Category: Regulation

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
A Drop in the Ocean

Photo: digieye
The FDA’s first premarket approval of a mentholated vape product reflects poorly on the agency’s authorization process.
By Stefanie Rossel
Lindsay Stroud
On June 21, the U.S. Food and Drug Administration for the first time authorized nontobacco-flavored vape products through its premarket tobacco product application (PMTA) pathway. The agency issued marketing granted orders (MGO) for two Njoy Ace menthol flavor pods and two disposable e-cigarettes, Njoy Daily Menthol 4.5 percent and Njoy Daily Extra Menthol 2.4 percent. The news was hailed as a “significant decision” and a “watershed moment for the sector” that will have a “huge and significant impact” on the global reduced-risk products market.
Upon closer inspection, however, the authorization is less of a breakthrough than these superlatives suggest. Instead, it again highlights the many problems with the agency’s authorization process for electronic nicotine-delivery systems (ENDS) and novel nicotine products.
Lindsey Stroud, senior fellow with the Taxpayers Protection Alliance, describes the recent FDA authorization as a small step in the right direction in what has otherwise been a regulatory nightmare. “While allowing the sale of a nontobacco-flavored ENDS, FDA seems to understand that adults who use menthol-flavored combustible cigarettes should have access to products which are significantly less harmful,” she says. “Unfortunately, the FDA still continues to deny the sale of all other flavored ENDS, despite their effectiveness in helping adults quit smoking and remain smoke-free.”
Stroud is also concerned about the informal market. “Despite FDA not having issued authorization orders for flavored ENDS, a large, unregulated marketplace exists in the United States—99.9 percent of which are nontobacco flavored,” she says. “FDA must recognize the role that other flavors play in tobacco harm reduction because denialism isn’t stopping the flourishing non-FDA-authorized ENDS marketplace.”
Jeffrey Smith
Jeffrey Smith, a senior fellow in harm reduction at the R Street Institute, says he welcomes any action by the FDA Center for Tobacco Products (CTP) that supports reduced-risk options for those who smoke. “Unfortunately, in the grand scheme of things, the awarding of an MGO to the four Njoy menthol variants is unlikely to be a sign of a significant shift in the decision-making process at the CTP,” he says. “If the regulatory environment does not change through external pressures, it is unlikely that the actions of the CTP will evolve in a swift and effective manner.”
Gray Market to Persist
While optimists may detect a new willingness to approve reduced-risk products (RRPs) in the CTP’s recent product authorizations, few expect the regulatory floodgates to open to an avalanche of product approvals.
“Since the awarding of the Njoy menthol products, there haven’t been any additional actions or signals that more may be coming,” says Smith. “The only additional communications I have seen from the CTP since the Njoy announcement was a letter from the FDA to the clerk of the Supreme Court informing the court that the CTP had granted a marketing order to four menthol-flavored e-cigarette products. The case is the Logic v. FDA, where Logic is arguing that the CTP had adopted a blanket policy of rejecting menthol-flavored products.”
Stroud says the menthol announcement is a positive development but notes that the FDA remains opposed to any flavors that don’t exist in traditional tobacco products. “Dr. Brian King, director for the Center for Tobacco Products, is very anti-flavor, if not anti-vape,” she says. “Going back to at least 2015 and his time at the CDC [Centers for Disease Control and Prevention], King has been first to tout the Bloomberg party line that ‘flavors hook kids.’ This is in direct contrast to U.S. youth survey data, which finds flavors as one of the least-cited reasons why youth vape. FDA must recognize the role of flavors, their appeal to adults who smoke and how flavors help to reinforce a negative taste—literally—associated with combustible cigarette smoke. Until FDA recognizes this, the U.S. ENDS market will remain a large gray market.”
Unlike most other vape products that have received FDA authorization to date, the Njoy menthol variants are technologically up to date and relatively popular with consumers. “According to Altria’s first-quarter 2024 report, Njoy made up 4.3 percent of the U.S. retail market, but this will likely grow as Njoy is now the only menthol-flavored—and nontobacco-flavored—ENDS product legally permitted to be for sale in the U.S.,” says Stroud.
She is undecided about the FDA decision’s potential impact on the global RRP landscape. “I would imagine that with FDA recognizing the importance of menthol, most countries would follow the agency’s findings,” she says. “Unfortunately, due to a de facto flavor ban in the U.S., there is precedent for countries to restrict flavors, despite them not experiencing a huge surge in youth vaping as the U.S. did in 2019.”
“The awarding of a marketing granted order to the four Njoy menthol variants is unlikely to be a sign of a significant shift in the decision-making process at the CTP.”
Depressing Number
Nicotine companies have long lamented the FDA’s product authorization process, which they say is needlessly time-consuming and costly and favors deep-pocketed players over less generously resourced applicants. Stroud and Smith believe the process can be streamlined only through external interventions.
To illustrate the challenge, Stroud recalls the tremendous technological progress in ENDS products, which went from cigalikes to larger open systems, back to pods and then on to disposables. “The FDA’s draconian regulations don’t account for the technological improvement that has been applied to ENDS,” she says. “FDA and Congress could reform the Tobacco Control Act [TCA] in a huge way if they pushed the predicate date further ahead than February 2007. Requiring ENDS to undergo extensive testing and a massive bureaucratic application process is not only a farce to public health, but it restricts innovation and competition, which is very un-American.”
With Congressional assistance and a reworking of the TCA, the FDA could establish a notification process for new products and then focus on post-market surveillance to monitor the public health effects of the new products, according to Shroud.
“The FDA must also recognize what percentage of youth is permittable,” she says. “No other consumer good in America has been forced to deal with so much scrutiny that even one kid using the product is one kid too many. While youth vaping was a problem in 2019, it declined by more than 60 percent in the years since—all while the non-FDA-authorized ENDS market grew exponentially. FDA must recognize that adults are using these products and that their use is associated with a 10 percent decrease in cigarette units sold in America in 2023. That’s a win for public health. FDA must reform the process so we can accelerate even further declines in smoking.”
As of June 21, the FDA had authorized more than 16,000 tobacco products—mostly cigarettes and cigars, according to Stroud. “Twenty-seven MGOs for ENDS is a depressing number and makes up less than 1 percent of authorized products,” she says. “Worse, only 49 products have been authorized by FDA using the PMTA pathway. FDA’s own budget is problematic; it’s entirely funded by user fees paid for by only six classes of tobacco products and not from e-cigarettes. There is more of an incentive to authorize the products that are paying for a $275,000 annual salary, as made by the CTP director in 2023, than authorizing products that pay nothing. While FDA has been asking Congress for years to be able to collect user fees on products including e-cigarettes, they refuse to issue orders—and instead denied tens of millions of products. That could have been a lot of fees and would have funded a significant amount of surveillance while also recognizing tobacco harm reduction. It is something the agency must recognize if the mission is to reduce smoking.”

