Tag: Marketing Denial Order

Court Stays Logic MDO

Photo: de Art
A U.S. appeals court has stayed the Food and Drug Administration’s marketing denial order (MDO) for Logic Technology Development’s Logic Power Menthol E-Liquid Package and Logic Pro Menthol E-Liquid Package, according to a NATO newsletter.
The ruling allows retailers and wholesalers to continue selling the products for the duration of the stay.
The U.S. Circuit Court of Appeals for the 3rd Circuit will now consider a further motion from Logic regarding the MDO that the company has seven days to file, according to media reports.
“The foregoing motion for a partial administrative stay is GRANTED as follows. The FDA’s marketing denial order is TEMPORARILY STAYED as to the Logic Pro Menthol E-Liquid Package and the Logic Power Menthol E-Liquid Package products. Within seven days of this order, the petitioner must file its motion for a stay pending the petition,” the order states. “The FDA’s response must be filed within 10 days thereafter.”
The temporary administrative stay will remain in effect until a panel of the court decides on Logic’s new stay motion. If no timely stay motion is filed, the clerk is authorized and directed to vacate the temporary administrative stay.
Tobacco harm reduction advocates have questioned the FDA’s reasoning behind the Logic MDO, suggesting that the agency misinterpreted youth consumption statistics.
November 1, 2022
Logic Rejection Based on Fuzzy Math

Photo: vchalup
The FDA’s recent rejection of Logic products is based on questionable statistics, says the director of the Center for Substance Use Research.
By Neil McKeganey
Last week in Washington, D.C., at the FDLI Tobacco Conference, Brian King, director of U.S. Food and Drug Administration’s Center for Tobacco Products, explained that FDA would be using the recently released 2022 National Youth Tobacco Survey (NYTS) results to inform its judgment as to whether electronic nicotine-delivery system (ENDS) products being assessed under the premarket tobacco product application (PMTA) process would be deemed “appropriate for the protection of the public health.” For those unfamiliar with the National Youth Tobacco Survey, the just-published survey data showed that 9.4 percent of youth in the U.S. had used an e-cigarette in the last 30 days, that 84.9 percent of flavored e-cigarette-using youth had used a nontobacco flavor and that 26.6 percent of those had used menthol-flavored e-liquids.
If anyone in the audience thought that there might be a disconnect between King’s words and FDA actions, they were proved wrong barely a week later when marketing denial orders (MDO) arrived at the doorstep of Logic Technology Development for its Logic Power Menthol E-Liquid Package and its Logic Pro Menthol E-Liquid Package, with the FDA press release accompanying those denial orders expressly referring to the NYTS findings. In the light of King’s warning, you might think that the company receiving those denial orders could hardly have expected anything else. On the face of it, the NYTS figures are very scary, seemingly justifying immediate action on the part of the FDA. But as with all percentages, you have to look a little closer at what is actually being reported before you push the red button of alarm.
Within the CDC Mortality and Morbidity Weekly Report setting out the NYTS results, the prevalence of youth use of Logic products is shown to be 4.3 percent. However, that is not 4.3 percent of all U.S. youth but 4.3 percent of the 9.4 percent of youth who were currently vaping within the U.S. With that clarification, the numbers here begin to look very different to the headline announcements. Instead of alarming levels of Logic use among U.S. youth, the extent of that use reported by the CDC researchers is 4.3 percent of 9.4 percent, i.e., 0.4 percent. By their own calculations, the CDC authors estimate this to be 100,000 of all U.S. youth—hardly an epidemic of Logic use.
But it gets worse than this because the 0.4 percent figure of youth Logic use actually refers to the Logic brand not the two denied products. Unfortunately, the NYTS does not collect information on the specific Logic devices that youth in the U.S. are using. However, research currently underway by the Centre for Substance Use Research in Scotland does have these data. The Scottish researchers have been studying ENDS use among representative samples of U.S. youth and adults in 2021 and 2022, collecting data on over 20 leading ENDS brands and over 200 specific ENDS devices.
In this Scottish research, out of the 1,215 youth aged 13 to 17 surveyed in 2022, 0.2 percent had ever used a Logic Power and 0.5 percent had ever used a Logic Pro. When the Scottish researchers looked at youth e-cigarette use over the last 30 days, the levels of Logic use shrank even further with 0.1 percent of youth reporting having used the Logic Power in the last 30 days and the level of Logic Pro use so low that it was not even recorded.
In dispatching the MDOs for these two products, the FDA seems to have set aside a commitment to review the data around individual devices and liquids and to formulate a response in terms of the brand of products being used and justify the denial orders issued by reference to the NYTS data.
However, there is something even more troubling in the MDOs that have been dispatched this week. If the CDC researchers estimates of only 0.4 percent of U.S. youth having used a specific branded ENDS product is sufficient for the FDA to issue an MDO, one has to wonder at the relative value that is being placed here on the goal of helping adult smokers to quit and the goal of preventing youth vaping.
The good news in the NYTS research is that overall levels of e-cigarette use by youth in the U.S. is declining. The bad news is that it would appear from the Logic experience that for as long as the NYTS data reveal any level of youth ENDS use, no matter how small, the FDA may still regard that as sufficient to issue an MDO. The implicit suggestion here then is that the FDA are operating a zero-tolerance approach to youth ENDS use and are prepared to sacrifice the potential benefit of ENDS products for adult smokers on the altar of youth ENDS prevention.
Neil McKeganey is the director of the Center for Substance Use Research in Glasgow, Scotland.

