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Manufacturing

Learn about preparing marketing applications for deemed tobacco products

Join the FDA’s free, public meeting  on Oct. 28-29, 2019, for information about policies, processes, and general scientific principles for tobacco product application review, with a particular focus on deemed tobacco products such as cigars, waterpipes, and electronic nicotine delivery systems (ENDS), including e-liquids and electronic cigarettes.

  • Nominate an expert panelist by September 13, 2019
  • Register by September 30, 2019  

If you make, modify, mix, manufacture, fabricate, assemble, process, label, repack, relabel, or import any "tobacco product," then you are considered a tobacco product "manufacturer." Importers of “finished tobacco products,” may be tobacco product manufacturers, distributors, or both.

How Do I Comply with FDA's Tobacco Regulations?

If you are a tobacco product manufacturer, then you must, as applicable:

If you do not report this information or pay the assessed user fees, your products will be deemed "adulterated" under federal law and therefore, subject to regulatory action, including seizure and injunction. Submission of false information is also punishable by criminal and civil law.

If you do not pay assessed user fees, your products will be deemed "adulterated" under federal law and therefore, subject to regulatory action, including seizure and injunction. Submission of false information is also punishable by criminal and civil law.

  • Who: Every person who owns or operates any domestic establishment engaged in manufacturing tobacco products.
  • When:
    • Immediately upon first engaging in tobacco product manufacturing: Any "new" tobacco product, including deemed “finished tobacco products” manufactured on or after August 8, 2016.
    • Annually by June 30: Submit certain changes to the product listing. Examples of changes that require a submission include: 
      • Introduction of any tobacco products for commercial distribution that were not included in a previous listing
      • Discontinuation of manufacturing, preparation, compounding, or processing any tobacco products for commercial distribution
      • Resumed manufacturing, preparation, compounding or processing any tobacco products previously listed as discontinued
        Note: Only those making certain changes are required to submit or update their product listing information by June 30. Information previously submitted to FDA should not be resubmitted.
    • Annually by December 31:
      • All domestic manufacturers must re-register their establishments. 
      • Also, if certain changes were made to a product listing after the submission deadline of June 30, they must be submitted by December 31. Examples of changes that require a submission include:
        • Introduction of any tobacco products for commercial distribution that were not included in a previous listing
        • Discontinuation of manufacturing, preparation, compounding, or processing any tobacco products for commercial distribution
        • Resumed manufacturing, preparation, compounding or processing any tobacco products previously listed as discontinued
  • How to Submit: Use the Tobacco Registration and Listing Module of FDA’s Unified Registration and Listing Systems (FURLS)
    If you are unable to register online, please mail
    • Form FDA 3741 (PDF) (for cigarettes, smokeless tobacco, and roll-your-own tobacco) or
    • Form 3741a (PDF) (newly-regulated finished tobacco products)
  • Guidance: Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments

Resources: 

If you do not submit, your products may be considered "misbranded" under federal law and therefore, subject to regulatory action, including seizure and injunction. Submission of false information is also punishable by criminal and civil law.

•    Who: Every domestic manufacturer and importer
•    When: 

•    Guidance: Listing of Ingredients in Tobacco Products (updated November 2018)
•    Resources: 

If you do not report, your products may be deemed "misbranded" under federal law and therefore, subject to regulatory action, including seizure and injunction. Submission of false information is also punishable by criminal and civil law.

*For cigars and pipe tobacco, FDA intends to comply with the court’s order in Cigar Ass’n of America v. FDA, No. 1:16-cv-01460 (D.D.C.) and will not enforce the warning statement requirements for cigars and pipe tobacco until 60 days after the final disposition of Plaintiffs’ appeal. In addition, the agency does not intend to enforce the labeling requirements under sections 903(a)(2) and 920(a) for cigars and pipe tobacco while the injunction remains in effect. Cigar and pipe tobacco firms, however, may add the warnings and make these labeling changes while the injunction remains in effect.

If you do not report, your products may be deemed "misbranded" under federal law and therefore, subject to regulatory action, including seizure and injunction. Submission of false information is also punishable by criminal and civil law.

You must submit an application and obtain FDA authorization before marketing a "new tobacco product." You must determine a pathway to market and follow our regulations on sale, use, and distribution.

  • Who: Every domestic manufacturer and importer with a product not commercially marketed in the United States as of Feb. 15, 2007.
  • When: 
  • The above timeframes are for FDA response after review of a marketing application.  If there are deficiencies preventing authorization, it may take longer.  FDA encourages applicants to review information needed to support issuance of a marketing order prior to submission.
    • August 8, 2021:* Compliance date  for "new" combustible deemed products such as cigars, hookah tobacco, and pipe tobacco, on the market as of August 8, 2016 using any of the above pathways to market.  
    • August 8, 2022:* Compliance date for "new " noncombustible deemed “finished tobacco products,” such as electronic nicotine delivery systems, dissolvables, and nicotine gels, on the market as of August 8, 2016 using any of the above pathways to market

*FDA published a draft guidance on March 13, 2019 that proposes modifications to the compliance policy for certain deemed tobacco products, which, if finalized, would change the compliance dates for submission of premarket applications for these products. Read Draft Guidance: Modifications to Compliance Policy for Certain Deemed Tobacco Products for more.

If you would like to market your product as having reduced risk or harm of tobacco related disease:


Small Business Assistance for Tobacco Product Industry
1-877-287-1373
(9am EST-4pm EST)
SmallBiz.Tobacco@fda.hhs.gov
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Questions?

 



1. The CTP Portal provides more functionality than the existing FDA Electronic Submissions Gateway, or ESG, WebTrader tool. CTP recommends using the CTP Portal. However, if you already have an ESG WebTrader account, you can still use it to submit documents to CTP.


Additional Resources