The United States District Court has granted FDA’s request for an extension of the premarket review submission deadline for certain tobacco products, which FDA requested due to the COVID-19 pandemic. Applications are now required to be filed by Sept. 9, 2020 for many e-cigarettes, cigars and other deemed tobacco products.
FDA has compiled information and resources to assist with submission of premarket review applications.
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 Listing Module of FDA’s Unified Registration and Listing Systems (FURLS)
If you are unable to register online, please mail
- Guidance: Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments
- Database of registered establishments and listed products
- Webinar: Tobacco Product Listing Updates
- Webinar: Using the Tobacco Registration and Listing Module of FURLS - Tips and Recent Enhancements (21:07)
- Example completed registration and listing forms
- Feature: Upcoming Tobacco Product Listing Deadline—June 30: 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
- 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:
- Guidance: Listing of Ingredients in Tobacco Products (updated November 2018)
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.
- Aug. 8, 2021* "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.
- Aug. 8, 2022* "New" noncombustible deemed “finished tobacco products,” such as electronic nicotine delivery systems, dissolvables, and nicotine gels, on the market as of August 8, 2016
- All others:3
- 180 days prior to introduction into interstate commerce: New tobacco products submitted via Premarket Tobacco Application (PMTA)
- 90 days prior to introduction into interstate commerce: New tobacco products submitted for substantial equivalence (SE) review via an SE Report
- 60 days prior to introduction into interstate commerce: New tobacco product submitted with a request for exemption from substantial equivalence
*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.
- Who: Every domestic manufacturer and importer with a product not commercially marketed in the United States as of Feb. 15, 2007 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.
- How to Submit:
- Guidances and Rules:
- Guidance: Compliance with Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents
- Guidance: Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule
- Rule: Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products
- Rule: Refuse to Accept Procedures for Premarket Tobacco Product Submissions
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:
- Guidance: Health Document Submission Requirements for Tobacco Products
- 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:
- 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
- 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
- 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:
- Draft Guidance: Modified Risk Tobacco Product Applications
- Small Business Assistance for Tobacco Product Industry
(9am EST-4pm EST)
- Contact CTP
- Request a meeting with CTP's Office of Science5 or see our webinar on Meetings with the Office of Science.
- Electronic Submissions for Tobacco Products
- 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. 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.
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)].