TobaccoReporter logo

Tag: FDA

  • PCA Concerned Over FDA’s Proposed Tobacco Rules

    PCA Concerned Over FDA’s Proposed Tobacco Rules

    The Premium Cigar Association (PCA) said it will submit comments opposing portions of the U.S. Food and Drug Administration’s proposed rule on tobacco product establishment registration and product listing, arguing the measure could impose significant compliance costs on manufacturers and retailers. The association noted that premium cigar manufacturers remain exempt from the proposal as a result of successful litigation overturning the FDA’s Deeming Rule for premium cigars, but warned that many other products sold by its 3,500 retail members—including pipe tobacco and non-premium cigars—would be subject to new registration, recordkeeping, and inspection requirements.

    PCA CEO Joshua Habursky said the organization is concerned the proposal could lead to additional regulation and higher costs throughout the supply chain, particularly for small businesses. The association said it intends to oppose provisions it considers unnecessary and argues that increased compliance costs for manufacturers would ultimately be passed on to retailers and consumers through higher prices and reduced product choice.

  • FDA Finally Issues Proposed Rule to Require Foreign Tobacco Manufacturers to Register Facilities and List Products

    FDA Finally Issues Proposed Rule to Require Foreign Tobacco Manufacturers to Register Facilities and List Products

    By Dean R. Cirotta, President EAS Consulting Group

    On June 29, 2026, the FDA published a proposed rule in the Federal Register – “Establishment Registration and Product Listing for Tobacco Products” (Docket No. FDA-2025-N-7130, RIN 0910-AH59). https://www.federalregister.gov/documents/2026/06/29/2026-13047/establishment-registration-and-product-listing-for-tobacco-products

    The proposed rule would add a new a new part (21 CFR Part 1108) that would specifically prescribe the format, content, and procedures for establishment registration and tobacco product listing for both domestic and foreign manufacturers of tobacco products.  The FDA based many of the requirements in this proposed rule on the recommendations and interpretations originally outlined in an FDA guidance for industry entitled “Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments” which was finalized and first issued on November 12, 2009.

    This rule would allow FDA to further protect the public health by helping to ensure that owners and operators of domestic and foreign establishments that manufacture tobacco products sold in, distributed in, and/or imported into the United States, are complying with Federal law, including FDA’s premarket authorization requirements. Information that would be required by the rule would enable FDA to better pursue enforcement actions against non-compliant tobacco products that have entered commercial distribution or await entry into commercial distribution, at the border.

    The FDA feels the proposed rule would offer the following benefits:

    • It would close a regulatory gap by requiring foreign tobacco manufacturers to register with FDA and list products intended for U.S. distribution.
    • It would improve FDA’s ability to identify manufacturers and products in the marketplace.
    • It would provide additional information to support enforcement actions against non-compliant and unauthorized tobacco products.
    • It would help combat the importation of illegal or unauthorized tobacco products.
    • It would create a more level regulatory playing field between U.S. and foreign manufacturers.
    • It would provide FDA with greater visibility into the global tobacco supply chain. 

    The primary driver of this rulemaking is a longstanding regulatory gap. Under the Family Smoking Prevention and Tobacco Control Act, domestic owners and operators of tobacco product manufacturing establishments are already required to register their establishments and submit product listings with FDA. However, foreign owners and operators are not subject to these requirements unless FDA issues specific regulations — which it has not done until now. This gap has left FDA without visibility into the foreign manufacturers supplying tobacco products to American consumers, including electronic nicotine delivery systems (ENDS) and e-cigarettes.

    Key Takeaways from the Proposed Rule:

