Category: Regulation

  • FDA Warns 9 More for Illegal Vape Sales

    FDA Warns 9 More for Illegal Vape Sales

    The U.S. Food and Drug Administration issued warning letters to eight online retailers and one manufacturer for selling and/or distributing unauthorized flavored, disposable e-cigarettes.

    Some of the unauthorized products cited in the warning letters are marketed under brand names for disposable products, including Geek Bar and Lost Mary, according to the FDA. Other unauthorized products cited feature the names and/or images of celebrities.

    The firms receiving these warning letters sold and/or distributed e-cigarettes in the United States that lack authorization from FDA to be legally marketed in the U.S., which is in violation of the Federal Food, Drug, and Cosmetic Act.

    In addition to the violations mentioned in the warning letters, the firms were warned to address any violations that are the same as, or similar to, those stated in the warning letter and to promptly take necessary actions to comply with the law.

    Failure to promptly correct the violations can result in additional actions such as an injunction, seizure, and/or civil money penalty.

  • EU Pushing Again for Stricter Smoking Rules

    EU Pushing Again for Stricter Smoking Rules

    Credit: Doganmesut

    EU countries agreed Tuesday on a push for stricter anti-smoking rules, backing bans on smoking and vaping in many outdoor areas, including playgrounds and cafe patios.

    Health ministers from the bloc’s 27 nations meeting in Brussels adopted a recommendation inviting member states to crack down on secondhand smoke and vapor.

    “Today’s agreement is a crucial step towards our goal of a tobacco-free generation in Europe and is critical in protecting our children and young people from the harmful effects of second-hand smoke,” said the EU’s health commissioner, Oliver Varhelyi.

    The recommendation is non-binding, as health is the responsibility of individual member states. However, it indicates the policies governments could pursue in the future as they seek to reduce smoke-related deaths and ailments.

    It passed with all countries voting in favor apart from Germany and Greece, which abstained, underscoring some political divisions. Last week, the European Parliament voted against a similar text, according to media.

    The document approved on Tuesday calls on EU countries to extend restrictions in place for cigarettes to cover “emerging products”, such as heated tobacco devices and electronic cigarettes that are increasingly popular with young people. Governments should “provide effective protection” from aerosols emitted by these in indoor environments such as offices and public buildings.

    Following an initial proposal put forward by the European Commission in September, the text says such protection should also be granted in some outdoor areas. This, in practice, entails that all smoking should be banned in locations including swimming pools, beaches, zoos, rooftop bars, and restaurant terraces.

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

    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!”

  • FDA Renews MRTPs for General Snus

    FDA Renews MRTPs for General Snus

    After a scientific review, the U.S. Food and Drug Administration issued a renewal of modified risk granted orders to Swedish Match USA, Inc., for eight General Snus products.

    With the renewal, the products may continue to be marketed – as they have been authorized to do so since 2019 – with the following modified risk claim: “Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.” 

    The products receiving modified risk granted orders are: General Loose, General Dry Mint Portion Original Mini, General Portion Original Large, General Classic Blend Portion White Large-12ct, General Mint Portion White Large, General Nordic Mint Portion White Large-12ct, General Portion White Large, and General Wintergreen Portion White Large.

    The modified risk granted orders issued by FDA are specific to the products as mentioned above and expire Nov. 7, 2032. If the agency determines that, among other things, the continued marketing of the products no longer benefits the health of the population as a whole, the agency may withdraw the orders.

    “The FDA’s review determined that this modified risk claim is supported by scientific evidence, that consumers understand the claim, and that consumers appropriately perceive the relative risk of these products compared to cigarettes,” the FDA stated in a release. “FDA found that these modified risk products, as actually used by consumers, will significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and benefit the health of the population as a whole.

    “In particular, the available scientific evidence, including long-term epidemiological studies, shows that relative to cigarette smoking, exclusive use of these products poses lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis. The available evidence does not indicate significant youth initiation of these products.”

    The modified risk granted order does not permit the company to market the product with any other modified risk claim that conveys or could mislead consumers into believing that the products are endorsed or approved by FDA, or that the agency deems the products to be safe for use by consumers.

  • Thailand: Push to Ban Smoking in Cars

    Thailand: Push to Ban Smoking in Cars

    Image: andranik123

    Thailand’s Tobacco Products Control Committee wants to ban smoking in private cars to protect passengers from secondhand smoke, reports The Nation.

