Guidance on Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments

On Friday, September 15, 2017, the U.S. Food and Drug Administration (FDA) published revised Guidance for Industry on Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments.

What does it mean?
Section 905(b) of the Tobacco Control Act requires every person who owns or operates any “establishment” in the United States that manufactures, prepares, compounds, or processes a “tobacco product” to register with the FDA by December 31 of each year.

Who does this apply to?
This includes all owners who operate a facility in the United States that manufactures, prepares, compounds, or processes an e-vapor product. If you repackage or otherwise change the container, wrapper, or labelling of these products, then you also must register with the FDA by December 31 of each year.

What about existing facilities which haven’t already registered?
The FDA does not intend to enforce the requirement to register and submit product listing information under section 905 of the FD&C Act by December 31, 2016, provided that the submissions are received on or before September 30, 2017.

After September 30, 2017 establishments must register their facilities and products immediately upon first engaging in the manufacturing of a tobacco product.

Listing of Ingredients in Tobacco Products
Each tobacco product manufacturer or importer of tobacco products which were on the market on August 8, 2016 must submit a listing of all ingredients, including tobacco, substances, compounds, and additives that are added by the manufacturer to the tobacco, paper, filter, or other part of each regulated tobacco product by brand and by quantity in each brand and sub brand by November 8, 2017, as per Section 904 of the Food, Drug & Cosmetic Act.

If you are a “small-scale tobacco product manufacturer” of newly-regulated finished tobacco products, you have until May 8, 2018 to submit your ingredient listing.

For tobacco products entering the market after August 8, 2016; the manufacturer or importer must submit their ingredient listing 90 days prior to marketing.

How can we help?
Nerudia are here to support and guide you through this process. Contact us for more information on how we can help your business through the registration process.