The Food and Drug Administration (FDA) is announcing the availability of the guidance for industry entitled ``Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions.'' This guidance provides information in response to questions that FDA has received from manufacturers on demonstrating the substantial equivalence of a new tobacco product, including questions on when a modification to the label requires a premarket submission and review by FDA.
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Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions; Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance for industry entitled ``Demonstrating the Substantial Equivalence of a New Tobacco Product:...
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80 FR 12011
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“Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions; Guidance for Industry; Availability,” thefederalregister.org (March 5, 2015), https://thefederalregister.org/documents/2015-05023/demonstrating-the-substantial-equivalence-of-a-new-tobacco-product-responses-to-frequently-asked-questions-guidance-for-.