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  1. Compliance, Enforcement & Training

Manufacturing

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, are regulated as 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:

When: Register your establishment and list your tobacco products immediately upon first engaging in manufacturing of any tobacco product, including deemed “finished tobacco products”, and then annually re-register thereafter by December 31. 

Certain changes1 to product listing must be reported by June 30 each year, or December 31 if after the June 30 submission date. 

When: Submit data required for FDA to calculate user fees by the 20th of each month; Pay quarterly by the last day of each fiscal year quarter.

A manufacturer or importer that does not pay a user fee by the date specified in section 919 or by the 30th day after final agency action on a resolution of any dispute as to the amount of such fee is in violation of section 919 of the FD&C Act, and thus under section 902(4) its products are adulterated.  Adulterated products are subject to regulatory action, including seizure and injunction.  Submission of false information is also punishable by criminal and civil law.  

When: 90 days prior to the delivery for introduction into interstate commerce: 

  • Tobacco products regulated prior to the final deeming rule (i.e., cigarettes, cigarette tobacco, smokeless tobacco, and roll-your-own tobacco) entering the market after June 22, 2009.
  • Tobacco products regulated by the final deeming rule and entering the market after August 8, 2016.

If you do not submit, 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.

When:

When: Six months from the publication date of a final guidance for manufacturers of deemed, “finished tobacco products; 9 months from the publication date of final guidance for small manufacturers of these products.

90 days prior to the delivery for introduction into interstate commerce for tobacco products regulated prior to the final deeming rule (i.e., cigarettes, cigarette tobacco, smokeless tobacco, and roll-your-own tobacco) and those entering the market after publication date of final guidance.

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.

When: 90 days prior to the delivery for introduction into interstate commerce.

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.

When: Before distributing or displaying required warnings on packages and advertisements submit a new warning plan or supplement to an FDA-approved warning plan for a new brand OR before making changes to the distribution or display of warnings on packages or rotation of warnings in advertisements (see warning plan guidance documents for cigars and smokeless tobacco). 

When: Currently in effect for tobacco products that are marketed or distributed in the U.S. 

When: Any time a tobacco product will be introduced into interstate commerce with a label of “modified risk.” Product must also have a marketing order under section 911(g) of the FD&C Act. 

Importers and the import trade community – for additional information on importing tobacco products, including information on filing an entry, please refer to the following resources: 

Additional Resources


1. 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.
2. The United States District Court for the District of Columbia recently issued an order vacating the health warning requirements for cigars and pipe tobacco set forth in 21 CFR §§ 1143.3 and 1143.5 and remanding the Final Deeming Rule’s warning requirements for cigars and pipe tobacco back to the Agency. See Order, Cigar Ass’n of Am. v. U.S. Food & Drug Admin., No. 1:16-cv-01460 (D.D.C. September 11, 2020). Although the requirement has been vacated, cigar and pipe tobacco firms may choose to voluntarily comply with these health warning provisions. FDA will continue to enforce the other requirements it was already enforcing for cigars and pipe tobacco under the FD&C Act and its implementing regulations, such as not selling these products to individuals under 21 years of age or marketing them as modified risk tobacco products without an FDA order.
3. 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.
4. FDA encourages people to meet with FDA early in their process of developing an MRTP to discuss application submission and investigational requirements and recommendations.
5. The CTP Office of Science encourages early consultation by individuals intending to submit electronically, especially those making an electronic submission for the first time as this can facilitate a smooth process. This can be part of a pre-application meeting requested under Guidance for Industry and Investigators: Meetings with Industry and Investigators on the Research and Development of Tobacco Products. Individuals are expected to consult with the intended agency receiving unit for details on how (e.g., method of transmission, media, file formats, technical protocols) and whether to proceed with the eSubmission (Electronic Records; Electronic Signatures [21 CFR section 11.2(b)(2)].


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