Inspections, Compliance, Enforcement, and Criminal Investigations
Davis, Robert 24-Jan-06
Department of Health and Human Services
Public Health Service
555 Winderley PI., Ste. 200
RETURN RECEIPT REQUESTED
January 24, 2006
7392 Brunswick Circle
Boynton Beach, FL 33437
Dear Mr. Davis:
The Food and Drug Administration (FDA) has reviewed your web site at the Internet address http://www.All-natural-interferon.com and has concluded that claims in your labeling cause your product All-natural Interferon to be a drug as defined in section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)]. 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, 21 U.S .C. 321(g)(1)(B)]. Your web site claims that your product is useful in the prevention and treatment of avian flu and other forms of influenza.
The Internet labeling of your products on your web site bears the following claims:
"Is there anything we can do to prevent ourselves from contracting bird flu? . . . You want an immune system booster like our all-natural interferon, the plant-based miracle which mimic interferon, your own body's antibody-producing agent."
"This all-natural interferon stimulates your body's production of interferon . Interferon is a protein which is created by your body: it enhances your immune system so you develop potent protection against global health threats like an influenza pandemic. . . Interferons in the body also ward off ... common forms of influenza...."
These claims cause your product to be a drug, as defined in section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)]. Because your 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 U.S. C. 321(p)]. Under section 505 of the Act [21 U.S .C. 355(a)], 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 [21 U.S .C. 352(a)] because its labeling is false and misleading in that it suggests that this drug is effective for the prevention and treatment of avian flu and other forms of influenza when, in fact, these claims are not supported by competent and reliable scientific evidence.
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.
You must immediately correct these violations. If you do not immediately correct them, you may be subject to enforcement action without further notice. The Act provides for seizure of illegal products and for injunctions against the manufacturers and distributors of illegal products [21 U.S.C. 332 and 334]. Individuals and businesses that violate the Act may also be subject to criminal prosecution.
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 Shari H. Shambaugh, Compliance Officer, U.S. Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida 32751.
Emma R. Singleton
Director, Florida District