The U.S. Food and Drug Administration (FDA) issued a warning letter on March 16, 2016, to Alikay Naturals over its “Bentonite Me Baby” product line, identifying several violations of the Federal Food, Drug, and Cosmetics Act. First, FDA determined that “Bentonite Me Baby” is a drug “because it is an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or an article (other than food) intended to affect the structure or function of the body.” Second, FDA characterized the product as a “new drug” requiring an approved application on file “because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling.” Third, “Bentonite Me Baby” was deemed misbranded “because its labeling does not bear adequate directions for its intended uses” by failing to include directions for internal use. The agency also concluded the product was misbranded “because it is dangerous to health when used in the dosage or manner recommended in its labeling.” FDA laboratory tests apparently confirmed that “Bentonite Me Baby” skin and hair care products contain lead at levels of 37.5 parts per million or 37.5 micrograms per gram. According to FDA, “lead exposure is especially dangerous in children and pregnant women” and “Bentonite Me Baby,” which is indicated for both topical and internal use, threatens to “excacerbate” those risks due to the absence of instructions for internal use regarding dosage, frequency of administration, duration of administration, or preparation for use. There are no confirmed cases of lead poisoning associated with “Bentonite Me Baby” to date. FDA informed Alikay Naturals about its lead concerns in January 2016.
In a press release issued after the initial investigation but before the March warning letter, Alikay Naturals said FDA investigated “Bentonite Me Baby” as a food or drug rather than a product to be used topically to detox hair and skin as it is advertised. The company stated that it has never recommended the product to be ingested internally or used on small children. “Bentonite Me Baby” is marketed as medicinal clay and most consumers use the product as a mask for the hair and face.