FDA WARNING_LETTER - Earthworks Health - June 18, 2019

The FDA issued a Warning Letter to Earthworks Health, LLC, following an April 2019 review of their Facebook, YouTube, and website (www.earthworkshealth.com). The review identified multiple violations related to their products: 100% Food Grade Diatomaceous Earth (DE), Diatomaceous Earth Cosmetic Bundle, Goat Milk Soap with Food Grade Diatomaceous Earth, Nature’s Face Mask, and Natural Dog Treats.

The FDA determined that 100% Food Grade Diatomaceous Earth, Goat Milk Soap with Food Grade Diatomaceous Earth, Diatomaceous Earth Cosmetic Bundle, and Nature’s Face Mask are unapproved new human drugs and misbranded under Sections 505(a) and 502(f)(1) of the Federal Food, Drug, and Cosmetic Act (the Act). Claims on their internet labeling, including testimonials, indicated these products were intended for disease treatment, cure, mitigation, or prevention (e.g., "Internal De-Wormer," "Removes Toxins From The Gut," "pain relief," "treating skin problems like blemishes…and acne"). These products are not generally recognized as safe and effective for such uses and lack FDA approval.

Furthermore, the 100% Food Grade Diatomaceous Earth product for human use was deemed an adulterated human food under Section 402(a)(2)(C)(i) of the Act because its