    • The proposed rule would extend facility registration requirements to foreign establishments that engage in the “manufacture, preparation, compounding, or processing” of a tobacco product.
    • Foreign establishments would be subject to FDA inspection, a significant new compliance obligation for overseas manufacturers.
    • Foreign establishments would be required to submit product listing information identified for each tobacco product manufactured, prepared, compounded, or processed for commercial distribution.
    • The rule explicitly expands the definition of “manufacturer” to include specification developers (entities that design and control product specs), third-party/contract manufacturers, bulk tobacco product manufacturers, and repackagers/relabelers — meaning entities that outsource physical production, but control product design are not exempt.
    • Manufacturers would be required to submit information electronically through FDA’s online system, enabling them to register more quickly. Paper submissions would only be permitted via a formal waiver.
    • Domestic manufacturers must register within five business days of first engaging in manufacturing operations. Foreign manufacturers must register before any tobacco product manufactured at their establishment is imported or offered for import into the United States. Annual re-registration is required by December 31 of each year, with product listing updates required in both June and December.
    • Each listed product must include uniquely identifying information — brand and subbrand name, product category and subcategory, package type and quantity, characterizing flavors, nicotine source (tobacco-derived vs. non-tobacco derived), and nicotine concentration. ENDS products must also include e-liquid volume, battery capacity, and wattage.
    • The rule would require all manufacturers to maintain product labeling, advertising, and consumer information records for at least four years after their use, enabling FDA to verify compliance with labeling rules and check for marketing that targets youth or makes unauthorized health claims.

    For tobacco manufacturers, importers, and distributors, the proposed rule signals FDA’s continued focus on supply-chain transparency, imported product oversight, and enforcement against products that have not met applicable tobacco regulatory requirements.  

     Owners and operators of foreign facilities should consider the following:

    • Which sites and products will fall under this new rule
    • Are the sites prepared to host an FDA inspection
    • How will this affect the sites and the products they manufacture for the US market
    • Do they have all the product-specific information required by the new rule.
    • Do they have all the historical labeling, advertising and consumer information readily available
    • How will this affect their supply chain and importation of products into the US

    This proposed rule is clearly a priority, not only for the FDA, but also the administration, as the proposed rule references Executive Order 14212 and the Make America Healthy Again Commission’s 2025 strategy report, positioning the rule as part of broader administration efforts to crack down on illegal ENDS products and protect public health.

    The agency is asking for specific feedback and is accepting public comments before determining whether to issue a final rule. Therefore, companies should consider submitting comments. The public comment period closes on September 14, 2026. Comments can be submitted at Regulations.gov at

    Federal Register: Establishment Registration and Product Listing for Tobacco Products

    __________________________

    Dean Cirotta
    President, EAS Consulting Group

    Dean Cirotta serves as President for EAS Consulting Group, with management responsibility for all technical aspects of the company, including client relations and personnel. Prior to EAS’ acquisition by the Certified Laboratories family of companies, Dean served as Partner and President/COO of EAS from 2012-2019.

    Cirotta is a highly accomplished executive in the pharmaceutical and dietary supplement industries, including executive management roles overseeing regulatory affairs, compliance, quality assurance/control, operations, manufacturing, laboratory operations and financial and corporate management. Additionally, he has been actively involved in tobacco regulatory requirements for over 15 years, expanding EAS client services and cementing EAS’ reputation in the tobacco industry through the assessment of quality systems, implementation of quality systems in preparation for FDA Inspections and the anticipated TPMPs.

    Cirotta has over 35 years of experience in the FDA regulated industries. Prior to joining EAS, Mr. Cirotta was President and COO of UPM Pharmaceuticals, Leitner Pharmaceuticals and he served as Vice President of Global Regulatory Affairs for the pharmaceutical division of Bausch & Lomb.

  • FDA Issues MRTP Orders for 20 Zyn Products

    FDA Issues MRTP Orders for 20 Zyn Products

    The U.S. Food and Drug Administration issued Modified Risk Tobacco Product orders for 20 Zyn nicotine pouch products manufactured by Swedish Match USA, making Zyn the first nicotine pouch brand authorized to market reduced-risk claims compared with cigarettes. The FDA-authorized claim states that using Zyn instead of cigarettes lowers the risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis. The authorization applies to 10 Zyn flavors in both 3 mg and 6 mg nicotine strengths and builds on the products’ January 2025 authorization for sale through the FDA’s premarket tobacco product application pathway.

    The FDA said its decision followed an extensive scientific review of the products’ relative health risks, consumer understanding of the claim, youth use data, and overall population health impact. The agency concluded that the modified-risk claim is scientifically supported, that consumers understand its meaning, and that allowing the claim is expected to benefit public health. The authorization requires Swedish Match USA to conduct post-market surveillance and behavioral studies, and the orders will expire after five years unless renewed. The FDA also noted it retains the authority to withdraw the orders if continued marketing no longer benefits public health, including if youth uptake increases.

