Tag: PMTA

Bidi Vapor Prevails Over FDA in PMTA Denial Suit
The U.S. Court of Appeals for the Eleventh Circuit has ruled that the U.S. Food and Drug Administration’s marketing denial orders (MDOs) for Kaival Brands’ Bidi Vapor products are arbitrary and capricious.
“The Administration refused to consider the marketing and sales access restrictions plans based on both its need for efficiency and its experience that the marketing and sales access restrictions do not sufficiently reduce youth use of electronic nicotine products,” Chief Judge William Pryor wrote. “Because ‘agency action is lawful only if it rests on a consideration of the relevant factors,’ and the Administration failed to consider the marketing and sales access restrictions plans, the marketing denial orders were arbitrary and capricious.”
In the court’s 2-1 split decision, additionally, the majority stated:
- The court recognizes relevant distinctions between closed/cartridge systems (that are easy to conceal and use) and the open tank liquids sold in vape shops
- FDA’s refusal to review marketing plans was error and not harmless (disagreeing with Fifth and DC Circuits)
In the 70-page opinion, Bidi Vapor, Diamond Vapor, Johnny Copper, Vapor Unlimited, Union Street Brands and Pop Vapor, the petitioners in the case, had all appeals granted, denial orders vacated and remanded.
In her dissent, Judge Robin Stacie Rosenbaum wrote, “Spoiler alert: This opinion contains spoilers on how the U.S. Food and Drug Administration will resolve petitioner vaping product companies’ premarket tobacco product applications on remand from this appeal.”
She then stated “never mind. There’s nothing to spoil here. Anyone who knows all the relevant facts necessarily already knows how this one ends.”
She stated that the while the majority faulted the FDA for not considering the companies’ proposed restrictions on youth use, the FDA’s framework for evaluating PMTAs leaves “no room for doubt that the FDA will deny—in fact, under the Family Smoking Prevention and Tobacco Control Act, must deny—the applications on remand. To paraphrase the Borg, then, remand is futile.”
This story will be updated.
August 24, 2022
Bidi Vapor Prevails Over FDA in PMTA Denial Suit
The U.S. Court of Appeals for the Eleventh Circuit has ruled that the U.S. Food and Drug Administration’s marketing denial orders (MDOs) for Kaival Brands’ Bidi Vapor products are arbitrary and capricious. The majority stated that the FDA was wrong not to “even look at” the company’s marketing plans to prevent youth access.
“The Administration refused to consider the marketing and sales access restrictions plans based on both its need for efficiency and its experience that the marketing and sales access restrictions do not sufficiently reduce youth use of electronic nicotine products,” Chief Judge William Pryor wrote. “Because ‘agency action is lawful only if it rests on a consideration of the relevant factors,’ and the Administration failed to consider the marketing and sales access restrictions plans, the marketing denial orders were arbitrary and capricious.”
In the court’s 2-1 split decision, additionally, the majority stated:
- The court recognizes relevant distinctions between closed/cartridge systems (that are easy to conceal and use) and the open tank liquids sold in vape shops
- FDA’s refusal to review marketing plans was error and not harmless (disagreeing with Fifth and DC Circuits)
In the 70-page opinion (nearly half of which was the dissent), Bidi Vapor, Diamond Vapor, Johnny Copper, Vapor Unlimited, Union Street Brands and Pop Vapor, the petitioners in the case, had all appeals granted, denial orders vacated and remanded.
In her dissent, Judge Robin Stacie Rosenbaum wrote, “Spoiler alert: This opinion contains spoilers on how the U.S. Food and Drug Administration will resolve petitioner vaping product companies’ premarket tobacco product applications on remand from this appeal.”
She then stated “never mind. There’s nothing to spoil here. Anyone who knows all the relevant facts necessarily already knows how this one ends.”
She stated that the while the majority faulted the FDA for not considering the companies’ proposed restrictions on youth use, the FDA’s framework for evaluating PMTAs leaves “no room for doubt that the FDA will deny—in fact, under the Family Smoking Prevention and Tobacco Control Act, must deny—the applications on remand. To paraphrase the Borg, then, remand is futile.”
This story will be updated.
August 24, 2022
‘FDA Took Shortcuts in Reviewing PMTAs’

