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.