While optimists may detect a new willingness to approve reduced-risk products in the CTP’s recent product authorizations, few expect the regulatory floodgates to open to an avalanche of product approvals. | Photo: Tada Images
Significant Ruling
Smith says it is important to educate those affected by the failing 99.999 percent of all PMTA applications about the recent changes in the regulatory landscape and how those changes may lay a foundation for the significant changes necessary at the CTP.
“The first is the recent announcement by the Supreme Court where the Chevron Deference has been overturned,” he says. “This action by the court will now require that regulatory agencies follow the letter of the law and that the regulators would now have little leeway in the interpretation of how to apply regulatory law.
“The Chevron Deference has allowed the CTP to define the meaning of ‘appropriate for the protection of public health’ when conducting a review of the PMTAs and MRTPAs [modified-risk tobacco product applications]. Now, post-Chevron, if the Tobacco Control Act does not clearly outline the actions and process of enforcement of regulatory oversight in a manner that allows for the regulatory agency to action the law, the law will have to be amended to clarify the process, so legislators will have to work to make the law actionable … not the regulators that monitor the marketplace.”
Second, according to Smith, the Supreme Court may review four relevant lawsuits—Triton, Magellan, Lotus and Logic. Such a review may trigger action to change the TCA. “If the court decides to hear at least one of these cases, then the likely outcome is a requirement that the TCA be clarified so that the CTP will only enforce actions defined in the TCA,” says Smith. “If the TCA isn’t clear as to how to enforce it, then the law should be amended. Depending on how the policies are modified by the legislative branch, we may see shifts in the way that CTP reviews all tobacco and nicotine products, leading to a more effective regulatory environment. However, how the legislators refine the TCA will determine if the regulatory environment improves in a manner that supports the reduced-risk product marketplace.”
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.

