Tobacco Products

Small Business Assistance for Tobacco Products

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).

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

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

Is my product regulated by CTP?

Warning IconIn 2016, the FDA extended its authority to regulate all products that meet the definition of a tobacco product, including: 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.


Requirements for Tobacco Product Manufacturers, Importers, Wholesalers, and Distributors

For the newly-regulated products, FDA is limiting enforcement of most automatic provisions provided in the Food, Drug & Cosmetic Act, examples of which are listed in the Topics Section below, to only apply to "finished tobacco products."

When Do I Need To Comply?


Additional Resources Regarding Newly-Regulated Products:

Topics in this Section

Registration and Product Listing
Access information on the requirements and tools available for establishment registration and product listing of FDA regulated tobacco products.
User Fee Requirements
Access information about user fees from all domestic manufacturers and importers of cigarettes, snuff, chewing tobacco, roll-your-own tobacco, cigar, and pipe tobacco.
Ingredient Listing
Take a closer look at the process of submitting a list of ingredients.
Tobacco Health Documents
Find out how to submit tobacco health documents that "relate to health, toxicological, behavioral, or physiologic effects of current or future tobacco products, their constituents (including smoke constituents), ingredients, components, and additives."
Marketing a New Tobacco Product
Read how to submit an application and obtain FDA authorization before marketing a “new tobacco product.”
Reporting Quantities of HPHCs
Understand how to report quantities of harmful and potentially harmful constituents (HPHCs).

More OSBA Resources

Tobacco products imported or offered for import into the United States must comply with all applicable requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the Family Smoking Prevention and Tobacco Control Act. The Tobacco Control Act also requires FDA to report to Congress on the export of tobacco products that do not conform to U.S. tobacco product standards.

More information about importing and exporting tobacco products can be found here.

Wholesalers and distributors of tobacco products have responsibilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations as amended by the Family Smoking Prevention and Tobacco Control Act.

Restrictions on tobacco product manufacturers, retailers, and distributers include: prohibition of sponsorship of any athletic, musical, or other social or cultural event, or any team or entry in those events in a cigarette or smokeless tobacco brand name; and prohibition of the sale or distribution of items, such as hats and tee shirts, with cigarette and smokeless tobacco brands or logos.

More information about advertising and promotion of tobacco products can be found here.

Restrictions on certain tobacco products labeling include restrictions on tobacco products labeled or advertised with the terms “light,” “low,” “mild” or similar descriptors and requiring warnings on packages and advertisements of smokeless tobacco, cigarette tobacco, roll-your-own tobacco, and covered tobacco products.

More information about labeling of tobacco products can be found here.


 

 

Page Last Updated: 08/15/2017
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