29 Sep 2025
🚬FDA Guidance on Tobacco Product Commercial Marketing Requirements
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Establishing That a Tobacco Product Was Commercially Marketed in the United States
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 content outlines regulatory compliance requirements for tobacco manufacturers, including the need to demonstrate that products were marketed in the U.S. as of a specified date, impacting how businesses must operate within FDA guidelines. Non-compliance could hinder market entry for new products.