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We solicit information and comments, announced in the Federal Register and posted in dockets on Regulations.gov, from concerned citizens, industry, and organizations on a wide range of issues related to implementation of the Tobacco Control Act.
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Validation and Verification of Analytical Testing Methods Used for Tobacco Products; Draft Guidance for Industry; Availability; Request for Comments
Docket No: FDA-2021-D-0756
Date: February 22, 2022
Summary: The Food and Drug Administration is announcing the availability of a draft guidance for industry entitled "Validation and Verification of Analytical Testing Methods used for Tobacco Products" and requesting comments, including scientific and other information, concerning the recommendations set forth in the draft guidance. The draft guidance, when finalized, would provide information and recommendations related to the validation and verification of analytical test methods, including analytical testing of tobacco product constituents, ingredients, and additives, as well as stability testing of tobacco products. This draft guidance would help industry produce more consistent and reliable analytical data used to support regulatory submissions for finished tobacco products..
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- Provide a clear statement of whether you support or oppose the proposed rule or guidance.
- Include any of the following that support your position:
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- Read more tips for submitting effective comments on the regulations.gov website.
Your role in shaping tobacco regulation
Our regulatory process generally follows these steps:
- Rule/Regulation Proposed
We publish a proposed rule in the Federal Register. - Public Comments Considered
Our proposals generally have a 60-90 day review period. - Final Rule Issued
After considering all comments, we issue a final rule. - Compliance with New Rule Enforced
We must ensure that retailers and businesses comply with the regulation.