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Updated: May 31, 2026

Methods to Evaluate Cytotoxicity and Immunosuppression of Combustible Tobacco Product Preparations
Published on: January 10, 2015
Tobacco products, exemptions from substantial equivalence requirements. Final rule
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.
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