Daily Rules, Proposed Rules, and Notices of the Federal Government
Submit written requests for single copies of the draft guidance document entitled "Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions" to the Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850-3229. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the guidance document may be sent. See the
This draft guidance provides responses to questions we have received on the Federal Food, Drug, and Cosmetic Act's (the FD&C Act) provisions on new tobacco products and
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency's current thinking on “Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions.” It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.
An electronic version of the draft guidance document is available on the Internet at
This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in sections 905(j) and 910 of the FD&C Act, as amended by the Tobacco Control Act have been approved under OMB control number 0910-0673; the collections of information in 21 CFR part 25 have been approved under OMB control number 0910-0322.
Interested persons may submit to the Division of Dockets Management (see