Natural Adventure, LLC

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

your website offers Purity Sanitizer with 70% Alcohol and Purity Essential Oil Blend products for sale in the United States and that these products are intended to mitigate, prevent, treat, diagnose, or cure COVID-19[1] in people.

Passage 2

these products are unapproved new drugs sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a).

Passage 3

these products are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. § 352.

Passage 4

the labeling for your Purity Sanitizer with 70% Alcohol on the www.mynaturaladventure.com website represents that the product contains “anti-bacterial” essential oils, which were not classified as Category III for use as active ingredients in consumer antiseptic rub drug products in the 1994 TFM, as further amended.