Tag: Marketing Denial Order

Fifth Circuit Vacates Denials Citing ‘Triton’

The 5th Circuit Court of Appeals granted petitions for review to five vaping companies, citing its own decision in the Triton Distribution case as precedent.
The court sent the company’s marketing denial orders (MDOs) back to the U.S. Food and Drug Administration for additional scientific evaluation. As a result, the manufacturers may keep selling their products until the agency completes new reviews of their premarket tobacco applications (PMTAs), or until the Supreme Court takes action.
“Specifically, the court determined that (1) FDA did not give e-cigarette manufacturers fair notice of the rule requiring long-term studies for PMTAs; (2) FDA did not acknowledge or adequately explain its change in position; and (3) FDA ignored reasonable and serious reliance interests that manufacturers had in the pre-MDO guidance,” the 5th Circuit wrote in its ruling.
Five companies, Cloud House, Paradigm Distribution, SWT Global Supply, Vaporized and SV Packaging first challenged their MDOs in court in October 2021. The court consolidated the five cases, and in November 2021, all petitioners were granted stays pending review.
In January, the 5th Circuit found in favor of Wages and White Lion Investments (doing business as Triton Distribution) in the e-liquid manufacturer’s appeal of an MDO. The FDA later petitioned the Supreme Court to review the 5th Circuit’s ruling, and last month the Supreme Court agreed to hear the agency’s appeal.
The FDA challenged the Triton decision, and the U.S. Supreme Court agreed to hear that case. “But now another panel of the Fifth Circuit has applied the same rationale as in Triton to hold that these five, small-business manufacturers prevail for the same reason: FDA pulled a surprise switcheroo,” wrote the United States Vaping Association on X.
The 5th Circuit found that the recent petitions posed the same issues as Triton’s. “Petitioners spent substantial time and resources preparing their PMTAs based on FDA guidance that they would not need to submit long-term clinical studies,” the court wrote.
“Nevertheless, FDA rejected their PMTAs using the same boilerplate language it used for the Wages petitioners’ denials, as well as those of thousands of other e-cigarette manufacturers. Accordingly, for the reasons amply explained by the en banc court in Wages, we hold that FDA acted unlawfully here as well by denying Petitioners’ PMTAs based on the absence of long-term clinical studies.”

August 2, 2024
FDA Denies Marketing of Flavored Blu Products

The U.S. Food and Drug Administration issued marketing denial orders (MDOs) to Fontem U.S. for four Blu disposable products and one MyBlu e-cigarette product.

The denied products include a closed menthol e-liquid and several flavored disposable e-cigarettes. As a result, the company may not legally market or distribute these products in the United States. However, the company may submit new applications for the products that are subject to these MDOs.

The products that received MDOs are Blu Disposable Menthol 2.4 percent; Blu Disposable Vanilla 2.4 percent; Blu Disposable Polar Mint 2.4 percent; Blu Disposable Cherry 2.4 percent; and MyBlu Menthol 1.2 percent.

After reviewing the company’s premarket tobacco product applications, the FDA determined that the applications lacked sufficient evidence to demonstrate that permitting marketing of the products would be appropriate for the protection of the public health, which is the standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act.

More specifically, the FDA said the application lacked sufficient evidence regarding harmful and potentially harmful ingredients in the aerosol for one product and battery safety for several products. Additionally, the applicant did not present sufficient data demonstrating that the new products have a potential to benefit adult smokers, in terms of complete switching or significant cigarette use reduction, that would outweigh the risk to youth, according to the agency.

February 5, 2024
FDA Prevails in Logic Challenge

The U.S. Food and Drug Administration has defeated Logic Technology Development after the e-cigarette manufacturer asked the courts to block the regulatory agency’s market ban on Logic’s menthol-flavored e-cigarette products, according to media reports.

Logic filed a petition for review in the U.S. Court of Appeals for the Third Circuit, alleging the FDA violated the Administrative Procedure Act when it denied Logic’s premarket tobacco product application to market its menthol-flavored vaping products. The court denied that petition Thursday after concluding the FDA “based decisions on scientific judgments.”

