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There’s been a lot of news on recent issuances of US Food and Drug Administration (FDA) Warning Letters. Nearly all of them are claiming that the products a company is being “warned” about are not being lawfully sold due to their not being authorized for sale by the FDA through the premarket tobacco product application process, known as a “PMTA.” The result? FDA wants these products pulled from the shelves and that all sales of them cease. This new aggressive policy has resulted in over 15 million products being pulled from shelves in August alone.
This can occur as a product had not been permitted to remain for sale in the US market following last year’s PMTA application deadline. It can also occur, and we will see more instances of this in the future, due to a product’s continued sales in cases where the FDA concluded that a company’s PMTA was considered incomplete.
In fact, we are already seeing decisions made by the agency in relation to PMTAs that are considered insufficient in substance (i.e., the contents of the application), and therefore the agency refuses to allow the application to proceed through the review process. For example, on August 9, 2021, FDA published an announcement that 4.5 million product types were in need of immediate removal from store shelves due to their PMTA not being sufficient as a result of it not having included an Environmental Assessment in its application. I probably don’t need to say it, but man is that a lot of products!
5 Steps for Dealing With an FDA Warning Letter
When 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. Alternatively, you can present information and other evidence as to why sales of the merchandise is permissible. 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) and whether or not you believe a reason exists as to why the product(s) may lawfully be sold. It may be the case where you believe some should not be and others may be sold. Step 2: Take action to prevent these violations (and others) from happening again, if you believe violations did occur. 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. Alternatively, draft a letter to state why you believe such products may, in fact, be lawfully sold. 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 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.
We recommend seeking professional assistance when responding to a Warning Letter to help you with determining the legality of the merchandise at issue and to truncate risk. This is because you want to be thorough in your response without saying more than you need to. Learn more about Warning Letters and other FDA matters on our website at www.clarkespositolaw.com. Have questions? Call us at 917-546-6997 or email us at contact@clarkespositolaw.com.