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- How Do I Comply with FDA's Tobacco Regulations?
- When Do I Need to Comply with FDA's New Tobacco Regulations?
- Submit Online
- Compliance Webinars
Submit online to electronically upload regulatory documents, apply to market, and more.
Importers of finished tobacco products may be distributors, tobacco product manufacturers, or both. Importers who do not own or operate a domestic establishment engaged in the manufacture, preparation, compounding or processing of a tobacco product are not required to register their establishment or provide product listing. However, they must comply with all other applicable tobacco product manufacturer requirements.
Note: If you mix or prepare e-liquids, make or modify vaporizers, or mix loose tobacco, and you also sell these products, you may be regulated as both a retailer and a tobacco product manufacturer.
If you are a tobacco product manufacturer, then you must:
- Report user fee information.1
- Pay user fees.1
- Register your establishment and submit list of products, including labeling and advertisements.2
- Submit tobacco health documents.
- Submit ingredient listing.
- Apply to market your "new" tobacco product via one of three pathways.3
- Include required warning statements on packages and advertisements.
- Submit quantities of Harmful and Potentially Harmful Constituents.
- Submit a Modified Risk Tobacco Product application if you would like to market your product as having reduced risk or harm.
Compliance Date Updates:
- March 2019: Revised reporting compliance requirements for submission of Harmful and Potentially Harmful Constituents
- November 2018: Ingredient Listing Deadline Extended for Small-Scale Manufacturers and Importers Impacted by Recent Natural Disasters
- July/August 2018: Guidance: Compliance Policy for Certain Labeling and Warning Statement Requirements for Cigars and Pipe Tobacco
- November 2017: FDA extended the ingredient listing compliance deadlines for manufacturers and importers of deemed tobacco products to provide the same six month extension that previously only applied to those in certain natural disaster areas.
- August 2017: FDA published extended timelines to submit tobacco product review applications for regulated tobacco products that were on the market as of August 8, 2016.
- May 2017: FDA announced it was providing a three-month extension of all future compliance deadlines for requirements under the final deeming rule.
You must comply by these deadlines:
- Submit ingredient listing by
- May 8, 2018 for non-small-scale tobacco product manufacturers
- November 8, 2018 for "small scale tobacco product manufacturers," except small-scale manufacturers and importers impacted by recent natural disasters
- May 8, 2019 for "small scale tobacco product manufacturers" and importers impacted by recent natural disasters
(Products introduced after August 8, 2016, must submit ingredient listing 90 days before marketing.)
- Submit quantities of Harmful and Potentially Harmful Constituents by November 8, 2019.
- Submit a premarket application for "new" combustible tobacco products by August 8, 2021. (Deadline is based on whether or not the product is combustible—regardless of the pathway chosen (SE, Exemption Requests, or PMTA)).
- Submit a premarket application for "new" noncombustible tobacco products by August 8, 2022. (Deadline is based on whether or not the product is combustible—regardless of the pathway chosen (SE, Exemption Requests, or PMTA)).
- Stop distributing products with modified risk claims (other than "light," "low," or "mild") by August 8, 2016, unless you have a Modified Risk Tobacco Product order in place.
- Report user fee information for cigars and pipe tobacco by August 20, 2016, and monthly thereafter.4
- Pay user fees for cigars and pipe tobacco by December 31, 2016, and quarterly thereafter.4
- Submit tobacco health documents by:
- Submit cigar warning plans by August 10, 2017.
- Register your establishment and submit list of products, including labeling and advertisements, by October 12, 2017.5 (For products introduced after August 8, 2016, you must register and submit product listing immediately upon manufacturing.)
- Stop manufacturing products with modified risk claims, i.e., "light," "low," or "mild," or similar descriptors, unless you have a Modified Risk Tobacco Product order in place, by November 8, 2017. (Stop distributing these products into interstate commerce by December 8, 2017.)
- Submit tobacco health documents for "small scale tobacco product manufacturers" in certain natural disaster areas by May 8, 2018.
- Include required warning statements on packages and advertisements on "covered" tobacco products by August 10, 2018.7, 10
- For manufacturers of deemed finished products on the market as of August 8, 2016, who submitted initial registration and product listings by October 12, 2017:
- June 30, 2018: Update product listings
- December 31, 2018: Complete annual establishment registration
(For products introduced after August 8, 2016, you must register and submit product listing immediately upon manufacturing.)
Email FDA Form 3852 (PDF - 1.0 MB) to report user fee information.
Use FDA's Unified Registration and Listing Systems (FURLS) to register your establishment and submit product listings.
Submit other regulatory documents, except for user fees and registration and listing,8 to CTP electronically and securely using:
- FDA's eSubmitter software to package your documents and
- The CTP Portal9 to upload your eSubmitter package.
Additional Detail about Electronic Submissions
To assist users with greater detail on the electronic submissions process, FDA’s Center for Tobacco Products has created several reference documents:
- Overview of the Electronic Submissions Process for Industry. This document is a non-technical overview of the electronic submission process intended for industry representatives. It contains basic information about documents and data needed to successfully create and send a submission package.
