Inspections, Compliance, Enforcement, and Criminal Investigations
Global Healing Center 13-Mar-06
Department of Health and Human Services
Public Health Service
March 13, 2006
RETURN RECEIPT REQUESTED
Global Healing Center
Dr. Edward F. Group, III
2040 North Loop West Suite 108
Houston, TX 77018
The Food and Drug Administration (FDA) has reviewed your web site at the Internet address http://www.ghchealth.com and has concluded that claims in your labeling cause your product ViraZAP 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 treatment of avian flu.
The Internet labeling of ViraZAP on your web site bears the following claim
"Avian Flu Treatment
Help treat symptoms of Flu! Strengthen your immune system. Use ViraZap today. http://www.ghchealth.com/avian-flu-treatrnent.php"
The heading for the main page featuring ViraZAP also bears the claim "Avian Flu Treatment." The claim that ViraZap is an avian flu treatment causes 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 letter is not an all-inclusive review of your web site 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 this violation. If you do not immediately correct it, 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 violation 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 Edwin Ramos at the above address. If you have any questions regarding any issue in this letter, please contact Mr. Ramos at (214) 253-5218:
Michael A. Chapp