Defective Products

Bentonite Me Baby FDA Warning

Beauty product retailer Alikay Naturals has been issued a warning from the Food and Drug Administration for its product Bentonite Me Baby. The FDA has found that Bentonite Me Baby contains lead, a highly toxic metal. Bentonite Me Baby poses a serious risk of lead poisoning for anyone that uses it, and is especially dangerous to children and pregnant women. If you have purchased or used Bentonite Me Baby, you may have exposed yourself to a serious health risk. Please seek immediate medical attention. When the danger to your health has passed, please contact The Class Action News using the form on this page or by calling us at 817-455-6822. You may be part of a class action lawsuit.

Background

In a warning letter dated March 16, 2016 the FDA has issued a notification that Bentonite Me Baby is unapproved as a new drug and is misbranded under federal law. FDA laboratory analysis has found that the beauty product contains lead at levels of 37.5 parts per million (or 37.5 micrograms per gram). This amount of lead can cause lead poisoning in humans. In addition, Alikay Naturals has labeled the product for use externally on skin and hair, and internally (presumably by consuming the product). The FDA has said that Bentonite Me Baby is “dangerous to health when used in the dosage or manner recommended in its labeling.” The March 16 letter requires Alikay Naturals to take steps to correct the health risk and misbranding that their product poses. As of March 16, 2016 Alikay Naturals has not issued a product recall of Bentonite Me Baby.

Bentonite is a naturally occurring clay with various industrial and healthcare uses. It is useful as an ingredient in steel foundries, construction, and as an absorbent. In medicine, bentonite is found in bulk laxatives, skin care formulas, and in medical desiccants. It is important to note that bentonite complies with the FDA for contact with food and drugs. In other words, there is no lead in natural bentonite.

Alikay Naturals is a company that sells natural and organic beauty products. It operates out of Fort Myers, Florida. The company manufactures and sells more than 60 hair care, skin care, and bath and body products.

Health Risk

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 including anemia, neurological defects, irritability, constipation, muscular weakness, and chronic nephritis. In children, continued exposure to lead, even at low levels, can result in impaired cognitive function, including reduced IQ and behavioral difficulties. Fetuses can also be exposed to lead ingested by their mothers.

Potential Class action

If you have purchased or used Bentonite Me Baby by Alikay Naturals, you may have unknowingly come into contact with toxic lead. Lead poisoning is a serious health concern. Without proper labeling, Alikay Naturals has exposed its customers to a health risk that they were not aware of. Please contact us using the form on this page or call us at 817-455-6822. By completing our confidential inquiry you will be assisting us in the investigation of this alleged FDA violation.

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