FDA Cracks Down on Drug Claims and Misbranding
As pointed out previously, it is quite common to hear unapproved drug claims from individuals selling germanium sesquioxide. This is unfortunate as it gives the FDA reason to seek more aggressive actions against germanium products. You’ll find that this is one of the charges leveled by the FDA against germanium in the import alert issued in 1988 and revised in 1995. Profiteers make such claims in order to boost sales, and count on a remote possibility of being caught. The following are excerpts from a warning letter sent to HBX, Inc. May 13, 2004 on account of misbranding and unapproved drug claims associated with their Ge-132 OXY Germanium
"The Food and Drug Administration (FDA) has reviewed your web site at the following address: http://www.germaniumus.com. This review shows serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) in the labeling of your product GE-132 OXY Germanium. You can find the Act and implementing regulations through links on FDA’s Internet home page at www.fda.gov.
Under the Act, articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man are drugs [Section 201(g)(1)(B) of the Act]. Your web site claims that your product is useful in the prevention, treatment, or mitigation of diseases.
Your web site contains the following claims:
“Who should take germanium? Cancer patients, people recovering from cancer operations, and people undergoing chemotherapy. Also effective against diabetes, arthritis, paralysis and Alzheimer’s.”
“Those people who need germanium are as follows: Cancer patients during chemotherapy and radiation or after an operation- Aids, Alzheimer, Lyme disease, Parkinson disease and diabetes, . . . Hepatitis A, B, C, D, E-Heart Disease, High Blood Pressure, Rheumatoid Arthritis, . . . Asthma, . . . relief from Chronic Fatigue, . . . and other incurable diseases.”
“[G]ermanium has shown to be remarkably effective in treating lung cancer, cancer of the bladder, breast cancer, neurosis, asthma, diabetes, high blood pressure, heart failure, empyema, neuralgia, leukemia, encephalomalacia, uterine myoma, and cirrhosis of the liver.”
These claims cause your product to be a drug, as defined in section 201(g)(1)(B) of the Act. Because the 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. Under section 505 of the Act, a new drug may not be legally marketed in the United States without an approved New Drug Application (NDA).
Your web site (http://www.germaniumus.com) contains pictures of the seal of the FDA. The seal is displayed on your web site at numerous places, including the home, purchase, testimonial, and health tips pages. Your product is not approved by FDA, nor has FDA reviewed its formulation or the representations made for it. FDA believes that use of the FDA seal in the manner you have chosen to display it in the promotion of your product implies FDA approval or sanction of your product and its purported uses and thus could cause your product to be misbranded under section 403(a)(1). We request that you remove the pictures of the FDA seal from your web site.
Copyright © 2005 Designed Nutritional Products. For questions or comments E-mail email@example.com