Image: smolaw11
In establishing whether a nicotine product is appropriate for the protection of public health, the U.S. Food and Drug Administration held its Center for Tobacco Products (CTP) reviewers to a lower standard than the companies submitting premarket tobacco product applications, according to Alex Norcia writing in Filter.
Citing documents obtained through the Freedom of Information Act, Filter describes procedures such as batching and bracketing, which allowed the CTP to apply conclusions to categories of products rather than evaluating them separately. “Despite imposing extremely onerous bureaucratic requirements on applicants, the agency was happy to find ways to cut through its own paperwork,” writes Norcia.
“It’s clear that FDA allows itself efficient shortcuts that it has denied to applicants,” Clive Bates, director of The Counterfactual, told Filter.
“The problem has always been that FDA’s extraordinarily burdensome process was obviously tremendously wasteful for applicants, but of course it was always going to be unmanageable for the assessors in FDA. Without this sort of shortcut, the PMTA process would have become a human resources nightmare. So FDA has allowed itself the kind of efficiencies it should have offered to the applicants—batching and bracketing thousands of near-identical products.”
August 11, 2022
Joytech Parent Submits PMTA to FDA
China-based JWEI has announced today that they have successfully submitted a premarket tobacco product application (PMTA) to the U.S. Food and Drug Administration for a device created with “new innovative technology” that focuses on safety, harm reduction and is designed to curb underage use.
“JWEI has been a leader in this industry from the start and this milestone again reiterates our commitment to the industry and public health: ensuring our adult customers continued access to less harmful alternatives to traditional tobacco products, while setting a new standard preventing underage youth access.” said VP of JWEI Group Jason Yao.
JWEI is the parent to the brands Joytech, Eleaf, Wismec and Joyevita. The company did not offer additional information on the specific device submitted for the PMTA.
JWEI developed a set of principles to guide through every step of its new product development, led by safety and effectiveness studies in early 2019. “The design philosophy is the foundation and guide rails for designing, manufacturing, verifying, validating, and continuously improving innovative, responsible, reliable, and high-quality products,” the release states.
The limited product debut in the UK has received overwhelming recognition from users and commercial partners after a few months’ actual use, according to JWEI
“As one of the world-leading device manufacturers and innovators of e-cigarette and vaping products, JWEI has over 3,600 granted patents and multiple internationally recognized manufacturing and quality certifications (GMP, HACCP, ISO9001, ISO13485, EHS, and ERP),” according to a press release.
July 21, 2022
FDA Reviewing Oversight Rules After Botched Juul PMTA

The head of the U.S. Food and Drug Administration Tuesday said he has commissioned an independent review of the agency’s food and tobacco programs following months of criticism over its handling of the baby formula shortage and e-cigarette reviews, according to AP.
The announcement comes as FDA Commissioner Robert Califf attempts to push past several controversies that have dominated his second stint running the agency, including his issuing of a marketing denial order (MDO) to e-cigarette maker Juul Labs and later having to rescind that order and placing Juul’s premarket tobacco product application (PMTA) back under review.
“Fundamental questions about the structure, function, funding and leadership need to be addressed” in the agency’s programs, Califf said in a statement. The agency’s Center for Tobacco Products (CTP) is facing challenges navigating policy and enforcement issues from “an increasing number of novel products that could potentially have significant consequences for public health … CTP will continue its important work during the evaluation, including review pending applications and take enforcement actions as needed.”
Califf said the non-profit Reagan-Udall Foundation — a non-governmental research group created by Congress to support FDA’s work — would convene experts to deliver evaluations within 60 business days of both the food and tobacco operations.
“It may take some time to implement any recommended changes, but I am committed to addressing them and communicating them to the public in a timely manner,” Califf stated. “It is my belief that this effort will continue strengthening the FDA and better position the agency to deal with the many immediate public health issues we are facing, while preparing for the many scientific challenges and fascinating opportunities of the future.”
July 19, 2022
Juul Labs Exploring Options, Including Financing