October 28, 2022
Juul Lab Publishes Details of MDO Appeal

Photo: Juul Labs
Juul Labs has published its administrative appeal of the marketing denial order (MDO) issued by the U.S. Food and Drug Administration, which explains the company’s position, based on science and evidence, that the MDO was substantively and procedurally flawed. This appeal, referred to as a 10.75 appeal, is currently under review by the FDA.
In its press release for the MDO, the FDA stated that Juul Labs’ premarket tobacco product applications (PMTAs) “lacked sufficient evidence regarding the toxicological profile of the products” and that some of the “study findings raised concerns due to insufficient and conflicting data.”
Juul Labs believes that each of the deficiencies in the MDO is based on an incorrect and incomplete assessment of the data, and when the data are appropriately evaluated within the PMTAs, the FDA can properly assess the toxicological profile of Juul products and relative to other tobacco products, including combustible cigarettes. The appeal also shows that all perceived limitations could have been resolved by clarifications through the usual, iterative process that the FDA has followed for prior applications.
Through its 10.75 appeal, Juul Labs requests that the MDO be rescinded and its PMTAs be placed back into substantive review so that the FDA can complete a full and fair review to determine whether the Juul system is appropriate for the protection of public health. “We believe that once the FDA does a complete review of all of the science and evidence presented in the applications, without political interference, as required by law, we should receive marketing authorization for our products,” Juul Labs wrote in a press note.
For context: In July 2020, Juul Labs submitted PMTAs to the FDA for its currently marketed products and a new device with age-verification technology. The PMTAs included over 125,000 pages of data, information and analysis from over 110 scientific studies across nonclinical (75-plus studies), clinical (14 studies) and behavioral (21 studies) research programs to support the marketing of Juul products. The company also assessed its products relative to combustible cigarettes, an FDA-authorized heated-tobacco product (IQOS) and other marketed vapor products.
Despite this science and evidence, on June 23, 2022, the FDA issued an MDO for Juul Labs’ PMTAs. On July 5, the FDA stayed the MDO, announcing, on its own, that it would review the decision after determining “there are scientific issues unique to this application that warrant additional review.”
A summary of the Juul Labs responses to what the company believes are the deficiencies of the MDO is available here.
October 24, 2022
Confusion Persists About Magellan MDO

