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
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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.
