupplierInducedTotal
Jobs87,58129,42748,999166,007
Wages$3,277,220,400$2,092,844,100$2,527,825,000$7,897,889,500
Economic Output$9,151,211,700$7,272,386,500$8,033,914,100$24,457,512,300
     
Federal Taxes   $1,860,313,877
State and Local Taxes   $2,359,821,765
  Taxes on Businesses and Employees  $1,450,820,541
  Consumption Taxes   $909,001,224
Total Taxes   $4,220,135,642

 Of the jobs created by the industry in 2018, nearly 87,600 were direct jobs, including people working in the vapor product manufacturing and distribution chain, and most importantly, 58,430 jobs were at small, independent vapor retail stores, or vape shops.[3],[4]  (Table 4)

Table 4

Breakdown of Independent Vape Shop Jobs (2018)

 JobsPercent of JobsStores
Direct Jobs87,574100.0% 
Vape Shop Jobs58,42966.7%13,481

In 2021, we completed a full review of the current vapor industry to determine the current state of the industry.[5]  We found that following the imposition of significant restrictions on the sale of these products at the Federal, state and local levels, the impact of the vapor industry has decreased by about 11.6 percent.  Even so, it is still a major contributor to the US economy, and an even larger taxpayer.  (Table 5) 

While employment is down by about 32,400 jobs in the industry itself (or 24.2 percent), sales are down by just 11.6 percent.  At retail, due to higher prices, sales are down by just 9.7 percent.  However, this was before the FDA required that most vapor product producers pull their items from the shelves.[6]

Overall, due to higher state excise and sales tax rates, the amount collected by government’s has increased by about $494.2 million or 11.7 percent.

Table 5

Current Economic Impact of Nicotine Vapor Industry in the United States (2021)

 DirectSupplierInducedTotal
Jobs66,36428,09839,111133,575
Wages$2,741,178,400$2,018,273,300$2,243,794,900$7,003,246,600
Economic Output$8,087,436,700$6,879,165,500$7,124,240,600$22,090,842,800
     
Federal Taxes   $1,480,211,544
State and Local Taxes   $3,234,123,298
  Taxes on Businesses and Employees  $1,351,790,191
  Consumption Taxes   $1,882,333,107
Total Taxes   $4,714,334,842

A new federal tax on nicotine of 2.78-cents per milligram, as proposed in HR5376 will increase smoking in the United States, as people switch from more expensive vapor products to less expensive cigarettes. Not only will cigarette taxes be substantially lower than vapor taxes under the House bill, but the bill will increase cigarette sales.

In fact, the tax is regressive and a new tax on consumers making less than $400,000 a year.  It would also make cigarette taxes 9 times lower than those on less harmful vapor products.


The Negative Economic Effects of a New Regressive Tax on Nicotine Vapor Product Sales

Based on an analysis conducted by JDA, were the Federal government to impose a new tax on the sale of nicotine vapor products in HR 5376, the impact on the economy would be more than $7.0 billion, with as much as 3.7 billion milliliters in lost sales.[7] 

As many as 42,800 jobs would be lost throughout the country – at a time when nearly 2.6 million people are looking for work. Moreover, the jobs lost as a result of the proposed tax would result in a loss of $2.2 billion wages. Further, state and local governments would lose about $620.1 million in taxes from the vapor industry and its consumers.

Table 6

Economic Losses Resulting from a 2.78-cents per MG Tax on Nicotine Vapor Products

 DirectSupplierInducedTotal
Jobs-21,331-8,974-12,470-42,776
Wages-$869,866,251-$636,356,853-$707,328,020-$2,213,551,124
Economic Output-$2,562,607,363-$2,205,386,235-$2,255,024,480-$7,023,018,078
State and Local Taxes   -$620,087,422

Most importantly, a large number of the remaining 9,847 independent adult-only vapor shops would likely be forced to close, since their fixed costs could far outweigh any remaining sales.

These small, often family-owned retailers have already suffered under the regulations imposed on vapor products.  Between 2018 and 2021, over 3,630 of these stores have shut their doors, putting almost 23,500 people out of work.  These are real people, with real jobs, located throughout the United States.[8]

Table 7

Losses in Adult-Only Vapor Shops Since 2018

As of 2021JobsPercent of JobsStores
Direct Jobs66,364100.0% 
Vape Shop Jobs34,95752.7%9.847
Change from 2018JobsPercent ChangeStoresPercent Change
Direct Jobs-21,210-24.2%  
Vape Shop Jobs-23,472-40.2%-3,634-27.0%

Nicotine Tax Will Increase Cigarette Smoking and Black Market Sales

Economists have long known that for all normal goods, such as vapor products, higher prices lead to lower sales.  That is the nature of most markets and was first contemplated by the 256th couplet of Tirukkural, which was composed around the year zero.[9]

It was not until 1767 that the phrase “supply and demand” was first used by Scottish writer James Denham-Steuart in his Inquiry into the Principles of Political Economy.[10] Adam Smith popularized the term in his 1776 book The Wealth of Nations and brought it to the forefront of economic theory.[11]  In effect, higher taxes lead to higher prices which in turn would lead consumers to either: 

  1. Completely stop using nicotine products,
  2. Switch to another tobacco product, such as cigarettes,
  3. Continue to vape but purchase their products over the already growing black market.

