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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Better Bodz 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

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

Better Bodz
208 Monmouth Way
Clifton Park, NY 12065

Dear Sir or Madam:

The Food and Drug Administration (FDA) has reviewed your website at the Internet address http://ww1.betterbodz.com and has concluded that claims on this web site cause your products "InShape Dreamshape" 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 "InShape Dreamshape" bears structure/function claims, including the following:

. "In Shape Dream Shape is 100 grams of pure Gamma-Aminobutryic Acid (GABA) powder.... GABA is used primarily for fat loss as it has been shown to stimulate the body's ability to secrete the powerful fat burning hormone hGH during sleep."
. "[P]eople taking GABA tend to lose excess body 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 website 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 "InShape Dreamshape" 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.

Sincerely yours,

/s/

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