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FDA Requests Comments on Final Rule for FDA Regulation of Tobacco Products

The Food and Drug Administration has issued a direct final rule, effective April 14, 2011, which will amend certain of its general regulations to include tobacco products, where appropriate, in light of FDA’s authority to regulate these products under the Family Smoking Prevention and Tobacco Control Act. With these amendments, tobacco products will be subject to the same general requirements that apply to other FDA-regulated products.

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FDA is also issuing a companion proposed rule under FDA's usual procedures for notice and comment to provide a procedural framework to finalize the rule in the event it receives significant adverse comment and withdraw this direct final rule. Comments are due by February 14, 2011.