FDA WARNING_LETTER - Gaia Arise Farms Apothecary - April 09, 2020

On April 13, 2020, the FDA and FTC issued a Warning Letter to Gaia Arise Farms Apothecary after reviewing their website and social media on April 1 and April 9, 2020. The letter states that the company offers "True Viral Defense" or "Viral Defense Tincture" for sale, claiming it can mitigate, prevent, treat, diagnose, or cure COVID-19.

The FDA determined this product is an unapproved new drug, violating section 505(a) of the FD&C Act, and is misbranded under section 502. The introduction of this product into interstate commerce is prohibited under sections 301(a) and (d). The letter emphasizes the public health emergency declared for COVID-19 and the FDA's urgent measures to protect consumers from unapproved products making COVID-19 claims.

The company is required to immediately cease selling the unapproved product for COVID-19 related uses. Within 48 hours, they must email COVID-19-Task-Force-CDER@fda.hhs.gov detailing 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 the FDA's public list of companies receiving COVID-19 related warning letters.

The FTC also stated that advertising a product to prevent, treat, or