Inspections, Compliance, Enforcement, and Criminal Investigations
United Healthcare Laboratories 07-Jan-05
Department of Health and Human Services
Public Health Service
5100 Paint Branch Pkwy, HFS-607
JAN 7 2005
United Healthcare Laboratories
7271 Paramount Blvd.
Pico Rivera, CA 90660
To Whom It May Concern:
The Food and Drug Administration (FDA) has reviewed your web site at the Internet address http://www.fluaway .net and has concluded that claims in your labeling cause your product "Flu Prevention Total Body Defense" to be a drug as defined in section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) . You can find the Act and FDA's regulations through links on FDA's Internet home page: http://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 and treatment of influenza.
The Internet labeling of your product bears the following claims:
"200% Guaranteed Flu Prevention"
"Strengthen your body's ability to fight the flu"
"Total Body Defense--The #1 Recommended Flu Shot Alternative"
"Recommended by doctors to prepare for the upcoming flu season due to shortage in flu vaccines."
"Total Body Defense™ contains Methiserimmume™ to . . . help you fight the flu and all other common diseases ."
Furthermore, your website includes additional claims about ingredients in the product for prevention and treatment of other diseases such as cancer, cardiovascular disease, HIV, cystic fibrosis, pneumonia, etc. Examples of these claims include:
"Garlic apparently stimulates the body's immune system, particularly enhancing the macrophages and lymphocytes, which destroy cancer cells . . .."
"[A] number of experiments using an [sic] garlic product . . . concluded that it prevents and suppresses cancer."
"A group of researchers . . .used an aged garlic extract to treat melanoma, a skin cancer . . . . They also concluded that garlic suppressed the growth of cancerous cells."
"Green tea extract has become popular because of . . . its use in the prevention and treatment of a wide range of diseases. Surveys conducted in Japan show that people who consumed green tea had much lower incidence of stomach, liver, pancreatic, breast, lung, esophageal and skin cancers."
"[C]ysteine supplementation has been shown to suppress HIV replication . . . ."
"Heart disease. Cancer. AIDS . As unbelievable as it might sound, each of these deadly diseases often responds to a conenzyme Q10 . . . ."
[T]he benefits of this nutrient [Coenzyme Q10] are well documented in the medical journals. It's one of the most frequently prescribed heart "drugs" in Japan and widely used in Europe-and one company even owns the patent for the CoQ 10 treatment of AIDS ."
These claims cause your product Flu Prevention Total Body Defense 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). This drug is also misbranded within the meaning of section 502(a) of the Act because its labeling is false and misleading in that it suggests that the drug is effective for the prevention and treatment of influenza and other serious diseases, when, in fact, these claims are not supported by competent and reliable scientific evidence. This drug is also misbranded within the meaning of section 502(f)(1) of the Act, in that its labeling fails to bear adequate directions for use.
This letter is not an all-inclusive review of your websites 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 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 ensure 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 Compliance Officer Quyen Tien at the above address.
Joseph R. Baca
Office of Compliance
Center for Food Safety and Applied