Tobacco Products, Exemptions From Substantial Equivalence Requirements
fda-tobacco · Food and Drug Administration · Rule · Published 2011-07-05 · Effective 2011-08-04 · 76 FR 38961
Document
Document number
2011-16766
Federal Register citation
76 FR 38961
CFR reference
21 CFR 16
Type
Rule
Action
Final rule.
Category
fda-tobacco
Sub-agency
Food and Drug Administration
Publication date
2011-07-05
Effective date
2011-08-04
HHS docket
Docket No. FDA-2010-N-0646
Abstract
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.