Category: Regulation

  • FDA Proposes Landmark Rule to Limit Nicotine Levels in Cigarettes

    FDA Proposes Landmark Rule to Limit Nicotine Levels in Cigarettes

    The FDA is preparing to propose a rule to cap nicotine levels in cigarettes and certain other tobacco products to make them minimally or non-addictive. This effort aligns with the Biden administration’s broader public health goals to significantly reduce smoking rates, particularly among youth, and to curb tobacco-related illnesses and deaths. Tobacco use remains the leading cause of preventable death in the U.S., accounting for approximately 480,000 deaths annually.

    The proposed rule, part of the FDA’s comprehensive tobacco control strategy, is expected to face strong opposition from the tobacco industry and some policymakers. Critics argue that the move could unintentionally boost the black market for cigarettes and may not address existing addiction among smokers. Proponents, however, emphasize the measure’s potential to save millions of lives and reduce healthcare costs in the long term.

    This regulation, if implemented, would mark a historic step in tobacco control, as no other country has yet enforced nicotine limits in cigarettes to this degree. The FDA has been exploring such measures since 2009 when Congress gave it authority to regulate tobacco products under the Family Smoking Prevention and Tobacco Control Act. While the proposal is still in its early stages, public health advocates view it as a critical milestone in reducing the public health burden of smoking.

  • FDA Rule on Nicotine Content Clears OMB

    FDA Rule on Nicotine Content Clears OMB

    The Biden administration has moved closer to implementing a rule that would limit nicotine levels in cigarettes, with the proposal clearing an Office of Management and Budget review on Friday.

    Public health experts are optimistic about the potential impact. Studies suggest significantly reducing nicotine—by as much as 95%—could render cigarettes non-addictive, prompting many smokers to quit or transition to less harmful alternatives like e-cigarettes or nicotine pouches. Dorothy Hatsukami, a tobacco policy researcher, noted that minimally addictive cigarettes have shown promise in helping people quit smoking.

    However, critics warn of unintended consequences. Guy Bentley of the libertarian Reason Foundation argued that restricting nicotine levels could effectively ban cigarettes, fueling a black market and benefiting foreign entities.  “Biden’s ban is a gift with a bow and balloons to organized crime cartels with it, whether it’s cartels, Chinese organized crime, or Russian mafia. It’s going to keep America smoking, and it’s going to make the streets more violent,” said Rich Marianos, former assistant director of the U.S. Bureau of Alcohol, Tobacco, Firearms and Explosives and the current chair of the Tobacco Law Enforcement Network.

    The future of the rule remains uncertain given the upcoming change of administration and the likelihood of litigation by industry.

  • FDA Issues Final Guidance on Testing Methods

    FDA Issues Final Guidance on Testing Methods

    The FDA has published final guidance for the tobacco industry on the “Validation and Verification of Analytical Testing Methods Used for Tobacco Products.” This guidance provides recommendations for tobacco manufacturers on how to generate validation and verification data for analytical methods supporting regulatory submissions, including Substantial Equivalence (SE) reports, Premarket Tobacco Product Applications (PMTA), and Modified Risk Tobacco Product Applications (MRTPA). It also applies to testing and reporting harmful and potentially harmful constituents (HPHCs) in tobacco products and tobacco smoke.

    The updated guidance finalizes the draft issued in December 2021, incorporating comments received from stakeholders. Key changes include updates reflecting recent statutory revisions, such as the inclusion of synthetic nicotine under the definition of tobacco products, and clarifications on alternative validation procedures. The guidance also supports the use of national and international standard test methods and provides detailed recommendations on laboratory accreditation, statistical methods, and analytical test method validation, helping the industry produce more reliable and consistent data for regulatory purposes.

  • FDA Tightens Oversight on Vape, Pouch Imports

    FDA Tightens Oversight on Vape, Pouch Imports

    The FDA has updated import alerts 98-07 and 98-06 to strengthen the regulation of unauthorized e-cigarettes and other tobacco products entering the country. The changes clarify that all new vapor products must have FDA authorization to be marketed legally in the U.S. Under Import Alert 98-07, unauthorized vapor imports may face detention or refusal of entry without physical examination. The update also provides clearer guidance for importers, customs brokers, and federal partners, including links to the FDA’s searchable database of authorized tobacco products.

    Import Alert 98-06 focuses on non-e-cigarette tobacco products, including smokeless tobacco and nicotine pouches such as NOIS, LYFT, and SKRUF. These products, like vapor products, may also be detained if unauthorized. The FDA emphasized that mis-declared products remain a key focus, citing the seizure of three million units of unauthorized vapor products worth $76 million in collaboration with U.S. Customs and Border Protection. To date, the FDA has authorized only 34 vapor products and devices, underscoring its commitment to enforcing compliance and preventing illegal products from entering the market.

