Tobacco Products

Manufacturing

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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.

How Do I Comply with FDA's Tobacco Regulations?

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

Note: If you mix or prepare e-liquids, make or modify vaporizers, or mix loose tobacco, and you also sell these products, you will be regulated as both a retailer and a tobacco product manufacturer.

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

FDA intends to limit enforcement of most of the requirements described below to e-cigarettes, cigars, and other newly-regulated "finished tobacco products." As such, you must comply by these deadlines:

2016

2017

2018

2019

 Submit Online

Use FDA’s Electronic Registration and Listing Systems (FURLS) to Register your Establishment and submit product listings.

Submit regulatory documents8 to CTP electronically and securely using:

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 - Establishment Registration and Product Listing
    • Form 3741a - Registration and Listing for Owners and Operators of Domestic Deemed Tobacco Product Establishments

      Examples of Completed Registration and Listing Forms
    • Form 3742 -  Listing of Ingredients in Tobacco Products
    • Form 3743 - Tobacco Health Document Submission
    • Form 3787a - Cigarette Report: Reporting of Harmful and Potentially Harmful Constituents
    • Form 3787b - Smokeless Tobacco Product Report: Reporting of Harmful and Potentially Harmful Constituents
    • Form 3787c- Roll Your Own Tobacco Product Report: Reporting of Harmful and Potentially Harmful Constituents
    • Form 3852 - 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?


Footnotes

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. Except for user fees and registration and listing: 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.

 


 

Page Last Updated: 09/14/2016
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