Several court cases challenging the U.S. Food and Drug Administration’s issuing of marketing denial orders (MDOs) in response to its review of premarket tobacco product applications are still pending. Last week, three high profile tobacco harm reduction advocates filed their fourth amicus brief in support of companies that are challenging the FDA.
Credit: Sang Hyun Cho
Clive Bates, director of Counterfactual Consulting, David Abrams, a professor of social and behavioral sciences at the NYU College of Global Public Health, and David Sweanor, adjunct professor of law at the University of Ottawa, filed the latest brief in support of Chicago-based Gripum LLC, which has had its MDO temporarily stayed by the court while the FDA’s actions are reviewed.
“The PMTA process and [appropriate for the protection of public health] APPH test do not apply to combustible cigarettes, which have a much less onerous path to market; accordingly, the most dangerous products are easily accessible throughout the United States, and their manufacturers do not face the threat of financial ruin from FDA’s regulatory burdens and determinations,” the brief states. “FDA’s regime for evaluating ENDS amounts to a major barrier to entry for less harmful products than cigarettes and unjustified regulatory protection of the incumbent combustible cigarette trade. The harms arising from adult and adolescent cigarette smoking far outweigh the harms arising from youth use of ENDS.”
The group also addressed the FDA’s having established an onerous new standard of evidence in PMTAs. The FDA has admitted to using a “fatal flaw” checklist to deny over one million PMTAs without further consideration because they do not provide randomized controlled trials, cohort studies, or other types of (unspecified) evidence that FDA had retrospectively deemed necessary. They also state that the APPH test doesn’t differentiate between adults and youth.
“The APPH test applies to the ‘population as a whole.’ There is no distinction drawn between adolescents and adults in the Act. In some circumstances, ENDS use can be beneficial to adolescents who would otherwise smoke,” the brief states. “As a matter of policy, FDA chooses to take no account of such benefits to youth, but that approach is incompatible with the APPH test in either the PMTA pre-market review process TCA §910(c)(4) or in rulemaking for setting product standards §907(a)(3).”
The group filed similar briefs in three other cases: Triton v FDA – Fifth Circuit (17 Nov 2021), My Vape Order v FDA – Ninth Circuit (24 Nov) and Bidi Vapor v FDA – Eleventh Circuit (24 Nov).
The health groups that brought forward the submission deadline for U.S. premarket tobacco product applications (PMTAs) through litigation have asked the federal judge in that case to require the Food and Drug Administration to regularly report on its PMTA review process, reports Vaping360.
On Nov. 15, an attorney representing the plaintiffs sent a letter to U.S. District Court Judge Paul Grimm. The groups want Judge Grimm to force the FDA to explain its progress on PMTAs submitted by mass-market vaping brands.
“Plaintiffs will seek a modification that would require FDA to provide regular status reports to the Court giving FDA’s estimate of the date(s) by which it expects to complete its review of the Premarket Tobacco Product Applications (PMTAs) for all products for which PMTAs were filed by Juul, Vuse, NJOY, Blu, SMOK, Suorin, and any other brands that rank among the top 10 brands in market share, according to FDA,” wrote attorney Jeffrey Dubner on behalf of his clients.
Earlier in the review process, the FDA announced it would prioritize its resources to complete assessments of the most popular products first. But when the agency’s self-imposed one-year review deadline rolled around, the FDA had made no decisions on the products with the greatest market share.
To date, the FDA has ruled on only one mass-market vaping product—Vuse Solo, a dated product with limited market share.
In addition to asking Judge Grimm to monitor the FDA’s PMTA review progress on popular vape brands, the plaintiffs complain that the agency has not taken any enforcement actions against companies still waiting for a PMTA decision.
The plaintiffs in the lawsuit against the FDA are the American Academy of Pediatrics and its Maryland chapter, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, and Truth Initiative.
Court records show the FDA failed at reviewing submitted PMTA data as required and only looked for specific studies.
By Timothy S. Donahue
The term “fatal flaw” was used by the U.S. Food and Drug Administration for premarket tobacco product application (PMTA) submissions that didn’t have specific studies. The term has been at the center of nearly all lawsuits filed against the FDA for its handling of the PMTA process.
In court records reviewed by Voice Voice submitted in the Triton Distribution v. U.S. FDA case requesting a stay of the marketing denial order (MDO) the e-liquid manufacturer received from the FDA, the regulatory agency submitted an administrative record for the review of Triton’s PMTA that shows the agency did not fully review all PMTA data submitted, as required by law, but instead only looked for specific studies relating to flavors and youth use.
