FDA WARNING_LETTER - Medical Mikes, Inc. - January 06, 2023

On January 10, 2023, the FDA and FTC issued a Warning Letter to Medical Mikes (medicalmikes.com) for selling unapproved and misbranded cannabidiol (CBD) products claiming to mitigate, prevent, treat, diagnose, or cure COVID-19. This violates sections 505(a) and 502 of the FD&C Act, and sections 301(a) and (d) prohibiting introduction of unapproved/misbranded drugs into interstate commerce.

The agencies reviewed the website on December 7, 2022, and January 6, 2023, identifying claims like CBD boosting the immune system, preventing "Cytokine Storms," inhibiting COVID infection in human lung cells, and reducing viral infection loads. These claims establish the products' intended use as unapproved new drugs.

Medical Mikes must immediately cease selling these unapproved and unauthorized products. Within 48 hours, the company must email COVID-19-Task-Force-CDER@fda.hhs.gov detailing corrective actions, including steps to prevent recurrence and supporting documentation. Failure to comply may result in legal action, including seizure and injunction, and the firm will be added to FDA's public list of non-compliant companies.

The FTC also demands immediate cessation of unsubstantiated COVID-19 claims, citing violations of the FTC Act. Such violations can lead to injunction