• Deanna Clark-Esposito

Responding to an FDA “Warning Letter” in 5 Steps


There has been a lot of buzz in the news lately about the US Food and Drug Administration (FDA) issue warning letters to vape and tobacco products retailers. You should know that whether as a vape or 'tobacco products' importer or retailer, or a seller of a CBD product, when the FDA sends you a Warning Letter it means that immediate action must be taken to cease doing the activity or activities cited in the letter.

Whatever you do, don't ignore the letter and hope FDA will go away. It won't!

Rather, take the following set of steps to prepare an organized response and return the information within the timeframes allotted.

Step 1: Conduct an internal investigation to determine the cause(s) of the violation(s)

Step 2: Take action to prevent these violations (and others) from happening again

Step 3: Prepare a letter to the FDA explaining the specific steps you have taken to correct the violations, and include copies of any related documentation to support this position

Step 4: Where unable to take corrective action within 15 working days (or such other timeframe you're provided), send FDA a letter explaining why there is a delay and the time within which you will complete the correction

Step 5: Whether in relation to the complete explanatory letter or the one requesting additional time, send FDA your letter before the deadline and obtain a delivery confirmation from your mail carrier so you have proof of FDA’s receipt of your letter for your own records

Typically the FDA will indicate in the Warning Letter that the listed violations are not intended to be an all-inclusive list of violations against the company. Therefore, in your response ask if any additional violations have been identified, or if not, confirm that no others are pending at this time.


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