FDA vigorously enforces the Tobacco Control Act (TCA), which provides FDA with a wide array of powerful regulatory tools to protect the health of all American families.

Compliance and Enforcement

FDA closely monitors retailer, manufacturer, importer, and distributor compliance with Federal tobacco laws and regulations and takes corrective action when violations occur. 

FDA takes a 3-pronged approach to help industry comply with the law by:

• developing and providing compliance training and education
• monitoring regulated industry's compliance with the law through surveillance, inspections, and investigations
• taking action when necessary, including:
  • Warning Letters
  • Civil Money Penalty (CMP) Complaints
  • No-Tobacco-Sale Order (NTSO) Complaints
  • Seizures, Injunctions, and Criminal Prosecution

Helping Retailers Comply with FDA Regulations

Retailers play an important role in protecting the health of young people by following the law and refusing to sell regulated tobacco products to anyone under the age of 18. Find more information on our website, including:

• Retailer Education Materials
• Regulations & Guidance for Retailers
• Tobacco Retail Compliance Webinars
• Retailer Training and Enforcement
• Overview of Federal Laws and Regulations
• Misbranded and Adulterated NSE Tobacco Products

Manufacturer, Distributor, and Importer Compliance

To legally sell a new FDA-regulated tobacco product in the United States, you must receive a written order from FDA permitting the sale of a new tobacco product under one of three pathways to market.

In addition, any products marketed with modified risk claims must have an FDA order in effect that permits such sale or distribution.

If your product is found to be Not Substantially Equivalent (NSE), it is illegal to sell or distribute the product in interstate commerce and to import the product into the United States.

Manufacturers may not distribute any smokeless tobacco product without a required warning statement for every smokeless tobacco package and advertisement.

If you are found in violation of FDA rules and regulations, your product will be considered "misbranded" and/or "adulterated," making it illegal to sell or distribute the product in interstate commerce and to import the product into the United States. Doing so may result in FDA initiating regulatory action (e.g., seizures, injunctions).

FDA restricts the way tobacco manufacturers, retailers, and distributers can advertise and regulated tobacco products, especially marketing efforts designed to appeal to youth.

Additional Resources

• Electronic Submissions for Tobacco Products
• Reports to Congress
• Inspection database
• Establishment Registration and Tobacco Product Listing database