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U.S. Department of Health and Human Services

Tobacco Products

Further Amendments to General Regulations of the Food and Drug Administration to Incorporate Tobacco Products - Small Entity Compliance Guide


March 2012







This guidance is intended to help small businesses understand and comply with FDA’s amendments to certain of its regulations to include tobacco products, where appropriate, in light of FDA’s authority to regulate these products under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). With these amendments, tobacco products are subject to the same general requirements that apply to other FDA-regulated products. Parties must be in compliance with that final rule beginning on April 2, 2012.  






Contact FDA

(9am EST-4pm EST)

For General Inquiries:

Center for Tobacco Products Food and Drug Administration

10903 New Hampshire Avenue

Building 71, Room G335

Silver Spring, MD 20993-0002