FDA WARNING_LETTER - Life Unlearned, LLC - May 18, 2020

On May 19, 2020, the FDA and FTC issued a Warning Letter to www.lifeunlearned.com for promoting unapproved and misbranded vitamin D products with claims implying they can mitigate, prevent, treat, diagnose, or cure COVID-19. The website, participating in the Amazon Associates program, earns commissions by linking to these products.

The FDA determined these products are unapproved new drugs under section 505(a) and misbranded drugs under section 502 of the FD&C Act, violating sections 301(a), (d), and (k). Examples of violative claims include: "A recent analysis has shown that the severity of coronavirus patient outcomes is directly tied to the patient’s vitamin D status."

The letter demands immediate cessation of promoting such products and a response within 48 hours via email to COVID-19-Task-Force-CDER@fda.hhs.gov, detailing corrective actions and prevention measures. Failure to comply may result in legal action, including seizure and injunction. The firm will be added to FDA's public list of non-compliant firms.

The FTC also cited violations of the FTC Act, stating that claims of preventing, treating, or curing human disease require competent and reliable scientific evidence, which is lacking for COVID-19 related claims for these products. The FTC requires an email response within 48 hours to rcleland@ft