Logic alleged it was arbitrary and capricious for the FDA to apply the same regulatory framework to menthol that it used to remove fruit- and dessert-flavored e-cigarettes from commerce. The Third Circuit Court entered a stay on the FDA’s marketing denial orders (MDOs) in December 2022. The MDOs were the FDA’s first-ever MDOs directed at menthol e-cigarette products.

October 20, 2023
Ninth Circuit Denies Lotus MDO Review

Entrance to United States Court of Appeals for the Ninth Circuit . Headquartered in San Francisco, California, the Ninth Circuit is by far the largest of the 13 courts of appeals. (Credit: Eric BVD)

The U.S. Court of Appeals for the 9th Circuit on June 30 declined to review a Food and Drug Administration marketing denial order for Lotus Vaping Technologies’ flavored e-liquid products.

The FDA issued marketing denial orders for Lotus’ flavored products, finding that the petitioners’ applications lacked sufficient evidence showing that the flavored products would provide a benefit to adult users that outweighs the risks such products pose to youth.

Lotus challenged the ruling in court, but the judges held that the text of the Family Smoking Prevention and Tobacco Control Act authorizes the FDA to require that manufacturers submit comparative health risk data, which necessarily includes comparisons of flavored e-liquids to tobacco-flavored e-liquids.

The judges also held that the FDA did not arbitrarily or capriciously deny Lotus’ applications and that any error the agency committed by failing to consider Lotus’ marketing plans was harmless.

July 8, 2023
FDA Denies Marketing of 250+ E-liquids

The U.S. Food and Drug Administration on May 18 issued marketing denial orders to Mothers Milk WTA for more than 250 flavored and tobacco-flavored e-liquids.
After completing initial acceptance review and subsequently proceeding to and completing a substantive scientific review of the company’s premarket tobacco product applications (PMTAs), the FDA determined that the applications lacked sufficient evidence to show the products are appropriate for the protection of public health.
For example, the applications did not provide sufficient evidence to show comparative health risk data relative to other tobacco products on the U.S. market, information assessing the abuse liability of the new products, or that the new products could be manufactured consistently.
“One of our most important responsibilities is to ensure new tobacco products undergo scientifically rigorous premarket review,” said Matthew Farrelly, director of the Office of Science within the FDA’s Center for Tobacco Products, in a statement. “We remain committed to evaluating these applications based on a public health standard that considers the risks and benefits of the tobacco product to the population as a whole.”
To date, the agency has received premarket tobacco applications for more than 26 million deemed products, the majority of which are e-cigarettes. The agency says it has made determinations on 99 percent of these applications. This includes more than 1 million applications for non-tobacco nicotine products, including those containing synthetic nicotine, after Congress clarified FDA’s authority to regulate these products in April 2022.
Further, FDA has authorized 23 tobacco-flavored e-cigarette products and devices, which are the only e-cigarettes that currently may be lawfully sold or distributed in the U.S. FDA has also denied marketing applications for millions of products that did not meet the requirements in the law.

May 18, 2023
FDA Rejects 6,500 Flavored Vape Products

Photo: Surendra

On May 12, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) to 10 companies, which collectively manufacture and market approximately 6,500 flavored e-liquid and e-cigarette products. The companies may not market or distribute these products in the U.S., and retailers who sell these illegal products risk FDA enforcement action.
According to the FDA, the premarket tobacco product applications (PMTAs) provided insufficient evidence to show that permitting the marketing of these products would be appropriate for the protection of the public health. The flavor names of some of the products denied include Citrus, Strawberry Cheesecake, Cool Mint, and Menthol.
Since the spring of 2020, the FDA has received applications for over 26 million new tobacco products, the majority of which were for e-cigarette products. To date, FDA has completed review and taken action on over 99 percent of these applications, according to the agency.
“Science is a cornerstone of FDA’s tobacco product review process,” said Matthew Farrelly, director of the Office of Science within FDA’s Center for Tobacco Products in a statement. “Today’s decision to deny approximately 6,500 products was based on the lack of scientific evidence provided in the applications. We will continue to ensure all new tobacco products undergo robust, scientific premarket evaluation to determine whether they meet the appropriate public health standard to be legally marketed.”
The companies that received MDOs include Imperial Vapors, Savage Enterprises, Big Time Vapes, SWT Global Supply, Great Lakes Vapor, DNA Enterprise (“Mech Sauce”), Absolute Vapor and ECBlend.
FDA is withholding the names of the other two companies that received MDOs to protect potential confidential commercial information.

