Category: PMTA

FDA, Hyde Bar Disagree on MDO; Puff Bar Defiant

Credit: Jean Claude
It shouldn’t be this complicated. Magellan Technology says it didn’t receive a marketing denial order (MDO). The U.S. Food and Drug Administration says it did. It wouldn’t be the first time the regulatory agency made a mistake. The FDA seems to be making a habit of it recently.
Magellan claims that the FDA made a “glaring error” and the company did not receive an MDO for its 32 products under the Hyde brand. In an email, Jon Glauser, CEO of Magellan, stated that the FDA’s announcement is false for two reasons. First, the regulatory agency only issued the company a Refuse to Accept (RTA) letter and, second, the FDA failed to conduct a proper review of Magellan’s scientific evidence in its premarket tobacco product application (PMTA) review for its Hyde products.
“Contrary to the FDA’s statement, FDA only issued a Refuse to Accept letter for the identified Magellan products, not an MDO,” stated Glauser. “A Refuse to Accept letter is a refusal based on nothing more than a technical review of the applications’ contents which, in this case, was a missing document, i.e., a sworn certification related to the translation of certain components of the application. In other words, the Refusal to Accept was based on bureaucratic technicalities.
“This is much more than a misnomer or clerical error by the FDA since the agency elaborated that it had conducted a scientific review and reached a conclusion that the PMTAs ‘lacked sufficient evidence.’ However, no such scientific review was referred to and no scientific justification was provided in FDA’s correspondence today.”
Magellan currently has pending litigation against the regulatory agency with the Second Circuit Court of Appeals concerning an MDO issued by the FDA last year for Magellan’s pod-based Juno vaping products.
New FDA data from the 2022 National Youth Tobacco Survey (NYTS) shows that 2.5 million U.S. youth use e-cigarettes, according to the published findings in the Morbidity & Mortality Weekly Report released by the FDA in conjunction with the Centers for Disease Control and Prevention. This is a slight rise over last year’s data.
Armed with this information, the FDA also issued Puff Bar (no relation to Magellan products) a warning letter for receiving and delivering e-cigarettes in the U.S. without a marketing authorization order. The FDA also requested a response within 15 working days of receiving the letter, detailing how the company intends to address the FDA’s concerns.
It’s at least the second letter the FDA has sent to Puff Bar without any follow-up action. The FDA issued at least two warning letters for Puff Bar’s non-tobacco nicotine disposable products.
During a Next Generation Nicotine Conference in Miami, Patrick Beltran, CEO of Puff Bar, said his disposable products were the “end of the road” for vaping products. “This is the end of the road for vaping in my opinion. It doesn’t get any more convenient for the consumer than a disposable vape device.”
Beltran then blamed U.S. retailers and Chinese manufacturers for the youth initiation issues. “We’re pioneering the disposable industry and the disposable sector of this industry, and it’s very tough when I go to the store and I see people and I see these brands being pushed and there is no enforcement whatsoever,” he explained. “I have to go … I have to spend millions of dollars on a PMTA. Juul, [expletive] Juul, and I’m sure everyone here has heard the news what happened … It’s all [expletive],” referring to Juul’s MDO that the FDA later retracted.
During GTNF 2022, a nicotine industry conference held in Washington D.C. in September, Brian King, director of the the FDA’s Center for Tobacco Products, the division charged with regulating next-generation tobacco products, discussed the FDA’s ability to force companies to comply with its MDOs (and warning letters). So far, very few companies that have been told to remove their products from the market have complied (including Puff Bar). King said the agency has multiple enforcement options to bring both manufacturers and retailers to heel.
“We have several tools available to us, including advisory actions,” he said. “We also have regulatory enforcement actions, including voluntary recalls as well as various other requested recalls. We can also take administrative action, civil money penalties (in terms of manufacturers, that penalty cannot exceed $15,000 for any single violation or $1 million for any number of violations related to a single action),” explained King. “When it comes to judicial action, we can do seizure, injunction and also criminal prosecution. I will say that when it comes to enforcement and compliance, nothing is off the table.”
The FDA has not taken any serious action against any vaping company for violating it’s orders. Puff Bar products can still be found at retailers across the U.S., even though the company has received multiple warning letters from the FDA.
Puff Bar has not received an MDO from the regulatory agency to date.
After reviewing PMTAs for 32 Hyde e-cigarettes, however, the FDA issued MDOs for the applications submitted by Magellan (the company argues they were actually RTAs). In conducting its scientific review, the FDA determined that the applications lacked “sufficient evidence demonstrating that the products would provide a benefit to adult users that would be adequate to outweigh the risks to youth.”
No Hyde products have received marketing authorization orders from the FDA.
“To be sure, the FDA expressly wrote to Magellan that ‘The absence of these required FDA forms impedes FDA ingestion and processing of applications.’ In other words, FDA could not have conducted any scientific review because it refused to accept the application,” wrote Glauser. “Our counsel has demanded that FDA not only retract the press statement it made but also issue a corrective statement making clear that FDA did not issue an MDO to Magellan and that it has not yet conducted a scientific review of Magellan’s products.”
The FDA has a history of making mistakes in the PMTA process. It’s currently facing more than 20 lawsuits and has had to retract MDOs from numerous companies, including Juul Labs, Turning Point Brands and Kavial Brands, among others.
“Magellan Technology looks forward to addressing whatever administrative technicalities are present so that FDA can, in fact, conduct a full scientific review of its products,” wrote Glauser.
October 7, 2022
Second Chance: MDO Legal Win Presents Opportunity