Table 8

Shift in Vapor Sales to Combustible Cigarettes or Other Nicotine Products

 MillilitersPercent
Current Vapor Sales11,692,582,699 
Lost Vapor Sales-3,732,570,585 
   
Of Which  
  Switch to Other Products-2,283,717,02861.2%
  Quit-757,711,82920.3%
  Black Market-691,141,72918.5%

JDA’s modeling suggests that a large portion of consumers would react by purchasing unregulated products over the black market or make their own e-liquids. Overall, the market for vapor products would fall by about 31.9 percent, with 18.5 percent of that shifting to black market sales.  Of the remaining 81.5 percent of lost sales, 20.3 percent would be due to vapor users quitting the use of nicotine products entirely, while the remainder, 61.2 percent would result from consumers shifting to other nicotine-based products including combustible cigarettes.[12]

These figures (which reflect a price increase resulting from the tax of 53 percent) are conservative and are not out of line with other studies examining the substitution of vapor products and combustible cigarettes when taxes are imposed. 

For example, a study analyzing Minnesota’s 2013 tax on e-cigarettes suggested that it led to increased adult smoking and reduced smoking cessation.  The analysis suggested that there was cross elasticity of current smoking participation with respect to e-cigarette prices of 0.13.[13]  Note that this suggests that a 53 percent increase in the price of vapor products would increase smoking incidence by 6.89 percent.  Since about 34.1 million Americans currently smoke cigarettes, this would lead to an increase in the number of smokers of 2.16 million individuals.[14]  Since an estimated 8.1 million adults are vapor users, this would mean that more than a quarter of these people would switch to cigarettes.[15]

Still other studies have shown even higher demand elasticities and levels of substitution that are modeled here.[16]

– John Dunham & Associates, 2021

[1] See Rules Committee Print 117-17 Text Of Hr 5376, Build Back Better Act, November 3, 2021, found at https://rules.house.gov/sites/democrats.rules.house.gov/files/BILLS-117HR5376RH-RCP117-18.pdf 

[2] The Vapor Industry Economic Impact Study (2018), Prepared for Vapor Technology Association, by John Dunham & Associates, April 29, 2019.

[3] Ibid.  This includes as many as 3,094 jobs (803 shops) in Florida, 2,832 jobs (614 shops) in Ohio, 2,280 jobs (533 shops) in Pennsylvania, 1,522 jobs (359 shops) in Michigan and 898 jobs (204 shops) in Wisconsin.

[4] In addition, there are 11,920 full-time equivalent jobs created by vapor product sales at traditional retailers like supermarkets, convenience stores, drug stores, and department stores.

[5] The Vapor Industry Economic Impact Study (2021), prepared for Vapor Technology Association, by John Dunham & Associates, September 20, 2021.

[6] See for example: FDA Denies Marketing Applications for About 55,000 Flavored E-Cigarette Products for Failing to Provide Evidence They Appropriately Protect Public Health: Action Marks First Marketing Denial Orders for E-Cigarette Products; Press Release, Food and Drug Administration, August 26, 2021, at: https://www.fda.gov/news-events/press-announcements/fda-denies-marketing-applications-about-55000-flavored-e-cigarette-products-failing-provide-evidence

[7] Based on a multi-state, multi-market demand model developed for the Vapor Technology Association by John Dunham & Associates, 2021.

[8] The proposed federal tax on vaping liquids would harm small businesses, resulting in a 31.9 percent reduction in their overall sales. Very few businesses can withstand such a reduction in revenues.

[9] Chendroyaperumal, Chendrayan, The First Laws in Economics and Indian Economic Thought – Thirukkural, SSRN, January 29, 2010, at: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=1545247 The citation states: if people do not consume a product or service, then there will not be anybody to supply that product or service for the sake of price.

[10] Steuart, James, An Inquiry Into the Principles of Political Oeconomy: Being an Essay on the Science of Domestic Policy in Free Nations, James Williams; and Richard Moncrieffe, 1770.

[11] Smith, Adam, An Inquiry into the Nature and Causes of the Wealth of Nations, (London: Methuen and Co., Ltd.), 1904.

[12] Quit rates from: Estimating Consequences of a Ban on the Legal Sale of Menthol Cigarettes, prepared by Compass Lexecon for Lorillard Tobacco Company, January 19, 2011.  On-line at: https://www.thecre.com/ccsf/wp-content/uploads/2011/03/compass_1_19_2011.pdf  According to its website, Compass Lexecon is one of the world’s leading economic consulting firms.

[13] Based on a 40.7 percent increase in price. See: Saffer et al., E-Cigarettes and Adult Smoking: Evidence from Minnesota, NBER Health Economics Program, December 2019, at: https://www.nber.org/papers/w26589

[14] Fast Facts and Fact Sheets, Centers for Disease Control and Prevention, at: www.cdc.gov/tobacco/data_statistics/fact_sheets/index.htm?s_cid=osh-stu-home-spotlight-001

[15] Villarroel, Maria, et. al., Electronic Cigarette Use Among U.S. Adults, 2018, NCHS Data Brief No. 365, April 2020 at:  www.cdc.gov/nchs/products/databriefs/db365.htm

[16] Cotti, Chad, et al., The Effects of E-Cigarette Taxes One-Cigarette Prices and Tobacco Product Sales: Evidence From Retail Panel Data, National Bureau of Economic Research Working Paper 26724, Revised April 2021, at: http://www.nber.org/papers/w26724

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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