FDA WARNING_LETTER - Sage Moon Apothecary LLC - November 30, 2020

The FDA issued a Warning Letter to Ms. May of Sage Moon Apothecary on January 14, 2021, following a review of her websites and social media in September, October, and November 2020. The FDA determined that the products "Golden Milk Electuary-Mushroom Cocoa Blend," "Golden Milk Electuary," and "Beyond Elderberry Syrup" are unapproved and misbranded drugs.

The products are deemed drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) due to claims on the websites and social media indicating their intended use for the cure, mitigation, treatment, or prevention of disease. Examples of such claims include customer testimonials about relieving arthritis and joint pain, statements about inhibiting flu virus, and claims of being an anti-inflammatory and pain reliever for conditions like fibromyalgia and migraines.

These products are considered "new drugs" under section 201(p) of the Act because they are not generally recognized as safe and effective for their stated uses. Introducing new drugs into interstate commerce without prior FDA approval violates sections 301(d) and 505(a) of the Act.

Furthermore, the products are misbranded under section 502(f)(1) of the Act because they lack adequate directions for use. As they are intended for conditions requiring supervision by a licensed practitioner, it is impossible to provide adequate