2025-18806Notice

FDA Demands Tobacco Companies Prove They Sold Here First

Published Date: 9/29/2025

Notice

Summary

The FDA is asking for approval to collect info from tobacco companies about how they prove their products were sold in the U.S. This helps make sure only legal tobacco products are on the market. Tobacco businesses should get ready for new paperwork soon, but no big costs are expected right now.

Analyzed Economic Effects

2 provisions identified: 1 benefits, 1 costs, 0 mixed.

Tobacco firms must ready new paperwork

The FDA is asking OMB to approve a new information collection under the Paperwork Reduction Act of 1995 that asks tobacco companies to show how their products were commercially marketed in the United States. Tobacco businesses should prepare for new paperwork soon, though the FDA says no big costs are expected right now.

Aims to keep only legal tobacco for sale

The FDA says the information collection is meant to help ensure that only tobacco products that were legally commercially marketed in the United States remain on the market. If effective, this action is intended to reduce the presence of illegally marketed tobacco products.

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Key Dates

Published Date
Comments Due
9/29/2025
10/29/2025

Department and Agencies

Department
Independent Agency
Agency
Health and Human Services Department
Food and Drug Administration
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