The U.S Food and Drug Administration today authorized several tobacco-flavored products from Logic Technology Development for sale in the U.S.. The brands include Logic Vapeleaf, Logic Power and Logic Pro, including hardware devices. The agency also issued marketing denial orders to Logic for multiple other electronic nicotine-delivery systems (ENDS) products. Any of those products currently on the market must be removed or FDA may take enforcement action, according to the FDA.
These products were authorized after the agency said its review of the product applications concluded, among other things, that the “likely benefit for adult smokers who significantly reduce their cigarette use (or who switch completely and experience cigarette use cessation) outweighs the risk to youth, provided that the company follows postmarketing requirements to reduce youth access and youth exposure to their marketing.
While today’s action permits these specific products to be sold in the U.S., it does not mean these products are safe nor are they “FDA approved.”
“Retailers should contact Logic with any questions about products in their inventory. Applications for Logic’s additional products, including menthol, remain under FDA review,” an FDA release states. “The FDA has taken action on approximately 99 percent of the nearly 6.7 million ENDS products submitted for premarket authorization, including issuing marketing denial orders for more than 1 million ENDS products.”
The agency is close to making additional decisions on applications for popular ENDS products that account for a large part of the market. The continued marketing of these products has the potential to have a substantial public health impact—either positively or negatively—as they hold an overall large market share and are used by a lot of people.
“As a cardiologist, I’ve personally seen the devastating health effects of tobacco use, so I’m highly motivated for the FDA to help reduce death and disability caused by these products,” said FDA Commissioner Robert M. Califf. “We know that there is a demand among adult smokers to use e-cigarette products to try to switch from more harmful combusted cigarettes, but millions of youth are using these products and getting addicted to nicotine. The balance of these issues was considered by the agency’s career scientists when evaluating the potential marketing of e-cigarette products. They have made great progress and I know they will use the best available evidence with the most robust methods to ensure that products that continue to be marketed are appropriate for the protection of the public health.”
Under the premarket tobacco product application (PMTA) pathway, manufacturers or importers must demonstrate to the agency, among other things, that marketing of a new tobacco product would be appropriate for the protection of the public health. That statutory standard requires the FDA to consider the risks and benefits to the population as a whole, including users and non-users of tobacco products. The FDA must also consider the likely impact of the products on people’s behavior—specifically, the likelihood that existing users will stop using such products and the likelihood that those who do not use tobacco products will start using such products.
This is especially important for youth. Before a product is authorized under the PMTA pathway, the agency reviews a tobacco product’s components, ingredients, additives, constituents and health risks, as well as how the product is manufactured, packaged and labeled.
“Ensuring new tobacco products undergo premarket evaluation by the FDA is a critical part of our work to reduce tobacco-related disease and death,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “For the authorized products, the manufacturer demonstrated that possible benefits to adult smokers outweigh the risk of youth possibly initiating. We are making progress in our review of flavored ENDS, and we will continue to deny marketing of products where the applicant hasn’t provided enough evidence to show that the potential benefit to adult smokers outweighs the considerable risk to youth. We are committed to continuing to take the appropriate actions to protect our nation’s youth from the dangers of all tobacco products, including e-cigarettes, which remain the most commonly used tobacco product by youth in the United States.”
Logic is only the second company to have vaping products approved for marketing by the FDA. In Oct. of 2021, the agency authorized the marketing approval of three outdated vapor products to the RJ Reynolds (RJR) Vapor Company for its Vuse Solo device and two tobacco-flavored pods. The agency also denied Vuse PMTAs for flavored products other than tobacco.
The U.S. Food and Drug Administration has issued hundreds of warning letters for vaping products, typically illegal e-liquids. On Tuesday, however, the regulatory agency posted its first warning letter for vaping hardware products. The letter was issued on Feb. 14 to China-based Sigelei Vapor for two coil brands.
