FDA offers Small Business Assistance (to tell companies their products are banned)
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 (TCA).
OSBA answers questions from regulated industry, including small tobacco product manufacturers and retailers, consumers of regulated tobacco products, and the general public. OSBA responds to thousands of calls, emails, and correspondence every year and assists in answering specific questions about requirements of small businesses and how to comply with the law.
If you have questions about the TCA or compliance with FDA regulations and policies, please contact OSBA.
Is my product regulated by CTP?
In 2016, the FDA extended its authority to cover the following tobacco products: E-Cigarettes and all other Electronic Nicotine Delivery Systems (ENDS), Dissolvables, Pipe Tobacco, Hookah Tobacco, Cigars, as well as, Novel and Future Tobacco Products.
Since June 2009, the FDA has regulated the following tobacco products: Cigarettes, Roll-Your-Own Tobacco, and Smokeless Tobacco. Click here for more information about tobacco products regulated by CTP.
Requirements for Tobacco Product Manufacturers, Importers, Wholesalers, and Distributors
For the newly deemed products, FDA is limiting enforcement of most automatic provisions, examples of which are provided in the Topics Section below, that are provided in the Food, Drug & Cosmetic Act to only apply to finished tobacco products. Finished tobacco products refer to a tobacco product, including all components and parts, sealed in final packaging and intended for consumer use.
Additional Resources Regarding Newly Deemed Products:
- Notice to Industry: Additional Tobacco Products Now Regulated by the Food and Drug Administration
- Effective and Compliance Dates Applicable to Retailers, Manufacturers, Importers, and Distributors of Newly Deemed Tobacco Products
Topics in this Section
Read how to submit an application and obtain FDA authorization before marketing a “new tobacco product.”
Access information on the requirements and tools available for establishment registration and product listing of FDA regulated tobacco products.
Take a closer look at the process of submitting a list of ingredients.
Understand how to report quantities of harmful and potentially harmful constituents (HPHCs).
Access information about user fees from all domestic manufacturers and importers of cigarettes, snuff, chewing tobacco, roll-your-own tobacco, cigar, and pipe tobacco.