# Tobacco Products, Exemptions From Substantial Equivalence Requirements
> **Food and Drug Administration** · Final rule. · Published 2011-07-05 · Effective 2011-08-04 · 76 FR 38961
## Document
- **Document number:** 2011-16766
- **Category:** fda-tobacco
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 76 FR 38961
- **CFR reference:** 21 CFR 16
- **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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2011/07/05/2011-16766/tobacco-products-exemptions-from-substantial-equivalence-requirements)
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