A memo dated July 9, 2021, written by Anne Radway, the associate director of the FDA’s Center for Tobacco Products’ Office of Science, states that “based on the information available to date, FDA has determined this evaluation requires evidence that can demonstrate whether an applicant’s new non-tobacco flavored product(s) will provide an incremental benefit to adult smokers relative to the applicant’s tobacco-flavored product(s). In particular, the evidence necessary for this evaluation would be provided by either a randomized controlled trial (RCT) or a longitudinal cohort study. The absence of these types of studies is considered a fatal flaw, meaning any application lacking this evidence will likely receive a marketing denial order.”
Radway goes onto explain that due to the large number of PMTAs received, the agency would only conduct a Fatal Flaw review of PMTAs for non-tobacco flavored ENDS products.
“The Fatal Flaw review is a simple review in which the reviewer examines the submission to identify whether or not it contains the necessary type of studies. The Fatal Flaw review will be limited to determining presence or absence of such studies; it will not evaluate the merits of the studies,” Radway states. “To decrease the number of PMTAs without final action by September 9, 2021, [Office of Science] used a database query to identify the top twelve manufacturers with the largest number of pending PMTAs [in the substantive review stage of the process] … Following completion of filing those applications that are filed will immediately initiate Fatal Flaw review.”
Radway also states that for the remaining PMTAs not in [substantive review] for non-tobacco flavored e-liquid products, FDA will send a “General Correspondence letter requesting the applicant to confirm if their PMTA contains such evidence and, if so, to direct FDA to the location in the application where the studies can be found.”
During the first day of TMA’s “From Chance to Change” webinar on Nov. 17, panelists were disturbed by the findings that the agency, rather than reviewing a submission on its merits, simply searched for the presence or absence of certain studies.
Brittany Cushman
Brittani Cushman, senior vice president, general counsel and secretary at Turning Point Brands said that the “idea that so many of the applications were reviewed with an eye toward this so-called fatal flaw analysis” didn’t “feel like the right direction” for the PMTA review process.
The FDA admitted it made an error in TPB’s PMTA review and TPB did in fact submit studies that the agency decided during the PMTA process were needed, after saying for years the studies were not required. The FDA then rescinded TPB’s MDO and placed its applications back into substantive review. The agency has since rescinded or a court has stayed MDO’s for 10 companies and the agency is currently facing at least 45 lawsuits for it handling of the PMTA process. This is in addition to the dozens of requests for supervisory review.
“The way the review process has played out this far, really, feels like the incentive structure in the nicotine industry has been placed on its head,” explained Cushman. “It seems that the lower-risk products are receiving heightened scrutiny, kind of an opaque direction as to what’s sufficient. And it just doesn’t feel like these products are getting a kind of equitable treatment in the space.“
Triton Distribution had their MDO stayed by the 5th Circuit Court of Appeals with the court holding that Triton is likely to succeed on the merits of its case because the FDA “changed its regulatory requirements” and that this “switcheroo” to now require a randomized controlled trial and/or a longitudinal cohort study – which the Agency previously stated on numerous occasions would not be required – was arbitrary and capricious under the Administrative Procedure Act.
The court stated that the FDA failed to “reasonably consider the relevant issues and reasonably explain” the MDO. The Court further noted that FDA failed to consider Triton’s marketing plan, surveys, and evidence of potential benefits of flavored e-cigarettes. FDA also “failed to consider the company’s legitimate reliance interests, as Triton relied on FDA’s statements made in numerous public meetings, guidance documents and rulemakings” that it did not expect applicants would need to conduct long-term studies to support their PMTAs.
Cushman told webinar watchers that, at the end of the day, the FDA’s regulatory treatment of the various product categories is to the detriment of the adult smoker.
“We’re all down in the weeds of this. But it’s difficult to see how we ended up at this point. And it certainly can’t be where anyone wanted this process to play out,” she said. “I think this has led to a lot of detrimental outcomes. You have adults seeing a large number of vapor products being deemed as not appropriate for the protection of public health while seeing no change in [combustible] cigarette offerings in their local C-store … This is being celebrated not only by those who are ignorant to the science, but more perversely, those [who understand the science and should] know better.”
For more on this session from TMA 2021 read the next issue of Vapor Voice coming in mid-December.
A divided panel of the U.S. Court of Appeals for the Sixth Circuit rejected Breeze Smoke LLC’s application of a stay of the U.S. Food and Drug Administration’s order Friday, denying the company’s premarket tobacco product application (PMTA) for some of its vaping products.
In Breeze Smoke LLC v. FDA, the Sixth Circuit rejected the Fifth Circuit’s conclusion that the FDA had orchestrated a “surprise switcheroo” in the PMTA review process. This creates an interesting circuit split that might attract Supreme Court interest, according to Reason’s Jonathan Hadler.