“Our review of the website http://sigelei.com revealed that you manufacture and offer for sale or distribution to customers in the United States ENDS [electronic nicotine-delivery system] products without a marketing authorization order including: Sigelei Humvee 80 and Sigelei 213 Fog Coil,” the warning letter states.
The letter also states that Sigelei received a “refuse to accept” letter from the FDA on February 5, 2021 in response to the company’s premarket tobacco product applications (PMTAs) for six Sigelei products. “New tobacco products that do not have the required FDA marketing authorization order in effect, including your ENDS products covered by PMTA STN PM0001221 that resulted in a Refuse to Accept determination, are adulterated and misbranded,” the agency wrote.
The move signals a shift in the FDA’s typical regulatory action against companies selling illegal vaping products. The agency has traditionally only issued letters for e-liquids, but now hardware manufacturers have been put on notice. One manufacturer, who asked to remain anonymous to avoid FDA scrutiny, said the recent action is worrisome.
“The hardware segment has been operating almost at a near-normal, the same as before PMTAs were due. It hasn’t really hit home yet that FDA has the full intention to start enforcing hardware regulations too,” the manufacturer said. “This is going to hurt several companies and we are going to start to see smaller businesses end their marketing in the U.S.”
The letter also suggests that the warning is for all Sigelei products and not just the rejected PMTA products. “The violations discussed in this letter do not necessarily constitute an exhaustive list,” the letter states. “You should address any violations that are referenced above, as well as violations that are the same as or similar to those stated above, and promptly take any necessary actions to bring your tobacco products into compliance with the FD&C [Food, Drug & Cosmetics] Act.”
The 11th Circuit Court of Appeals granted the stays to Diamond Vapor, Johnny Copper and Vapor Unlimited. The ruling was in conjunction with Bidi Vapor’s stay. The 11th Circuit handles petitions for review from vaping businesses based in Florida, Georgia and Alabama. All four companies are based in Florida.
The decision allows the companies to continue selling their tobacco harm reduction products while the lawsuits remain active. A three-judge panel heard motions from the businesses and granted the stays by a 2-1 vote. The stays don’t guarantee that the companies will succeed in their challenges to the FDA denials, but they are an encouraging sign, according to Azim Chowdhury, a partner with Keller & Heckman law firm. He said courts usually grant stays only if the plaintiff’s case has a good chance of “succeeding on its merits.”
More than 30 companies have now sued the FDA and many of those appeals will be heard in federal courts over the next few weeks. No decisions have yet to be handed down, and early decisions could affect later ones, according to several attorneys. If there are conflicting decisions in multiple courts, the FDA’s PMTA process could eventually wind up being sorted out by the Supreme Court, according to Chowdhury.
Several anti-tobacco groups have sent a letter to the U.S. Food and Drug Administration urging the agency to act on the outstanding premarket tobacco product applications (PMTAs) and pushing for the denial of all flavored e-cigarette products.
It’s been more than four months since the FDA was supposed to decide which e-cigarette products can remain on the market, but the agency still hasn’t completed some of the reviews, including some of the bestselling e-cigarettes.
“We write to urge the U.S. Food and Drug Administration (FDA) to expedite decisions on the premarket tobacco product applications (PMTAs) still pending before the agency involving the flavored e-cigarette products, including those with menthol flavoring and, based on the best available scientific evidence, deny the pending applications for all non-tobacco flavored e-cigarettes in order to protect the nation’s young people from the health harms of these products,” the letter said.
The letter was signed by the American Academy of Pediatrics, the American Heart Association and the Campaign for Tobacco-Free Kids, among others.
“Every day that FDA delays action, more of our kids remain at risk,” said Matthew Myers, president of the Campaign for Tobacco-Free Kids. “While the FDA has ruled on applications from a lot of small companies, it hasn’t ruled on the applications from the large companies whose products are being used by a majority of kids.”
American Vaping Association President Gregory Conley pointed to data showing that youth vaping has been declining. According to the Centers for Disease Control and Prevention (CDC), use of e-cigarettes went down among middle and high school students from 2019 to 2020.
