FDA WARNING_LETTER - organic-beauty-recipes.com - June 03, 2020

On June 8, 2020, the FDA and FTC issued a Warning Letter to www.organic-beauty-recipes.com for promoting unapproved and misbranded products related to COVID-19. The website, an Amazon Associate, earned commissions by promoting essential oil products with claims implying they could mitigate, prevent, treat, diagnose, or cure COVID-19.

These claims caused the product to be an unapproved new drug under FD&C Act section 505(a) and a misbranded drug under section 502. Prohibited acts include introducing or delivering this product into interstate commerce (sections 301(a) and (d)) and misbranding a drug held for sale after interstate shipment (section 301(k)).

The FDA requested immediate cessation of promoting and participating in the sale of such unapproved products. The company must email COVID-19-Task-Force-CDER@fda.hhs.gov within 48 hours, detailing corrective actions, 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 stated that advertising products to prevent, treat, or cure human disease requires competent and reliable scientific evidence, which is lacking for the identified product regarding COVID-19. Violations of the FTC Act may lead to legal