Tobacco Registration and Listing Module (TRLM) – What You Need to Know

FDA Tobacco Registration and Product Listing

Tobacco Registration and Listing Module (TRLM)

In an effort to keep tobacco manufacturers and retailers up to date on all the latest news an compliance deadlines required by the U.S. Food and Drug Administration (FDA), Tobacco Business brings you another special feature about FDA compliance for tobacco manufacturers and retaielrs. Tobacco manufacturers must register its establishment and submit a list of products, including labeling and advertisements, by Sept. 30, 2017. A few weeks ago, we explained what you needed to to know about warning label plans [read more here]. Now, we’re taking a look at the Tobacco Registration and Listing Module (TRLM).

For any tobacco and newly regulated product introduced after August 8, 2016, manufacturers must register and submit a product listing as soon as it begins manufacturing it. Under section 905 of the Tobacco Control Act, every person who owns or operates any domestic establishment engaged in the manufacture, preparation, compounding, or processing of regulated tobacco product must register those establishments with the FDA. Also, registrants will be required to submit a list of all tobacco products that are being manufactured by that person for commercial distribution, along with certain accompanying information including all labeling. This compliance policy only applies to finished tobacco products, meaning those that are sealed in final packaging intended for consumer use.

If this seems confusing, consider the next three questions and if all three apply to you or your business, you will need to submit registration and listing for your products:

  1. You are an owner of operator of any:
  2. Establishment located in the United States that:
  3. Is engaged in any of the following tobacco product activities:
  • Manufacturing
  • Preparing
  • Compounding
  • Processing
  • Repackaging (or otherwise changing the container, wrapper, or labeling)

If the above applies to you and you need to register your products and submit a listing, you will do this through the TRLM, part of the FDA’s Unified Registration and Listing System (FURLS). In May 2017, the FDA announced a three-month extension of all future compliance deadlines for requirements defined by the final deeming rules. Because of this extension, the FDA delayed enforcing the submission deadline for establishment registration and product listing but the new deadline to do so is by Sept. 30, 2017.

You will be required to report changes to your product list biannually in the following situations:

  1. If a product is introduced for commercial distribution that has not been included on a previous list;
  2. If you have discontinued the manufacturing, preparing, compounding, or processing for commercial distribution;
  3. If you have resumed the manufacturing, preparing, compounding, or processing of a product for commercial distribution after previously reporting them as discontinued;
  4. Any material change to information previous submitted.

When you go to register, you will be asked to provide the name and full address of each establishment involved in manufacturing the registrant owns or operates, name and places of business of the owner of the operator, an email address and Data Universal Numbering System (D-U-N-S) number. If the business’ ownership is split between partners, the name of each partner must be provided. If it is a corporation, the name of each corporate office, director, and the state of incorporation must be provided.