19 Sep 2025
🚬FDA Notice on Exemptions for Tobacco Product Regulation
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request, Exemptions From Substantial Equivalence Requirements for Tobacco Products
Summary
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The document outlines compliance and regulatory requirements for tobacco product manufacturers seeking exemptions from substantial equivalence standards, which directly affects their business operations. This includes obligations to submit detailed requests and reports, influencing financial and operational workflows.