Photo: andranik123
How companies can make the most of a recent court ruling requiring the FDA to reassess thousands of PMTA rejection notices.
By Neil McKeganey
It would be hard to overstate the threat that youth vaping in the United States poses to the use of e-cigarettes as a means of tobacco harm reduction. Respected national surveys have shown a rising trend in youth vaping, with the threat to the vaping industry as predictable as night following day.
Former Food and Drug Administration Commissioner Scott Gottlieb could not have been clearer in signaling that threat when he said that the offramp to adult smoking could not be justifiably achieved at the cost of the on-ramp of teen vaping. If anybody was in any doubt about the risks that youth vaping poses to the entire e-cigarette industry, those doubts would have surely been extinguished in the recent ruling against Juul Labs, which required the company to pay in excess of $438 million to compensate states for the harms caused by past marketing practices increasing the likelihood of youth using their eponymously named vaping device.
For vaping companies, the threat of youth vaping may have lifted slightly in a recent U.S. court ruling requiring the FDA to pay attention to what vapor companies are doing in trying to restrict youth access to their products. Odd as it may sound, after having encouraged vapor companies to pay attention to their marketing and sales practices in light of the rising trend in youth vaping, the FDA’s position appears to have been that those efforts were almost certainly doomed to fail, with youth accessing what are often easy-to-conceal vaping products with relatively little difficulty through their social networks.
With vapor companies having invested heavily in age verification software, point-of-sale restrictions and in the removal of flavored e-liquids, it would have been a bitter pill to swallow to be told that the regulators had largely ignored those efforts to reduce youth access to their products.
The logic behind the FDA’s decision seems to have been that it would be easier to expedite the large number of premarket tobacco product applications (PMTAs) by adopting a “Fatal Flaw” approach—rejecting those applications that did not present data from either longitudinal customer studies or randomized trial evaluations and simply ignoring what the companies were doing to lessen the likelihood that their products would be found in the hands of youth.
By ruling against the FDA in legal action initiated by six vapor companies that had received marketing denial orders without the FDA even paying attention to their youth sales restriction efforts, the judges have effectively provided vapor companies with a second chance to have their PMTA applications reassessed.
So, what should vapor companies do given the legal victory that has been dropped in their lap? Clearly, it is going to be important for companies to do all they can to restrict youth access to their vapor products. But actions taken by these companies is not the same thing as being able to present evidence to the FDA that their products are not being used by youth.
To this end, research undertaken by the Centre for Substance Use Research (CSUR) in Scotland may help many of the companies concerned. For the last two years, the CSUR has been measuring the prevalence with which over 200 e-cigarette devices are being used by youth and adults within the United States. This ongoing research provides vapor companies with product-specific data showing the extent to which their products are being used, or more crucially, are not being used by youth.
Valuable as the data from this study undoubtedly are, vapor companies also have to be able to show the benefit of their products to adult smokers. The fastest route to obtaining this data is through an actual use study in which adult smokers using a company’s vapor products are monitored over a number of weeks to determine how many smokers are able to quit or reduce their cigarette smoking through using the company’s vapor products.
To obtain a marketing authorization, vapor companies have to be able to show two things—that their products are not being used by youth and that they can help adult smokers in quitting or reducing cigarette consumption. Succeed in these two things and vapor companies can have a bright future. Fail in either one and the future looks a lot bleaker.
Neil McKeganey is the director of the Center for Substance Use Research in Glasgow, Scotland.

