CSMS Message: 16-000561

Title:Food and Drug Administration and Tobacco Products under the Deeming Rule
Date:2016-07-06
To:abi,edi,partner
Links:previous, original, next

The U.S. Food and Drug Administration (FDA) recently finalized a rule, “Deeming Tobacco Products to be Subject to the Federal Food, Drug and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act” (Deeming rule). The Deeming rule published in the Federal Register on May 10, 2016, and extends FDA's authority in Chapter IX of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to additional products (“newly deemed” products) that meet the definition of “tobacco product” in the law such as electronic cigarettes, cigars, hookah, and pipe tobacco, as well as their components and parts.

Implementation dates for the provisions that apply to newly deemed, imported products are located on our website, and product codes are available on the ORA Product Code Builder webpage. Prior to August 8, 2016, declaration of the newly deemed products is not required. Beginning on August 8, 2016, all newly deemed, imported products must be declared to FDA with their appropriate product codes.

FDA will provide more information to the importing community prior to the August 8, 2016 effective date for the newly deemed products.