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FDA Retail Tobacco Compliance Program

The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) became law on June 22, 2009. It gives the Food and Drug Administration (FDA) the authority to regulate the manufacture, distribution, and marketing of tobacco products to protect public health.

The Tobacco Control Act:  

  • Recognizes that virtually all new users of tobacco products are under 18—the minimum legal age to purchase these products. Many new users will become addicted before they are old enough to understand the risks and ultimately may die too young of tobacco-related diseases. The Tobacco Control Act seeks to, among other things, prevent and reduce tobacco use by young people.
  • Recognizes that tobacco products are legal products available for adult use, prohibits false or misleading labeling and advertising for tobacco products and provides the tobacco industry with several mechanisms to submit an application to FDA for new products or tobacco products with modified risk claims.
  • Gives FDA enforcement authority as well as a broad set of sanctions for violations of the law and directs FDA to contract with states to assist FDA with retailer inspections.

This overview highlights some of the provisions of the Tobacco Control Act and is not intended to be a comprehensive guide or to reflect FDA's interpretation of the Tobacco Control Act.

About the FDA's Center for Tobacco Products

The Center for Tobacco Products (CTP) oversees the implementation of the Family Smoking Prevention and Tobacco Control Act. Some of the Agency's responsibilities under the law include setting performance standards, reviewing premarket applications for new and modified risk tobacco products, requiring new warning labels, and establishing and enforcing advertising and promotion restrictions.

The Division of Tobacco Prevention and Control

In response to this Act, the FDA issued a Funding Opportunity Announcement for state Tobacco Enforcement programs to conduct FDA Tobacco Compliance Check Inspections for compliance with provisions of these regulations with respect to retail outlets on behalf of the FDA.  Funds under this contract supplement state tobacco enforcement funds and are restricted, by statute, for use only for the FDA tobacco inspection efforts. The Division of Tobacco Prevention and Control (Division) was awarded the first FDA contract in 2011.  Through the FDA awards, Pennsylvania received funding to conduct approximately 10,000 Tobacco Compliance Check Inspections across the commonwealth per year. 

FDA State Tobacco Compliance Check Inspection Results

Compliance Check Inspections results of Pennsylvania tobacco product retailers, to include, warning letters and civil money penalties are displayed on FDA's website at http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm232109.htm

If you witness a retailer selling tobacco to a minor (less than 18 years of age) or other unlawful sales practices, please report it to the FDA.

Report a Potential Tobacco Violation

Examples of Potential Tobacco Product Violations You Can Report to the FDA

Reports can be submitted anonymously; however, reports accompanied by names and contact information are helpful in cases when FDA needs to follow up for more information.  The Potential Tobacco Product Violations Form provides an opportunity for the public and other stakeholders to report a variety of potential tobacco product violations that include, but are not limited to:

  • Sales to minors
  • Flavored cigarette sales
  • Advertising/promotion/marketing restrictions (e.g., Describing the tobacco product as "light," "mild," or "low" or claiming that the product is safer or less harmful without an FDA order in effect; distributing t-shirts or other novelty items with the brand name of a cigarette or smokeless tobacco product; and event sponsorship in the brand name of a cigarette or smokeless tobacco product)
  • Free samples
  • Vending machines in prohibited areas/self-service display/direct access to cigarette or smokeless tobacco
  • Sale of cigarettes in packs of less than 20

Potential Tobacco Product Violations Reporting

Submit a FDA complaint Form 3779 online.

Always Comply with Tobacco Sale ID Requirements

All tobacco retailers and retail employees must follow FDA's age and ID requirements when selling regulated tobacco products. It's hard not to be tempted by peer pressure from friends or co-workers. But, by following the regulations, such as not selling to anyone under the age of 18, you can help protect minors from the dangers of tobacco addiction.

Impersonal Modes of Tobacco Sales

Retailers must sell regulated tobacco in a direct, face-to-face exchange – unless the tobacco products are being sold in a location where no minors are present or permitted to enter at any time.

It becomes easier for minors to access regulated tobacco products if they are available via self-service displays and vending machines. But FDA's regulations are designed to stop kids from obtaining tobacco. Watch the video below to learn more about regulations related to impersonal modes of tobacco sales.

FDA's Age and ID Requirements for Sales of Regulated Tobacco

FDA's tobacco compliance and enforcement program includes inspecting tobacco retailers to make sure they are not selling regulated tobacco products to anyone under the age of 18, and that they are checking IDs to verify the age of customers under the age of 27. The sale of tobacco products to minors is the most commonly observed violation during inspections of retail stores.

Retailers can follow FDA's age and ID rules by following these steps:

  1. Request photo ID from customers under the age of 27
  2. Verify the customer's age using the photo ID
  3. Verify that the appearance of the customer matches the physical description and photo on the ID

For more information, please contact:

Pennsylvania Department of Health
Bureau of Health Promotion and Risk Reduction
Division of Tobacco Prevention and Control
625 Forster Street, Room 1032 Health and Welfare Building
Harrisburg, PA 17120
(717) 783-6600