August 1, 2024
Taiwan: No ENDS Approved Yet

Image: tang90246
Taiwan’s Health Promotion Administration (HPA) has reminded suppliers and consumers that it has not approved any e-cigarettes or heated-tobacco products (HTPs), reports Taipei Times.
The warning came after security footage showed a lawmaker using an HTP in the legislature’s corridors.
Novel tobacco and nicotine products require government approval in Taiwan. To date, the HPA has received applications for authorization for HTPs from 12 companies. It has rejected the applications of eight while two of the remaining four have been asked to furnish additional information.
The HPA has a panel of toxicology, public health and addiction experts to assess requests for authorized use of HTPs. The panel has so far convened 30 meetings.
Taiwanese law punishes the manufacture, import, sale, supply, display or advertisement of unauthorized novel tobacco products by a maximum penalty of TWD5 million ($152,263) while users may be fined TWD10,000.
July 30, 2024
Stricter Tobacco Rules in Thailand

Photos courtesy of Mathijs Aliet
Tobacco manufacturers and importers in Thailand will be subject to stricter rules under a new draft regulation approved by the cabinet recently, reports The Pattaya Mail.
Among other provisions, they will have to report the components of their products and the substances released during combustion.
What’s more, tobacco manufacturers may not use flavor additives in their products or label them in a way that implies health benefits or suggests increased vitality.
The regulation sets maximum limits for substances released during combustion. Tar must not exceed 10 mg per cigarette, nicotine must not exceed 1 mg per cigarette, and carbon monoxide must not exceed 10 mg per cigarette.
The regulation also mandates the disclosure of information about the components and combustion byproducts of tobacco products.
The certification fee is set at THB100,000 ($2,768) per certificate and THB2,000 for a replacement certificate. The regulation will take effect 180 days after its publication in the Royal Gazette and will be valid for four years.
July 15, 2024
CTP Updates Compliance Website

Credit: Postmodern Studio
The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) has announced an enhancement to its website, which will more easily present information about tobacco compliance check outcomes.
The agency noted in a statement that the database is designed to be a resource for various audiences, including the general public, public health groups and the tobacco industry.
The new database offers the ability to search for various compliance and enforcement outcomes among brick-and-mortar and online retailers, including warning letters, civil money penalties and no-tobacco-sale orders.
Previously, this information lived in various locations across the FDA website, so the enhancement will allow site visitors to more easily find outcomes from the FDA’s compliance and enforcement efforts of retailers in one centralized location, according to reports.
This centralized database will be updated monthly with the latest compliance check outcomes. “The enhancements to this database reflect CTP’s continued efforts to optimize transparency and communication with stakeholders,” the statement continued.
July 9, 2024
NYC Wants Wholesalers to End Vape Sales

Image: f11photo
The mayor of New York City has requested a Manhattan judge to intervene immediately and halt the sale of illegal flavored vapes by 11 wholesalers in New York.
The city filed suit against the wholesalers in April, citing data that kids and teens are getting hooked on flavored e-cigarettes at alarming rates.
Now, the city’s lawyers say they need a preliminary injunction to force the illegal flavored vape peddlers to quit their noxious practices immediately, according to the New York Post.
“While we have already filed a lawsuit to hold these distributors accountable for their actions, the motion we have filed will help us ensure that they can no longer peddle this poison to our children while this case is being litigated,” Adams said in a statement after the request for an injunction was filed Monday.
Court records show that city investigators were able to directly place orders from the wholesalers.
The probers also were able to uncover sales invoices from vape distributors in the city, the documents show.
July 3, 2024
Top Court to Hear Triton PMTA Denial Order Suit
The U.S. Supreme Court agreed on Tuesday to hear the U.S. Food and Drug Administration’s defense of the agency’s rejection of two companies’ premarket tobacco product applications (PMTAs) to sell flavored vape products that it has determined pose health risks for young consumers.
The justices took up the FDA’s appeal filed after a lower court ruled that the agency had failed to follow proper legal procedures under federal law when it denied the applications to bring their nicotine-containing products to market.
The Supreme Court is due to hear the case in its next term, which begins in October, according to Reuters.
Two e-cigarette liquid makers, Triton Distribution and Vapetasia LLC, filed FDA applications in 2020 for products with flavors such as sour grape, pink lemonade, and crème brulee and names such as “Jimmy The Juice Man Strawberry Astronaut” and “Suicide Bunny Bunny Season.”
An FDA rule that took effect in 2016 deemed e-cigarettes to be tobacco products, like traditional cigarettes, subject to agency review under a 2009 federal law called the Tobacco Control Act. The rule said manufacturers of the products would need to apply for approval to continue selling them.
July 2, 2024
Swedish Match Presents to FDA on General Snus

