Source: FDA, 12/28/16

The Food and Drug Administration recently published the final guidance titled Listing of Ingredients in Tobacco Products. This guidance is intended to assist manufacturers and importers making tobacco product ingredient submissions to the FDA, as required by the Tobacco Control Act. Revisions to this guidance include minor clarifying and editorial changes to promote consistency throughout the FDA’s guidances and updated submission compliance dates.

The guidance also explains the statutory requirement to submit a list of all ingredients in tobacco products, who submits ingredient information, what information is included in the submissions, how and when to submit the information, the FDA’s compliance policies, and definitions.

Under the policies outlined in the guidance, the FDA does not intend to enforce the submission requirement for newly deemed tobacco products that were on the market as of August 8, 2016, until August 8, 2017, or February 8, 2018 for small-scale manufacturers. Tobacco products entering the market after August 8, 2016, must submit the ingredient information at least 90 days before the product is introduced into interstate commerce.

FDA is currently accepting ingredient listings for tobacco products and encourages manufacturers to start the processes as early as possible.

Read the guidance for more information.