In a recent warning letter to Earthworks Health, LLC, the U.S. Food and Drug Administration (FDA) scrutinized the company's online marketing of three cosmetic products for treatment-related, and therefore new drug, claims.
The letter states, "The FDA reviewed your website at the Internet address ... and has determined that you take orders there for the products 'Diatomaceous Earth Cosmetic Bundle,' 'Goat Milk Soap with Food Grade Diatomaceous Earth,' and 'Nature’s Face Mask.'
"The claims on your website establish that these products are drugs under section 201(g)(1)(B) and/or 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §§ 321(g)(1)(B) and/or 321(g)(1)(C)] because they are intended for use in the cure, mitigation, treatment or prevention of disease and/or are intended to affect the structure or function of the human body."
Examples from the website included:
- Diatomaceous Earth Cosmetic Bundle, for “[T]reating skin problems like blemishes…and acne”;
- Goat Milk Soap with Food Grade Diatomaceous Earth, to “[C]ontrol acne”; and
- Nature’s Face Mask, with “Comfrey Root Powder [an ingredient in your product] (restructuring and pain relief from acne or cystic acne).”
The FDA cautioned these products are not generally recognized as safe and effective for the above referenced uses. They were therefore deemed as new drugs under section 201(p) of the Act [21 U.S.C. § 321(p)].
"New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)]," writes the FDA. "FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective."
This is a good reminder for cosmetic manufacturers to be careful when straddling the line between a cosmetic and drug. It's all in the claims.