The Biannual Tobacco Product Listing Deadline: What Does the Deadline Mean to You, and How is FDA Helping You Comply?
Biannual Tobacco Product Listing Deadline
Twice every year, manufacturers of tobacco products must report to FDA certain changes made to their tobacco products listing. The agency has undertaken efforts to educate those who could be affected by answering questions such as: What is the tobacco product listing requirement? What types of changes trigger the requirement, and when doesn’t it apply? What steps should companies take to make sure they’re in compliance?
Read on to learn about the basics of the product listing requirement. Also, find a roundup of FDA resources for helping companies comply. All domestic tobacco product establishments are required to register those establishments with FDA by December 31 of each year.
By June 30 and December 31 every year: important deadlines for product listings
The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), enacted in 2009, requires the owners and operators of domestic establishments engaged in manufacturing tobacco products to submit product listings. Since the final deeming rule became effective in August of 2016, the listing requirement applies to all tobacco products including e-liquids and other electronic nicotine delivery systems (ENDS), cigars, pipe and hookah tobacco, nicotine gel, and dissolvable nicotine products. The Act requires that certain changes to a tobacco product listing be reported to FDA twice a year: once during June and once during December.
The product listing requirement pertains to updates, inactivations, and new listings. As outlined below, only those making certain changes are required to submit or update their product listing information. Information previously submitted to FDA should not be resubmitted.
Notably, all registered tobacco product manufacturers must update their product listing once during June and once during December if they have made any of the following changes:
- Introduced any tobacco products for commercial distribution that were not included in a previous listing
- Discontinued manufacturing, preparation, compounding, or processing any tobacco products for commercial distribution
- Resumed manufacturing, preparation, compounding or processing any tobacco products previously listed as discontinued
- Made any required or voluntary material change to any listing information previously submitted, such as a name, labeling, consumer information, or advertisement changes. A material change to labels and advertisements would include the addition of the required warnings for cigars or the required warning for covered tobacco products.
These resources from FDA contain information to help those responsible for tobacco product listing
- Guidance for Industry: Registration and Product Listing for Owners and Operators of Domestic Product Establishments. This document is intended to help owners and operators of domestic product establishments with legally required submissions for registration, as well as product listing.
- Tobacco Registration and Listing Module – Next Generation (TRLM NG) Instructions Webpage. FDA recommends that you submit your product listings online using TRLM NG.
- TRLM NG Help Webpage. From this page, you can access a wealth of information, including the TRLM NG User Guide and a training video.
- FDA tobacco compliance webinar: “Tobacco Product Listing Updates.”
Have additional questions?
Feel free to email FDA at: CTPRegistrationandListing@fda.hhs.gov.
Or, if you are a small business, consider these two additional options:
- Visit Tobacco Small Business Assistance.
- Or, send an email to SmallBiz.Tobacco@fda.hhs.gov.
For more information on how to comply with FDA’s tobacco product regulations or for a list of upcoming tobacco product submission deadlines, please visit CTP’s manufacturing webpage.