Inspections, Compliance, Enforcement, and Criminal Investigations

Black Onyx World LLC dba Alikay Naturals 3/16/16

  

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

Public Health Service
Food and Drug Administration
 
Florida District
555 Winderley Place, Suite 200
Maitland, Florida 32751
Telephone:   407-475-4700
Fax: 407-475-4770 

 

VIA UPS NEXT DAY AIR
w/ DELIVERY CONFIRMATION
 
March 16, 2016
 
Rochelle Graham, CEO
Alikay Naturals/Black Onyx World, LLC
5891 Country Lakes Drive
Fort Myers, FL 33905
 
Dear Ms. Graham:
 
This letter concerns your product “Bentonite Me Baby,” which your firm distributes online and through various retail stores. The U.S. Food and Drug Administration obtained a sample of your “Bentonite Me Baby” product on or about January 20, 2015. FDA laboratory analysis determined that “Bentonite Me Baby” contains lead (Pb) at levels of 37.5 parts per million (ppm) or 37.5 micrograms per gram (µg/g). Lead is a naturally occurring element whose toxicity in humans has been well documented. As described below, your “Bentonite Me Baby” is an unapproved new drug sold in violation of sections 505(a) and 301(d) of the Food, Drug and Cosmetic Act (the FD&C Act) [21 U.S.C. §§ 355(a) and 331(d)]. Furthermore, the product is a misbranded drug under section 502 [21 U.S.C. § 352] and sold in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
 
Unapproved New Drug and Misbranded Drug
 
“Bentonite Me Baby” 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 diagnosis, 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:
  • “Skin . . . Pulls the impurities out of the skin to reduce acne, inflammation, and eczema.”
  • “Internal . . . Works to aid in colon and detox cleansing to remove harmful toxins from the body, which helps many things including raising energy levels.”
Moreover, “Bentonite Me Baby” 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 FDA for your “Bentonite Me Baby.” The distribution or sale of “Bentonite Me Baby” in interstate commerce without such an approved application violates these provisions of the FD&C Act.
 
Furthermore, your “Bentonite Me Baby” 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 “Bentonite Me Baby” 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, the product’s label states: “For use internally do research or consult a professional before beginning use.” 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 “Bentonite Me Baby” 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 topical and internal use, contains lead (Pb) at levels of 37.5 ppm or 37.5 µg/gram.[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, “Bentonite Me Baby” 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 above are not intended to be an all-inclusive list of violations that exist in connection with your products.  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 enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.
 
On January 28, 2016, at your location in Fort Myers, FL, FDA investigators presented your firm with the laboratory analysis of your “Bentonite Me Baby” product. To date, your firm has not voluntarily recalled the product. To initiate a recall of this product, please contact the Florida District Office Recall Coordinator, Meredith Cobb, at (407) 475-4722. 

Please advise this office in writing within 15 working days of receipt of this letter as to the specific steps that you have taken to correct the violations noted above and to ensure that similar violations will not recur. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, state the reason for the delay and the date by which you will complete the corrections. You can find guidance and information for the regulated industry regarding regulations for drug products through links at FDA's website at http://www.fda.gov/oc/industry.

Please direct your reply to the U.S. Food and Drug Administration, Erica M. Katherine, Compliance Officer at the address noted above. If you have any questions with regard to this letter, the compliance officer can be reached at (407) 475-4731 or email
Erica.Katherine@fda.hhs.gov.
 
 
Sincerely,
/S/
Susan M. Turcovski
Director, Florida District


[1] For example, if a consumer ingests 15 grams of the product (approximately one tablespoon), 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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