In a continuing effort by various federal and state agencies to stop COVID-19 related frauds, the FDA has implemented “Operation Quack Hack.” As such, the FDA has issued close to 50 warning letters, and estimates that it will issue hundreds more to a variety of companies. The warning letters allege fraudulent COVID-19 treatments and tests. FDA is working with online marketplaces, social media websites, domain name registers, and consumer reports to identify products ranging from unapproved drugs, colloidal silver, vitamin supplements, OTC hand sanitizers, herbal remedies, and CBD, among others. The warning letters typically offer a limited period of time for the companies to take corrective action. Companies unfamiliar with the FDA process often profess innocence but agree to comply with the FDA’s recommended corrective action.
Companies should be aware of the far-reaching implications of such letters as they represent more than just a “warning.” A warning letter is a predicate to the FDA enforcement process. Failure to appropriately respond to a warning letter may lead to substantial civil fines, TROs, injunction, seizure and/or criminal prosecution with criminal fines of $500,000 for corporations and $250,000 for individuals. While FDA has discretion whether or not to take further enforcement action (FDA Regulatory Process Manual (§ 4-11, April 2019) and such letters are labeled as “informal and advisory”, response to an FDA warning letter requires the skill of an experienced FDA attorney.
Warning letters are “publicly available” and posted on the FDA website. As such, a company must take the necessary steps to minimize reputational damage among its various stakeholders. A warning letter may affect the ability to obtain and keep government contracts and places the company squarely on FDA’s future radar. In addition, a warning letter may trigger the FTC and state regulatory authorities to begin their own enforcement over the issues FDA has identified. It is important to also note that judicial reliance on FDA statements made in warning letters often occurs, inferring label claims are unlawful.
How Frier Levitt Can Help
Our FDA attorneys, including multiple clinician attorneys, are well versed in the myriad of laws and regulations enforceable by the FDA. We assist clients in developing strategies to appropriately respond to FDA warning letters, including deadline extensions, compliance steps, corrective action plans, and business preservation.
Our multi-disciplinary team of attorneys can shepherd clients though the complex FDA process, particularly as it pertains to the applicable requirements for responding to warning letters. Contact Frier Levitt to speak with an attorney today.