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Category: FDA

  • FDA Targets ‘Disguised’ Nicotine Products in Retail Crackdown

    FDA Targets ‘Disguised’ Nicotine Products in Retail Crackdown

    The U.S. Food and Drug Administration issued warning letters to eight retailers for selling unauthorized nicotine pouches and dissolvable tobacco products designed to resemble candy, breath strips, and cough drops, raising concerns that the items could both appeal to children and be accidentally ingested by young kids. According to the agency, the products’ labeling, advertising, and design mimic everyday consumer goods, “disguising” them and making it easier for youth to conceal their use from adults.

    Acting Center for Tobacco Products Director Bret Koplow said no tobacco product should look like candy and described the practice as a tactic to mask the products’ true nature. The retailers were cited for violating the Federal Food, Drug, and Cosmetic Act by selling products without FDA authorization and were ordered to correct the violations or face potential penalties, including seizures, injunctions, and/or fines. The action follows recent FDA guidance outlining enforcement priorities for unauthorized electronic nicotine delivery systems and nicotine pouch products, part of a broader push to remove youth-appealing products from the market.

    The agency noted it has now issued more than 800 warning letters to manufacturers and distributors and over 1,000 to retailers over unauthorized tobacco sales, and reminded retailers to consult its updated list of legally marketed products and use available compliance materials.

  • CTP Director Touts Progress, Future in Statement

    CTP Director Touts Progress, Future in Statement

    The FDA’s Center for Tobacco Products says it has made significant progress in streamlining the review of premarket tobacco product applications (PMTAs), reducing its backlog by approximately 70% in 2025 and eliminating the queue for initial acceptance review. In a statement dated May 7 and released today (May 13), acting Director Bret Koplow said new efficiencies are allowing applications to move into review almost immediately, while accelerated filing and scientific review processes—particularly for nicotine pouches and electronic nicotine delivery systems—are helping bring compliant products to market more quickly.

    Koplow also highlighted the success of a pilot program for nicotine pouch applications, which led to authorizations for six products within three months, a record pace for the agency. The FDA plans to apply lessons from the pilot more broadly, including expedited review for product modifications and increased real-time communication with applicants, signaling a shift toward faster but still science-based regulatory decision-making in the nicotine category.

    Read the full release here.

  • FDA Changes PMTA Structure

    FDA Changes PMTA Structure

    On May 8, the FDA issued updated guidance outlining its current enforcement approach for electronic nicotine delivery systems (ENDS) and nicotine pouch products without premarket authorization, emphasizing that its policies are nonbinding and reflect the agency’s current priorities. The guidance indicates that while unauthorized products remain illegal, the FDA does not intend to prioritize enforcement against products with pending and sufficiently complete applications under scientific review, allowing the agency to better allocate resources.

    The document also clarifies that enforcement will focus on products with higher public health risks, including those appealing to youth or lacking required safety features, while encouraging manufacturers to provide transparency around application status. The FDA said it will maintain a public-facing list of products under review, as part of efforts to improve visibility for stakeholders and streamline regulatory oversight.

    “For four years, nicotine pouch manufacturers, suppliers, and retailers like Nicokick.com have been patiently waiting for authorization decisions, and this guidance finally gives them the ability to stop operating in a grey area of regulation,” said Laura Leigh Oyler, Vice President of Regulatory Affairs for Nicokick.com. “For an agency that typically operates without much clarity, this is mind-blowingly clear — file a PMTA for your product that includes everything the FDA has explicitly listed they expect to see, wait 180 days, and then you can launch your product in the market. This is a ground-breaking announcement for American consumers who deserve a wealth of options as they try to leave cigarettes behind.”

  • WSJ: Trump Ready to Fire Makary

    WSJ: Trump Ready to Fire Makary

    According to The Wall Street Journal, President Donald Trump signed off on a plan to remove FDA Commissioner Marty Makary, though the decision has not yet been finalized and could still change. The report, citing people familiar with the matter, said Makary has faced mounting criticism within the administration over his management of the agency, including clashes with officials at the Department of Health and Human Services and the White House. His handling of key policy areas—including drug approvals, vaccines, and vaping regulation—has drawn particular scrutiny.

