Department of Health and Human Services' logo Department of Health and Human Services

Public Health Service
Food and Drug Administration
Dallas District

 

4040 N. Central Expwy
Dallas, TX 75204-3145

March 13, 2006
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED

Edward F. Group, III
Global Healing Center
2040 North Loop West #108
Houston, TX 77018

Ref. No. 2006-DAL-WL-15

Dear Mr Group:

The Food and Drug Administration (FDA) has reviewed your website at the Internet address 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 USC 321(g)(1)(B)]. You can find the Act and FDA's regulations through links on FDA's Internet home page 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 USC 321(g)(1)(B)]. Your website claims that your product is useful in the treatment of avian flu.

The Internet labeling of ViraZAP on your website bears the following claim:

"Avian Flu Treatment

Help treat symptoms of Flu! Strengthen your immune system. Use ViraZap today. 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 USC 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 USC 321(p)]. Under section 505 of the Act [21 USC 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 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 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 USC 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.

Sincerely,
/s/
Michael A. Chappell
District Director

This page was posted on February 12, 2008.

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