As a manufacturer, importer or retailer of tobacco or CBD products, should you receive an FDA Warning Letter, do not ignore it. FDA Warning Letters should be addressed within the timeframe indicated in the notice. We have included some basic guidance in responding to FDA Warning Letters below -
1. Conduct an internal investigation to determine the cause(s) of the violation(s). 2. Take action to prevent these violations (and others) from happening again. 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. 4. Where unable to take corrective action within 15 working days (or such other timeframe FDA has indicated), send the FDA a letter explaining why there is a delay and provide the time within which you will complete the correction. 5. In either case, ensure that your letter to the FDA will arrive before the deadline indicated on the warning letter and obtain delivery confirmation from the mail carrier so that you have a record of delivery for your records. It is important to note that FDA Warning Letters are not intended as exhaustive lists of potential violations by your company - in your response, you should ask FDA whether any additional violations have been identified or whether other violations are currently pending. You can read more about addressing FDA Warning Letters on the Clark-Esposito Law Firm, P.C. website by clicking below. You can also reach out directly at email@example.com for assistance with all tobacco and CBD matters.