The Sixth Circuit’s order, on behalf of Judges Moore and Gilman, concluded that the FDA had never committed itself to accepting PMTA applications for flavored vaping products that lacked long-term studies. Rather, the FDA had merely indicated that “it might accept evidence other than long-term studies, if that evidence had sufficient scientific underpinnings to meet the [Tobacco Control Act’s] statutory mandate of demonstrating that flavored ENDS devices are appropriate for the protection of public health” (emphasis in original).
Thus the court concluded that Breeze Smoke had failed to demonstrate the strong likelihood of success on the merits necessary to support a stay. Judge Kethledge dissented, noting his agreement with the Fifth Circuit’s decision in Wages and White Lion Investments LLC v USFDA.
While rejecting Breeze Smoke’s stay request, the Sixth Circuit panel did note some concern with the FDA’s handling of the company’s application, particularly its “formulaic consideration” of Breeze Smoke’s plans to prevent marketing to youth. This failing, and the impact of a PMTA denial on Breeze Smoke’s business were still not enough to convince a majority of the panel to enter a stay however.
The U.S. Food and Drug Administration devastates small businesses with a plethora of marketing denial orders.
By Timothy S. Donahue
At press time, the U.S. Food and Drug Administration had yet to approve an electronic nicotine-delivery system (ENDS) product for sale in the U.S. But it had killed much of the U.S. market for such products. As of Sept. 23, the agency had issued 323 marketing denial orders (MDOs) accounting for more than 1,167,000 flavored vaping products. In addition, the FDA previously refused to accept (RTA) or refused to file (RTF) a significant share of the nearly 7 million applications it received from more than 500 companies.
At least four lawsuits contesting MDOs have been filed in the 2nd, 4th, 6th and 11th Circuit Courts of Appeals against the FDA. Turning Point Brands (TPB) filed a petition for review with the United States Court of Appeals for the 6th Circuit. The petition forced the FDA to provide an administrative record for its decisions on PMTAs. TPB sells various flavored e-liquids marketed under the Solace, VaporFi and Vapor Shark brands.
In a surprise move as this magazine was going to press, the FDA rescinded Turning Point Brands’ MDO. The FDA admitted it made an error in TPB’s PMTA review and TPB did in fact submit studies that the agency decided during the PMTA process were needed, after saying for years the studies were not required. The FDA had not yet responded to the remaining cases as of press time.
“Upon further review of the administrative record, FDA found relevant information that was not adequately assessed,” the FDA letter to TPB states. “Specifically, your applications did contain randomized controlled trials comparing tobacco-flavored ENDS to flavored ENDS as well as several cross-sectional surveys evaluating patterns of use, likelihood of use, and perceptions in current smokers, current ENDS users, former tobacco users, and never users, which require further review.”
TPB was asking the court to review the FDA order “on the grounds that it is arbitrary and capricious, an abuse of discretion, contrary to the Federal Food, Drug and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act of 2009, and otherwise not in accordance with law.” The company requests the court “vacate or modify” the FDA order and asks that TPB be allowed to “continue to market the products subject to the challenged order.” Bidi Vapor filed a similar suit in the U.S. Court of Appeals for the 11th Circuit, BMF (Bad Modder Fogger) filed in the 4th Circuit and Magellan Technology, parent to DemandVape, has filed in the 2nd Circuit (those lawsuits are still active).
Credit: CASAA
In addition to its arbitrary claim, Magellan also claims in its court petition that the “FDA’s issuance of an MDO in the absence of a finalized rule” setting forth the required contents of a PMTA is unlawful. “FDA’s adoption of a comparative efficacy standard for the granting of a marketing order for non-tobacco- and non-menthol-flavored ENDS products versus tobacco-flavored ENDS products is, in reality, a disguised tobacco product standard that has been adopted and is being applied by FDA through adjudication rather than adopted through notice-and-comment rulemaking,” states Magellan’s petition.
According to Mitch Zeller, the director of the FDA’s Center for Tobacco Products (CTP), many of the accepted applications ultimately received an RTF letter because they did not include required information. “For example, companies received RTF letters for not including required content such as ingredient listings, labels for each product to be marketed or adequate environmental assessments,” he wrote.
In a joint news release with Zeller and acting FDA Commissioner Janet Woodcock, the FDA explained that the applications from many MDO recipients “lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by the levels of youth use” of ENDS products.