    Speaking at a seminar on Nov. 5, Rerngruedee Pathanwanit of the Ramathibodi Medical School at Mahidol University said that approximately 70 percent of Thais are affected by secondhand smoke and an average of 20,688 Thais die of health complications caused by secondhand smoke each year.

    She also pointed out that Thailand stands fifth in the list of countries where women aged 15 to 49 are affected by secondhand smoke.

    Suwanna Ruangkanchasetr, deputy director of the Tobacco Control Research and Knowledge Management Center, told the seminar that recent research found that up to 55 percent of families with children in the one-five age group had smokers in the house.

    Researchers also found unsafe levels of nicotine in the hair of children in homes with smokers, she added.

  • FDA Warns Companies For Selling ‘Smart’ Vapes

    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.”

  • FDA to Review 2ONE Marketing Application

    FDA to Review 2ONE Marketing Application

    The U.S. Food and Drug Administration has accepted for review 2ONE Labs’ premarket tobacco product application (PMTA) for 2ONE brand nicotine pouches.

    According to 2ONE Labs CEO Vincent Schuman, this means that the company’s application will now enter the next critical phase of the FDA review process. “Our company will continue to fully fund this application through to its successful completion, and our wholesale, retail and sponsorship partners should view this ‘acceptance’ as a sign of our ability to navigate this complex PMTA process and our unwavering commitment to support the long-term availability of the 2ONE brand in the U.S. market,” Schuman said in a German-language statement.

    “We have developed 2ONE nicotine pouches for adult consumers—21 and older—who find it difficult to switch from combustible or traditional oral tobacco products. The availability of the 2ONE brand in the market over the past five years and the interest and growth our brand has achieved through strong retail partnerships, such as with Circle K, have shown that it is possible even for innovative companies to identify and introduce unique brands that truly offer adults the perfect transition product.”

    Earlier this month, 2ONE Labs filed a trademark infringement lawsuit and a preliminary injunction against Imperial Brands subsidiaries’ Zone nicotine pouch trademark. The suit alleges that Imperial’s Zone products willfully infringe the 2ONE nicotine pouch brand.

  • Industry Group Files Amicus Brief in Triton Case

    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.

  • Taxpayer Group Files Amicus Brief

    Taxpayer Group Files Amicus Brief

    Image: hafakot

    The Taxpayers Protection Alliance (TPA) submitted an amicus curiae brief to the U.S. Supreme Court in support of the Wages and White Lion Investments case, challenging the Food and Drug Administration’s regulation of e-cigarettes under the Family Smoking Prevention and Tobacco Control Act (TCA). The TPA argues that the FDA’s actions have been arbitrary, capricious and detrimental to public health.

    The brief contends that the TCA’s standard for determining what is “appropriate for the protection of the public health” is unconstitutionally vague, providing insufficient guidance to regulated entities and delegating excessive authority to the FDA. This vagueness has led to unpredictable enforcement, adversely affecting both taxpayers and adults who smoke and are seeking safer alternatives to conventional cigarettes.

    Furthermore, the TPA criticizes the FDA for failing to recognize the significant benefits of e-cigarettes as a smoking cessation tool, as acknowledged by leading health organizations such as Public Health England. According to the TPA, the TCA is clear on the need for the FDA to consider the impact of e-cigarettes on smoking cessation, yet the agency has abjectly failed to undertake this analysis. The TPA highlights the FDA’s stringent regulatory approach and high denial rates for new e-cigarette products, which the group says stifle market diversity and limit consumer choice, particularly harming adults who smoke and who might benefit from less harmful alternatives.

    The TPA also notes the FDA’s disregard for market realities and consumer preferences, particularly the benefits of open-system e-cigarettes that allow for customization and have been shown to be more effective for quitting smoking.

    The TPA urges the Supreme Court to uphold the 5th Circuit’s decision, affirming that the FDA’s regulatory approach under the TCA is arbitrary and capricious and violates due process. The TPA calls for a regulatory framework that adequately considers the benefits of e-cigarettes and gives regulated parties fair notice of how their products will be evaluated.

  • Supreme Court to Hear Avail, Reynolds PMTA Case

    Supreme Court to Hear Avail, Reynolds PMTA Case

    TR Archives

    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.