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U.S. Department of Health and Human Services

Tobacco Products

Exemptions From Substantial Equivalence Requirements


21 CFR Parts 16 and 1107 

July 2011







The Food and Drug Administration (FDA) is issuing this final rule to establish procedures for requesting an exemption from the substantial equivalence requirements of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). The final rule describes the process and statutory criteria for requesting an exemption and explains how FDA reviews requests for exemptions. This regulation satisfies the requirement in the Tobacco Control Act that FDA issue regulations implementing the exemption provision. 





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