- Electronic Submission File Formats and Specifications. This document will be most helpful to users with some previous knowledge of computer and information technology, but it also provides greater detail about file types and electronic submission standards for all tobacco product-related electronic submissions.
- Common Errors and Questions that Delay Submission Processing. Contains additional references related to electronic submissions to CTP, including confidentiality and trade secret policies as well as links to relevant FDA guidance documents.
If you are unable to submit online, you can mail to CTP's Document Control Center:
- a CD/DVD/flash drive containing your eSubmitter package or
- the following paper forms and supporting documentation (if you use eSubmitter, you do not have to mail paper forms)
- Form 3741 (PDF - 888 KB) - Establishment Registration and Product Listing
- Form 3741a (PDF - 987 KB) - Registration and Listing for Owners and Operators of Domestic Deemed Tobacco Product Establishments
Examples of Completed Registration and Product Listing Forms
- Cigarettes: Example Registration and Product Listing Form (PDF - 194 KB)
- Roll Your Own Tobacco: Example Registration and Product Listing Form (PDF - 134 KB)
- Smokeless Tobacco: Example Registration and Product Listing Form (PDF - 116 KB)
- E-Liquid: Example Registration and Product Listing Form(PDF - 20 KB)
- Cigars: Example Registration and Product Listing Form (PDF - 20 KB)
- Vape Pen: Example Registration and Product Listing Form (PDF - 20 KB)
- Form 3742 (PDF - 882 KB) - Listing of Ingredients in Tobacco Products
Learn more about how to Submit Ingredient Listing for Tobacco Products.
- Form 3743 (PDF - 784 KB) - Tobacco Health Document Submission
- Form 3787a (PDF - 1.5 MB) - Cigarette Report: Reporting of Harmful and Potentially Harmful Constituents
- Form 3787b (PDF - 900 KB) - Smokeless Tobacco Product Report: Reporting of Harmful and Potentially Harmful Constituents
- Form 3787c (PDF - 821 KB) - Roll Your Own Tobacco Product Report: Reporting of Harmful and Potentially Harmful Constituents
- Form 3852 (PDF - 1.0 MB) - User Fees: Report of Tobacco Product Removals Subject to Tax
Note: Submissions delivered by couriers or physical mail will be considered timely only if received by the CTP Document Control Center during delivery hours on or before the due date. If the due date falls on a weekend or holiday, the delivery must be received on the prior business day.
- FDA Regulation of Tobacco Products
- Requirements for Establishment Registration
- Registration Definitions FDA Intends to Use in Implementing the Establishment Registration and Product Listing Requirements
- Who Must Register With FDA?
- Common Issues With Registration
- Product Listing – Who Must Report to FDA?
- Registration and Product Listing – When to Submit?
- Biannual Updates of Product Listing
- What Information to Include for Establishment Registration
- Submitting Registration and Product Listing
- Examples of Who Must Register and List
- Additional Resources
Meeting with Office of Science (40:11)
- Contact us
- For small business assistance, contact our Office of Small Business Assistance.
- Request a meeting with CTP's Office of Science
- Also see our webinar on Meetings with the Office of Science.
1. Only domestic manufacturers and importers of cigarettes, snuff, chewing tobacco, roll-your-own tobacco, cigars, and pipe tobacco must report (monthly) and pay (quarterly) user fees.
2. Any domestic establishment engaged in manufacturing regulated tobacco products must register, and every registrant must file a list of its regulated tobacco products.
3. A "new tobacco product" is defined in in section 910(a)(1) of the Federal Food Drug & Cosmetic Act.
4. Domestic manufacturers and importers of cigar and pipe tobacco must begin reporting on August 20 and paying user fees on December 31. Only domestic manufacturers and importers of cigarettes, snuff, chewing tobacco, roll-your-own tobacco, cigars, and pipe tobacco must report (monthly) and pay (quarterly) user fees.
5. Any domestic establishment engaged in manufacturing regulated tobacco products must register, and every registrant must file a list of its regulated tobacco products.
6. Unless FDA has issued an order denying or refusing to accept the submission, products for which timely premarket applications have been submitted by the applicable compliance date identified above will be subject to a continued compliance period for 12 months after the initial compliance period. Once the continued compliance period ends, new tobacco products on the market without authorization will be subject to enforcement. Products entering the market after August 8, 2016 are not covered by the foregoing compliance policy and will be subject to enforcement if marketed without authorization after August 8, 2016.
7. A "covered tobacco product" is defined in the final rule, Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products.
8. To report user fee information, use Form 3852. To register your establishment and submit list of products, use FDA Unified Registration and Listing System (FURLS).
9. 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.
10. For cigars and pipe tobacco, please see: Compliance Policy for Certain Labeling and Warning Statement Requirements for Cigars and Pipe Tobacco .
- FDA's Tobacco 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 Newly Deemed Tobacco Products