Inspections, Compliance, Enforcement, and Criminal Investigations

Best Bentonite 6/17/16

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Dallas District Office
4040 North Central Expressway
Suite 300
Dallas, Texas 75204-3128

 

June 17, 2016
 
2016-DAL-WL-26
 
 
 
WARNING LETTER
 
UPS OVERNIGHT
                                                                                                     
 
Marshall A. Dunlap, Owner
Best Bentonite
11650 Otis Road
Guthrie, OK 73044
 
Dear Mr. Dunlap:
 
The Food and Drug Administration (FDA) conducted an inspection of your firm located at 11650 Otis Road, Guthrie, Oklahoma 73044, on February 9 and 12, 2016. During this inspection the FDA obtained a sample of your “Best Bentonite” product. FDA laboratory analysis determined that your “Best Bentonite” contains lead (Pb) at levels of 37.5 parts per million (ppm) or 37.5 micrograms per gram (μg/g). We have also reviewed your website, www.bestbentonite.com. Based on our review, FDA has determined that you offer “Best Bentonite” for sale 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.
 
Misbranded Drug
 
Furthermore, your “Best Bentonite” product is a misbranded drug under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)], because its labeling does not bear adequate directions for its intended uses. "Adequate directions for use" means directions under which a layperson can use a drug safely and for the purposes for which it is intended (see 21 CFR 201.5). The labeling for “Best Bentonite” does not contain sufficient information to enable a layperson to use this product safely and for the purposes for which it is intended. For example, your website, www.bestbentonite.com, provides testimonials indicating that “Best Bentonite” is intended for ingestion. Your product does not include information for internal use related to frequency of administration, duration of administration, time of administration, and preparation for use (see 21 CFR 201.5(c),(d), (e), and (g)). Thus, your product's labeling fails to bear adequate directions for its intended uses, causing it to be misbranded under section 502(f)(1) of the FD&C Act.
 
Additionally, your “Best Bentonite” is misbranded under section 502(j) of the FD&C Act [21 U.S.C. § 352(j))] because it is dangerous to health when used in the dosage or manner recommended in its labeling. FDA laboratories determined your product, indicated both for ingestion and dermal use, contains lead (Pb) at levels of 37.5 ppm or 37.5 μg/g.[1] Lead is hazardous to all humans, but lead exposure is especially dangerous to children and pregnant women. 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, chronic exposure to lead, even at low levels, is associated with impaired cognitive function, including reduced IQ and behavioral difficulties. Fetuses can also be exposed to lead ingested by their mothers. These concerns are exacerbated by the absence of instructions for internal use regarding dosage, frequency of administration, duration of administration, or preparation for use. Thus, “Best Bentonite” is misbranded under section 502(j) of the FD&C Act because the product is dangerous to health when used in the dosage or manner recommended in its labeling. The introduction or delivery for introduction into interstate commerce of this misbranded product violates section 301(a) of the FD&C Act [21 US.C. § 331(a)].
 
The violations described in this letter are not meant to be all-inclusive. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with the FD&C Act and applicable FDA regulations.
 
Failure to promptly correct the violations specified above may result in regulatory action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.
 
We note that on February 17, 2016, you were presented via phone call, the laboratory analysis of  the FDA collected sample of “Best Bentonite.” Again on March 3, 2016, you were contacted by FDA via phone where you indicated that you would voluntarily recall “Best Bentonite.” To date, your firm has not voluntarily recalled “Best Bentonite.” To initiate a recall of this product, please contact the Dallas District Office Recall Coordinator, Casey Hamblin at (214) 253-5222.
 
In addition, the FDA Center for Drug Evaluation and Research (CDER) issued a Safety Alert on March 23, 2016 concerning the lead (Pb) content and potential safety hazard associated with your product (see Best Bentonite Clay FDA Alert).
 
You should respond to this office in writing within fifteen (15) working days of receipt of this letter. Your response should describe the specific actions you will take, or have taken, to correct the violations. It should also include an explanation of each step being taken to prevent recurrence of similar violations. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the time within which corrections will be completed.
 
Please send your reply to the Food and Drug Administration, Attention: S. Alexander Hamblin, Compliance Officer, at the above letterhead address. If you have any questions regarding any issue in this letter, please contact S. Alexander Hamblin at samuel.hamblin@fda.hhs.gov or (214) 253-5240.
 
  
Sincerely,
/S/ 
Reynaldo R. Rodriguez, Jr.
Dallas District Director
 


[1] For example, if a consumer ingests 15 grams of the product (approximately one tablespoonful), the total lead consumption could be 562.5 µg Pb. Even if only half of the ingested lead is actually absorbed, this may result in significantly elevated blood lead levels, particularly in children. 

 

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