Juul Labs on Friday said it is in the early stages of exploring several options including financing alternatives, as the company deals with lawsuits and a potential ban on sales of its e-cigarettes by U.S. health regulators.
Bloomberg News earlier reported, citing sources, that Juul’s bankers at Centerview Partners are sounding out investors for a possible $400 million first-lien term loan due August 2023.
The proceeds would help refinance an existing term loan, which has around $394 million outstanding and matures on the same date, the report added.
A spokesperson for Juul told Reuters that the company is looking at options to protect its business and to address the “impact of the FDA’s now stayed order so we can continue offering our products to adult consumers who have or are looking to transition away from traditional cigarettes.”
Bloomberg News in its report said Juul was also considering a new $150 million second-lien term loan, which may have an August 2024 maturity, to help pay down some of the first-lien term loan and to increase liquidity, the report said.
Financing proposals for either loan are due July 21, according to the report.
Last month, the Food and Drug Administration (FDA) blocked sales of Juul e-cigarettes and said the applications “lacked sufficient evidence” to show that sale of the products would be appropriate for public health.
However, Juul appealed the agency’s order and earlier this month FDA put on hold its ban saying it would do an additional review of the company’s marketing application.
July 16, 2022
It’s Official: FDA Denies Juul Market Access

Photo: steheap
Today, the U.S. Food and Drug Administration confirmed what many had already been anticipating: Juul Labs must remove all currently marketed Juul products from the U.S. market.
“Today’s action is further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards,” said FDA Commissioner Robert M. Califf. “The agency has dedicated significant resources to review products from the companies that account for most of the U.S. market. We recognize these make up a significant part of the available products and many have played a disproportionate role in the rise in youth vaping.”
These marketing denial orders (MDO) pertain only to the commercial distribution, importation and retail sales of these products, and do not restrict individual consumer possession or use—the FDA cannot and will not enforce against individual consumer possession or use of Juul products or any other tobacco products.
After reviewing the company’s premarket tobacco product applications, the FDA determined that the applications lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health. In particular, some of the company’s study findings raised concerns due to insufficient and conflicting data—including regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods—that have not been adequately addressed and precluded the FDA from completing a full toxicological risk assessment of the products named in the company’s applications.
The FDA says that, to date, it has not received clinical information to suggest an immediate hazard associated with the use of the Juul device or Juul pods. However, the MDOs issued today reflect FDA’s determination that there is insufficient evidence to assess the potential toxicological risks of using the Juul products.
“There is also no way to know the potential harms from using other authorized or unauthorized third-party e-liquid pods with the Juul device or using Juul pods with a non-Juul device,” the agency wrote in a statement.
“The FDA is tasked with ensuring that tobacco products sold in this country meet the standard set by the law, but the responsibility to demonstrate that a product meets those standards ultimately falls on the shoulders of the company,” said Michele Mital, acting director of the FDA’s Center for Tobacco Products. “As with all manufacturers, Juul had the opportunity to provide evidence demonstrating that the marketing of their products meets these standards. However, the company did not provide that evidence and instead left us with significant questions. Without the data needed to determine relevant health risks, the FDA is issuing these marketing denial orders.”
June 23, 2022
Marketing Approvals for NJOY ‘Daily’ Vapes
Photo: NJOY
The U.S. Food and Drug Administration has approved the premarket tobacco product applications (PMTA) for NJOY’s Daily Rich Tobacco 4.5% and NJOY Daily Extra Rich Tobacco 6%.
“It should be noted that our determination that the marketing of these products is APPH [appropriate for the protection of public health] is based in part on the submitted microbial stability data,” the agency wrote in its marketing granted order (MGO).
The designation does not mean the products are safe and they are not “FDA approved,” the agency said, but the MGOs allows the NJOY to legally market the authorized products in the United States.
While approving NJOY’s Daily Rich Tobacco 4.5% and NJOY Daily Extra Rich Tobacco 6%, the FDA denied authorization for multiple other Daily e-cigarette products. These are presumed for products with nontobacco flavors. Any of those products that remain on the market must be removed or risk FDA enforcement, the agency said. Applications for two menthol-flavored Daily products remain under FDA review.
Additionally, the authorization imposes marketing restrictions on the company to greatly reduce the potential for youth exposure to advertising for these products. The FDA said it will closely monitor how these products are marketed and will act as necessary if the company fails to comply with any applicable statutory or regulatory requirements, or if there is a notable increase in the number of non-smokers—including youth—using these products.
On April 26, the FDA authorized four NJOY Ace products through the PMTA pathway.
June 10, 2022
PMTA Deadline Approaching

