Get Your Voice Heard: FDA Seeks Comments on New Requirements for Tobacco Manufacturers

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The U.S. Food and Drug Administration (FDA) has issued a proposed rule, “Establishment Registration and Product Listing for Tobacco Products,” that could significantly affect both foreign and domestic tobacco product manufacturers.

One of the biggest proposed changes is the expansion of FDA’s registration and product listing requirements to foreign tobacco product manufacturers. Foreign establishments would be required to register with FDA and submit product listing information before their products are imported or offered for import into the United States.

Foreign manufacturers would also face ongoing requirements involving registration updates, product listings, recordkeeping, electronic submissions, and FDA inspections.

For domestic manufacturers, the proposed rule would largely formalize and clarify existing FDA requirements. It would also provide a broader and more detailed explanation of who qualifies as a tobacco product “manufacturer,” potentially covering specification developers, third-party manufacturers, bulk manufacturers, repackagers, and relabelers.

Why This Matters

The proposal will create new compliance responsibilities throughout the tobacco and vape industries, particularly for foreign manufacturers entering the U.S. market. It will also affect how domestic businesses handle registration, reporting, product listings, and recordkeeping.

Most importantly, industry stakeholders still have an opportunity to weigh in.

Comments are due September 14, 2026. Manufacturers and other affected businesses should consider whether the proposed requirements create compliance, implementation, or operational concerns that should be raised with FDA before the rule is finalized.

Clark-Esposito Law Firm, P.C. can assist businesses in evaluating the proposed requirements and preparing comments for submission to FDA. If your business may be affected, now is the time to consider whether your voice should be included in the regulatory record.

In need of assistance? Give our office a call today at (917) 546-6997 or schedule an intake meeting, we would be happy to speak with you.

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