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Public Health Service |
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1431 Harbor Bay Pkwy |
Department of Health and Human Services
December 12, 2006
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED
GSCM Ventures
1802 N Carson St #212-2772
Carson City, NV 89743
Dear Sir or Madam:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address www.herbalphentermine.com and has determined that the product "Herbal Phentermine" is promoted for conditions that cause the product to be a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 USC 321(g)(1)(13)]. The therapeutic claims on your website establish that your product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of this product with these claims violates the Act.
Examples of some of the claims observed on your website include:
- (An ingredient in your product) "L-Carnitine … [d]ecreases symptoms of depression; [h]elps prevent cataracts.…"
- (An ingredient in your product) "Green Tea … [a] few medical conditions in which green tea is reputed to be helpful: … cancer, rheumatoid arthritis, high cholesterol levels, cardiovascular disease, infection, and impaired immune function."
Moreover, the following are examples of reference citations on your website that are used to promote acetyl-l-carnitine (an ingredient in your product) for treatment or prevention of neurological diseases:
- Hudson S, Tabet N. Acetyl-l-carnitine for dementia (Cochrane Review). Cochrane Database Syst Rev. 2003; CD0031S8. Abstract.
- Brooks JO 3rd, Yesavage JA, Carta A, Bravi D. Acetyl-l-carnitine slows decline in younger patients with Alzheimer's disease: a reanalysis of a double-blind, placebo-controlled study using the trilinear approach. Int Psychogeriatr 10(2):193-203. (1998) Abstract.
- Thal IJ, Carta A, Clarke WR, Ferris SH, Friedland RP, Petersen RC, Pettegrew JW, Pfeiffer E, Raskind MA, Sano M, Tuszynski MH, Woolson RE A 1-year multicenter placebo-controlled study of acetyl-l-carnitine in patients with Alzheimer's disease. Neurology 47(3):705-711 (1996). Abstract.
- Pettegrew JW, Klunk WE, Panchalingarn K, Kanfer JN, McClure RJ. Clinical and neurochemical effects of acetyl-l-carnitine in Alzheimer's disease. Neurobiol Aging 16(1):1-4 (1995). Abstract.
- C.S.I.R. (Council of Scientific and Industrial Research). 1948-1976. The Wealth of India. 11 vols. New Delhi.
Furthermore, the name of your product is an implied disease claim. In combination with the general claims regarding weight loss, the name Herbal Phentermine suggests that your product is an alternative to the prescription drug Phentermine. Because Phentermine is a prescription drug intended to treat obesity, which is a disease, the name of your product promotes it for use in the treatment of that disease.
These claims cause your product to be a drug, as defined by Section 201(g)(1)(B) of the Federal Food, Drug and Cosmetic Act (Act), 21 USC 321(g)(1)(B). Because this product is not generally recognized as safe and effective when used as labeled, it is also a new drug as defined in Section 201(p) of the Act [21 USC 321(p)]. New drugs may not be legally marketed in the United States without prior approval from FDA as described in Section 505(a) of the Act [21 USC 355(a)]. FDA approves new drugs on the basis of scientific data submitted by a drug sponsor to demonstrate that the drugs are safe and effective. Your product is also misbranded under section 502(f)(1) of the Act in that the labeling for this drug fails to bear adequate directions for use [21 USC 352(f)(l)]
This letter is not intended to be an all-inclusive review of your website and products your firm markets. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.
Please advise this office, in writing and within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.
Your reply should be addressed to Marshalette Edwards, Compliance Officer, at the address listed on the letterhead.
Sincerely,
/s/
Barbara Cassens
District Director
This page was posted on February 18, 2008.