Category: U.S. FDA

Robert Kennedy, Jr. Tapped to Lead Trump’s HHS

President-elect Donald Trump has nominated Robert F. Kennedy, Jr. to serve as the new secretary of the Department of Health and Human Services (HHS). The effects Kennedy will have on the nicotine market remain unclear. Kennedy must still be confirmed by Congress.
“For too long, Americans have been crushed by the industrial food complex and drug companies who have engaged in deception, misinformation, and disinformation when it comes to Public Health,” Trump posted. “The Safety and Health of all Americans is the most important role of any Administration, and HHS will play a big role in helping ensure that everybody will be protected from harmful chemicals, pollutants, pesticides, pharmaceutical products, and food additives that have contributed to the overwhelming Health Crisis in this Country.”
As the leader of HHS, Kennedy will oversee the FDA, which regulates vaping, nicotine pouches, and all other nicotine and tobacco products through its Center for Tobacco Products.
Kennedy’s position on vaping, nicotine, and tobacco harm reduction (THR) remains an unknown. During the presidential campaign, Trump promised that, if elected, he would “save vaping” after meeting with Tony Abboud of the Vapor Technology Association.
“I saved Flavored Vaping in 2019, and it greatly helped people get off smoking,” Trump said on his Truth Social platform in September. “I raised the age to 21, keeping it away from the ‘kids.’ Kamala and Joe want everything banned, killing small businesses all over the country. I’ll save Vaping again!”
November 15, 2024
FDA Warns Companies For Selling ‘Smart’ Vapes

The U.S. Food and Drug Administration issued warning letters to nine online retailers and one manufacturer for selling or distributing unauthorized disposable e-cigarettes designed to resemble smart technology, including smartphones and gaming devices.
The products mentioned in the warning letters are promoted as having various designs and functions that might attract young people, according to an agency press release. These include features like playing games, connecting to smartphones, receiving text or call notifications, playing music, and customizing products with personalized wallpaper.
“These products may resemble smart devices, but there’s nothing smart about them,” said Brian King, director of the FDA’s Center for Tobacco Products (CTP). “They’re illegal to sell and a flagrant attempt to target kids.”
The agency states that the designs of the unauthorized products cited in the warning letters are likely to appeal to youth because they help conceal the nature of the products as tobacco products from parents, teachers or other adults. Example images of unauthorized products cited in the warning letters compared to electronic devices on the consumer market, such as smartphones and gaming devices.
“The firms receiving these warning letters sold and/or distributed e-cigarettes in the United States that lack authorization from FDA to legally market a new product, which is in violation of the Federal Food, Drug and Cosmetic Act,” the release states.
In addition to the violations mentioned in the warning letters, the retailers and manufacturer were warned to address any violations that are the same as, or similar to, those stated in the warning letter and promptly take any necessary actions to comply with the law. Failure to promptly correct the violations can result in additional FDA actions such as an injunction, seizure and/or civil money penalty.
“FDA is steadfast in our commitment to enforce the law,” said John Verbeten, director of the CTP’s Office of Compliance and Enforcement. “We will continue to take appropriate measures, working hand in hand with our federal enforcement partners, to address unauthorized tobacco products, especially those most appealing to youth.”
October 30, 2024
Industry Group Files Amicus Brief in Triton Case