September 12, 2022
Gripum Denied MDO Petition for Review by Appeals Court

Seventh Circuit Court of Appeals
A U.S. appeals court denied a petition to review the Food and Drug Administration’s marketing denial order (MDO) to Illinois-based e-liquid manufacturer Gripum, reports Vaping360.
Gripum submitted premarket tobacco product applications (PMTAs) in September 2020 for about 200 bottled e-liquid products in nontobacco flavors. The company received an MDO on Sept. 8, 2021. Gripum filed a petition for review on Oct. 8 and was granted a stay of FDA enforcement in November 2021. The company participated in oral arguments before the court on April 20.
Gripum argued that the MDO was unfairly issued because Congress and the FDA did not establish any “ascertainable standards” to determine if the company’s products are “appropriate for the protection of public health.” The company also said that the agency changed the evidentiary standard for a successful PMTA after the application deadline had passed and that the agency failed to conduct individualized PMTA reviews as required by the Tobacco Control Act.
The 7th Circuit Court of Appeals rejected all of Gripum’s arguments, finding that the FDA’s approach to resolving the application was both reasoned and consistent with the Tobacco Control Act.
Gripum’s defeat follows a successful MDO challenge by six vapor companies. On Aug. 23, the U.S. Court of Appeals for the 11th Circuit granted petitions for review filed by Bidi Vapor, Diamond Vapor and four other companies challenging the FDA’s rejection of their e-cigarette applications.
August 30, 2022
Vapor Makers Prevail Over FDA in PMTA Denial Suit

