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Tag: FDA

  • FDA Rolls out New Features in CTP Portal to Assist Submission Process

    FDA Rolls out New Features in CTP Portal to Assist Submission Process

    Today (July 17), the U.S. Food and Drug Administration introduced new enhancements to its Center for Tobacco Products Portal NextGen, expanding its web-based submission system for premarket tobacco product applications and substantial equivalence (SE) reports. New features include the ability to upload folders and subfolders, label submission documents directly within the portal, and save contact information for future filings, reducing administrative burden and improving submission consistency. Based on user feedback, the updates are intended to streamline the application process for tobacco manufacturers and applicants.

    As part of the transition, the FDA will phase out eSubmitter for PMTA and SE submissions after Nov. 14, with applicants expected to use the web-based forms in CTP Portal NextGen. PDF forms will remain available for those unable to use the portal, while eSubmitter will continue to support other submission types, such as ingredient listings and harmful and potentially harmful constituent reports, until additional web forms are introduced. The agency said it plans to provide further training and guidance as it expands the portal’s capabilities.

  • Minnesota AG Sues Local Company for Selling Flavored Vapes

    Minnesota AG Sues Local Company for Selling Flavored Vapes

    Minnesota AG Keith Ellison filed a lawsuit against local e-cigarette manufacturer Maduro Distributors, alleging the company sold banned flavored vape products under its The Loon brand that were marketed in ways appealing to youth. The complaint, filed in Ramsey County District Court, accuses the Fridley-based company of selling products with flavors including cotton candy and blue razz slushy, using “kid-friendly characters” in promotions, and falsely representing some products as FDA-approved.

    The Loon sells disposable and refillable vapes as well as nicotine pouches and previously received an FDA warning letter for marketing unauthorized products, according to The Minnesota Star Tribune. Maduro said it had changed flavor names before Minnesota’s 2024 ban took effect and removed the FDA approval claim from a third-party website, arguing it had cooperated with state officials.

  • Former CTP Toxicologist Accuses FDA of Approving Zyn Without Full Facts

    Former CTP Toxicologist Accuses FDA of Approving Zyn Without Full Facts

    A report published yesterday (July 14) by The Examination and STAT raised questions about the U.S. Food and Drug Administration’s review process for Philip Morris International’s Zyn nicotine pouches, alleging that agency scientists had unresolved concerns about the composition and potential health implications of the pouch material before the product was authorized for sale. The report said FDA toxicologist Christy Leppanen questioned whether regulators had adequately assessed possible microplastic exposure after conducting informal tests that found Zyn pouches did not dissolve when exposed to saliva or other conditions. Leppanen alleged that the FDA did not seek additional information from PMI about the pouch material before approving the product, while former FDA officials cited in the report questioned whether the agency fully evaluated all product components as required under federal law.

    The allegations come as nicotine pouches have become one of the fastest-growing segments of the tobacco and nicotine market. The U.S. nicotine pouch market is estimated to grow 37% in 2026 to $6.8 billion, according to TobaccoIntelligence, with companies promoting pouches as lower-risk alternatives to combustible cigarettes because they deliver nicotine without smoke exposure. The FDA has authorized certain nicotine pouches, including Zyn, based on a review of whether the products are appropriate for the protection of public health, weighing potential risks such as youth uptake against potential benefits for adult smokers transitioning away from cigarettes. PMI defended the authorization process, citing the FDA’s scientific review, while the FDA said its evaluation did not identify additional concerns regarding the ingredients or materials used in Zyn products. Concerns raised by Leppanen and other scientists center on whether pouch materials could release microscopic particles during use and what long-term effects those exposures may have. The FDA’s recent decision allowing PMI to communicate that Zyn use instead of cigarettes lowers the risk of certain smoking-related diseases represented a major regulatory milestone for the category, but, according to The Examination, the allegations in the report may fuel additional debate over product standards, disclosure requirements, and the depth of scientific reviews for emerging nicotine products.

  • 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.