Tobacco Products

Manufacturing


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FDA review and evaluation of tobacco product applications

Join the FDA on Oct 22-23, 2018, for a public meeting on tobacco product submissions to discuss the application submission and review process for tobacco products. Register by October 5, 2018 (extended). If you are unable to attend, you can submit comments online to docket FDA-2018-N-3504 by December 7, 2018.

The meeting seeks to improve public understanding of the policies and processes for tobacco product application review, including the general scientific principles behind various application pathways.

Submit Online

Submit online to electronically upload regulatory documents, apply to market, and more.

CTP Portal thumbnail

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 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.

How Do I Comply with FDA's Tobacco Regulations?

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

When Do I Need to Comply with FDA's New Tobacco Regulations?

Compliance Date Updates:

You must comply by these deadlines: 

2018

2019

2021

  • Submit a premarket application for "new" combustible tobacco products by August 8, 2021. (Revised deadline is based on whether or not the product is combustible—regardless of the pathway chosen (SE, Exemption from SE, or PMTA)).

2022

  • Submit a premarket application for "new" noncombustible tobacco products by August 8, 2022. (Revised deadline is based on whether or not the product is combustible—regardless of the pathway chosen (SE, Exemption from SE, or PMTA)).

2016

  • 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

2017

2018


Submit Online

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:

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:

If you are unable to submit online, you can mail to CTP's Document Control Center:

  • 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.


Compliance Webinars

 Watch additional compliance webinars.


Questions?


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 .


 

Page Last Updated: 09/25/2018
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