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U.S. Department of Health and Human Services

Tobacco Products

Overview: Tobacco Retailer Warning Letters





The Food and Drug Administration (FDA), Center for Tobacco Products (CTP), generally sends Warning Letters to retailers the first time a tobacco compliance check inspection reveals a violation of the federal tobacco laws and regulations that FDA enforces. Failure to promptly and adequately correct all violations and ensure compliance with all applicable laws and regulations may lead to enforcement actions, including Civil Money Penalties. We post all Warning Letters online at http://go.usa.gov/Ebd (case sensitive).

The Warning Letter includes:

  • References to relevant laws and regulations
  • The date the store was inspected, and if a sale was made, the approximate time
  • The particular violation(s) inspectors observed and an explanation of the evidence used to support the violation(s)
  • A statement directing the retailer to correct the violation(s)
  • Notice that enforcement action may come without further notice if violations are observed in the future
  • A request to submit a written response to FDA within (15) working days of receiving the Warning Letter


What should you do if you receive a Warning Letter?   

  • Review the letter carefully to see what charges are listed.
  • Contact CTP if you would like more information. The Warning Letter includes contact information.
  • Respond in writing to the Warning Letter within 15 working days by mail or email. Include the following in your response to the Warning Letter:
    • An explanation of the steps you will take to correct the violation(s) and prevent future violations (for example, retrain your employees, remove the problematic items, etc.); and
    • Your current contact information including telephone number and email address.
  • Promptly and adequately correct the violations listed and be sure that you comply with all applicable laws and regulations.


Federal law requires tobacco retailers to, among other things:

  • Check photo ID of everyone appearing under age 27 who attempts to purchase cigarettes, cigarette tobacco, or smokeless tobacco.
  • Only sell cigarettes, cigarette tobacco, and smokeless tobacco to anyone age 18 or older.
  • Only sell cigarettes, cigarette tobacco, and smokeless tobacco in a direct, face-to-face exchange.
  • Do NOT give away free samples of cigarettes.
  • Do NOT break open cigarette or smokeless tobacco packages to sell products in smaller amounts.
  • Do NOT sell cigarette packages containing fewer than 20 cigarettes.
  • Do NOT sell single cigarettes, also called “loosies.”
  • Do NOT give away free samples of smokeless tobacco except from a “qualified adult-only facility.”
  • Do NOT sell flavored cigarettes or flavored cigarette tobacco (other than menthol).


For further information about the laws and regulations that apply to tobacco retailers, contact us at:

Food and Drug Administration
Center for Tobacco Products
9200 Corporate Boulevard
Rockville, MD 20850-3229
Visit www.fda.gov/breakthechain for more resources.