This week, the Coalition of Manufacturers of Smoking Alternatives (CMSA), a trade coalition that represents a diverse array of members who manufacture and distribute smoking harm reduction products, filed an amicus curiae brief before the Supreme Court of the United States supporting White Lion Investments, dba as Triton Distribution, in its case against the U.S. Food and Drug Administration.
In its brief, CMSA argues that FDA violated the Family Smoking Prevention and Tobacco Control Act (TCA) in its wholesale rejection of applications for flavored vaping products by applying a surprise and improperly adopted standard and foregoing the required notice-and-comment process. The brief emphasizes that the U.S. Congress specifically requires the FDA to undergo a transparent rulemaking process before imposing any restriction that amounts to a “tobacco product” standard.
“Importantly, this process tasks FDA with considering the broader public health effects of any such standard, ‘such as creating demand for and increasing the use of unregulated black-market products,’ or other harmful consequences,” the CMSA states. “In its efforts to unilaterally reject flavored vapor product applications based on a new and heightened standard, FDA unlawfully sidestepped this critical regulatory check and operated outside the bounds of its authority.”
The CMSA states that the FDA circumvented the very procedures Congress imposed to check the arbitrary or unreasonable exercise of such delegated power, and causes real harms as the FDA “misleads and whipsaws” manufacturers seeking to provide a robust set of options for consumers seeking to quit smoking,” the CMSA wrote in its brief. Further adding that “the long delays in FDA’s review of the many PMTAs (premarket tobacco product applications) it has received, coupled with the moving goal posts imposed via the review process, creates a level of uncertainty that severely deters investment and innovation in new products with harm-reduction potential.”
Earlier this week, 13 members of Congress, including U.S. Senator Roger Marshall and U.S. Representative Andy Harris, filed an amicus brief supporting the position of Triton Distribution and CMSA. In their brief, the members of Congress write, “There is a clear lack of authority for such a ban. Congress has specifically prohibited the FDA from banning products. Despite this, the FDA imposed a categorical prohibition.”
Also, the Global Action to End Smoking wrote in its amicus brief to SCOTUS that the FDA strayed from a “sensible, science-based harm-reduction approach, adopting an all-or-nothing stance that exalts outright cessation and all but ignores the harm-reduction strategy that Congress mandated…. [ignoring the] overwhelming scientific evidence that e-cigarettes containing flavor additives have an important role to play in moving adult smokers down the continuum of risk.”
SCOTUS announced Dec. 2, 2024 as the date for the U.S. Food and Drug Administration v. Wages and White Lion Investments, LLC, d/b/a Triton Distribution hearing.

October 18, 2024
Supreme Court to Hear Avail, Reynolds PMTA Case

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The Supreme Court of the United States has agreed to consider another case involving federal approval of vapes at the request of the Biden administration on Friday.
The case arose after the Food and Drug Administration denied R.J. Reynolds Vapor Company’s request to introduce three flavored vapes on the market. The FDA said the company failed to meet federal requirements concerning tobacco products’ marketing, but the company contends that the decision was arbitrary and capricious.
Reynolds is based in North Carolina, and the federal appeals courts located there and in D.C. already had precedent on the books unfavorable to the manufacturer.
Under federal law, companies can challenge the FDA denying of a marketing order for a new tobacco product in Washington, D.C., or where the company’s principal place of business is located, reports The Hill.
The 5th U.S. Circuit Court of Appeals has been more sympathetic to the industry, making it an attractive place for companies to contest their products being denied.
The 5th Circuit’s rule effectively enables it to host any tobacco company’s challenge, so long as its lawsuit is joined by a convenience store or other retail seller within the 5th Circuit’s borders—which span Louisiana, Mississippi and Texas.
Reynolds instead filed its challenge in the 5th Circuit alongside Avail Vapor Texas and the Mississippi Petroleum Marketers and Convenience Stores Association. The federal government attempted to move venues, but the 5th Circuit said the additional challengers meant the case was properly brought.
No matter which way the justices rule, they are not expected to address the merits of the FDA’s denial. The Supreme Court only took up the question of whether the 5th Circuit was a proper venue.
“There is no circuit conflict over the meaning of this venue provision. And other vehicle problems abound,” the company wrote in court filings urging the justices to turn away the appeal.
October 6, 2024
FDA Issues Final Rule for Tobacco 21

