FDA WARNING_LETTER - Musthavemom.com - May 20, 2020

On May 26, 2020, the FDA and FTC issued a Warning Letter to www.musthavemom.com for promoting unapproved and misbranded products related to COVID-19. The website, participating in the Amazon Associates program, earned commissions by linking to colloidal silver, vitamins, minerals, herb oils, and a homeopathic drug product.

The FDA observed claims on the website implying these products could mitigate, prevent, treat, diagnose, or cure COVID-19. These claims cause the products to be unapproved new drugs under section 505(a) and misbranded drugs under section 502 of the FD&C Act. Introducing or delivering these products into interstate commerce is prohibited under sections 301(a) and (d), and misbranding after shipment is prohibited under 301(k).

The letter emphasizes the public health emergency declared for COVID-19 and the urgent need to protect consumers from unapproved products. The FDA requested immediate cessation of promoting and participating in the sale of such products. The website must review its materials to ensure no misleading claims are made.

Within 48 hours, the recipient must email COVID-19-Task-Force-CDER@fda.hhs.gov describing corrective actions, including steps to prevent recurrence and supporting documentation. Failure to comply may result in legal action, including seizure and injunction. The firm will be added to FDA's public list of