FDA WARNING_LETTER - Desert Alchemist LLC - December 15, 2020

The FDA issued a Warning Letter to Desert Alchemist on December 4, 2020, following a review of their etsy.com webpage and social media (Facebook, Instagram) in December 2020. The letter identifies that products including Fortify, Lion’s Mane, The Great Work, Mind Ease, Sweet Balance, Happy Heart, Flair Snare, and Cordycepts sinensis double extract are marketed with claims establishing them as unapproved new drugs.

Violations include claims of intended use for disease cure, mitigation, treatment, or prevention, such as "immuno-modulating, antiviral, anti-fungal, and anti-bacterial properties" for Fortify, "myelin sheath repair promotion of axonal regeneration" for Lion's Mane, "cholesterol control" for The Great Work and Happy Heart, "eliminate anxiety" for Mind Ease, "blood sugar control" for Sweet Balance, "regulate acid reflux" for Flair Snare, and "stop metastasizing in certain cancerous cells" for Cordycepts sinensis. Testimonials on Facebook also support these drug claims.

These products are deemed "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their claimed uses, thus violating sections 301(d) and 505(a)