Courtesy: US FDA
Manufacturers of nontobacco nicotine (NTN) products on the market as of April 14, 2022, that wish to continue to market their products are required to submit a premarket tobacco product application (PMTA) to the U.S. Food and Drug Administration by May 14, 2022.
The May 14 deadline is only for applicants submitting electronically, as required by the FDA. Applicants can, however, request a waiver from the FDA to submit a PMTA in a different format. An application submitted in hard copy must be received by the FDA no later than 4 p.m. Eastern Daylight Time on Friday, May 13.
The FDA received from the U.S. District Court of Maryland a 14-day extension to file the first PMTA status reports required by the court’s revised remedial order on April 29.
“The extension request is supported by good cause. Compiling the information needed for the status report has required considerable time and effort, and defendants have been working with plaintiffs to resolve any ambiguities about which applications will be covered in the status report,” the motion states.
The new law additionally provides that an NTN product with a tobacco-derived “previous version” that received a negative action on a PMTA from the FDA, such as a refuse-to-file or marketing denial order, may not continue to be marketed after May 14, 2022, without receiving a marketing granted order from the FDA.
Such products must be removed from the market, even if a new PMTA is submitted, until the marketing granted order is received, according to the agency. Products on the market after July 13, 2022, without an FDA marketing granted order are in violation of section 910 of the Food, Drug and Cosmetic Act and may be subject to FDA enforcement.
For products not on the market on April 14, 2022, a PMTA must be submitted to the FDA and marketing authorization must be received before the product can be sold in the United States.
May 12, 2022
FDA Authorizes Several NJOY Products

Photo: NJOY
The U.S. Food and Drug Administration on April 26 authorized four NJOY products through the premarket tobacco product application (PMTA) pathway. The FDA issued marketing granted orders to NJOY for its Ace closed e-cigarette device and three accompanying tobacco-flavored e-liquid pods—NJOY Ace Pod Classic Tobacco 2.4 percent, NJOY Ace Pod Classic Tobacco 5 percent and NJOY Ace Pod Rich Tobacco 5 percent.
The decision is significant because, unlike previous marketing orders—the FDA earlier authorized varieties of BAT’s Vuse Solo brand and Japan Tobacco International’s Logic e-cigarette—this one covers a product with a decent market share. While Vuse overall is a bestseller, the variety that received marketing approval in October 2021 is based on outdated technology and used by only a few people.
According to Nielsen and analyst reports, which measure financial data typically from convenience stores (and not vape shops), NJOY is the third-largest vape manufacturer in the United States, holding a little more than 3 percent of the market.
The most recent authorization is also the first for a brand not owned by a major tobacco firm.
“Looking at the situation with rose-colored glasses, an independent pioneer like NJOY getting two nicotine vaping products through the convoluted FDA authorization process is something to celebrate,” Greg Conley, the president of the American Vaping Association, told Filter. “Unlike the only two other companies with authorizations, NJOY could not subsidize their applications with cigarette sales, so they were at a disadvantage from the start.”
While authorizing NJOY Ace tobacco-flavored pods, the FDA rejected other Ace e-cigarette products. Applications for two menthol-flavored Ace e-liquid pods remain under FDA review.
No flavored product has yet received FDA authorization, even though tobacco harm reduction advocates insist flavors are necessary to lure smokers away from combustible cigarettes. “The FDA’s current policy of denying all flavors and deferring action on menthol applications is evidence of just how broken the agency is,” Conley told Filter. “The FDA still has not accepted that millions of adult vapers will not be switching to tobacco flavors anytime in the future.”
Under the PMTA pathway, the applicant must demonstrate to the FDA that marketing of the new tobacco product would be appropriate for the protection of the public health, the FDA explained in a statement. According to the agency, the authorized NJOY products were found to meet this standard because chemical testing was sufficient to determine that overall harmful and potentially harmful constituent (HPHC) levels in the aerosol of these products is lower than in combusted cigarette smoke.
“Further, data provided by the applicant demonstrated that participants who had used only the authorized NJOY Ace products had lower levels of exposure to HPHCs compared to the dual users of the new products and combusted cigarettes,” the FDA wrote. “Therefore, these products have the potential to benefit adult smokers who switch completely or significantly reduce their cigarette consumption.”
April 27, 2022