Departmentof Health and Human Services PublicHealth Service 5100 Paint Branch Parkway
College Park, Maryland 20740
February 28, 2003
WARNING LETTER
VIA OVERNIGHT DELIVERY
Bryan Green
1 -supplements.net
c/o Powerhouse Supplements
576 Glenrose Lane
Cincinnati, OH 45244
Dear Mr. Green:
The Food and Drug Administration (FDA) has reviewed your web site at the address:http://www.l-supplements.net. This review shows what we believe to be violationsof the Federal Food, Drug, and Cosmetic Act (the Act) in the labeling of yourproducts Thermbuterol, Gut Cutter, Dymetadrine Xtreme, and 3-Andro Xtreme. Youcan find the Act and the dietary supplement labeling regulations through linkson FDA?s Internet home page at: http://www.fda.gov.
Under the Act, dietary supplement labeling may include claims about the supplement?s effect on the structure or a function of the human body. To be permissible under the Act, these "structure/function" claims must be truthful and may not be misleading.
The labeling of Thermbuterol, Gut Cutter, Dymetadrine Xtreme, and 3-Andro Xtreme bears structure/function claims that include the following:
- Thermbuterol: "build muscle fast," " enhancing your body?s own muscle-building," and "increasing your lean muscle mass by enhancing your body?s own muscle-building.. *" . "
- Gut Cutter: "feel totally powerful," and ". . . bodybuilding compound."
- Dymetadrine Xtreme: "strength supplementation, " "not only are you stronger and can train with ultra high intensity, " "preserves lean muscle mass," and "supporting lean muscle mass growth."
- 3-Andro Xtreme: "will also help increase strength instantly."
Based on the scientific data available to us, we do not believe that theseclaims are substantiated. If these claims do not have an adequate scientificbasis, they are false or misleading and cause your products to be misbrandedwithin the meaning of Sections 403(a)(1l) and 403(r)(6)(B) of the Act. Section301(a) of the Act prohibits the introduction or delivery for introduction intointerstate commerce of any food, including a dietary
supplement, that is misbranded. Section 301(k) of the Act prohibits the doing of any act with respect to a food, including a dietary supplement, if such act is done while such article is held for sale (whether or not the first sale) after shipment in interstate commerce and results in such article being misbranded. If you have data which you believe substantiates your claims.
Please share it with us within fifteen (15) working days of your receipt ofthis letter. In addition, except for health claims authorized by FDA, claimsthat a dietary supplement is intended to prevent, diagnose, mitigate, treat,or cure a disease (disease claims), may cause the supplement to be an unapprovednew drug. The Act prohibits the introduction of unapproved new drugs into interstatecommerce. If you are making disease claims for Thermobuterol. Gut Cutter, DymetadrineXtreme. or 3-Andro Xtreme, please be aware that these claims may violate theAct and subject you or the products to regulatory action without further notice.
This letter is not an all-inclusive review of your web site and the productsthat your firm markets. It is your responsibility to ensure that all productsmarketed by your firm comply, with the Act and its implementing regulations.
The Act authorizes the seizure of illegal products and injunctions against the manufacturers and distributors of those products. You should take prompt action to correct any violations identified in this letter. Failure to do so may result in enforcement action without further notice.
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 any violations and to assure that similar violations do not occur. 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.
Any reply should be sent to the attention of Compliance Officer Quyen Tienat the above address.
Sincerely yours,
/s/
Joseph R. Baca
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