    The reported move follows a turbulent period at the FDA marked by leadership turnover and internal disruptions, including recent high-profile departures and ongoing restructuring efforts. Earlier in the week, Trump reportedly criticized Makary for not moving quickly enough on authorizing flavored vaping and nicotine products, an issue that has become a point of tension within the administration.

    Makary, a former Johns Hopkins surgeon nominated in late 2024 and confirmed in 2025, has been a visible figure in the administration’s health agenda, including its “Make America Healthy Again” initiative. While no official confirmation has been issued by the White House or HHS, sources cited in the report indicated growing consensus among senior officials that a leadership change at the FDA may be imminent.

  • FDA Authorizes Four New ENDS Products

    FDA Authorizes Four New ENDS Products

    The U.S. Food and Drug Administration has authorized four Glas electronic nicotine delivery system products through the PMTA pathway, including Classic Menthol, Fresh Menthol, Gold, and Sapphire pods containing 5% nicotine. The decision marks the first FDA authorization of ENDS products beyond traditional tobacco and menthol flavors, expanding the range of legally marketed vaping products in the U.S. to 45.

    The agency said the authorization was based on evidence that the products’ device access restriction technology—requiring age verification via government ID, smartphone pairing, and biometric checks—can effectively limit youth access.

    “By helping to prevent youth use, device access restrictions are a potential game changer,” said Dr. Bret Koplow, acting director of the FDA’s Center for Tobacco Products. “This technology is also an indication of the role innovation may serve in the effort to protect young people from threats posed by nicotine use and addiction while helping to enable [the] availability of an expanded array of flavored options for adults who smoke who may use these products to completely switch away from regular cigarettes.”

    The FDA emphasized that marketing must be targeted to adults and that the company must monitor and report on youth prevention measures, while noting that authorization could be withdrawn if compliance requirements are not met or if youth usage increases.

  • FDA Expands List of Harmful Tobacco Constituents

    FDA Expands List of Harmful Tobacco Constituents

    The U.S. Food and Drug Administration announced that it finalized the addition of 18 chemicals to its list of Harmful and Potentially Harmful Constituents (HPHCs), bringing the total to 111 substances identified in tobacco products, smoke, or aerosol. The list is intended to highlight compounds that pose known or potential risks to human health and applies across cigarette, e-cigarette, cigar, and hookah tobacco product categories.

    The newly added constituents include a range of flavoring agents, solvents, and byproducts, many of which are commonly associated with e-liquid formulations. FDA said the update provides greater transparency for the public while also signaling to manufacturers which chemicals may receive increased scrutiny during the review of new product applications. The agency emphasized that inclusion on the HPHC list does not constitute a ban, but triggers reporting requirements under the Federal Food, Drug, and Cosmetic Act.

    The agency also opened a new consultation on three additional compounds—pulegone, furfuryl alcohol, and methyl eugenol—frequently used as flavoring ingredients, with public comments due by May 26. In addition, FDA confirmed that respiratory toxicants identified by the National Institute for Occupational Safety and Health (NIOSH) will now be considered as a criterion for future additions to the list. The agency said it expects to continue updating the HPHC list as new scientific evidence emerges.

    The constituents added to the Register are: Acetic Acid, Acetoin (also known as 3-hydroxy-2-butanone), Acetyl Propionyl (also known as 2,3-pentanedione), Benzyl Acetate, Butyraldehyde, Diacetyl, Diethylene Glycol, Ethyl Acetate, Ethylene Glycol, Furfural, Glycerol, Glycidol, Isoamyl Acetate, Isobutyl Acetate, Methyl Acetate, n-Butanol, Propionic Acid, and Propylene Glycol.

  • FDA Sends ENDS Comment Period Reminder

    FDA Sends ENDS Comment Period Reminder

    Today (April 8), the U.S. Food and Drug Administration’s Center for Tobacco Products issued a reminder that the public has until 11:59 p.m. EDT on May 11 to submit comments on its draft guidance for flavored e-cigarette applications, docketed as FDA-2026-D-1817 on Regulations.gov.