The U.S. Food and Drug Administration announced a final rule raising the minimum age for certain restrictions on tobacco product sales. The requirements are in line with legislation signed in December 2019, which immediately raised the federal minimum age for the sale of tobacco products in the United States from 18 to 21.
Once implemented, the requirements are expected to help decrease underage tobacco sales.
Beginning Sept. 30, retailers must verify with photo identification the age of anyone under the age of 30 who is trying to purchase tobacco products, including e-cigarettes. Previously, this requirement applied to anyone under the age of 27. It’s important for retailers to request and examine photo IDs to verify age from anyone under 30, regardless of appearance, as research has shown that it is difficult for retailers to accurately determine the age of a customer from appearance alone.
Additionally, starting Sept. 30, retailers may not sell tobacco products via vending machines in facilities where individuals under 21 are present or permitted to enter at any time. Previously, this prohibition applied to facilities where individuals under 18 were present or permitted to enter at any time.
These changes, and the other changes made by the final rule, aim to maximize the public health impact of the original December 2019 legislation, according to an agency press release.
“Today’s rule is another key step toward protecting our nation’s youth from the health risks of tobacco products,” said Brian King, director of the FDA’s Center for Tobacco Products. “Decades of science have shown that keeping tobacco products away from youth is critical to reducing the number of people who ultimately become addicted to these products and suffer from tobacco-related disease and death.”
The Further Consolidated Appropriations Act, signed into law on Dec. 20, 2019, increased the federal minimum age for selling tobacco products from 18 to 21 across the United States. Since then, it has been illegal to sell tobacco products, including e-cigarettes, to anyone under 21. The law also directed the FDA to take action today, increasing the age of certain requirements for tobacco product sales, as explained above.
The agency also continues to provide retailers with resources to improve compliance with tobacco laws and regulations, including age of sale restrictions. For example, the FDA has developed a voluntary education program, “This is Our Watch,” which offers free resources to assist retailers in calculating the age of customers, including a digital age verification calendar and an age calculator app. Retailers can also find information on tobacco products that may be legally marketed in the United States through the Searchable Tobacco Products Database. Updated resources, including further information on these latest requirements, will be made available on the FDA’s website in the near future.
August 29, 2024
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
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
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
Durbin Decries Menthol Vape Order

Credit: Dick Durbin
When the U.S. Food and Drug Administration authorized the marketing of four Njoy brand menthol e-cigarette products, Senator Dick Durbin was disappointed. He said the agency should have done better. The move marks the first nontobacco-flavored e-cigarette products to be authorized by the FDA.
“Flavors like menthol are used by Big Tobacco companies to mask the harsh taste of their dangerous products. FDA knows this from its own experience seeking to ban the production of menthol cigarettes to protect the public health,” Durbin stated. “We’ve seen that children begin nicotine use with menthol. Today’s authorization of menthol-flavored vapes will create an opening for more children to become addicted to harmful products.”
Earlier this month, Durbin, chair of the Senate Judiciary Committee, held a committee hearing titled “Combatting the Youth Vaping Epidemic by Enhancing Enforcement Against Illegal E-Cigarettes.” The hearing underscored the alarming level of youth e-cigarette use and the role that flavors—such as menthol—play in youth use of tobacco products and examined how federal agencies have failed to enforce laws designed to protect children from a lifetime of nicotine addiction.
Tony Abboud, executive director of the Vapor Technology Association, who also spoke at Durbin’s hearing, said he applauds the FDA’s decision to “finally follow the massive body of science” that shows flavored e-cigarettes help people quit smoking. However, Abboud said the move does little to address the massive problems surrounding the regulatory agency’s authorization process.
“The reality is that this news, while a tiny step in the right direction, again reveals a more troubling pattern—the FDA acting only in self-interest to quell political pressure rather than acting in the interest of the American people,” said Abboud. “The only vapes authorized today are all owned by the biggest cigarette companies.
“Today’s authorizations once again demonstrate Brian King and the FDA’s hypocritical allegiance to those cigarette companies whose deadly cigarettes and other combustible products that the FDA continues to flood the market with at a record pace.”
June 25, 2024