FDA Issues Steps to Request FD&C Act Tobacco Equivalence Exemption
The Food and Drug Administration has issued a final rule, effective August 4, 2011, that establishes a procedure for requesting an exemption from the substantial equivalence requirements of the Federal Food, Drug, and Cosmetic (FD&C) Act applicable to tobacco products.…
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Among the procedures included in this final rule is the requirement that a request for an exemption and all information supporting the request be submitted in an electronic format. The final rule also addresses FDA’s review of an exemption request and establishes procedures for rescinding an exemption. The final rule states these requirements offer an additional channel for legally introducing new tobacco products that result from minor modifications of tobacco products that can be sold under the FD&C Act and that successfully introducing a product through this channel is expected to reduce costs.