    Separately, Philip Morris International said the decision expands its portfolio of FDA-authorized modified-risk products, which also includes IQOS heated tobacco products and General snus. PMI U.S. CEO Stacey Kennedy said the authorization provides adult nicotine consumers with FDA-reviewed, science-based information about the health benefits of switching completely from cigarettes to Zyn.

  • FDA Proposal Would Allow Oversight of Foreign Manufacturers

    FDA Proposal Would Allow Oversight of Foreign Manufacturers

    The U.S. Food and Drug Administration proposed a rule requiring foreign tobacco product manufacturers to register their manufacturing facilities and list the tobacco products they sell in the U.S., closing a regulatory gap that currently exempts overseas manufacturers from requirements already imposed on domestic companies. The agency said the proposal would strengthen its ability to identify and take action against illegal tobacco products—particularly unauthorized disposable e-cigarettes—and create a more level playing field for U.S. manufacturers.

    If finalized, the rule would require both foreign and domestic manufacturers to register their establishments, submit detailed product information, and update registrations annually and product listings twice a year. Foreign facilities would also become subject to FDA inspections, giving the agency greater oversight of products before they enter the U.S. market. Manufacturers would also be required to maintain records of labeling, advertising, and consumer information for at least four years.

    According to the FDA, the proposal would improve enforcement by providing more comprehensive information on tobacco products manufactured for the U.S. market and expanding oversight of foreign producers. Acting Center for Tobacco Products Director Bret Koplow said the rule would help ensure all companies selling tobacco products in the U.S. operate under the same standards while strengthening the agency’s ability to keep illegal products out of the marketplace. Public comments will be accepted through Sept. 14.

  • 5th Circ. Backs FDA’s Block on Vape Marketing

    5th Circ. Backs FDA’s Block on Vape Marketing

    The U.S. Court of Appeals for the Fifth Circuit upheld the U.S. Food and Drug Administration’s denial of marketing applications for menthol-flavored e-cigarette products submitted by two vape manufacturers, ruling that the agency reasonably concluded the products’ potential benefits for adult smokers did not outweigh the risks of youth initiation. The decision affirms the FDA’s application of the “appropriate for the protection of public health” standard required under the Premarket Tobacco Product Application (PMTA) pathway.

    The ruling, against Triton Distribution and Vapetasia LLC, reinforces the FDA’s authority to reject flavored vaping products where applicants fail to provide sufficient evidence that the products offer a net public health benefit.

  • FDA Reports Efforts Prevented 450K Youth from Vaping

    FDA Reports Efforts Prevented 450K Youth from Vaping

    The U.S. Food and Drug Administration published new information in a special issue of the American Journal of Preventive Medicine highlighting the measurable public health impact of its youth tobacco prevention efforts, particularly the “The Real Cost” campaign. According to studies featured in the issue, the campaign is estimated to have prevented roughly 444,252 U.S. youth from initiating e-cigarette use between 2023 and 2024, while also reducing an estimated $42 million in illegal e-cigarette sales that would have otherwise been consumed by minors. The findings are based on peer-reviewed research and analyses conducted by FDA scientists and external collaborators, reinforcing the campaign’s effectiveness in shaping youth behavior at scale.

    FDA officials, including leadership from the Center for Tobacco Products, emphasized that the results demonstrate how sustained, evidence-based public education can materially shift youth attitudes and reduce nicotine initiation. The special journal issue compiles 12 studies examining campaign reach, audience segmentation, behavioral impact, and cessation engagement. One analysis found that roughly three-quarters of surveyed youth reported exposure to at least one prevention ad, with especially strong reach among higher-risk groups, while another showed more than 253,000 visits driven to the SmokefreeTeen cessation platform, including over 11,000 completed quit plans.

    The FDA’s broader claim is that “The Real Cost” campaign — launched in 2014 for cigarettes and expanded in 2018 to address vaping — has become a long-running model for data-driven prevention messaging. Officials argue that its demonstrated impact on youth behavior and attitudes provides a foundation for expanding educational efforts, including potential messaging aimed at influencing adults who smoke toward cessation and harm reduction, while maintaining a continued focus on preventing youth initiation.

  • FDA: Youth Tobacco Use Remains Near Historic Lows

    FDA: Youth Tobacco Use Remains Near Historic Lows

    Today (June 23), the U.S. Food and Drug Administration reported continued declines in youth tobacco use, releasing findings from its 2025 National Youth Tobacco Survey showing that current use of tobacco products among middle and high school students fell between 2022 and 2025 across overall tobacco products, combustible products and e-cigarettes. Earlier this year, the FDA released raw NYTS data without comment.

