Tobacco Products

Small Business Assistance for Tobacco Product Industry

The Center for Tobacco Products (CTP) Office of Small Business Assistance (OSBA) provides technical and other nonfinancial assistance to small tobacco product manufacturers to help them and other small businesses to comply with the requirements of the Tobacco Control Act and its policies and regulations.

Submit comments on FDA review and evaluation of tobacco product applications

The FDA held a public meeting on “Tobacco Product Application Review” in October 2018. In addition to the public meeting, FDA opened a docket to receive feedback and comments on all aspects of the product review process. Submit comments online to docket FDA-2018-N-3504 through December 7, 2018.

How Do I Comply?

 

*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

Other requirements for tobacco products


Questions & Answers

  1. I am a vape shop with hundreds of different e-liquids. Do I need to submit an application for each flavor/ingredient variant or nicotine strength? Can I bundle similar products into one, or just a few, applications?
  2. What is the "registration and product listing" process and timeframe to comply?
  3. What are the costs associated with submitting an application?
  4. Who has to pay user fees and what are the deadlines?
  5. How can a vape shop be considered a manufacturer?

Read more commonly asked questions and answers.


Contact Small Business Assistance

We answer questions from regulated industry, including small tobacco product manufacturers, importers, and retailers. We respond to thousands of calls, emails, and correspondence every year to assist in answering specific questions about the requirements of small businesses and how to comply with the law.

If you have any questions about the Tobacco Control Act or compliance with FDA regulations and policies, please contact us.

1-877-287-1373
(9am EST-4pm EST)

Tobacco-Small Business (SmallBiz.Tobacco@fda.hhs.gov)

 

 

Page Last Updated: 10/29/2018
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English