Image: Tobacco Reporter archive
Experts from Swedish Match USA, an affiliate of Philip Morris International, presented to the Tobacco Products Scientific Advisory Committee on June 26, 2024, according to a PMI press release. The committee, comprising independent scientific researchers, provides regulatory guidance to the U.S. Food and Drug Administration’s Center for Tobacco Products.
The half-day meeting was part of the FDA’s review of Swedish Match’s request to continue marketing General Snus products in the U.S. as modified-risk tobacco products (MRTPs) and to expand permitted use of the reduced-risk claim to reach, and transition, more legal-age smokers away from cigarettes.
Initially granted by the FDA in October 2019, Swedish Match can communicate to legal-age consumers that “Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis.” Currently, that message is accessible only on the General Snus website.
Swedish Match presented to the committee real-world evidence showing the claim is delivering on its promise to reduce harm to individual tobacco users and benefit the health of the population and should be renewed.
In its renewal submission, Swedish Match is seeking to expand use to additional lawful marketing channels, such as point-of-sale display and direct mail to age-verified consumers.
“As FDA’s Center for Tobacco Products Director Brian King said when unveiling its new five-year strategic plan, this is a critical moment in the history of tobacco product regulation,” Gerry Roerty, general counsel for Swedish Match, said to committee members. The center’s mission is to make smoking-related disease and death a part of America’s past, and “today, together, we can meaningfully advance that goal,” Roerty told committee members.
During the meeting, representatives from Swedish Match and committee members discussed a range of scientific, technical and consumer-communications topics. The company provided an overview of its responsible marketing practices and presented evidence and research demonstrating low levels of use by unintended populations.
General Snus is a smokeless tobacco product, traditionally produced in Sweden, that is nonfermented and air cured. The modified-risk products submitted for renewal include eight General Snus varieties that have been made available in the U.S. for more than a decade: General Snus Original (pouch); General Snus Original (loose); General Snus White (pouch); General Snus Mint (pouch); General Snus Wintergreen (pouch); General Snus Mini Mint (pouch); General Snus Classic Blend (pouch); and General Snus Nordic Mint (pouch).
“We are understandably proud of our commitment to a cigarette-free America, which is achievable much faster if policy is guided by science,” said Stacey Kennedy, president of the Americas region and CEO of PMI’s U.S. business. “America’s 28 million adult smokers have been bombarded with misinformation about smoke-free products, which can cause confusion and prolong the most harmful form of nicotine consumption—smoking. We look forward to continuing dialogue with the FDA as it continues to consider renewal of this modified-risk authorization.”
The General Snus products were first authorized as “appropriate for the protection of the public health” through the premarket tobacco product application (PMTA) process in 2015 following a PMTA submission earlier that same year.
Since then, Swedish Match USA has submitted eight annual reports over as many years, the last four of which were combined with MRTP annual reporting.
July 2, 2024
Major Australian Pharmacies Against Vape Sales

Image: Catrina Haze
Several major pharmacy chains in Australia have stated that they will not stock vapes once their sale is prohibited outside of pharmacies and a prescription requirement for adults is lifted.
In communications with their stakeholders, TerryWhite Chemmart, Priceline Pharmacy, National Pharmacies in South Australia and 777 Group in West Australia all voiced strong disagreement with new laws allowing the sale of vapes without prescriptions.
In a statement, The Pharmacy Guild of Australia said Blooms and thousands of independent pharmacies had also opposed the government’s deal with the Greens to open access for adults from October.
Chemist Warehouse has told the ABC it is still looking at the implications of the decision and seeking more information on how it will work.
While those pharmacies have indicated they will not be moving to stock vapes, franchisors under the brands are technically able to make an independent decision to do so.
Many pharmacies under those brands already supply vapes nationwide or are licensed to do so. The key dispute raised by them is the “down scheduling” of vapes from requiring scripts to being available behind the counter for adults once they have had a conversation with their pharmacist.
Health Minister Mark Butler said earlier this week that pharmacies would not be forced to stock vapes and the government did not expect that all pharmacies would.
June 28, 2024
Australia Softens Prescription Mandate

Photo: Zerophoto | Adobe Stock
Australia will soften a proposed ban on vaping following opposition from the Greens party, leading the government to agree to revise a bill that would have limited vapes to those with a doctor’s prescription.
The agreement between the ruling center-left Labor Party and the Greens will lead to the passage of legislation later this week that restricts the sale of vapes to pharmacies and removes them from retail shelves. This move is aimed at curbing the rise in youth vaping.
However, the bill falls short of the government’s initial ambition to restrict sales only to those with a doctor’s prescription, which would have been a world first. The amended bill will take effect on July 1, reports Reuters.
Under the compromise deal, vapes will be moved “behind the counter” in October. Customers will need to have a conversation with the pharmacist before making a purchase, and those under 18 years old will need a prescription.
Health Minister Mark Butler said in a statement that the government “welcomed constructive engagement with the crossbench and secured the support of the Greens for our world-leading vaping laws.”
The Labor Party does not have a majority in the upper house and must negotiate with other parties and independent senators to pass legislation.
June 25, 2024