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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Galens Garden 17-Dec-04

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

5100 Paint Branch Pkwy, HFS-607
College Park, Maryland 20740




DEC 17 2004

WARNING LETTER

CERTIFIED MAIL
RETURNED RECEIPT

Galen Ballard
Galens Garden
7941 22nd Avenue North
St. Petersburg, Florida 33710

Dear Mr. Ballard:

The Food and Drug Administration (FDA) has reviewed your web site at the Internet address http://www.galensgarden.com and has concluded that claims in your labeling cause your product "Factor 12: Opti-cillin" 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:

  • "Factor Twelve: Opti-cillin . . . providing antibacterial, antiviral, and antifungal support against infections and infectious diseases ."

  • "Factor Twelve: Opti-cillin is an alternative to yearly flu shots."

  • "[A]n alternative solution for the growing ineffectiveness of synthetic antibiotics ."

  • "Herbal Antibiotic, Antiviral, and Antifungal Product"

  • "A Flu Shot Alternative!"

  • "At first signs of infection, [or] flu. . . take 3 capsules twice daily for 10 days for maximum therapeutic benefit ."

In addition, your website provides a list of groups that you claim may benefit from taking Opti-cillin, including people suffering from seasonal chronic colds or flu, people susceptible to bronchitis or pneumonia, people with chronic fungal skin infections, and people with herpes simplex Type 1 or 2.

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 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. Please note that we observed similar claims for your products on another website you operate, www.titanlabs.com.

This letter is not an all-inclusive review of your websites 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.

Sincerely,

/S/

Joseph R. Baca Director
Office of Compliance
Center for Food Safety and Applied Nutrition