|Company:||Chi Machine International|
|Subject:||Labeling/New Drug Application|
|Issuer:||Center for Food Safety and Applied Nutrition|
|Issued:||Jan. 7, 2005||Closed:||
Department of Health and Human Services
Public Health Service
5100 Paint Branch Pkwy, HFS-607
JAN 7 2005
Chi Machine International
4222 Ethel Avenue, Suite 24
Studio City, CA 91604
To Whom It May Concern:
The Food and Drug Administration (FDA) has reviewed your web site at the Internet address http://www.chimachine4u.com and has concluded that claims in your labeling cause your product "BetaLoe Immune System Defense Supplement" 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 and other diseases.
The Internet labeling of your product bears the following claims:
"Protection for defense against flu, SARS, and Anthrax"
(Testimonial) "The usual dose of 2 tablets, taken on an empty stomach will substantially lower the risk of developing Influenza & other infections. I have several patients on BetaLoe . . . no one has come down with Influenza."
" "Why would a person want to use BetaLoe? . . . Look around you . . .SARS outbreaks, deadly flu outbreaks, Anthrax threats . . . ."
Your website also makes claims about ingredients in the product for prevention and treatment of other diseases, including arthritis, coronary heart disease, and cancer.
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). 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 website 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 Nutrition