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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Net Unique Inc. 26-Mar-04

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

Public Health Service
Food and Drug Administration

 

5100 Paint Branch Parkway
College Park, Maryland 20740


March 26, 2004

Warning Letter for Weight Loss Products
"Chito Block 2000 Plus C" and "Ultra Carbo Blocker 2000"


CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Eley Rozen, President
Net Unique Inc.
P.O. Box 770326
Coral Springs, FL 33077

Dear Mr. Rozen:

The Food and Drug Administration (FDA) has reviewed your web site at the Internet address http://www.goweightless.com and has concluded that claims on this web site cause your products "Chito Block 2000 Plus C" and "Ultra Carbo Blocker 2000" 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 of Chito Block 2000 Plus C and Ultra Carbo Blocker 2000 bears structure/function claims that include the following:

• Chito Block 2000 Plus C:

o "blocks up to 6 grams of saturated, incoming fat before it lands on the thighs, hips, waist and rear"
o "traps fat, thereby preventing its absorption and subsequent storage"

• Ultra Carbo Blocker 2000:

o "1 capsule blocks up to 400 calories (aprox. [sic] 100 gr) of carbohydrates from starch, and up to 100 calories (aprox. [sic] 25 gr) of carbohydrates from sugar"
o "Ultra Carbo Blocker 2000 can also reduce sugar cravings"
o "helps to stop complex carbohydrates (starches) being broken down - as well as preventing glucose being converted to fat"

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 U.S.C. § 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 U.S.C. § 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 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 Chito Block 2000 Plus C and Ultra Carbo Blocker 2000 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, of 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 yours,

/s/

Joseph R. Baca
Director
Office of Compliance
Center for Food Safety and Applied Nutrition