But even with the drop, the CDC said it “estimated that more than 2 million U.S. middle and high school students reported currently using e-cigarettes in 2021.”
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).
E-liquid manufacturers and retailers are still figuring out how to survive the FDA’s erratic regulatory rules.
By Maria Verven
The vaping industry has been in a downward spiral ever since the U.S. Food and Drug Administration began issuing marketing denial orders (MDOs) for electronic nicotine-delivery system (ENDS) products. When a product with a premarket tobacco product application (PMTA) receives an MDO, it must immediately be pulled from store shelves and removed from the market.
The FDA has issued MDOs for nearly all the approximately 6.7 million PMTAs it received. At press time, the agency was still reviewing an estimated 80,000 products, according to Mitch Zeller, director of the FDA’s Center for Tobacco Products (see “From Chance to Change,” page ?). To date, only Phillip Morris International’s IQOS device and Heatsticks and R.J. Reynolds Vapor Co.’s Vuse Solo, along with two tobacco-flavored pod cartridges, have received marketing granted orders.
The FDA also rescinded or was ordered by a court to stay at least 10 MDOs. This has caused a massive amount of confusion in the industry, especially for vape shop owners and vapor distributors who are struggling to keep only legal products on their store shelves.
Complicating matters, many manufacturers have started using synthetic nicotine in their flavored vaping products and products that had otherwise received an MDO. Synthetic nicotine is in a regulatory void as it isn’t yet being regulated at the federal level, although the FDA has stated it may be considered a component of an e-cigarette, which would put synthetic nicotine under its purview.
Many ENDS business owners say that the industry is also still suffering from the 2019 e-cigarette or vaping use-associated lung injury (EVALI) crisis that was wrongly blamed on nicotine vaping products by the FDA and the U.S. Centers for Disease Control and Prevention. It took more than a year for both government entities to state publicly that the true culprits behind EVALI were illegal THC-based vaping products. Vapor business owners must also combat the never-ending amount of misinformation that is broadcast by anti-vaping groups and the mass media.
Business owners, additionally, have major concerns about the current nicotine tax in President Joe Biden’s Build Back Better Act (as of this writing, the bill was still in the Senate). The current version of the nicotine tax applies only to vaping products and nicotine pouches. The government would tax nicotine bought by manufacturers at the rate of $50.33 per 1,810 mg of nicotine—or 2.8 cents/mg if the bill passes with the tax included.
To get a better understanding of what is happening at the street level in the ENDS industry,Vapor Voice asked a group of manufacturers, retailers and industry leaders about their experience with the FDA and how the agency’s regulatory actions have impacted their businesses.
Vapor Voice: How have the FDA’s marketing denial orders affected your business?
Char Owen
Char Owen, vice president of American Vapor Manufacturer:I think the negative PR around vaping has caused sales to stagnate for most manufacturers and vapor shops. It has also increased the smoking rates for the first time in many years. It’s heartbreaking for us to watch people revert to smoking again.
Unfortunately, most of the industry has changed to synthetic. Over 95 percent of our sales are flavored e-liquid, and with others switching, there was no choice but to switch. We only manufacture open system e-liquids in many flavors, all created from nontobacco-derived nicotine. Our biggest selling products have always been fruit flavors.
We are trying to bring in new products, such as botanicals, that can help our customers with cravings but remove nicotine from the equation. For us, it has always been about harm reduction, nothing more.
Schell Hamel, president of The Vapor Bar:Sales were affected long before the MDO was received. This down spiral began with the media attacking all vapor products as killing people when they clearly knew it was illegal THC products and the entire vapor industry handcuffed to Juul’s reputation.
According to the MDO, all products made in our lab were denied. It seemed as if they used a rubber stamp to deny anything submitted, all without review. I heard them doing similarly across the industry, then approving Vuse.
Schell Hamel
Jay Oku, business development at Five Pawns:Hundreds if not thousands of customers have been adversely affected from these misguided PMTA, sale and shipping regulations.
