FDA WARNING_LETTER - earthley wellness - April 09, 2020

On April 9, 2020, the FDA and FTC issued a Warning Letter to Earthley and Modern Alternative Mama regarding the sale of unapproved and misbranded products claiming to mitigate, prevent, treat, diagnose, or cure COVID-19. The agencies reviewed websites (https://earthley.com, https://modernalternativemama.com) and social media (www.facebook.com/pg/earthley) on April 2 and April 8, 2020.

The FDA determined that the herbal tinctures and remedies offered are unapproved new drugs, violating section 505(a) of the FD&C Act (21 U.S.C. § 355(a)), and are misbranded drugs under section 502 (21 U.S.C. § 352). The introduction of these products into interstate commerce is prohibited by sections 301(a) and (d) (21 U.S.C. § 331(a) and (d)). The letter emphasizes the public health emergency declared for COVID-19.

The FTC also cited violations of the FTC Act (15 U.S.C. 41 et seq.) for advertising products to prevent, treat, or cure human disease without competent and reliable scientific evidence, specifically noting the lack of such studies for COVID-19 related claims.

The company must