11.23.16
The Food and Drug Administration (FDA) issued a Warning Letter to Best Bentonite, Guthrie, OK. Not only did the product contain lead at unacceptable levels of 37.5 parts per million (ppm) or 37.5 micrograms per gram (μg/g), the company's website www.bestbentonite.com, makes product claims that are in violation of the Federal Food, Drug, and Cosmetic Act (“the FD&C Act”). More specifically, FDA has determined that your “Best Bentonite” is an unapproved new drug under section 505(a) of the FD&C Act [21 U.S.C. § 355(a)] and a misbranded drug under section 502 of the FD&C Act [21 U.S.C. § 352], as detailed below.
Unapproved New Drug
“Best Bentonite” is a drug as defined by section 201(g)(1) of the FD&C Act [21 U.S.C. § 321(g)(1)] because it is an article intended for use in the cure, mitigation, treatment, or prevention of disease, and/or an article (other than food) intended to affect the structure or function of the body. Labeling statements documenting the intended uses of this product include, but are not limited to the following:
Best Bentonite
On the website www.bestbentonite.com, dated February 18, 2016:
Under the heading “Mixing & Activation”:
- “Benefits: The benefits I’ve experienced are primarily increased energy and clear skin . . . When I’m taking the clay internally my skin clears up pretty quickly . . . I find it psychologically gratifying knowing that I am pulling toxins out of my gut and liver . . ..”
- “This product works great on poison ivy . . . If the rash comes out in full force, one application will relieve the itching for 12 hours! . . ..”
- “Tracy uses this clay for athlete’s foot. My son came home and told me he had athlete’s foot . . . I mixed some up in water and had him put it on his feet. The athlete’s foot was gone within a couple hours . . ..”
- “Mark uses clay for MRSA”
Under the heading “Testimonials”:
- “To stop Smoking . . . First take a dose of the liquid clay to clear the body of nicotine.”
- “[B]entonite clay is one of the most important medicines that is in our arsenal for disease control. Viral, bacterial, and poison, as in the case of that recluse spider that bit me.”
- “My brother was diagnosed with Parkinson’s . . . Thanks to you . . . and the Bentonite my brothers (sic) hand stopped shaking.”
- “I use it primarily to suck out poison from insect and snake bites. I have been bitten by the brown recluse spider 5 times . . . It will remove most toxins right thru (sic) the skin.”
- “I managed to get the courage to take it internally . . . After some research I came to the conclusion that it was the clay killing off the Candida in my intestines.”
- “I could really feel the clay drawing at the fungal infection area. I am happy to say its (sic) been over 3 weeks with no additional treatment and the fungus has not returned.”
Moreover, “Best Bentonite” is a "new drug" as defined by section 201(p) of the FD&C Act [21 U.S.C. § 321(p)], because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. Under sections 301(d) and 505(a) of the FD&C Act, a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. There is no approved application on file with the FDA for your “Best Bentonite.” The distribution or sale of “Best Bentonite” in interstate commerce without such an approved application violates these provisions of the FD&C Act.