We had been developing products to maximize harm reduction for years and were always fascinated with the cleanliness (free of nitrosamines) and the molecular merits of synthetic nicotine. We switched all of our domestic products to synthetic nicotine mid-2020. We are grateful to have maintained our sales volume through 2021.
We saw an increase in overall sales since making the switch to nontobacco-derived nicotine, yet we’ve also seen a longer sales cycle with new accounts due to the number of MDO products that companies are selling through to make room on their shelves. Despite a slight increase in gross sales, net numbers are relatively flat due to the increase in manufacturing and shipping costs in 2021.
Trent Bohl, owner of EZJ Rolling Equipment and Smokey Joes West:It’s logistically added challenges, and the horizon looks like a tough road ahead. While many Juice manufacturers have shifted gears to get into compliance, the shift toward disposables and the future ban of them will be tough for Vape as a whole.
From recent headlines, it seems the FDA doesn’t seem to play well unless you are Big Tobacco.
Do you think there’s a growing black market of products that are no longer legal?
Owen: I absolutely know there is a growing black market. A quick Twitter or Instagram search proves that. So far, those black market dealers have not been targeted by the FDA. Only registered manufacturers have been on their radar.
We need to support and grow the harm reduction industry instead of growing a black market. For harm reduction to be successful, it must be regulated and supported by our federal bodies. Without their support, we risk creating a dangerous environment for consumers. I have a great amount of respect for the U.K. in recognizing this.
Oku: Every day the black market continues to grow. The attrition of retailers, manufacturers and distributors is being caused by excessive rogue state taxation, the PACT Act that complicates accounting and reporting, and misguided government overreach that results in flavor bans.
Jay Oku
Numerous disposable manufacturers are selling mass quantities of vapor products through back doors. Some of these black market brands push immature non-lab-produced concoctions with cartoons on their labels. These regulations push people who benefit from tobacco harm reduction technology to inferior products and even worse, back to cigarettes.
Bohl: I have stores in New Mexico, and in Mexico, which outright banned vapes. The black market is huge in Mexico; any low-dollar mercado or corner OXXO seems to have them. The USA will follow suit I suspect, given the demand for vape. When one reflects on how the black market vape cannabis carts disrupted the industry and damaged lives and harmed the reputation of the industry, it’s just going to be that times 10.
What has been your experience with FDA inspections?
Owen: Personally, I had a good inspector, but it truly is the luck of the draw, and it hasn’t been the case for everyone. In my case, he was only there to find proof of manufacturing of any MDO products, and his paperwork was written to support that. My batching logs were not reviewed nor my manufacturing practices.
One member had their inspector show up at 7 p.m. on Halloween. Another member had the FDA come to her home and photograph her home office instead of her manufacturing establishment. He then took photographs of her neighbor’s home. There were instances where the inspector pressured staff when owners or managers were not present to make MDO’d products and then sent warning letters.
The American Vapor Manufacturer is usually involved in a warning letter meeting every couple of weeks. We even help nonmembers with those. It’s a very tricky process, and it’s good to have someone there who can be objective and help both the FDA and the manufacturer resolve the matter.
Trent Bohl
Bohl: I haven’t seen them from this industry perspective, but from the agricultural side and medical marijuana side, one thought comes to mind: brutal for some, not bad for others.
What ultimately will result from these MDOs?
Owen: What the FDA did was extremely arbitrary and capricious. I feel that anyone who can afford to challenge them in court will be able to prove that. My concern is for all the small businesses that cannot afford to do that.
If something doesn’t change, you will see manufacturers close and smoking rates rise. In almost all industries except vaping, small business is celebrated. This is a shame because those small shops are the ones with the hearts for harm reduction.
To lose those small businesses would be a devastating blow to the effort in moving this country to becoming smoke-free.
Oku: I am optimistic that the FDA will reconsider or rescind MDOs and revise their outdated ambiguous and debilitatingly cost-prohibitive PMTA process.
