Inspections, Compliance, Enforcement, and Criminal Investigations
Certified Natural Laboratories, Inc. 22-Jun-05
Department of Health and Human Services
Public Health Service
Kansas City District
June 21, 2005
RETURN RECEIPT REQUESTED
Ref. KAN 2005-11
Dennis P. Wilke, President
Certified Natural Laboratories, Inc.
701 E 2nd Street N
Wichita, KS 67202-2713
Dear Mr. Wilke:
The Food and Drug Administration (FDA) completed an inspection of your firm, located at the address above, on February 24, 2005. We have also reviewed your website at the Internet address http://www.certifiednatural org/wholesale/ and have concluded that claims on this web site and your product labels cause your products "fatblast X-TREME," "Extreme Fat Burner," and "Advantage Carb Blocker" to be misbranded under the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and FDA's regulations through links on FDA's Internet home page: http://www.fda.gov.
Under section 403(r)(6) of the Act, dietary supplement labeling may include claims about the supplement's effect on the structure or function of the human body (structure/ function claims), provided that certain requirements are met [21 U.S.C. 343(r)(6)(A)]. One of these requirements is that the manufacturer of a dietary supplement bearing a "structure/function" claim must have substantiation that the claim is truthful and not misleading [21 U.S.C. 343(r)(6)(B)].
The labeling for these products, including product labels and your website, bears structure/function claims, including the following:
"The special blend of herbs in Certified Natural Fat Block helps your body remove the unwanted fat from the food you eat. "
"B]inds with fat in the gastrointestinal tract to prevent the absorption of fat into the bloodstream. "
Extreme Fat Burner
"Garcinia Cambogia one of the most effective fat burners known"
Advantage Carb Blocker:
"Weight Loss can be achieved by the ability of Advantage Carb Blocker's ingredients to block unnecessary carbohydrates."
We have reviewed these claims and have concluded that they are not supported by reliable scientific evidence . Because these claims lack substantiation, they are false and misleading, and cause your products to be misbranded under sections 403(a)(1) and 403(r)(6)(B) of the Act [21 U.S.C. 343(a)(1), (r)(6)(B)]. It is a violation of section 301(a) of the Act [21 U.S.C. 331(a)], to introduce or deliver for introduction into interstate commerce any food, including a dietary supplement, that is misbranded.
This letter is not an all-inclusive review of your web site and the products that your firm markets. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.
The Act authorizes injunctions against manufacturers and distributors of illegal products and seizure of such products [21 U.S.C. 332, 334]. You should take prompt action to correct any violations, including the violations identified in this letter. Failure to do so may result in enforcement action without further notice.
If you have scientific evidence which you believe substantiates that your claims for "fatblast XTREME", "Extreme Fat Burner", and "Advantage Carb Blocker" are truthful and not misleading, please provide it to us within fifteen (15) working days of receipt of this letter. Alternatively, please advise this office, in writing and within fifteen working days of receipt of this letter, as to the specific steps that you have taken to correct the noted violations and to ensure that similar violations do not occur in the future. If corrective action cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be made.
Your reply should be sent to the attention of Compliance Officer Joseph G. Kramer at the above address.
John W. Thorsky
Kansas City District