    In 2025, approximately 2 million students, or 7.2% of U.S. middle and high school students, reported using any tobacco product in the past 30 days, while 2.7% reported using multiple tobacco products and 2.6% reported using combustible products.

    E-cigarettes remained the most commonly used category at 5.2%, followed by nicotine pouches at 1.7% and cigarettes at 1.4%. While nicotine pouch use increased among high school students over the 2022-2025 period, FDA said overall youth use remained low and was stable between 2024 and 2025. The agency said the findings support ongoing youth prevention efforts, including enforcement against unauthorized tobacco products and educational campaigns, while continuing to inform regulatory reviews of new tobacco and nicotine products.

  • FDA Memo Questions Flavored-Vape Reversal: AP  

    FDA Memo Questions Flavored-Vape Reversal: AP  

    A newly released FDA memo is raising questions about the agency’s watershed authorization of fruit-flavored e-cigarettes after revealing that the products were not significantly more effective at helping smokers quit than tobacco-flavored alternatives, according to the Associated Press. The decision drew criticism from public health groups and Democratic lawmakers, who argue the authorization departs from the agency’s long-standing position that fruit and dessert flavors require a particularly high evidentiary standard because of their appeal to youth.

    The six-page document, published weeks after the FDA approved mango- and blueberry-flavored vaping products from Glas Inc., acknowledged that study data showed no statistically significant difference in smoking cessation outcomes between users of the fruit-flavored products and those using tobacco-flavored e-cigarettes. The finding contrasts with previous FDA authorizations of flavored products, including menthol e-cigarettes from Juul Labs and NJOY, which demonstrated measurable benefits over tobacco-flavored products.

    However, the AP said regulators explained that the Glas flavored vapes “did not have to demonstrate added adult benefit,” because young people were unlikely to use them. Glas requires users to unlock each e-cigarette with an age-verifying cellphone app. The memo indicates that FDA regulators instead relied heavily on the company’s age-verification technology, concluding that youth uptake was unlikely because users must unlock devices through a smartphone app.  The approval was finalized shortly before the departure of former FDA Commissioner Marty Makary and comes amid broader scrutiny of the agency’s recent approach to vaping regulation.

  • Report Accuses Trump of Cashing in on FDA Changes

    Report Accuses Trump of Cashing in on FDA Changes

    A report by KFF Health News accuses President Donald Trump of expanding his personal investments in major tobacco companies and benefiting from substantial political donations from industry interests as his administration simultaneously pursued policies favorable to the tobacco and nicotine industry. The report alleges that Trump increased his holdings in several tobacco companies, including Philip Morris International and Altria Group, as his administration pushed the FDA for regulatory changes, drawing criticism from public health advocates and former regulators who argue the measures benefit tobacco companies at the expense of tobacco-control efforts.

    The report also highlights more than $20 million in contributions from tobacco and vaping interests to Trump-aligned political groups and inauguration activities since late 2023, including multimillion-dollar donations from industry players such as Reynolds American. While the White House rejected suggestions of improper influence and said its nicotine-related policies are based on scientific evidence supporting harm reduction for adult smokers, critics cited in the report contend that the administration’s actions represent one of the most industry-friendly tobacco policy shifts in recent years.

  • Zest Gets Injunction Against FDA for Pouches

    Zest Gets Injunction Against FDA for Pouches

    Zest Brands LLC announced that it secured a preliminary injunction from the U.S. District Court for the Middle District of Florida, allowing its ZEO Universe nicotine pouch products to remain on the U.S. market while the company challenges an FDA Refuse-to-File (RTF) decision related to its May 2022 Premarket Tobacco Product Applications. The injunction temporarily stays the FDA’s action as the case proceeds through the courts.

    According to the company, the court found Zest Brands is likely to succeed on claims that the FDA failed to adequately assess the impact of its 2021 PMTA regulations on small businesses, as required under the Regulatory Flexibility Act. The court also indicated that aspects of the agency’s actions may have been “arbitrary and capricious.” Zest said it remains committed to working with the FDA to complete the PMTA process and is currently in discussions with strategic and financial partners to support future growth.