Sample Ephedra Warning Letter
This document was issued on February 28, 2003.
|DEPARTMENT OF HEALTH & HUMAN SERVICES||Public Health Service|
Food and Drug Administration
College Park, MD 20740
THIS LETTER IS REPRESENTATIVE OF THE LETTERS THAT WILL BE ISSUED BY THE AGENCY TODAY, FEBRUARY 28, 2003.
VIA OVERNIGHT DELIVERY
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.1-supplements.net. This review shows what we believe to be violations of the Federal Food, Drug, and Cosmetic Act (the Act) in the labeling of your products Thermbuterol, Gut Cutter, Dymetadrine Xtreme, and 3-Andro Xtreme. You can find the Act and the dietary supplement labeling regulations through links on 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 these claims are substantiated. If these claims do not have an adequate scientific basis, 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. Section 301(a) of the Act prohibits the introduction or delivery for introduction into interstate 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 of this letter.
In addition, except for health claims authorized by FDA, claims that a dietary supplement is intended to prevent, diagnose, mitigate, treat, or cure a disease (disease claims), may cause the supplement to be an unapproved new drug. The Act prohibits the introduction of unapproved new drugs into interstate commerce. If you are making disease claims for Thermbuterol, Gut Cutter, Dymetadrine Xtreme, or 3-Andro Xtreme, please be aware that these claims may violate the Act 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 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 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 Tien at the above address.
Joseph R. Baca
Office of Compliance
Center for Food Safety and Applied Nutrition
- Federal Register 68 FR 10417
Proposed Rule - March 5, 2003: Dietary Supplements Containing Ephedrine Alkaloids; Reopening of the Comment Period