FDA Drafts Two Guidance Documents
Published in CSP Daily News
FDA CTP posted two draft guidance documents and an advance notice of proposed rule-making
ROCKVILLE, MD –The FDA Center for Tobacco Products (CTP) has issued draft guidance documents for substantial equivalence and warning plans—as well as an advance notice of proposed rule making.
- Draft Guidance for Industry and FDA Staff Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions. This draft guidance provides information in response to frequently asked questions that the CTP received from manufacturers and other interested stakeholders on demonstrating the substantial equivalence of a new tobacco product. The CTP is requesting comments by November 8, 2011.
- Draft Guidance for Industry Submission of Warning Plans for Cigarettes and Smokeless Tobacco Products.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. Comments are requested by November 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. The CTP is requesting comments by December 8, 2011.
The CTP is encouraging stakeholders view these documents and submit comments, as well as visit www.fda.gov/tobaccoguidance for more information.