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Public Health Service |
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5100 Paint Branch Pkwy |
March 26, 2004
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED
New You Labs
6593 Wolcottsville Rd
Akron, NY 14001
Dear
Sir or Madam:
The Food and Drug Administration (FDA) has reviewed your web site at the Internet address http://www.newyoulabs.com and has concluded that claims on this web site cause your products “Metabo Fat Blocker” and “EXtreme 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 USC 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 USC 43(r)(6)(B).
The labeling of “Metabo Fat Blocker” and “EXtreme Carb Blocker” bears structure/function claims, including the following:
Metabo Fat Blocker:
- “[C]an bind to dietary fat and provide a feeling of fullness – thus suppressing the appetite.”
- “Binds with the fat you eat – reducing the amount of fat you absorb …”
- “[O]n average, most people who weigh 180-260 pounds can lose about 7-10 pounds a week with our Metabo Fat Blocker™.”
EXtreme Carb Blocker:
- “EXtreme Carb Blocker helps you reduce starch calories by blocking alpha-amylase. [T]he undigested starch and its calories simply pass through the body undigested.”
- “neutralize up to 66 percent of the starch consumed in a meal”
- “inhibits the absorption of carbohydrates and sugar.”
- “Blocks carb absorption”
- “Helps reduce sugar cravings
- “Controls carb cravings”
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 or misleading, and cause your products to be misbranded within the meaning of sections 403(a)(1) and 403(r)(6)(B) of the Act. 21 USC 343(a)(1), (r)(6)(B). It is a violation of section 301(a) of the Act to introduce or deliver for introduction into interstate commerce any food, including a dietary supplement, that is misbranded. 21 USC 331(a).
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 USC 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 “Metabo Fat Blocker” and “EXtreme 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 Quyen Tien at the above address.
Sincerely,
/s/
Joseph R. Baca
District Director,
Office of Compliance
Center for Food Safety and Applied Nutrition
This page was posted on July 31, 2005.