  • Latvia: Tobacco Sellers Look for Loopholes in New Regulations

    Latvia: Tobacco Sellers Look for Loopholes in New Regulations

    Tobacco sellers in Latvia are reportedly looking for loopholes in the new regulations that go into effect this month, according to Euro News.

    Beginning January 2025, tobacco products, including disposable vapes, refillable e-cigarettes, and nicotine pouches, cannot be sold to individuals under 20 years old, and vaping products can no longer have flavors other than tobacco. The amount of nicotine in nicotine pouches will also be reduced.

    According to Latvijas Televizija, a Latvian public television channel, companies selling refill cartridges are looking for ways to circumvent the new rules and continue selling the same products—some are planning to sell separate bottles of flavoring and nicotine that customers can mix themselves.

    “Certainly, after the new year, there will be alternatives that can be offered to the client, but they will not have such a wide range. Let’s increase the range bit by bit and, after some time, it will definitely be bigger,” said Jakaterina Smirnova, representative of e-cigarette company Ecodumas.

    “I assume that, similarly to other products, relatives and friends who travel will be able to bring them [the banned products] from abroad. Like all illegal things, Telegram trading will probably also develop. And it’s hard to stop,” said Anrijs Matiss, a board member of the Traditional and Smokeless Tobacco Products Association.

    The association estimates a state budget loss of €10 million annually following the new laws.

    The nicotine pouch industry expects that products will disappear from retail shelves, at least temporarily.  

  • Milan Bans Outdoor Smoking

    Milan Bans Outdoor Smoking

    no smoking

    Milan has banned smoking in outdoor and public areas, effective Jan. 1, 2025, reports Euro News.

    The ban includes “all public spaces, including streets” but provides an exception for isolated spaces as long as smokers maintain a distance of at least 10 meters from other people. Those caught violating the ban face fines ranging from €40 to €240.

    The ban aims to improve the city’s air quality and protect the health of citizens from secondhand smoke. Milan is one of Europe’s most polluted cities in terms of air quality.  

    The new law does not apply to electronic cigarettes, however.

  • Iowa Vape Companies Sue to Block Registry

    Iowa Vape Companies Sue to Block Registry

    A group of e-cigarette and vaping product distributors and retailers is suing the state of Iowa to block enforcement of a new law set to take effect in February.

    Alternatives to Smoking and Tobacco Inc., Global Source Distribution, Triton Distribution, Smokin Hot, Central Iowa Vapors WDM, and Route 69 Vapor filed the lawsuit in the U.S. District Court for the Southern District of Iowa.

    The companies allege that House File 2677 violates the supremacy clause and equal protection clause of the U.S. Constitution as well as the equal protection clause of the Iowa Constitution.

    State records show House File 2677 was introduced on March 27, 2024, with backing from lobbyists for R.J. Reynolds and other tobacco companies. Lobbyists for the American Cancer Society Action Network declared their opposition to the bill within two days, according to Iowa Capital Dispatch.

    The bill was approved in the Iowa House on April 3, 2024, and in the Iowa Senate on April 19, 2024. Governor Kim Reynolds signed it into law on May 17, 2024.

    The law stipulates that manufacturers whose electronic nicotine-delivery systems—more commonly known as electronic cigarettes, e-cigarettes, and vaping products—are sold in Iowa must certify that their products “have received a marketing authorization” from the Food and Drug Administration or that their applications for authorization were filed by September 2020 and are still under review.

    The Iowa Department of Revenue is then tasked with producing a publicly accessible directory listing all certified vaping products—at which point any retailer selling products not on the registry is subject to fines or other enforcement action.

  • On Jan. 1, New Illinois Vape Laws go Into Effect

    On Jan. 1, New Illinois Vape Laws go Into Effect

    New Illinois laws that go into effect Jan. 1, will place more restrictions on electronic cigarettes.

    One law prohibits the advertising, marketing or promoting of an electronic cigarette in a manner that is likely to cause a person to mistake it for an object that is anything other than what it is, a tobacco product.

    State Sen. Julie Morrison, D-Lake Forest, said some e-cigarettes are designed to look like school supplies, like highlighters, erasers and pencil sharpeners.

    “This law will prohibit tobacco companies from pulling the wool over the eyes of educators and guardians whose job it is to keep kids safe,” said Morrison.

    Elizabeth Hicks with the Consumer Choice Center said the assault on vaping may push some Illinoisans back to regular combustible cigarettes, leaving taxpayers to pick up the tab, according to media reports.

    “Taxpayers unfortunately also suffer in addition to consumers,” said Hicks. “The annual Medicaid costs for smoking-related illnesses in Illinois is over $2 billion, which is one of the highest throughout the country.”

    Another law prohibits electronic cigarettes purchased by mail, online or through other remote sale methods from being shipped to anyone in the state other than a distributor or retailer.

  • 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.