Since 2016, FDA action against the industry has resulted in warning letters and fines to those breaking the rules, yet there’s little to no enforcement. Many MDO products are being sold since there was an enormous glut of inventory in preparation for the September 2021 ruling.
There will invariably be an increase in synthetic nicotine products until those, too, are regulated out of the market.
Congress has been slipping anti-vaping bills into much larger spending packages, such as during the 2019 holiday break deep in the Omnibus Spending Bill. These bills implement devastating regulations that put our industry and the health of our customers in jeopardy.
Bohl: The goal stated by the FDA 15 years back was the end of combustibles. Vape could have helped that. I am buying a decent stock, fearing the day one more freedom is taken away in the name of safety.
The original “Vaping Vamp,” Maria Verven owns Verve Communications, a PR and marketing firm specializing in the vapor industry.
Mitch Zeller, the director of the Food and Drug Administration’s Center for Tobacco Products, plans to retire in April 2022 after serving in the post since 2013, reports The Washington Post. In a letter to staff, acting FDA Commissioner Janet Woodcock praised his work as “invaluable and instrumental” to advancing “numerous historic public health milestones in tobacco regulation.”
A graduate of Dartmouth College and the American University Washington College of Law, Zeller has been working on FDA issues for more than 30 years. He began his career as a public interest attorney in 1982 at the Center for Science in the Public Interest (CSPI). In 1988, Zeller left CSPI to become counsel to the human resources and intergovernmental relations subcommittee of the House of Representatives’ government operations committee, where he conducted oversight of enforcement of federal health and safety laws.
In 1993, Zeller joined the staff of then FDA Commissioner David Kessler. What began as a two-week assignment by Kessler to examine the practices of the tobacco industry led to his serving as associate commissioner and director of the FDA’s first Office of Tobacco Programs. Instrumental in crafting the agency’s 1996 tobacco regulations, Zeller also represented the FDA before Congress, federal and state agencies. Zeller also served as an official U.S. delegate to the World Health Organization working group for the Framework Convention on Tobacco Control.
In 2000, Zeller became executive vice president of the American Legacy Foundation. His responsibilities there included marketing, communications, strategic partnerships and, in 2002, creating the foundation’s first Office of Policy and Government Relations. That year, Zeller joined PinneyAssociates, where, as senior vice president, he provided strategic planning and communications advice.
He left PinneyAssociates in 2013 to begin his second stint at the FDA.
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.
The U.S. Food and Drug Administration has rescinded the marketing denial order (MDO) issued Sept. 15, 2021, for Humble Juice Co.’s flavored e-liquid products, the company announced on Nov. 5.
Humble had filed a petition in October with the U.S. Court of Appeals for the Ninth Circuit, challenging the FDA’s decision and seeking to have the MDO vacated. Following the receipt of the rescission letter, Humble withdrew its petition as FDA’s rescission of Humble’s MDO places the brand’s flavored e-liquids back into the PMTA review process and provides Humble with a pathway to market its products while its PMTAs are pending.
FDA’s rescission letter states that upon further review it identified information contained in Humble’s PMTA that requires additional evaluation such as “randomized controlled trials comparing tobacco-flavored ENDS to flavored ENDS as well as several cross-sectional surveys evaluating intentions to use or likelihood of use in current smokers, current ENDS users, former tobacco users, and never users.”
The agency also stated that due to the unusual circumstances, it “has no intention of initiating an enforcement action” against any of Humble’s flavored e-liquid products with pending PMTAs. Humble will continue to market its products while its application remains in the review process.
“FDA’s decision to rescind the MDO re-instills our faith in this challenging but science-based regulatory process,” said Humble CEO Daniel Clark. “We remain confident in and proud of our extensive PMTA submission. We are committed to working with the FDA to obtain marketing orders for the products submitted in our initial PMTAs in order to provide Humble’s adult consumers with flavor-filled and affordable e-juice long into the future.”