Photo: Damir Khabirov
The U.S. Food and Drug Administration has confirmed that Magellan Technology received marketing denial orders (MDOs) on Oct. 6 for 32 products.
In response to the FDA press statement announcing the order, Magellan Technology denied having received an MDO, saying the agency had refused to accept its premarket tobacco product application (PMTA) on a technicality without reviewing the PMTA on its merits.
Magellan Technology demanded that the FDA not only retract the press announcement but also issue a corrective statement, making clear that the FDA did not issue an MDO to Magellan and that it has not yet conducted a scientific review of Magellan’s products.
In response to an inquiry by Vaping360, the FDA reiterated that it had served Magellan Technology with an MDO.
“After reviewing premarket tobacco applications for 32 Hyde e-cigarettes, FDA issued marketing denial orders for these applications submitted by Magellan Technology Inc. on Oct. 6,” the agency told Vaping360. “In addition to the MDOs issued on Oct. 6, as acknowledged by Magellan Technology Inc. in their statement, FDA also issued a Refuse to Accept letter for other Hyde e-cigarette products.”
October 14, 2022
Magellan Denies Receiving MDO

Photo: Surendra
Magellan Technology insists it did not receive a marketing denial order (MDO) for its Hyde Brand, despite a U.S. Food and Drug Administration announcement to the contrary.
In an email to Tobacco Reporter’s sister publication, Vapor Voice, Magellan CEO Jon Glauser said his company had received a “refuse to accept” (RTA) letter. An RTA is not a judgment on the product’s appropriateness for the protection of public health. It is merely a determination that the premarket tobacco product application doesn’t conform to the FDA’s standards, and it leaves the applicant the option to refile.
“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,” wrote Gauser. “In other words, the refusal to accept was based on bureaucratic technicalities.”
In its letter to Magellan, the FDA wrote that the absence of the forms prevented the agency from accepting and processing the 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.”
Magellan is not the first company to take issue with the FDA’s handling of the PMTA process. The agency is currently facing more than 20 lawsuits and has had to backtrack on MDOs issued to companies such as Juul Labs, Turning Point Brands and Kavial Brands.
October 7, 2022
Court Rejects Gripum’s MDO Appeal

Photo: Mikhail Reshetnikov
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
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.”
August 24, 2022
Court Refuses to Suspend Fontem MDO

A U.S. appeals court denied Fontem US’ request to suspend the Food and Drug Administration’s marketing denial orders (MDO) for certain Myblu products.
On April 8, the FDA rejected several of the company’s premarket tobacco product applications on the basis that they lacked sufficient evidence to show that permitting the marketing of those products would be appropriate for the protection of public health.
The court rejected Fontem’s July 12 request for a stay, saying that the e-cigarette company had waited too long to file the motion.
“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.
The court also stated that Fontem “has not made a strong showing” that it is likely to succeed in its appeal of the MDO on merits.
“The court ruling does not affect our progress through the FDA’s administrative appeals process, through which we intend to convince the agency that approval should be granted for Myblu products,” said a spokesperson for Fontem US.
“In the meantime we continue to supply Myblu to the majority of retailers. The MDO does not apply to Blu disposables which constitute 50 percent of Blu share in the U.S. market.”
July 25, 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
Marketing Orders for Vuse Vibe and Vuse Ciro
The U.S. Food and Drug Administration on May 12 gave R.J. Reynolds Vapor Co. (RJRVC) permission to continue marketing the original-flavor varieties of its Vuse Vibe and Vuse Ciro products. In October 2021, the FDA authorized the marketing of Vuse Solo original flavor.
“These authorizations represent the broadest portfolio of market authorizations provided to any company in the U.S for premarket tobacco product applications (PMTA),” said David O’Reilly, director of scientific research at RJRVC’s parent company, BAT, in a statement. “Continued focus on science and innovation has supported the robust submissions, which have enabled FDA to evaluate and authorize the marketing of these products.
“We are proud of the work undertaken by the team to achieve this significant regulatory milestone and are confident in the quality of our applications.”
While approving the original-flavor varieties, the FDA denied RJRVC’s applications for the marketing of Vuse-branded products with other flavors. Those flavored vapor products are not currently marketed or sold in the U.S., according to BAT. The company says it is reviewing the FDA’s decision on those applications to determine next steps.
RJRVC’s application to market menthol-flavored Vuse products remains under FDA review and those products can remain on market pending a decision from the agency.
May 12, 2022