The PMTAs submitted by TPB and subsequently denied market access and the brought back under review by the FDA included an in-depth toxicological review, a clinical study and studies on patterns and likelihood of use, according to a motion to stay filed by TPB on Sept. 30. “In light of the unusual circumstances,” the FDA’s Center for Tobacco Products (CTP) Director Matt Holman stated in the letter. “FDA has no intention of initiating an enforcement action” against TPB’s products that had previously received an MDO.
Many of the current lawsuits against the FDA accuse the FDA of many of the same issues TPB’s withdrawn suit claimed. For example, TPB’s stay said the agency had moved the goalposts for data needed to receive a marketing order based on what the agency “learned” from the “review [of] PMTAs for flavored ENDS so far,” according to the stay. TPB noted that the “North Star of administrative law” is that agencies cannot induce regulated parties to rely on “agency representations about regulatory requirements” then penalize them using the previously unannounced criteria after the fact.
“But that is precisely what FDA did here,” the stay motion states. “[The] FDA reasoned that TPB failed to conduct ‘a randomized controlled trial and/or longitudinal cohort study’ or other studies performed ‘over time’ to show that TPB’s specific flavored products help adult users stop smoking more than tobacco-flavored products do. Yet FDA previously deemed these studies unnecessary.”
Tony Abboud, executive director of the Vapor Technology Association, suspects the FDA made an internal policy decision to change the PMTA standard to make it impossible after the fact for a company to comply and get a flavored ENDS application approved. “I think that that decision is being implemented application by application, which I don’t believe is fair under the law,” said Abboud. “I think that the refocusing on open system flavored e-liquids is a direct result of the public and political pressure that was placed upon the FDA by Congress, which expressly said they were trying to interfere with the regulatory process.”
What’s in a name?
Critics say the FDA has made several “sloppy” mistakes in reviewing PMTAs and issuing MDOs. Numerous companies say the agency was inconsistent in banning flavors based solely on the flavor’s name. Bidi Vapor’s parent, Kaival Brands, said that the agency banned its “Arctic” flavor, misidentifying it as a “not-menthol” flavor. TPB also says in its stay motion that the FDA is forcing TPB to pull nonflavored products from the market; however, the FDA’s order applies to “Authentic Tobacco” and “Bold Tobacco” yet not “Classic Tobacco” (which the FDA is still considering).
Credit: Cursed Senses
“Those are the same flavors with the same formulations; they just use different names across product lines. The same goes for ‘Ripe Tobacco’ (forbidden) and ‘Smooth Tobacco’ (reprieve) and for ‘Mint’ (banned) and ‘Mighty Menthol’ (allowed for now),” the stay explains. “It is anyone’s guess why some of these products must exit the market immediately yet others might pass muster if FDA actually reviews TPB’s studies.”
Since January 2021, the agency has issued at least 170 warning letters to firms that collectively have listed more than 17 million ENDS products with the FDA and that did not submit premarket tobacco product applications (PMTAs) for the products by Sept. 9, 2020. Applications for products manufactured by major companies, such as Vuse, Juul, Logic and blu, are still under review. During this time, the agency also granted substantial equivalence (SE) status (marketing approval) to over 350 combustible products from the cigar, pipe and hookah tobacco product categories.
Amanda Wheeler, president of the American Vapor Manufacturers Association (VMA) and the owner of Jvapes e-liquids (see “No Surrender,” page ?), assisted more than 230 small-sized to mid-sized e-liquid manufacturers in submitting PMTAs for more than 1.7 million products. Nearly all of those applications received either an RTA, RTF or an MDO.
Wheeler tweeted on Sept. 9 that it was a “tough day” for the industry because “lots of very good people who I respect deeply and who helped thousands of smokers quit got told by our government that their products were illegal. To all of you, I am so very sorry. To your customers, I am even more sorry. Our government is wrong on this.”
Before the announcement, many industry experts said that banning most e-cigarettes from the market could harm public health. In a commentary published on the Reason Foundation’s website, Guy Bentley, the organization’s director of consumer freedom research, states that the sooner that U.S. public health officials embrace vaping’s potential to improve public health by reducing smoking and smoking-related deaths, “the better off we’ll all be.” The result of shutting down a vast portion of the vape industry, he warns, will be more smoking.
Anti-vaping activists, by contrast, argued for a ban on e-cigarettes. In a recent blog post, Laurie Rubiner, executive vice president of domestic programs at the Campaign for Tobacco-Free Kids, and Linda Mendonca, president of the National Association of School Nurses and an assistant professor at the Rhode Island College School of Nursing, wrote that the “evidence is clear” that as long as any flavored e-cigarettes remain on the market, kids will get their hands on them (no reference to evidence was provided).
