27 Jun 2025

🚬FDA Proposes Collection on Tobacco Product Exemption Requirements

Agency Information Collection Activities; Proposed Collection; Comment Request; Exemptions From Substantial Equivalence Requirements for Tobacco Products

Summary

The Food and Drug Administration (FDA or Agency) 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 "Exemptions From Substantial Equivalence Requirements for Tobacco Products."

Agencies

  • Health and Human Services Department
  • Food and Drug Administration

Business Impact ?

$$ - Med

The FDA is proposing a collection of information related to exemptions from substantial equivalence requirements for tobacco products. This directly impacts tobacco manufacturers, as they will need to comply with new reporting requirements, affecting operational costs and regulatory strategy.

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