May 12, 2023
Reynolds to Appeal Menthol MDOs

Photo: BAT

BAT will appeal the U.S. Food and Drug Administration’s marketing denial orders for its Vuse Vibe Tank Menthol 3.0 percent and Vuse Ciro Cartridge Menthol 1.5 percent, the company announced in a statement.
On Jan. 24, the FDA denied marketing applications for two menthol refills used in Vuse Vibe and Vuse Ciro vaporizers, which are sold in the U.S. by BAT subsidiary R.J. Reynolds. According to the agency, Reynolds’ applications presented insufficient evidence to show that the potential benefit to adult smokers outweighs the risks of youth initiation and use.
“Reynolds intends to seek a stay of enforcement immediately and will pursue other appropriate avenues to allow Vuse to continue offering its innovative products to adult nicotine consumers age 21-plus without interruption,” the company said.
“We believe that menthol vapor products are critical to helping adult smokers migrate away from combustible cigarettes. FDA’s decision, if allowed to go into effect, will harm, not benefit, public health.
“We remain confident in the quality of all of Reynolds’ applications, and we believe that there is ample evidence for FDA to determine that the marketing of these products is appropriate for the protection of public health.”
Anti-tobacco campaigners countered that menthol e-cigarettes appeal to underage consumers. “Existing evidence demonstrates that nontobacco-flavored e-cigarettes, including menthol flavored e-cigarettes, have a known and substantial risk with regard to youth appeal, uptake and use; in contrast, data indicate tobacco-flavored e-cigarettes do not have the same appeal to youth and therefore do not pose the same degree of risk,” said Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, in a statement.
Morgan Stanley said it expected the rejected products to remain on the U.S. market for the duration of BAT’s appeal, with minimal impact on the company’s operations. “Longer term, should today’s denial order reflect a broader effort by the FDA to ban menthol e-cigarettes, BAT’s U.S. cigarette business could benefit given its menthol mix as it might discourage some smokers from quitting or switching to reduced-risk products,” the bank wrote in a note to investors. Reynolds’ Newport brand represents about 40 percent of BAT’s U.S. cigarette dollar sales, according to Morgan Stanley.
The Jan. 24 rejection of the Vuse refills underscores the FDA’s ongoing reluctance to approve menthol e-cigarette flavors. To date, the agency has approved only tobacco-flavored e-cigarettes.
However, the FDA has granted both a premarket tobacco product application and modified-risk tobacco product designation to IQOS’ menthol variant, which may eventually leave Philip Morris International’s heat-not-burn product as one of the few menthol reduced-risk alternatives on the market.
The FDA is targeting publishing a final rule to ban menthol cigarettes in August 2023, but considering expected industry litigation, final implementation could be five to six years away, according to Morgan Stanley.

