FDA Continues to Issue Warning Letters

The Food and Drug Administration has continued its onslaught of sending warning letters to retailers across the country. Specifically, the FDA regularly does compliance checks of retailers to test for Tobacco Control Act violations. If a warning letter is issued, the alleged violator has 15 days to respond. If the warning letter is not adequately address, the FDA can, and often takes further action to ensure compliance.

Under the relevant regulations, a warning letter from the FDA 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

Over the last month, the FDA has issued over 200 warning letters. If not dealt with properly, the retailer is in jeopardy of having formal enforcement proceedings against them. Such proceedings can result in large civil penalties and license revocation.

If you or your company receives a warning letter, it important to deal with accurately and timely. At tobacco tax refund, we are experienced in dealing with FDA matters such as warning and enforcement letters.

About the author: Mr. Donnini is the president and founder of Tobacco Tax Refunds, Inc. He is also multi-state sales and use tax attorney and an associate in the law firm Moffa, Sutton & Donnini, PA, based in Fort Lauderdale, Florida. Mr. Donnini has extensive knowledge handling wholesale tax controversy and refunds.

In his law practice Mr. Donnini's primary practice is multi-state sales and use tax as well as state corporate income tax controversy. Mr. Donnini also practices in the areas of federal tax controversy, federal estate planning, Florida probate, and all other state taxes including communication service tax, cigarette & tobacco tax, motor fuel tax, and Native American taxation. Mr. Donnini obtained his LL.M. in Taxation at NYU. Mr. Donnini is licensed to practice law in Florida. If you have any questions please do not hesitate to contact him via email [email protected] or phone at 954-639-4496.