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.
Is my product regulated by CTP?
In 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?
- Requirements for all tobacco product manufacturers
- Effective and Compliance Dates Applicable to Retailers, Manufacturers, Importers, and Distributors of Newly-Regulated Tobacco Products
Additional Resources Regarding Newly-Regulated Products:
Topics in this Section
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.
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.
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.
Contact Small Business Assistance
(9am EST-4pm EST)
Additional Contact Information
- Small Entity Compliance Guide: FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements
- Small Entity Compliance Guide: Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products
- FDA's New Regulations for E-Cigarettes, Cigars, and All Other Tobacco Products
- Submit a comment to the FDA
- Guidance documents for manufacturers and retailers
FDA Tobacco Compliance Webinars Letters to Industry
- Connect with CTP: email updates, blogs, social media
Retailer Overview of FDA Regulations for Selling Tobacco Products
- Retail Information: Education Materials
Reports to Congress Manufacturing