Inspections, Compliance, Enforcement, and Criminal Investigations
PolyCil Health Inc 23-Nov-05
Department of Health and Human Services
Public Health Service
Los Angeles District
November 23, 2005
PolyCil Health Inc
2420 W. Carson Street #210
Torrance, California 90501
Dear Mr. Benveniste:
The Food and Drug Administration (FDA) has reviewed your website at the Internet address http://www.immunocil.com and has concluded that claims in the labeling for your product Immunocil™cause the product 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 homepage: 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 website claims that your product is useful in the prevention and treatment of avian flu and other forms of influenza.
The Internet labeling of your product bears the following claims:
"about a month ago, I started to feel typical flu symptoms. I was sneezing, felt achy and feverish. A Friend of mine gave me six Immunocil™ tablets that I started taking one a day. After six days, I felt great, and all the symptoms went away."
"When taken as a daily nutritional supplement, Immunocil™ can work as a virus inhibitor by helping to prevent the replication and spread of common viruses..."
"Immunocil™ has been shown to act as a viral-cell infusion inhibitor for *** Influenza (flu) types A-B."
"An Alternative to the Flu Shot."
"Immunocil™...has been shown in studies...to inhibit the spread of some common viruses, including the flu, Immunocil's active ingredient, Humic Acid, blocks viruses, such as the flu, from attaching to a host cell in your body."
"Immunocil™ can be taken for both flu prevention and treatment. For prevention, laboratory studies have shown that Immunocil™ blocks viruses from replicating and spreading, preventing you from getting sick. Studies have also shown Immunocil™ to be effective as a treatment."
The Internet labeling for Immunocil™ also makes specific reference to "Asian bird flu" and suggest that the product is effective in preventing and treating that form 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 their 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 an all-inclusive review of your website and the products that your form 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 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 haven 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:
Pamela A. Schweikart
Director of Compliance
US Food ad Drug Administration
Irvine, CA 92612
Alonza E. Cruse