Fda Warning Against Alikay Bentonite

[sithembile]

I checked but couldn't find whether this had been posted.


Posted 01/28/2016]

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/reportDownload 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

 

[Kinky4Agirl]

Ok, I guess I won't use it then...lol, thanks for taking the time to post this OP. We need the bad as well as the good..

 

[trclemons]

I checked but couldn't find whether this had been posted.


Posted 01/28/2016]

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/reportDownload 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

I didn't know about this. Thanks for sharing.

 

[ajargon02]

Bumping 4 all 2 see

 

[Theresamonet]

This isn't the first time there's been an issue like this with her products, right? I may have to stay away from this brand.

 

[B_Phlyy]

I have a tub of this sitting on my kitchen counter because I had no idea how to make it usable for me. Glad to know I can throw it out. Thanks for the info.

 

[Bunnyhaslonghair]

Dang, blackonyx. I hope her brand survives.

 

[steph0105]

Here is Alikays response:

FORT MEYERS, Fla., Jan. 29, 2016 /PRNewswire/ -- The Food and Drug Administration (FDA) released a consumer alert today about Alikay Naturals Bentonite Me Baby product. We would like to clarify some key facts in the investigation. The initial consumer report that was filed with the FDA was subsequently closed due to the consumer alleged falsification of facts and statements. On January 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. 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." Alikay Naturals is an all-natural luxury hair, skin, bath and body product line specifically advertised for topical use.

Bentonite Clay is a natural clay that is a detoxifier used on the skin, hair and body. There are several sources that educate consumers on how to use and the benefits of bentonite clay. Bentonite Me Baby has been available on the Alikay Naturals website since 2010 and was recently released online and in major retail stores. Our label specifies that it is not recommended that the Bentonite Me Baby be mixed with a metal spoon or metal utensils. Rochelle Grahamis 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. There have not been any videos, posts, or statements demonstrating or suggesting the ingestion of Bentonite Me Baby from Alikay Naturals or BlackOnyx77. 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 Rochelle Graham.

The FDA currently regulates coloring and labeling in cosmetics. There is currently no set standard in the cosmetic industry to measure the amount of what they consider as harmful lead. The FDA has performed several tests and studies on other cosmetics that potentially have lead in them. One report is on the levels of lead found in lipstick. In a study published in 2011 entitled, "Lipstick and Lead: Questions & Answers," it states Lipstick, as a product intended for topical use with limited absorption, is ingested only in very small quantities….It is not scientifically valid to equate the risk to consumers presented by lead levels in candy, a product intended for ingestion, with that associated with lead levels in lipstick, a product intended for topical use and ingested in much smaller quantities than candy-(FDA.GOV)

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.

Website:
http://www.prnewswire.com/news-rele...kay-naturals-bentonite-me-baby-300212400.html

 

[mzteaze]

So this is based on someone trying to use the product in an unintended method (trying to eat the product).

Alrighty then.

 

[Kinky4Agirl]

I hate to say this, but controversy is enough to scare me away from the products completely whether true or not.

 

[krissyhair]

My understanding of these facts ( please someone correct me if I'm wrong)

The product may have high lead levels based on a food consumption standard.

Alikay released a statement saying the product is not meant to be ingested, and it's safe based on a hair/cosmetic standard?

What are the actual lead levels?

 

[CodeRed]

But like how do you accidentally categorize a hair product as a food product then say it's not safe to use

 

[steph0105]

My understanding of these facts ( please someone correct me if I'm wrong)

The product may have high lead levels based on a food consumption standard.

Alikay released a statement saying the product is not meant to be ingested, and it's safe based on a hair/cosmetic standard?

What are the actual lead levels?

I would like to know the actual lead levels as well.

 

[sithembile]

I wonder why the authorities investigated? Was a complaint filed or was it a random test?