“To truly protect kids and end the youth e-cigarette epidemic, the FDA must eliminate the flavored and high-nicotine products—including the popular menthol flavor—that have driven this crisis,” the pair write. “Parents, educators and health advocates are counting on the FDA to take them off the shelves.”
Tom Miller, attorney general for the state of Iowa, said the FDA actions against flavors endanger public health. He said that the best science available indicates that most youths are not getting e-cigarettes from vape shops and that a significant number of adults are using products from vape shops to move away from combustible cigarettes.
“Let’s not forget the overwhelming risk to public health: The CDC [U.S. Centers for Disease Control and Prevention] estimates the burden of tobacco use in the United States is 480,000 lives a year, all of which is due to the use of cigarettes,” Miller said in a statement. “We believe in the strong, science-based regulation of alternative tobacco products, and the FDA is the best agency to undertake that task. Policymakers must strike the right balance between making accessible potentially lifesaving lower risk nicotine products while discouraging use by those who wouldn’t smoke, especially youth.”
Impacts of regulation
Several studies have suggested that if vape product sales were restricted to tobacco flavors, many would return to combustible tobacco. One study found that approximately one-third of U.S. vapers aged 18 to 34 say flavor bans would push them back to smoking traditional cigarettes. The study published in Nicotine & Tobacco Research analyzed data from February to May 2020 and looked at 2,159 young adults in Atlanta, Boston, Minneapolis, Oklahoma City, San Diego and Seattle, examining support for e-cigarette sales restrictions and the perceived impact of flavor and vaping bans.
Credit: JHVEPhoto
Two other recent studies showed similar results. A study in JAMA Pediatrics showed that following San Francisco’s flavor ban, teens were more likely to smoke than those in other school districts. A different study in Nicotine & Tobacco Research shows that teens who vape would be smoking cigarettes if vapes hadn’t become available.
Recent evidence also seems to show that the overall youth use of e-cigarettes in the U.S. is declining. According to the 2021 National Youth Tobacco Survey (NYTS), the FDA and the CDC found that youth use of e-cigarettes fell sharply in 2021. It’s the second consecutive year of major declines. As is typical in the release of the NYTS data every year, media reports about the NYTS were all over the board. One headline read, “Big Drop in U.S. Teen Vaping with Covid Closures” while another read, “Teen Vaping Craze Shows No Sign of Slowing.”
The study shows that an estimated 11.3 percent (1.72 million) of high school students and an estimated 2.8 percent (320,000) of middle school students reported current e-cigarette use, lower than the 19.6 percent (high school) reported in 2020 and substantially lower than the 27.5 percent (high school) reported in 2019, according to previous FDA statements. Middle school vaping fell to 2.8 percent this year from 4.7 percent in 2020—a 40.4 percent decline. Middle school past 30-day vaping in 2020 fell 55.2 percent from 2019.
Chris Allen, chief scientific officer at Broughton, a contract research organization (CRO) delivering analytical, scientific and regulatory services for the ENDS industry, said that the FDA might well be using the NYTS to justify the “flurry of MDOs” issued for flavored e-liquids. He also said the majority of the companies that have fallen foul of the recent MDOs are responsible manufacturers supporting tobacco harm reduction.
“I completely accept that youth use is unacceptable; however, the issue doesn’t appear to lie primarily in open systems but a product that is currently outside the jurisdiction of FDA: a disposable containing synthetic nicotine,” Allen said. “Regardless of the product, or the source of nicotine, there’s no place for irresponsible marketing and distribution practices that keeps adding fuel to this fire. I fear that the latest action is simply going to lead to a seismic shift into the black market and unregulated (synthetic nicotine) products, which will be near on impossible for the U.S. government to control. From my personal perspective, this doesn’t seem an appropriate way to support THR [tobacco harm reduction].”
Industry representatives predict major battles at the state level. “States are just going to ban the sale of any non-FDA approved product,” said a vape shop owner, who asked not to be identified as he had not yet received an MDO. “This is just going to be a never-ending stream of court battles. I hope every company is at least considering appealing the MDO decisions. The whole PMTA process was a giant bait-and-switch.”
Manufacturers that submitted their applications by the Sept. 9, 2020, deadline but who have not yet received an MDO can effectively continue to sell their products as no ruling has been made on them; however, the FDA has made it clear that any company that does continue to sell these products will be doing so unlawfully, although they are not likely to face any enforcement action due to the agency’s limited resources.
