Tobacco Retailer Warning Letter

Tobacco Retailer Warning Letter

Center for Tobacco Issues More Warning Letters than Any Other Center

Tobacco retailer warning letters are surprisingly active area of FDA regulation. In 2014 the FDA issued 8,220 tobacco retailer warning letters. This surpassed the 470 warning letters issued to device, drug, food, supplement, pet, and cosmetic companies combined. An active area of regulation requires careful attention.

Tobacco retailer warning letters also require a strategic response. The volume of tobacco retailer warning letters indicates a strict application of the  Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) and its regulations in effect, such as the Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents, found at Title 21 of the Code of Federal Regulations, Part 1140 (21 C.F.R. Part 1140).

Tobacco Retailer Warning Letter Can Result in Civil Money Penalties

The FDA’s 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. This effort to avoid CMP underscores the need for the right response.

The right response is:

  • Timely – only 15 days for initial response;
  • Professional – avoid anger, Constitutional issues like free speech, or accusations about the legality of the tobacco retailer warning letter;
  • Detailed – the reply should address every concern raised and cite appropriately to the regulations;
  • Corrective – part of the detail should be a comprehensive plan of action to correct violations.

Following the above outline provides a strong basis to respond to a tobacco retailer warning letter. Please call or Washington D.C. or Charlotte offices if you would like a complimentary consultation for your tobacco retailer warning letter.