January 25, 2023
FDA Denies Two Vuse Menthol Vapor Products

Photo: rangizzz

The U.S. Food and Drug Administration issued marketing denial orders (MDOs) for R.J. Reynolds Vapor Co.’s Vuse Vibe Tank Menthol 3.0 percent and the Vuse Ciro Cartridge Menthol 1.5 percent.
“Consistent with the authorities granted by Congress, the FDA remains committed to evaluating new tobacco product applications based on a public health standard that considers the risks and benefits of the tobacco product to the population as a whole,” said Brian King, director of the FDA’s Center for Tobacco Products. “The applications for these products did not present sufficient scientific evidence to show that the potential benefit to adult smokers outweighs the risks of youth initiation and use.”
“Existing evidence demonstrates that nontobacco-flavored e-cigarettes, including menthol-flavored e-cigarettes, have a known and substantial risk with regard to youth appeal, uptake and use; in contrast, data indicate tobacco-flavored e-cigarettes do not have the same appeal to youth and therefore do not pose the same degree of risk,” the FDA wrote in a statement.
“Given these existing differences in youth risk, applicants need to provide robust evidence to demonstrate that using their menthol-flavored e-cigarette products are likely to promote a complete switch or are likely to significantly reduce combustible cigarette use in adult smokers beyond that facilitated by tobacco-flavored e-cigarette products. Data from the 2022 National Youth Tobacco Survey found that Vuse was the second most common brand youth e-cigarette users reported ‘usually’ using.”
“Today’s decision pertains to the specific application submitted for review by FDA,” said King. “It is the responsibility of the applicant to provide sufficiently robust scientific evidence to demonstrate that the necessary public health standard has been met. In this case, the presented evidence did not meet that standard.”
In assessing the implications of the most recent MDOs for RJRV’s parent company, BAT, Morgan Stanley noted that Vuse Vibe and Vuse Ciro represent only a small portion of BAT’s overall e-cigarette sales in the U.S.
“Should it choose to appeal, we would expect its products to remain on the market as the appeal is ongoing, resulting in minimal/no operating impact,” the investment bank wrote in a note to investors.
Morgan Stanley said the MDO provides another example of the FDA’s ongoing reluctance to approve menthol e-cigarette flavors. To date, the agency has approved only tobacco-flavored e-cigarettes.
The financial institution also noted that the FDA has granted both a premarket tobacco product application and modified-risk tobacco product designation to IQOS’ menthol variant, which may make it one of the few menthol reduced-risk alternatives on the market.
The FDA is targeting publishing a final rule to ban menthol cigarettes in August 2023, but considering expected industry litigation, final implementation could be five to six years away, according to Morgan Stanley.

January 24, 2023
Avail Loses MDO Case

Photo: Avail Vapor

A U.S. court rebuffed Avail Vapor’s appeal of the Food and Drug Administration’s refusal to allow its products on the market, reports Reuters. The ruling is the latest in a series of court orders upholding the agency’s regulation of the e-cigarette industry.
The 4th U.S. Circuit Court of Appeals on Dec. 12 found that the FDA had acted within its authority in rejecting Avail Vapor’s premarket tobacco product applications.
In 2016, the FDA determined that e-cigarettes were subject to its regulation and gave manufacturers until 2020 to apply for approval of vapor products.
Avail Vapor sought approval for its products in 2020, telling the FDA that they could help smokers quit by switching to e-cigarettes. The company said it had measures in place that would ensure that its liquids would not be sold to minors.
The FDA denied the application in 2021, saying that the company had not presented long-term studies supporting its claim that its products, which included fruit flavors, were more effective at helping smokers quit than tobacco-flavored liquids, which the agency has said are less appealing to minors.
Avail lost an administrative appeal and then petitioned the 4th Circuit to overrule the agency. The company argued that the FDA failed to inform applicants in 2019 that they would need long-term studies. It also said the agency was obligated to consider the sales plan.
Circuit Judge J. Harvie Wilkinson wrote that Avail “encourages us to neglect the forest for the trees” by focusing on procedural objections rather than the FDA’s mandate to protect public health.
The FDA has denied more than 55,000 applications from e-cigarette products. Those denials have been previously upheld by the D.C. Circuit, 3rd Circuit and 7th Circuit.

December 13, 2022
A Taste of Things to Come?