Numerous companies are appealing their MDOs. Many are appealing MDOs they believe were wrongly issued because the PMTAs were for tobacco and/or menthol flavors. The AVM is helping its member companies file formal appeals with the FDA because the agency “in their sloppy haste, FDA not only threw out flavored products. They also threw out many [companies] [regular] tobacco and menthol flavors. We’re starting with some of those appeals specifically for what we feel were sort of administrative errors with tobacco and menthol and also working on broader appeals.”
Companies can also contact the CTP’s Office of Small Business Assistance (OSBA) with general questions regarding statutory and regulatory requirements, including the appeals process. Another option is the FDA Office of the Ombudsman, the agency’s “focal point for addressing complaints and assisting in resolving disputes between companies.”
Deanna Clark with the Clark-Esposito Law Firm stated in a blog post that each company must submit its own submission appealing the FDA decision. Companies should not send in an appeal combined with other companies, she cautioned. “Next, you want to address arguments refuting [the] FDA’s basis for your denial. It can’t just be where you’re complaining about how it’s unfair and the government sucks,” said Clark. “You need to use some rational basis behind what you’re submitting to them. And thirdly, you need to submit it to the right office and make sure it gets to the right people within the right timeframe.”
The e-cigarette saga with the FDA is far from over. Between lawsuits and appeals, many decisions may eventually be left out of the hands of the FDA entirely. The FDA’s ombudsman and appeals court judges could now decide the fate of flavored e-liquids. Congress could possibly step in and change the statutes, but many have said that is unlikely. The industry is also still waiting for decisions on the PMTAs filed by the major tobacco companies, and if anyone is approved, it may open the door for standard equivalency products. The only thing that hasn’t changed in the vaping industry is its uncertain future.
The U.S. Food and Drug Administration has rescinded another marketing denial order (MDO), placing Fumizer’s flavored vapor products back under review, reports Filter. Fumizer received its MDO in September.
This rescission comes just weeks after the agency withdrew an MDO issued to Turning Point Brands (TPB).
In a letter to Fumizer’s, the FDA stated that “upon further review of the administrative record, FDA found relevant information that was not adequately assessed previously.”
“Specifically,” the letter states, Fumizer’s “application did contain randomized controlled trials comparing tobacco flavored ENDS [electronic nicotine-delivery systems] to flavored ENDS as well as several cross-sectional surveys evaluating patterns of use, likelihood of use and perceptions in current smokers, current ENDS users, former tobacco users and never users, which require further review.”
The FDA has indicated that it “does not intend to initiate an enforcement action” on Fumizer’s flavored vapor products returning to the market during the new review.
Many MDO recipients have complained that the FDA has been “shifting its goal posts,” during the review process, demanding certain studies that it did not appear to require before the PMTAs were filed.
According to industry insiders, the most recent MDO recission demonstrates that TPB’s successful petition for review and motion for a stay wasn’t a one-off, resulting from the legal jurisdiction it was filed in.
“A rescission in California for Fumizer is evidence of the systemic failure of the agency to ‘adequately assess’ the science and data of a wide range of small- and mid-sized applicants while giving all of their time and attention to the large companies like Juul and Reynolds,” a source told Filter
Multiple companies have challenges their MDOs. Triton, Bidi and Gripum recently received some temporary form of stay, and My Vape Order has demanded a recission due to the fact its PMTA includes some of the same data and studies that also appears in TPB’s applications.
The U.S. Food and Drug Administration has authorized the marketing of four oral tobacco products that are no longer on the market—Verve Discs Blue Mint, Verve Discs Green Mint, Verve Chews Blue Mint, and Verve Chews Green Mint, manufactured by Altria subsidiary U.S. Smokeless Tobacco Co.
“We are pleased that FDA has determined that Verve oral nicotine products are appropriate for the protection of public health,” said an Altria spokesman. “While we discontinued selling Verve on Feb. 2, 2019, we applied learnings from this successful application to our on! submissions, which remain under review by FDA. Oral nicotine products play an important role in our vision of moving beyond smoking and remain an important part of our portfolio of products to transition adult smokers away from cigarettes.”
In a press release dated Dec. 17, 2018, Altria said it would stop the production and distribution of Verve oral nicotine products based upon the expected financial performance of these products and the regulatory restrictions that burdened the company’s ability to quickly improve these products. “We do not see a path to leadership with these particular products and believe that now is the time to refocus our resources,” wrote Chairman and CEO Howard Willard at the time.
It its Oct. 19, 2021, marketing order, the FDA said it had determined the marketing of Verve products would be consistent with the statutory standard, “appropriate for the protection of the public health.” This includes a review of data showing that youth, nonsmokers and former smokers are unlikely to initiate or reinitiate tobacco use with these products.