Credit: Tanasin
A split 11th Circuit on Tuesday told the U.S. Food and Drug Administration it shouldn’t have denied six e-cigarette companies’ premarket tobacco product applications (PTMAs) to sell flavored vaping products without first taking a look at their marketing and sales plans designed to minimize youth exposure and access.
The U.S. Court of Appeals for the Eleventh Circuit granted petitions for review filed by Bidi Vapor, Diamond Vapor and four other companies challenging the FDA’s rejection of their e-cigarette applications in a 2-1 decision. According to Chief Judge William Pryor, the agency didn’t assess “the companies’ marketing and sales-access-restriction plans designed to minimize youth exposure and access.”
The court explicitly labeled the FDA’s decision-making as “arbitrary and capricious.” Prior legal decisions have determined that FDA action must consider all relevant factors in order to be legally justifiable. In the case of these vape manufacturers, the court ruled that the FDA had not performed such consideration.
“These tobacco companies submitted survey information from their customers about smoking cessation, literature reviews, scientific studies about switching to e-cigarettes, smoking cessation, and the role of flavors, and details about its marketing and youth-access-prevention plans,” notes the court in its opinion. “For example, Diamond uses technology for its online sales that relies on public records to verify a purchaser’s age.”
Vapor industry advocates welcomed the decision. Gregory Conley, director of legislative and external affairs at the American Vapor Manufacturers Association said that while court ruling does not order the FDA to grant PMTAs—and that the agency is likely to deny the applications in the future—the companies involved could end up in the queue for review in 2025, which keeps them in business.
“Additionally, this leaves the door open for further litigation on these and other PMTAs,” Conley wrote on Twitter. “The FDA’s vague and undefined ‘appropriate for the protection of public health’ standard has long been open for attack. This is just the start.”
The 11th Circuit decision follows revelations that forced the FDA to admit to not considering all evidence when issuing marketing denial orders (MDOs) to vape products made by Juul and Turning Point Brands. In the interests of public health, future FDA decision-making must engage with all available evidence, not just evidence that leads to their preferred outcomes.
The court also recognized relevant distinctions between closed/cartridge systems and the e-liquids used in open systems. The court also found that the FDA’s refusal to review marketing plans was “error and not harmless” (disagreeing with Fifth and DC Circuits).
All petitioners’ appeals were granted, denial orders vacated and remanded.
In her dissent, Judge Robin Stacie Rosenbaum wrote that anyone who knows all the relevant facts of this lawsuit probably already knows how this case will eventually end.
“The Majority faults the FDA for not considering the companies’ proposed restrictions on kids’ use. And to be sure, the FDA said that factor would be relevant,” stated Rosenbaum. “But even assuming that the FDA erred when it didn’t consider the Companies’ proposed marketing and access-restriction plans, the FDA’s framework for evaluating pre-market tobacco product applications 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.”

August 24, 2022
D.C. Court Rejects Prohibition Juice Co. Appeal of MDO

On July 26, the United States Court of Appeals for the District of Columbia rejected an appeal by four e-liquid manufacturers that challenged the FDA’s denial of their premarket tobacco product applications (PMTAs), ruling that the agency acted within Congress’ authorization, and its decisions were supported by evidence.
Prohibition Juice Co., Cool Breeze Vapor, ECig Charleston, and Jay Shore Liquids argued that the FDA lacked statutory authority to require that the manufacturers establish that their flavored liquids carry greater public health benefits than unflavored liquids.
According to the motion, the companies also challenged the PMTA denials as arbitrary and capricious, asserting that the FDA: (1) departed from an earlier guidance document, changing both the types of evidence the agency would accept and the substantive showing it expected parties to make; (2) underscored the potential importance of marketing plans including measures to limit youth access to their products but then failed to consider the plans petitioners submitted; and (3) overlooked various other aspects of the problem.
“We deny the petitions for review. The FDA plainly had statutory authority under the Tobacco Control Act to regulate as it did. As to the arbitrary and capricious challenges, we hold that the FDA did not change the evidentiary or substantive standard from its 2019 Guidance,” the court wrote in its motion. “We also hold that any error in the FDA’s failure to consider the marketing plans was harmless because the manufacturers failed to identify how individualized review of the plans they submitted could have made any difference.
“Finally, the FDA did not otherwise fail to consider important aspects of the problem. We accordingly deny the petitions for review.”
The D.C. Circuit has not stayed the enforcement of any MDO.
August 1, 2022
Court Denies Stay of Fontem’s Marketing Denial Order
Fontem US had its request for an emergency motion for a stay of its marketing denial order (MDO) denied by the United States Court of Appeals for the District of Columbia. The court denied the stay mainly because Fontem waited too long to file the motion. The denial was filed July12.
Fontem Ventures, a subsidiary of Imperial Brands PLC and parent to Fontem US, owns the global e-cigarette brand blu. The ruling means that legally, Fontem should have to pull its Myblu products from store shelves that received MDOs from the FDA while the appeal of its MDO goes through the legal process.
“Fontem has demonstrated that the marketing denial order is causing it harm, but by waiting more than two months after the marketing denial order’s issuance to seek emergency relief, Fontem weakened its claim of irreparable harm,” the court wrote. “That delay also suggests it may have been practicable to seek a stay from the agency.”
The court stated that Fontem “has not made a strong showing” that it is likely to succeed in its appeal of the MDO issued by the U.S. Food and Drug Administration on merits, noting that as to the multiple bases for the MDO identified by the FDA, the agency likely afforded Fontem fair notice.
“Fontem US, LLC has not satisfied the stringent requirements for a stay pending court review,” the court wrote.
The FDA issued MDOs to several myblu brand products manufactured by Fontem US. Tobacco and vaping products subject to a negative action regarding a premarket tobacco product application (PMTA) submission, including those subject to an MDO, may not be offered for sale, distributed or marketed in the US.
“On April 8, FDA issued MDOs to Fontem US, LLC for several myblu electronic nicotine-delivery system (ENDS) products after determining their applications lacked sufficient evidence to show that permitting the marketing of these products would be appropriate for the protection of the public health,” the FDA stated in a release.
Fontem’s appeal is expected to move forward and the court is requiring the case to be expedited
and the following briefing schedule is to apply:

Petitioner’s Brief August 10, 2022

Respondent’s Brief September 9, 2022

Petitioner’s Reply Brief September 30, 2022

Deferred Appendix October 7, 2022

Final Briefs October 14, 2022
“The Clerk is directed to calendar this case for oral argument on the first appropriate date following completion of briefing. The parties will be informed later of the date of oral argument and the composition of the merits panel,” the court wrote.
July 25, 2022
JWEI Submits PMTA to U.S. FDA for New Vape Device
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 Suspends Juul Market Ban Pending Court Appeal

Photo: steheap
The U.S. Food and Drug Administration has temporarily halted its ban on Juul Labs products while the e-cigarette maker appeals the agency’s decision, the FDA announced on Twitter.
On June 23, the FDA ordered Juul Labs to pull its e-cigarettes from U.S. store shelves, saying the e-cigarette manufacturer had submitted insufficient evidence that they were “appropriate for the protection of the public health.”
A federal appeals court then granted Juul Labs a emergency stay of the order to give the judges time to evaluate the merits of Juul’s appeal. The e-cigarette company separately asked the FDA to stay its own order pending the appeal.
In a series of Twitter messages, the FDA said it had determined that there are scientific issues unique to the Juul application that warrant additional review. The agency stressed that the stay suspends but does not rescind it the marketing denial order (MDO).
The FDA initially rejected Juul’s request for a stay, prompting Juul to seek a stay of the ban in court, according to The Wall Street Journal.
In its court filing challenging the FDA ruling, Juul said the agency had overlooked more than 6,000 pages of data that the company had submitted to the FDA on the aerosols that users inhale. Juul also suggested that the FDA’s decision was influenced by political pressure.
The FDA’s marketing denial order for Juul surprised many in the vaping business, especially in the wake of marketing authorizations for vapor products manufactured by competitors such as Reynolds American Inc. and NJOY Holdings. A pioneer in the vaping segment and backed by Altria Group—a company boasting decades of experience with regulatory compliance—Juul labs appeared in a better position than most to meet the agency’s exacting standards.
Public health advocates criticized the stay of the FDA ruling.
“It is deeply disappointing and harmful to our nation’s kids that the FDA has issued an administrative stay of its marketing denial order for Juul’s e-cigarette products,” wrote Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, in a statement.
“This decision will allow the continued sale, at least for now, of the brand most responsible for creating and fueling the youth e-cigarette epidemic. We are nearly 10 months past a court-ordered deadline for the FDA to complete its review of e-cigarette marketing applications and can’t afford more delays by the FDA in removing kid-friendly products from the market.”
July 6, 2022
Juul: FDA ‘Overlooked’ 6,000 Pages of Aerosol Data

