FDA WARNING_LETTER - Blossom Nature, LLC - February 19, 2021

The FDA issued a Warning Letter to Blossom Nature, specifically Ms. Krassowizki, following a December 2020 review of their website, www.blossom-nature.com, and Amazon product page for St. John’s Wort. The FDA determined that claims on these platforms establish the St. John’s Wort product as a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act), due to its intended use in the cure, mitigation, treatment, or prevention of disease.

The St. John’s Wort product is deemed a "new drug" under section 201(p) of the Act because it is not generally recognized as safe and effective for its claimed uses. Introducing or delivering this product into interstate commerce without prior FDA approval violates sections 301(d) and 505(a) of the Act. Furthermore, the product is misbranded under section 502(f)(1) of the Act because it lacks adequate directions for its intended use. As a prescription drug, it requires supervision by a licensed practitioner, making it impossible to provide adequate directions for layperson use. This misbranding violates section 301(a) of the Act.

Blossom Nature is required to take prompt action to address these violations and notify the FDA in writing within fifteen working days of receipt of the letter, detailing specific