Natural Adventure, LLC – FDA Warning Letter, Mar 12, 2021

On April 1, 2021, the FDA and FTC issued a Warning Letter to My Natural Adventure regarding unapproved and misbranded products related to COVID-19. The agencies reviewed www.mynaturaladventure.com and associated social media on February 26 and March 12, 2021.

The FDA observed the sale of "Purity Sanitizer with 70% Alcohol" and "Purity Essential Oil Blend" with claims to mitigate, prevent, treat, diagnose, or cure COVID-19. These products are deemed unapproved new drugs under section 505(a) and misbranded drugs under section 502 of the FD&C Act, violating sections 301(a) and (d). The Purity Sanitizer, despite containing ethyl alcohol, does not conform to the 1994 TFM or subsequent amendments due to "anti-bacterial" essential oils not classified for use in consumer antiseptic rubs, nor does it align with temporary FDA policies for hand sanitizers during COVID-19.

The letter demands immediate cessation of sales for all unapproved and unauthorized COVID-19 related 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