Nveed Chaudhary | Photo Courtesy of the Broughton Group

What the recent marketing denial order for Logic’s menthol vapes implies for flavored e-cigarettes
By Stefanie Rossel
On Oct. 26, the U.S. Food and Drug Administration wrote a new chapter in the story of electronic nicotine-delivery systems (ENDS) regulation. That day, the agency for the first time rejected a premarket tobacco product application (PMTA) for a menthol e-cigarette. Logic Technology Development received marketing denial orders (MDOs) for its Logic Power Menthol E-Liquid Package and its Logic Pro Menthol E-Liquid Package.
In a press release accompanying its decision, the FDA said the rejection was based on a full scientific review. The applications, the FDA argued, “lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of the public health.” The evidence provided within the application, it said, did not demonstrate that these menthol-flavored e-cigarettes were more effective in promoting complete switching or significant cigarette use reduction relative to tobacco-flavored e-cigarettes among adult smokers.
In its statement, the agency also referred to the 2022 National Youth Tobacco Survey (NYTS), which had been released shortly before the Logic MDO. “For nontobacco-flavored e-cigarettes, including menthol-flavored e-cigarettes, existing evidence demonstrates a known and substantial risk with regard to youth appeal, uptake and use,” the FDA wrote.
Tobacco harm reduction advocates were dismayed. The MDO shattered their hopes that mentholated vapor products would be allowed to remain on the market as a less risky alternative to mentholated cigarettes, which the FDA wants to prohibit. They were also surprised given that the FDA in late 2021 authorized 22nd Century Group to market its reduced-nicotine VLN Menthol King brand as a modified-risk tobacco product.
According to data by the Centers for Disease Control and Prevention, menthol-flavored products accounted for 37 percent of all cigarette sales in the U.S. in 2019 and 2020.

Misplaced Priorities

Critics also lambasted the agency’s focus on the risk of youth uptake at the expense of the opportunity to move adult smokers to lower risk products. Christopher Russell, director at Russell Burnett Research and Consultancy, made up a quick calculation based on recent NYTS data. Of the 2.55 million U.S. students who had used an e-cigarette in the past 30 days according to the survey, 84.9 percent had used flavored vapes. Of the current flavor vapers, 26.6 percent consumed menthol ENDS, which corresponded to 2.12 percent of U.S. youth having vaped menthol in the past 30 days. “MDOs for menthol e-cigarettes,” he concluded, “equals banning menthol to 100 percent of adults in order to protect under 3 percent of youth.”
Neil McKeganey, co-director of the Centre for Substance Use Research, went a step further, quoting a Scottish study carried out by his institution that looked at ENDS use among representative samples of U.S. youth and adults in 2021 and 2022. Out of the 1,215 youth aged 13 to 17 surveyed in 2022, he said, 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 to 0.1 percent of youth reporting having used the Logic Power during that period whereas the level of Logic Pro use was so low that it was not even recorded.
“In dispatching the MDOs for these two products,” he stated, “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.”
Jim McDonald of Vaping360 predicted a rise in illicit trade if the FDA blocks the legal path to market for menthol vape products. The FDA, he said, ignored the fact that most youth vapers use unauthorized gray market flavored disposable vapes, many of which are menthol flavored. “They will continue using these products, too, while the FDA pursues its goal of eliminating legal vaping, locked into the belief that its ‘authority’ has some effect on the market,” wrote McDonald.
In March, the FDA authorized Logic devices with tobacco-flavored refills. To date, the agency has not approved a single vapor product with nontobacco flavors.
Shortly after receiving its MDO, Logic Technology Development secured a stay of the FDA order in court, allowing retailers and wholesalers to continue selling Logic menthol products for the duration of the stay. Even if the court requires the FDA to reevaluate the evidence, this does not guarantee a more favorable outcome for Logic and the future of menthol vape in the United States.

