Inspections, Compliance, Enforcement, and Criminal Investigations
Pro Star International, Inc. 26-Mar-04
Department of Health and Human Services
Public Health Service
5100 Paint Branch Parkway
March 26, 2004
Warning Letter for Weight Loss Products
"Lean Image Carb Blocker"
RETURN RECEIPT REQUESTED
Pro Star International, Inc.
107 RR620 South, Suite A2
Austin, TX 78734
Dear Mr. Smutek:
The Food and Drug Administration (FDA)has reviewed your web site at the Internet address http://www.prostarnutrition.com/1100/ and has concluded that claims on this web site cause your product "Lean Image 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.2ov.
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 "Lean Image Carb Blocker" bears structure/function claims, including the following:
"Lean Image Carb Blocker .. help[s] reduce cravings...."
"Lean Image Carb Blocker helps you reduce starch calories by blocking alpha-amylase... the undigested starch and its calories simply pass through the body undigested. This blocking of starch calories helps you lose weight. . . ."
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 "Lean Image 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, of the specific steps 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 with 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.
Joseph R. Baca
Office of Compliance
Center for Food Safety and Applied Nutrition