02.01.16
Late last week, the US FDA issued a warning to consumers not to use Bentonite Me Baby, a product sold by Alikay Naturals, because of a potential lead poisoning risk.
According to the FDA, the product’s labeling indicates that it can be ingested and applied topically to hair and skin for a variety of conditions.
FDA said its 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.
FDA also said it learned that this product may contain lead from the Minnesota Department of Health. The agency has not confirmed any cases of lead poisoning associated with the product.
In response to FDA’s consumer alert, Alikay Naturals—the natural skin and hair care line created in 2009 by Rochelle Graham-Campbell—released a statement to “clarify some key facts in the investigation.”
According to Alikay Naturals, “the initial consumer report that was filed with the FDA was subsequently closed due to the consumer alleged falsification of facts and statements. On Jan. 25, 2016, we received information that the Florida District of the FDA wanted to conduct a separate investigation. The FDA conducted its investigation based on the presumption of categorizing the Bentonite Me Baby as a food or drug product for consumption.”
The company continued, “Although, Alikay Naturals advertises the product for topical use for hair and skin, the FDA test results that were provided to Alikay Naturals were compared to candy and food products. The FDA report released stated that "FDA has not confirmed any cases of lead poisoning associated with the product."
According to the firm, Alikay Naturals is an all-natural luxury hair, skin, bath and body product line specifically advertised for topical use.
Bentonite Me Baby has been available on the Alikay Naturals website since 2010 and was recently released online and in major retail stores that include Target stores, Amazon.com, and Sally Beauty Supply.
According to the company, it’s “label specifies that it is not recommended that the Bentonite Me Baby be mixed with a metal spoon or metal utensils."
Graham is the CEO of Black Onyx World, LLC as well as beauty and lifestyle vlogger known as BlackOnyx77. Alikay Naturals and BlackOnyx77 do not recommend nor have promoted the use of Bentonite Me Baby on children, according to Alikay Naturals.
Her company contends there have not been any videos, posts, or statements demonstrating or suggesting the ingestion of Bentonite Me Baby from Alikay Naturals or BlackOnyx77. In addition, Alikay Naturals has not received any reports or complaints regarding Bentonite Me Baby in association with elevated levels of lead prior to the release of the report released by the FDA.
"Although, our previous label stated the benefits of hair, skin and internal use of bentonite, we never provided the recommendations or recipes for internal consumption. The label did provide recommendations for the use on hair and skin. In addition, our label advised that the consumer consulted a physician if they chose to do it internally. Our Bentonite Me Baby is not marketed as a food or consumption product. We do not support the use of this product on children. I have a genuinely transparent relationship with all of my consumers, many who have been around before the release of Bentonite Me Baby. There are thousands who have used our product on a consistent basis without any problems. I will be releasing a video statement to give specific details surrounding the FDA's investigations and findings," said Graham.
The company also noted, “We are compassionate and aware of the serious effects from the consumption of lead, this is why we do not recommend the consumption of topical use products. We highly accentuate the education of all of our products continuously to ensure the maximum benefits. Our brand stands firm by the quality and validity of our products. We are conducting our own investigation including getting the Bentonite Me Baby tested in an independent laboratory.”
According to the FDA, the product’s labeling indicates that it can be ingested and applied topically to hair and skin for a variety of conditions.
FDA said its 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.
FDA also said it learned that this product may contain lead from the Minnesota Department of Health. The agency has not confirmed any cases of lead poisoning associated with the product.
In response to FDA’s consumer alert, Alikay Naturals—the natural skin and hair care line created in 2009 by Rochelle Graham-Campbell—released a statement to “clarify some key facts in the investigation.”
According to Alikay Naturals, “the initial consumer report that was filed with the FDA was subsequently closed due to the consumer alleged falsification of facts and statements. On Jan. 25, 2016, we received information that the Florida District of the FDA wanted to conduct a separate investigation. The FDA conducted its investigation based on the presumption of categorizing the Bentonite Me Baby as a food or drug product for consumption.”
The company continued, “Although, Alikay Naturals advertises the product for topical use for hair and skin, the FDA test results that were provided to Alikay Naturals were compared to candy and food products. The FDA report released stated that "FDA has not confirmed any cases of lead poisoning associated with the product."
According to the firm, Alikay Naturals is an all-natural luxury hair, skin, bath and body product line specifically advertised for topical use.
Bentonite Me Baby has been available on the Alikay Naturals website since 2010 and was recently released online and in major retail stores that include Target stores, Amazon.com, and Sally Beauty Supply.
According to the company, it’s “label specifies that it is not recommended that the Bentonite Me Baby be mixed with a metal spoon or metal utensils."
Graham is the CEO of Black Onyx World, LLC as well as beauty and lifestyle vlogger known as BlackOnyx77. Alikay Naturals and BlackOnyx77 do not recommend nor have promoted the use of Bentonite Me Baby on children, according to Alikay Naturals.
Her company contends there have not been any videos, posts, or statements demonstrating or suggesting the ingestion of Bentonite Me Baby from Alikay Naturals or BlackOnyx77. In addition, Alikay Naturals has not received any reports or complaints regarding Bentonite Me Baby in association with elevated levels of lead prior to the release of the report released by the FDA.
"Although, our previous label stated the benefits of hair, skin and internal use of bentonite, we never provided the recommendations or recipes for internal consumption. The label did provide recommendations for the use on hair and skin. In addition, our label advised that the consumer consulted a physician if they chose to do it internally. Our Bentonite Me Baby is not marketed as a food or consumption product. We do not support the use of this product on children. I have a genuinely transparent relationship with all of my consumers, many who have been around before the release of Bentonite Me Baby. There are thousands who have used our product on a consistent basis without any problems. I will be releasing a video statement to give specific details surrounding the FDA's investigations and findings," said Graham.
The company also noted, “We are compassionate and aware of the serious effects from the consumption of lead, this is why we do not recommend the consumption of topical use products. We highly accentuate the education of all of our products continuously to ensure the maximum benefits. Our brand stands firm by the quality and validity of our products. We are conducting our own investigation including getting the Bentonite Me Baby tested in an independent laboratory.”