Inspections, Compliance, Enforcement, and Criminal Investigations
HBX, Inc. 13-May-04
Department of Health and Human Services
Public Health Service
College Park, Maryland 20740
MAY 13 2004
RETURN RECEIPT REQUESTED
40-16 82nd ST
Elmhurst, NY 11373
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.
The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products.
You should take prompt action to correct these deviations and prevent their future recurrence. Failure to do so may result in enforcement action without further notice.
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.
You should direct your reply to Kristen Moe, Compliance Officer, at 5100 Paint Branch Parkway (HFS-607), College Park, MD. If you have any questions concerning this letter, please contact Ms. Moe at 301-436-2064.
Joseph R. Baca
Office of Compliance
Center for Food Safety
and Applied Nutrition