Manufacturing
Note: In April 2021, FDA announced its plans to propose tobacco product standards within the next year to ban menthol as a characterizing flavor in cigarettes and ban all characterizing flavors (including menthol) in cigars. Read more.
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.
- Who: Every person who owns or operates any domestic establishment engaged in manufacturing tobacco products.
- Submit: Use the Tobacco Registration and Product Listing Module Next Generation (TRLM NG) application.
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:
- Database of registered establishments and listed products
- Webinar: Tobacco Product Listing Updates
- Example completed registration and listing forms
- Cigarettes (PDF - 194 KB)
- Roll Your Own Tobacco (PDF - 134 KB)
- Smokeless Tobacco (PDF - 116 KB)
- E-Liquid (PDF - 20 KB)
- Cigars (PDF - 20 KB)
- ENDS (PDF - 20 KB)
- Feature: The Biannual Tobacco Product Listing Deadline: What Does the Deadline Mean to You and How is FDA Helping You Comply?
- Who: Domestic manufacturers and importers of cigarettes, snuff, chewing tobacco, roll-your-own tobacco, cigars, and pipe tobacco.
Does NOT apply to: Manufacturers of electronic nicotine delivery systems (such as vaporizers or e-cigarettes), dissolvables or nicotine gels. - Report User Fee Information
- Submit FDA Form 3852 and copies of supporting documents via email to [email protected] or via mail (there is no online submission form)
- Pay User Fees
- Pay online via the iReceivable system (requires Invoice Number and amount owed to create an iReceivable account);
- ACH Wire Transfer payment to the U.S. Department of Treasury, as noted on your invoice;
- Check to FDA, as noted on your invoice.
- Additional Information
- Guidance: Small Entity Compliance Guide: Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products
- Rule: Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Cigars and Pipe Tobacco
- Resource: Tobacco User Fee Assessment Formulation by Product Class
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.
- Who: Every domestic manufacturer and importer
- How to Submit:
- Use Electronic Submissions for Tobacco Products.
- If you are unable to submit online, mail submissions to CTP’s Document Control Center, using FDA Form 3742 (PDF). (See example forms in the Resources below.)
- Guidance: Listing of Ingredients in Tobacco Products (updated November 2018)
- Resource:
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.
- 180 days prior to proposed introduction into interstate commerce: New tobacco products submitted via Premarket Tobacco Application (PMTA)
- 90 days prior to proposed introduction into interstate commerce: New tobacco products submitted for substantial equivalence (SE) review via an SE Report
- 60 days prior to proposed introduction into interstate commerce: New tobacco product submitted with a request for exemption from substantial equivalence
- Who: Every domestic manufacturer and importer with a product not commercially marketed in the United States as of February 15, 2007 must submit an application and obtain FDA authorization before marketing a "new tobacco product." You must determine a pathway to market and comply with FDA’s regulations regarding sale, use, and distribute.
- How to Submit:
- Use Electronic Submissions for Tobacco Products.
- If you are unable to submit online, please mail submissions to CTP’s Document Control Center.
- Resources:
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.
- Who: All domestic tobacco product manufacturers, importers, and distributors
- How to Submit:
- Use Electronic Submissions for Tobacco Products.
- If you are unable to submit online, mail submissions to CTP’s Document Control Center, using the correct form for your tobacco type:
- Draft Guidance: Reporting of Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke, including the list of 20 HPHCs
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.
- Who: Domestic manufacturers and importers of current and future “finished tobacco products” with respect to documents developed between June 23, 2009 and December 31, 2009
- How to Submit:
- Use Electronic Submissions for Tobacco Products.
- If you are unable to submit online, mail submissions to CTP’s Document Control Center, using FDA Form 3743 (PDF).
- Guidance: Health Document Submission Requirements for Tobacco Products
- Resources:
- Tobacco Health Documents: Technical Working Specifications (PDF - 111KB)
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).
- Who: All domestic tobacco product manufacturers, importers, distributors, or retailers, as applicable, of cigars and smokeless tobacco products.
- How to Submit:
- Use Electronic Submissions for Tobacco Products.
- If you are unable to submit online, mail submissions to CTP’s Document Control Center.
- Guidance: Submission of Warning Plans for Cigars
- Draft Guidance: Submission of Warning Plans for Smokeless Tobacco
- Webinar: Cigar Warnings and Warning Plan Requirements
When: Currently in effect for tobacco products that are marketed or distributed in the U.S.
- Who: All domestic tobacco product manufacturers, importers, distributors, and retailers, as applicable.2
- Guidances:
- Compliance Policy for Certain Labeling and Warning Statement Requirements for Cigars and Pipe Tobacco
- Compliance Policy for Required Warning Statements on Small-Packaged Cigars
- Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops
- FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements
- Resource:
- Labeling and Warning Statements for Tobacco Products, including specific requirements by product
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.
- Who: All domestic tobacco product manufacturers, importers, and distributors who would like to sell or distribute a “modified risk tobacco product” i.e. any tobacco product sold or distributed for use to reduce harm or reduce the risk of tobacco-related disease that is associated with commercially marketed tobacco products.4
- How to Submit:
- Use Electronic Submissions for Tobacco Products.
- If you are unable to submit online, mail submissions to CTP’s Document Control Center.
- Draft Guidance: Modified Risk Tobacco Product Applications
- Resources:
- Small Business Assistance for Tobacco Product Industry
1-877-287-1373
(9am - 4pm ET) - [email protected]
- Contact CTP
- Request a meeting with CTP's Office of Science5 or see our webinar on Meetings with the Office of Science.
Additional Resources
- Electronic Submissions for Tobacco Products
- Tobacco Registration and Listing – Next Generation (TRLM NG) Instructions
- FDA's Deeming Regulations for E-Cigarettes, Cigars, and All Other Tobacco Products
- CTP Glossary
- Effective and Compliance Dates Applicable to Retailers, Manufacturers, Importers, and Distributors of Deemed Tobacco Products
- Tobacco Compliance Webinars
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)].