“Ensuring new tobacco products undergo a robust premarket evaluation by the FDA is a critical part of our mission to protect the public—especially kids,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products, in a statement.
“While these are mint flavored products, data submitted to the FDA show the risk for youth uptake of these particular products is low, and stringent marketing restrictions will help prevent youth exposure. Importantly, evidence shows these products could help addicted smokers who use the most harmful combusted products completely switch to a product with potentially fewer harmful chemicals.”
Wages and White Lion Investments, parent to Triton Distribution, has been granted a stay of the marketing denial order (MDO) it received from the U.S. Food and Drug Administration. The panel of judges for the U.S. Court of Appeals for the Fifth Circuit issued the order on Oct. 15 that also granted motions to expedite the appeal case and a ruling for emergency relief.
Credit: Pixelbliss
The motion granted means the company can continue to market its electronic nicotine-delivery system (ENDS) products until the court decides on the company’s appeal of the FDA’s decision to deny its premarket tobacco product applications (PMTAs).
Triton Distribution filed a motion to stay after the FDA denied the company’s PMTA, in which Triton stated that it had been irreparably harmed as a result of the FDA’s actions and faced an imminent shutdown of its business if the motion to stay had not been granted.
“Black-letter rules of administrative law prevent an agency from retroactively changing legal requirements and from doing so without accounting for reliance interests. FDA failed to satisfy these requirements when it executed an about-face on the evidence it required to support a premarket tobacco product application (“PMTA”) for a marketing order for flavored electronic nicotine delivery system (“ENDS”) products almost a year after such applications were due,” the motion states. “FDA also acted arbitrarily and capriciously by ignoring relevant evidence found in Petitioner Wages and White Lion Investments, LLC d/b/a Triton Distributions (“Triton”) PMTA and applying a double standard to its consideration of that evidence when it issued Triton a marketing denial order (“MDO”). Further, by imposing a new, across-the-board requirement that flavored ENDS products be demonstrably more effective at promoting smoking cessation than otherwise identical tobacco-flavored products, FDA acted contrary to its authority under Section 910 of the Food, Drug and Cosmetic Act (“FDCA), 21 U.S.C. § 387j, and not in accordance with law.”
At least six companies have filed lawsuits challenging the agency’s decision to make the companies remove their products from the market. Last week, the FDA rescinded the MDO issued to Turning Point Brands (TPB) and the company will be allowed to continue marketing its vapor products while the FDA re-reviews the company’s premarket tobacco product application (PMTA).
The FDA admitted it made an error in TPB’s PMTA review and TPB did in fact submit studies that the agency decided during the PMTA process were needed, after saying for years the studies were not required. “Upon further review of the administrative record, FDA found relevant information that was not adequately assessed,” reads the FDA letter to TPB. “Specifically your applications did contain randomized controlled trials comparing tobacco-flavored ENDS to flavored ENDS as well as several cross-sectional surveys evaluating patterns of use, likelihood of use, and perceptions in current smokers, current ENDS users, former tobacco users, and never users, which require further review.”
The U.S. Food and Drug Administration announced today it has authorized the marketing approval of three new vapor products to the RJ Reynolds (RJR) Vapor Company for its Vuse device and two tobacco-flavored pods It marks the first set of electronic nicotine-delivery system (ENDS) products ever to be authorized by the FDA through the premarket tobacco product application (PMTA) pathway. It also denied Vuse PMTAs for flavored products other than tobacco.
The FDA issued marketing granted orders for RJR’s Vuse Solo closed ENDS device and accompanying tobacco-flavored e-liquid pods, specifically, Vuse Solo Power Unit, Vuse Replacement Cartridge Original 4.8% G1, and Vuse Replacement Cartridge Original 4.8% G2.
The agency suggests the data submitted to the FDA by RJR demonstrated that marketing of these products is appropriate for the protection of public health. The authorization allows these products to be legally sold in the U.S.
“Today’s authorizations are an important step toward ensuring all new tobacco products undergo the FDA’s robust, scientific premarket evaluation. The manufacturer’s data demonstrates its tobacco-flavored products could benefit addicted adult smokers who switch to these products – either completely or with a significant reduction in cigarette consumption – by reducing their exposure to harmful chemicals,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “We must remain vigilant with this authorization and we will monitor the marketing of the products, including whether the company fails to comply with any regulatory requirements or if credible evidence emerges of significant use by individuals who did not previously use a tobacco product, including youth. We will take action as appropriate, including withdrawing the authorization.”
Under the PMTA pathway, manufacturers must demonstrate to the agency that, among other things, marketing of the new tobacco product would be appropriate for the protection of the public health. These products were found to meet this standard because, among several key considerations, the agency determined that study participants who used only the authorized products were exposed to fewer harmful and potentially harmful constituents (HPHCs) from aerosols compared to users of combusted cigarettes, according to a release.
