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The Tobacco Control Act and related regulations give FDA tools to help keep tobacco out of the hands of America’s youth. But you also have an opportunity to play a key role. The public is crucial in helping FDA enforce tobacco regulations to protect America’s youth. 

What Is a Potential Tobacco Product Violation?

Potential tobacco product violations include (but are not limited to):

• Sales to underage purchasers
• Flavored cigarette sales
• Illegal marketing and advertising – The Tobacco Control Act gives the FDA the ability to regulate certain marketing and advertising activities by the tobacco industry, including:
  • Describing tobacco products as “light,” “mild,” or “low” – or claiming a product is safer or less harmful without an FDA order
  • Distributing t-shirts or other promotional or novelty items with brand names of cigarette or smokeless tobacco products 
  • Sponsoring events using the brand name of a tobacco product
• Distribution of free samples of tobacco products except in limited circumstances
• Placement of cigarette or smokeless tobacco product vending machines in prohibited areas (or providing access to self-service or direct access of tobacco products in prohibited areas)
• Sale of cigarettes in packages of less than 20
• Manufacture or sale of unauthorized tobacco products

How Can I Report a Potential Tobacco Violation?

If you see what you believe to be a violation of the Tobacco Control Act or other related regulations, you can:

• Submit online: Potential Tobacco Product Violations Reporting - Form FDA 3779
• Call the Tobacco Call Center using CTP's toll-free number: 1.877.CTP.1373
• Send an email: CTPCompliance@FDA.hhs.gov
• Print and mail:
  
  Paper form to
  
  Potential Tobacco Products Violation Report
  Food and Drug Administration
  Center for Tobacco Products
  Office of Compliance and Enforcement
  Document Control Center
  Building 71, Room G335
  10903 New Hampshire Avenue
  Silver Spring, MD 20993

What Happens When I Submit a Potential Violation?

FDA will evaluate any report submitted to determine if the activity is a violation of the Tobacco Control Act or related regulations. Before deciding what follow-up action, if any, is necessary, we will check to see if the product named in the complaint is regulated by FDA. If the product is regulated by a different federal or state agency, or different part of FDA, we will forward the complaint to the applicable entity for review.

FDA does not rely solely on what was submitted to take enforcement action. After reviewing a complaint, our investigation may include:

• Performing an inspection of a tobacco product manufacturer, distributor, or importer;
• Conducting a compliance check inspection of a tobacco retailer; or
• Initiating monitoring and surveillance of a tobacco product manufacturer’s or retailer’s website.

FDA may determine that there is no evidence of a violation, or we may find evidence of the reported violation or of other potential violations that requires additional surveillance, monitoring, and/or inspections.

Privacy and Anonymity

All reports to FDA remain private to the extent allowed by law as explained in FDA’s Privacy Policy. Reports can be submitted anonymously; however, reports accompanied by names and contact information are helpful if FDA regulators need to follow-up for more information.

Children's Privacy: FDA will not collect or store information from children under 13. If a child sends us an email inquiry or comment, we will answer it and then delete the email from our files.