FDA MedWatch - Bentonite Me Baby – Bentonite Clay by Alikay Naturals: Consumer Warning - Risk of Lead Poisoning

Bentonite Me Baby – Bentonite Clay by Alikay Naturals: Consumer Warning - Risk of Lead Poisoning

AUDIENCE: Consumer

ISSUE: FDA is warning consumers not to use “Bentonite Me Baby” by Alikay Naturals because of a potential lead poisoning risk. FDA laboratory analysis of the product found elevated lead levels. Exposure to lead can cause serious damage to the central nervous system, the kidneys, and the immune system. In children, chronic exposure to lead, even at low levels, is associated with impaired cognitive function, including reduced IQ, behavioral difficulties, and other problems. See the FDA Consumer Warning for a product photo.

BACKGROUND: “Bentonite Me Baby” is sold online and in retail outlets, including Target stores, Amazon.com, and Sally Beauty Supply, and is marketed as medicinal clay. The product’s labeling indicates that it can be ingested and applied topically to hair and skin for a variety of conditions. FDA learned that this product may contain lead from the Minnesota Department of Health. FDA has not confirmed any cases of lead poisoning associated with the product.

RECOMMENDATION: Consumers should not purchase or use “Bentonite Me Baby.” Anyone who has used this product or provided it to a child should consult a health care professional immediately.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the Consumer Warning page, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm483843.htm

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You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm

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