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
Document Control Center

Building 71, Room G335
Silver Spring, MD 20993-002

Courier Deliveries

Page Last Updated: 05/17/2017
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