The U.S. Food and Drug Administration overlooked a key part of Juul’s premarket tobacco product application (PMTA) when the agency ordered Juul Labs’ products off the U.S. market, according to court documents.
In court filings Tuesday, Juul said the agency overlooked more than 6,000 pages of data that the company had submitted to the FDA on the aerosols that users inhale, according to the Wall Street Journal.
Juul also said the agency failed to consider the totality of Juul’s evidence, which the company said established that the public-health benefits of Juul products significantly outweighed the potential risks.
“FDA’s order acknowledged that ‘exposure to carcinogens and other toxicants present in cigarette smoke were greatly reduced with exclusive use’ of Juul products compared with combustible cigarettes,” Juul Labs stated in court documents.
The company added that the decision was reached “against a backdrop of immense political pressure” from Congressional lawmakers who “tainted the entire agency process” by pushing for a Juul ban. Juul officials say its products are held to a different regulatory standard than those made by rivals.
“If the court does not intervene, [Juul Labs] products will disappear from store shelves and politics will have won over sound science and evidence,” the filing said.
A federal appeals court last week granted Juul Labs a temporary stay of the FDA’s marketing denial order that requires the vaping company to pull its e-cigarettes off the U.S. market.
“The purpose of this administrative stay is to give the court sufficient opportunity to consider petitioner’s forthcoming emergency motion for stay pending court review and should not be construed in any way as a ruling on the merits of that motion,” the court wrote.
The FDA has until July 7 to respond to Juul’s motion and Juul Labs has until July 12 to reply to the FDA response if submitted.
“Having received the emergency temporary stay, we are now seeking the ability to continuously offer our products to adult smokers throughout our appeal with the court and science- and evidence-based engagement with our regulator,” said Joe Murillo, Juul Labs’ chief regulatory officer.
Last week, the Wall Street Journal reported that the company is mulling a potential bankruptcy filing if the FDA ban is upheld.
June 28, 2022
U.S. Appeals Court Delays FDA’s Ban on Juul

Credit: Tanasin
A federal appeals court today granted Juul Labs Inc. a temporary stay of the U.S. Food and Drug Administration’s order for the vaping company to pull its e-cigarettes off the U.S. market.
“The purpose of this administrative stay is to give the court sufficient opportunity to consider petitioner’s forthcoming emergency motion for stay pending court review and should not be construed in any way as a ruling on the merits of that motion,” the court wrote.
The e-cigarette maker had earlier asked the court to pause what it calls an “extraordinary and unlawful action by the regulatory agency that would require it to immediately halt its business.
The company filed an emergency motion with the U.S. Court of Appeals in Washington as it prepares to appeal the FDA´s decision.
Juul said that the FDA cannot argue that there was a “critical and urgent public interest” in immediately removing its products from the market when the agency allowed them to be sold during its review.
The company noted that the FDA denied its application while authorizing those submitted by competitors with similar products.
The order sets a briefing schedule of June 27 for the petitioner’s emergency motion; July 7 for the respondent’s response, and July 12 for the reply.
The request for an emergency stay while waiting to file an appeal was expected.
“We respectfully disagree with the FDA’s findings … intend to seek a stay and are exploring all of our options under the FDA’s regulations and the law, including appealing the decision and engaging with our regulator,” said Joe Murillo, chief regulatory officer at Juul Labs, said in a statement. “We remain committed to doing all in our power to continue serving the millions of American adult smokers who have successfully used our products to transition away from combustible cigarettes, which remain available on market shelves nationwide.”
The marketing denial order, which concerns the FDA’s analysis of Juul products has not been released to the public. “Any portion of the record that was placed under seal . . . before an agency remains under seal in this court unless otherwise ordered,” the emergency motion states.
June 24, 2022