27 Jun 2025

🏭FDA Notice on Reporting Harmful Constituents in Tobacco Products

Agency Information Collection Activities; Proposed Collection; Comment Request; Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic Act

Summary

The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic Act.

Agencies

  • Health and Human Services Department
  • Food and Drug Administration

Business Impact ?

$$$ - High

The content outlines compliance requirements for tobacco manufacturers regarding reporting harmful constituents, indicating potential regulatory costs and operational changes necessary for meeting FDA standards. Businesses involved in tobacco product manufacturing or importing will need to adjust their practices and reporting processes accordingly.

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