    The reminder relates to draft guidance the agency released on March 11, titled “Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications – Considerations Related to Youth Risk,” which outlines how the FDA plans to weigh the youth appeal of flavored products against any added benefit they may provide to adults compared with tobacco-flavored options, including expectations for evidence on adult switching, youth initiation risk, and the potential use of device access-restriction technology.

  • FDA Allows Fontem to Continue Selling Pouches Amid Court Battle

    FDA Allows Fontem to Continue Selling Pouches Amid Court Battle

    The U.S. Food and Drug Administration confirmed it will not block production or sales of Fontem US’s Zone nicotine pouches while a lawsuit over the product’s pending premarket tobacco product application proceeds, Law 360 reported. Fontem argued that the agency unlawfully delayed reviewing its application, leaving the product in regulatory limbo.

    The FDA said it will not take enforcement action during the litigation, allowing the pouches to remain on the market. Fontem recently voluntarily dismissed its suit in Texas and plans to refile in Washington, D.C. The case underscores ongoing tension between regulators and manufacturers over PMTA backlogs and the treatment of newer oral nicotine products, which differ from traditional cigarettes and vapes.

    According to Law 360, industry observers believe the court battle could set a precedent for how the FDA handles delayed applications and exercises enforcement discretion in the growing nicotine pouch sector.

  • FDA’s Pouch Fast-Track Scheme Stalling Over Youth Worries

    FDA’s Pouch Fast-Track Scheme Stalling Over Youth Worries

    A fast-track review program at the U.S. Food and Drug Administration aimed at accelerating authorizations for nicotine pouch products has stalled, as agency scientists weigh concerns about youth uptake and risks to non-users against potential harm-reduction benefits for smokers, according to sources cited by Reuters. Reuters said applications tied to pouch brands from Philip Morris International (Zyn) and British American Tobacco (Velo) remain under review despite expectations that decisions would be made by the end of 2025 under the pilot scheme. The FDA has already authorized six products under Altria Group’s on! brand, but reviewers are said to be taking a more cautious stance on other applications where evidence of net public-health benefit is viewed as less clear-cut.

    While FDA data shows pouch use among middle- and high-school students remains relatively low, it has been rising, prompting heightened scrutiny. Tobacco companies argue the pilot program is critical for restoring legal market competition amid a surge of unregulated products, while public-health advocates warn that rapid authorizations could fuel new addiction trends. The FDA said decisions continue to be guided by science and statutory standards rather than external pressure.

  • FDA Outlines Risk-Based Approach to ENDS Flavors

    FDA Outlines Risk-Based Approach to ENDS Flavors

    Yesterday (March 9), the U.S. Food and Drug Administration (FDA) issued a draft guidance outlining how it will evaluate flavored electronic nicotine delivery systems (ENDS) under the Premarket Tobacco Product Application (PMTA) process. The document clarifies the agency’s current thinking on determining whether such products are “appropriate for the protection of the public health” (APPH), the legal standard under the Federal Food, Drug, and Cosmetic Act. Although non-binding, the guidance emphasizes that applicants must demonstrate a net public health benefit, meaning any potential benefits to adult smokers, such as helping them switch from or reduce combustible cigarette use, must outweigh the risks to non-users, particularly youth.

    The guidance adopts a “risk-proportionate” approach based on the level of youth appeal associated with different flavors. According to the FDA, high-risk flavors such as fruit, candy, dessert, and other sweet varieties face a particularly high evidentiary burden. They must demonstrate significant added benefits for adult smokers compared with tobacco-flavored products. Lower-risk flavors, including menthol, mint, and some novel flavors such as spices, may require a smaller demonstrated adult benefit to meet the APPH standard. Applicants are encouraged to provide scientifically valid evidence, including sensory perception studies, consumer response assessments, and population-level data, to evaluate both youth appeal and potential adult benefits.

    The agency also addressed mitigation strategies designed to reduce youth access, including device access restrictions such as fingerprint authentication or geofencing. While these technologies may form part of a broader youth-prevention strategy, the FDA said they are generally insufficient on their own to offset the risks associated with highly youth-appealing flavors. The guidance reinforces the agency’s product-specific, evidence-based review process, with the most scrutiny applied to flavored products that present the greatest risk of youth initiation.