Understanding the FDA’s Requirements

Despite Logic Technology Development’s travails, Nveed Chaudhary, chief scientific and regulatory officer at Broughton Group, is confident the recent MDOs do not mark the beginning of the end for menthol and other nontobacco-flavored e-liquids in the U.S.
While he agrees with McKeganey that the FDA’s positions are being driven in large part by the data from cross-sectional studies like the NYTS, Chaudhary believes the fundamental issue is how the PMTA studies were designed, how the data has been interpreted and how the arguments have been presented to the FDA. “Based on the original PMTA guidance and then the Final Rule, many, if not all, of the applications for menthol and nontobacco-flavored products were considered to be ‘equal,’” he says. According to Chaudhary, the relative benefits of all the ENDS flavors together were compared with the risks of smoking combustible cigarettes. The youth access measures introduced were the same across all flavors of a given platform.
“What has become very clear from the FDA’s recent communications, especially through the MDOs, is that they do not consider all flavors of ENDS to have the same risk profile—in this case, the risk of promoting on-ramping amongst youth,” says Chaudhary.
“Therefore, the expectation from the FDA has evolved. Given the data from studies such as NYTS, the FDA are now saying that the PMTA applications need to demonstrate that there is additional benefit of the menthol over tobacco flavors for current smokers—essentially that the additional benefit outweighs the continued risk of youth finding menthol more attractive. Over time, as the industry presents this data to FDA and FDA begin to approve menthol-flavored products, I can imagine a situation where the same would apply to other nontobacco and nonmenthol flavors—only that, for these flavors, an additional benefit for smokers compared with menthol that outweighs the risk on youth use would be required.”

Remediating Deficiencies

Chaudhary believes that “with the addition of a few relatively inexpensive studies and an overhaul of the dossier to build the arguments that FDA want to see,” Logic Technology Development should be able to convince the agency of the additional benefits of nontobacco flavors.
Attempts at rectification, however, may prove futile. In January 2020, the FDA banned all flavors except tobacco and menthol in cartridge-based e-cigarettes. In September 2020, the agency signaled that it would not authorize flavored products without extraordinary evidence. With Logic Technologies Development being part of Japan Tobacco International, one of the world’s leading players, it may furthermore be assumed that the company submitted a very comprehensive application.
While acknowledging that many of the applicants are large multinationals with the financial power to conduct large complex studies, Chaudhary says this does not mean that the studies that the FDA is now looking for were in fact conducted. “It all goes back to the industry’s understanding of the PMTA guidance and final rule back in September 2020 and the way in which the FDA have chosen to enforce the rule today,” he says. “The ongoing view of FDA is that that NYTS illustrates a preference for menthol flavors amongst youth. Therefore, since the original studies were designed to compare all flavors of ENDS to combustible cigarettes; they are not geared to demonstrate additional benefit of menthol flavors compared with tobacco flavors. I would say for any new applications, that has to be a central question to which the application must provide answers.”
Chaudhary deems it likely that much of the data required to build these arguments already exists in the comprehensive PMTA applications—perhaps with some gaps that could be potentially filled with relatively inexpensive studies. He expects the FDA to apply the same logic to flavored disposable products, which are exempt from the agency’s 2020 flavor ban and have recently experienced a surge in sales. “I would imagine that unless any company has constructed their PMTAs to show the additional benefit of flavors compared to menthol and menthol compared with tobacco flavor, they will also receive MDOs,” says Chaudhary.
“I think we all agree that this is awful news for U.S. smokers who will be denied the wide range of options that they need to stop smoking,” he continues. “It seems that the only way to re-offer smokers these critical choices is to ensure that we as an industry are responsible. We must ensure that we understand the evidence the FDA want to receive and provide this data to them so that menthol and ultimately other flavors can be authorized back into the marketplace, and all smokers can continue their off-ramping journeys.”
Chaudhary says the industry needs to move forward, put aside grievances that have arisen as a result of how the FDA has enforced the PMTA final rule and provide the agency with the data it wants to see to ensure that smokers can have these products in their hands at the earliest opportunity.
“Any integrated technology that can minimize or even eliminate underage use of e-cigarettes would lower the risk of youth use and therefore lower the bar for the additional benefit data that the FDA are now asking for,” he says.

Stefanie Rossel is Tobacco Reporter’s editorial contributor. An experienced trade journalist, she combines sharp reporting skills with in-depth knowledge of the tobacco and vapor industries. Prior to joining Tobacco Reporter, Stefanie was editor-in-chief at Tobacco Journal International, where she worked for a decade. Fluent in English, German and French, Stefanie covers tobacco news around the world. She is based in Germany.

December 1, 2022