Draft Guidance for Industry and Food and Drug Administration Staff; Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions; Availability

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The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions." This draft guidance provides responses to questions FDA has received on the Family Smoking Prevention and Tobacco Control Act's (Tobacco Control Act) provisions on new tobacco products and substantial equivalence, including questions on changes to packaging and labeling. This draft guidance is not final nor is it in effect at this time.