 

[B_Phlyy]

*Rummages trash for tub of clay*

Not sure how old my little tub is as I got it as a re-gift from my mom (and who knows how long she had it before she gave it to me), but it clearly states ion the label that the product can be internally used for colon and detox cleansing. I doesn't give explicit instructions on ratios of clay to liquid for internal consumption or how often to ingest it, but there is the option for internal usage on my product.

Now I knew I would never use it that way, but I can think of loads of people who may have wanted to do a "natural" detox who might have used the product. If they got sick or had an adverse reaction and filed a complaint, then that explains what could have started an investigation. The thing with this product though is that it Alikay Naturals is saying it is strictly a cosmetic. However, because the label says that there is potential for internal usage, the FDA probably classified it as a food or drug (more than likely it's a drug). So the standards for topical only application wouldn't apply to this product as it doesn't have topical only instructions. Hence the reason it was compared to candy versus a lipstick.

 

[krissyhair]

I find it concerning that the responding press release says not recommend for children.

 

[Rain20]

Kids will taste things they are not supposed to. Best not to have around if you have little ones that get into everything.

Does any other bentonite clay have these warnings?

 

[sithembile]

*Rummages trash for tub of clay*

Not sure how old my little tub is as I got it as a re-gift from my mom (and who knows how long she had it before she gave it to me), but it clearly states ion the label that the product can be internally used for colon and detox cleansing. I doesn't give explicit instructions on ratios of clay to liquid for internal consumption or how often to ingest it, but there is the option for internal usage on my product.

Now I knew I would never use it that way, but I can think of loads of people who may have wanted to do a "natural" detox who might have used the product. If they got sick or had an adverse reaction and filed a complaint, then that explains what could have started an investigation. The thing with this product though is that it Alikay Naturals is saying it is strictly a cosmetic. However, because the label says that there is potential for internal usage, the FDA probably classified it as a food or drug (more than likely it's a drug). So the standards for topical only application wouldn't apply to this product as it doesn't have topical only instructions. Hence the reason it was compared to candy versus a lipstick.

In that case, Alikay is in the wrong then, IMO. Even if they have changed this on their new labels, they should have publicised a warning not to use it internally or recalled them because people still have the old labels. There is a difference between food grade and cosmetic grade materials.

 

[mzteaze]

Two things, bentonite clay and lead levels

Kids will taste things they are not supposed to. Best not to have around if you have little ones that get into everything.

Does any other bentonite clay have these warnings?

Yes. Since California is enforcing its own new disclosure labels, many other bentonite clay products have to disclose lead as well. It's causing a bit of a panic.

One toothpaste clearly compares its levels to the levels found in produce.

From what I read, this seems to a bit of panic over not much. The company needs to fix their label

 

[sikora]

So this is based on someone trying to use the product in an unintended method (trying to eat the product).

Alrighty then.

Bingo! I hope she can recover from this.

 

[meka72]

Because the label clearly acknowledged internal use, I find Alikay's response misleading. As someone mentioned, if the labels changed and internal consumption was no longer acknowledged, then Alikay should have noted that.

*Rummages trash for tub of clay*

Not sure how old my little tub is as I got it as a re-gift from my mom (and who knows how long she had it before she gave it to me), but it clearly states ion the label that the product can be internally used for colon and detox cleansing. I doesn't give explicit instructions on ratios of clay to liquid for internal consumption or how often to ingest it, but there is the option for internal usage on my product.

Now I knew I would never use it that way, but I can think of loads of people who may have wanted to do a "natural" detox who might have used the product. If they got sick or had an adverse reaction and filed a complaint, then that explains what could have started an investigation. The thing with this product though is that it Alikay Naturals is saying it is strictly a cosmetic. However, because the label says that there is potential for internal usage, the FDA probably classified it as a food or drug (more than likely it's a drug). So the standards for topical only application wouldn't apply to this product as it doesn't have topical only instructions. Hence the reason it was compared to candy versus a lipstick.