FDA Announces Intent to Regulate OTP

FDA Announces Intent to Regulate OTP

FDA expects to issue a deeming regulation in summer 2012 to cover other tobacco products. Cigars, e-cigs and cigarillos are among tobacco products about to meet with U.S. Food and Drug Administration (FDA) scrutiny. The agency has announced its intent to issue a “deeming regulation” sometime during the summer of 2012 to cover other tobacco [...]

FDA Calls For Comments

FDA Calls For Comments

The FDA is encouraging retailers to send comments, data, research or other information related to non-face-to-face sale and distribution of tobacco products. The FDA is extending the comment period until Jan. 19, 2012, for an Advance Notice of Proposed Rule-Making (ANPRM) that was published in the Federal Register of Sept. 9, 2011 (76 FR 55835). [...]

FDA Seeks Comments On Draft Guidance

FDA Seeks Comments On Draft Guidance

FDA Center for Tobacco Products posted two Draft Guidance documents and an Advance Notice of Proposed Rule-Making, and encourages retailers to review the documents and submit comments.  • Draft Guidance for Industry and FDA Staff Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions. This draft guidance provides information in [...]