FDA Seeks Comments On Draft Guidance

FDA Center for Tobacco Products posted two Draft Guidance documents and an Advance Notice of Proposed Rule-Making, and encourages retailers to review the documents and submit comments. 

Draft Guidance for Industry and FDA Staff Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions. This draft guidance provides information in response to frequently asked questions that the Center for Tobacco Products receives from manufacturers and other interested stakeholders on demonstrating the substantial equivalence of a new tobacco product. Please submit your comments by Nov. 8, 2011. More information is also available on the Substantial Equivalence Webpage.

Draft Guidance for Industry Submission of Warning Plans for Cigarettes and Smokeless Tobacco Products. This guidance is intended to assist persons submitting warning plans for cigarettes and warning plans for smokeless tobacco products. Please submit your comments by Nov. 8, 2011.

Advance Notice of Proposed Rule-Making (ANPRM): Non-Face-to-Face Sale and Distribution of Tobacco Products and Advertising, Promotion, and Marketing of Tobacco Products. This ANPRM was issued to obtain information related to the regulation of non-face-to face sale and distribution of tobacco products and the advertising, promotion, and marketing of tobacco products. Please submit your comments by Dec, 8, 2011.

Visit www.fda.gov/tobaccoguidance for more information.




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