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  • Public Health Groups Sueing FDA Over New Vape, Pouch Stance

    Public Health Groups Sueing FDA Over New Vape, Pouch Stance

    A coalition of public health organizations, including the Campaign for Tobacco-Free Kids, American Academy of Pediatrics, American Heart Association, and American Lung Association, filed a federal lawsuit yesterday (July 14) challenging the U.S. Food and Drug Administration’s May 2026 enforcement guidance for e-cigarettes and nicotine pouches. The plaintiffs argue the policy unlawfully allows unauthorized products to remain on the market without the premarket scientific review required under the Tobacco Control Act, creating an enforcement safe-harbor for products that FDA has previously identified as posing significant youth appeal.

    Filed in the U.S. District Court for the District of Maryland, the lawsuit seeks to overturn the guidance, alleging it violates both the Tobacco Control Act and the Administrative Procedure Act, and could have significant implications for manufacturers and retailers by determining whether products with pending marketing applications can continue to be sold while awaiting FDA review.

  • FDA Releases PATH Study Data from Wave 8

    FDA Releases PATH Study Data from Wave 8

    The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) and the National Institutes of Health’s National Institute on Drug Abuse (NIDA) released the Wave 8 Public-Use Files from the Population Assessment of Tobacco and Health (PATH) Study, providing researchers with nationally representative survey data collected between January and December 2024. The longitudinal study tracks tobacco and nicotine use among U.S. adults and youth and is a key source of evidence used by FDA to inform tobacco regulatory decisions under the Family Smoking Prevention and Tobacco Control Act.

    The agencies also updated the Wave 7 Biomarker Restricted-Use File with new tobacco-specific nitrosamine and F2-isoprostane data, expanding the resources available for studying tobacco exposure and health effects. Researchers can request access to the restricted-use biomarker files, while the public-use datasets, documentation, and updated master linkage files are available for download.

    The PATH Study is one of the most widely used data sources for analyzing trends in tobacco and nicotine product use, including cigarettes, e-cigarettes, and oral nicotine products. The latest data release is expected to support ongoing research into consumer behavior, product use patterns, and health outcomes that inform both FDA regulatory science and industry analysis.

  • FDA Faces $10M Lawsuit from Cigar Companies Over User Fees

    FDA Faces $10M Lawsuit from Cigar Companies Over User Fees

    Nine premium cigar manufacturers filed a lawsuit in the U.S. Court of Federal Claims seeking at least $10 million plus interest in refunds of FDA user fees paid between 2016 and 2023. The lawsuit follows the cigar industry’s victory in a separate legal challenge that resulted in premium cigars being exempted from FDA regulation, with the companies arguing they should not have been required to pay user fees on products the agency ultimately lacked authority to regulate.

    Arturo Fuente, Ashton, CLE Cigar, J.C. Newman, Oliva, La Flor Dominicana, My Father Cigars, Padrón, and Rocky Patel contend they paid the fees despite premium cigars being excluded from most FDA requirements and are now seeking reimbursement after the FDA stopped collecting user fees on premium cigars following a key 2023 court ruling. Court filings in the earlier litigation suggested the government could face more than $100 million in past user fee refunds. The case has been assigned to Judge Edward H. Meyers, with the plaintiffs represented by Morgan Lewis, including attorney Michael Edney, who led much of the industry’s successful challenge to the FDA’s premium cigar regulations.

  • CAPHRA Says FDA’s Pouch Pivot Should Trigger Policy Rethink 

    CAPHRA Says FDA’s Pouch Pivot Should Trigger Policy Rethink 

    The Coalition of Asia Pacific Tobacco Harm Reduction Advocates is urging governments across the Asia-Pacific region to review the U.S. Food and Drug Administration’s recent authorization allowing 20 Zyn nicotine pouch products to carry reduced-risk claims for adult smokers. CAPHRA said the FDA’s decision recognizes the principle of relative risk following scientific review and should encourage regulators to distinguish between combustible cigarettes, high-risk smokeless tobacco products, and lower-risk smoke-free nicotine alternatives.

    The group called on policymakers to adopt evidence-based, risk-proportionate regulation, strengthen youth access restrictions and product standards, and ensure adult consumers receive accurate information about the comparative risks of nicotine products, arguing that treating all nicotine products as equally harmful undermines public health objectives.

  • 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.