“The toxicological assessment also found the authorized products’ aerosols are significantly less toxic than combusted cigarettes based on available data comparisons and results of nonclinical studies. Additionally, the FDA considered the risks and benefits to the population as a whole, including users and non-users of tobacco products, and importantly, youth,” the release states. “This included review of available data on the likelihood of use of the product by young people. For these products, the FDA determined that the potential benefit to smokers who switch completely or significantly reduce their cigarette use, would outweigh the risk to youth, provided the applicant follows post-marketing requirements aimed at reducing youth exposure and access to the products.
The FDA also issued 10 marketing denial orders (MDOs) for flavored ENDS products submitted under the Vuse Solo brand by RJR. Due to potential confidential commercial information issues, the FDA is not publicly disclosing the specific flavored products.
These products subject to an MDO for a premarket application may not be introduced or delivered for introduction into interstate commerce. Should any of them already be on the market, they must be removed from the market or risk enforcement. Retailers should contact RJR with any questions about products in their inventory. The agency is still evaluating the company’s application for menthol-flavored products under the Vuse Solo brand.
“Additionally, today’s authorization imposes strict marketing restrictions on the company, including digital advertising restrictions as well as radio and television advertising restrictions, to greatly reduce the potential for youth exposure to tobacco advertising for these products,” the release states. “RJR Vapor Company is also required to report regularly to the FDA with information regarding the products on the market, including, but not limited to, ongoing and completed consumer research studies, advertising, marketing plans, sales data, information on current and new users, manufacturing changes and adverse experiences.
The FDA may suspend or withdraw a marketing order issued under the PMTA pathway for a variety of reasons if the agency determines the continued marketing of a product is no longer “appropriate for the protection of the public health,” such as if there is a significant increase in youth initiation. While today’s action permits the products to be sold in the U.S., it does not mean these products are safe or “FDA approved.”
The agency will continue to issue decisions on applications, as appropriate, and is committed to working to transition the current marketplace to one in which all ENDS products available for sale have demonstrated that marketing of the product is “appropriate for the protection of the public
Triton Distribution filed a motion to stay the U.S. Food and Drug Administration’s decision to issue the company marketing denial orders (MDOs) for its premarket tobacco product applications (PMTAs). The company requested a decision from the judge by Oct. 15.
“Black-letter rules of administrative law prevent an agency from retroactively changing legal requirements and from doing so without accounting for reliance interests. FDA failed to satisfy these requirements when it executed an about-face on the evidence it required to support a premarket tobacco product application (“PMTA”) for a marketing order for flavored electronic nicotine delivery system (“ENDS”) products almost a year after such applications were due,” the motion states. “FDA also acted arbitrarily and capriciously by ignoring relevant evidence found in Petitioner Wages and White Lion Investments, LLC d/b/a Triton Distributions (“Triton”) PMTA and applying a double standard to its consideration of that evidence when it issued Triton a marketing denial order (“MDO”). Further, by imposing a new, across-the-board requirement that flavored ENDS products be demonstrably more effective at promoting smoking cessation than otherwise identical tobacco-flavored products, FDA acted contrary to its authority under Section 910 of the Food, Drug and Cosmetic Act (“FDCA), 21 U.S.C. § 387j, and not in accordance with law.”
Triton states that it has been irreparably harmed as a result of the FDA’s actions and faces an imminent shutdown of its business in approximately two weeks. This is why Triton entered an emergency stay of the “FDA’s MDO for Triton’s products by October 15, 2021, and order expedited merits briefing. Respondent FDA consents to the proposed expedited merits briefing schedule but opposes a stay.”
At least six companies have filed lawsuits challenging the agency’s decision to make the companies remove their products from the market. Last week, the FDA rescinded the MDO issued to Turning Point Brands (TPB) and the company will be allowed to continue marketing its vapor products while the FDA re-reviews the company’s premarket tobacco product application (PMTA).
The FDA admitted it made an error in TPB’s PMTA review and TPB did in fact submit studies that the agency decided during the PMTA process were needed, after saying for years the studies were not required. “Upon further review of the administrative record, FDA found relevant information that was not adequately assessed,” reads the FDA letter to TPB. “Specifically your applications did contain randomized controlled trials comparing tobacco-flavored ENDS to flavored ENDS as well as several cross-sectional surveys evaluating patterns of use, likelihood of use, and perceptions in current smokers, current ENDS users, former tobacco users, and never users, which require further review.”
