FDA WARNING_LETTER - ananda, llc - April 02, 2020

On April 6, 2020, the FDA and FTC issued a Warning Letter to Ananda Essential Oils after reviewing their website, anandaessentialoils.com, on March 27 and April 2, 2020. The letter states that the company offers essential oil products for sale in the U.S. with claims to mitigate, prevent, treat, diagnose, or cure COVID-19.

The FDA determined these products are unapproved new drugs, violating section 505(a) of the FD&C Act, and misbranded drugs under section 502. The introduction of these products into interstate commerce is prohibited by sections 301(a) and (d). The letter emphasizes the public health emergency declared for COVID-19 and the urgent need to protect consumers from unapproved products.

Ananda Essential Oils is required to immediately cease selling these unapproved and unauthorized products. They 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. The firm will be added to FDA's public list of firms selling fraudulent COVID-19 products. The FTC also requires immediate cessation of unsubstantiated claims, warning of potential legal action and monetary penalties.