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  • Title: Tobacco products, exemptions from substantial equivalence requirements. Final rule.
    Author: Food and Drug Administration, HHS.
    Journal: Fed Regist; 2011 Jul 05; 76(128):38961-75. PubMed ID: 21735763.
    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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