Laboratory analysis shows the clay skin and hair product contains 37.5µg/g
The FDA has confirmed that Alikay Naturals’ Bentonite Me Baby clay skin and hair product – which sell in Sally and Target stores – contains lead at levels of 37.5 micrograms per gram (µg/g).
The US watchdog also stated that the product violates a number of sections of the FD&C Act. Firstly, Bentonite Me Baby is misbranded, the FDA said, because its labelling does not have adequate instructions for its intended use; and secondly, the product is misbranded because it is dangerous to health when used in the dosage or manner recommended in its labelling.
Alikay Naturals previously labelled its Bentonite Me Baby product as suitable for use on skin, hair and body as well as for internal use, to aid in detoxing the body and removing toxins. However, its CEO Rochelle Graham-Campbell stated that the company “never provided the recommendations or recipes for internal consumption… and our label advised that the consumer consulted a physician if they chose to do it internally.”
The FDA has since confirmed that Bentonite Me Baby is categorised as a drug because it is a product made for use in the cure and treatment, and/or a product (other than food) created to affect the structure or function of the body. However, the FDA explained, Bentonite Me Baby is a “new drug” because it is not generally recognised as safe and effective for use under the conditions recommended in its labelling. Moreover, there is no approved application on file with the FDA for Bentonite Me Baby.
In a letter dated 16 March, the FDA wrote to CEO Rochelle Graham of Fort Meyers, Florida, stating: “Lead is hazardous to all humans, but lead exposure is especially dangerous to children and pregnant women. Exposure to lead can cause serious damage to the central nervous system, the kidneys, and the immune system. Sustained consumption of products containing high lead levels can produce lead poisoning, which has a number of symptoms…These concerns are exacerbated by the absence of instructions for internal use regarding dosage, frequency of administration, duration of administration, or preparation for use.”
The FDA concluded the warning by saying that if Graham does not correct the violations promptly, enforcement action may take place.
Bentonite Me Baby has been aware of the FDA’s concerns since January when FDA investigators presented Alikay Naturals with laboratory analysis of its Bentonite Me Baby product. The FDA noted in its letter that to date, Alikay Naturals has not voluntarily recalled the product.