|Subject:||Labeling/Promotional Claims False & Misleading/New Drug|
|Issuer:||Los Angeles District Office|
|Issued:||Feb. 2, 2006||Closed:||
Department of Health and Human Services
Public Health Service
Los Angeles District
RETURNED RECEIPT REQUESTED
February 2, 2006 W/L 15-06
3959 E. Speedway Blvd. Suite 316
Tucson, AZ 85712
The Food and Drug Administration (FDA) has reviewed your web site at the Internet address http://www.progressivedoctors.com and has concluded that claims in your labeling cause your products ImmunoFlu™ Flu and Cold Formula and ImmunoFlu™ Daily Immunity Boost/Energy Formula to be drugs 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 products are 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:
(under heading "Influenza / Bird Flu/Colds") "The Most Powerful Natural/Organic...Anti-Flu Formulas"
"No Other Products (Prescription or OTC), Can Compare to The Powerful Therapeutic Effects That Address The Cause of...The flu - Be It Viral or Bacterial"
These claims cause your products to be drugs, as defined in section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)]. Because your products are not generally recognized as safe and effective when used as labeled, they are also new drugs 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 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. If you have any questions concerning this letter, you may contact Barbara Rincon, Compliance Officer at telephone number (949) 608-4439.
Your reply should be addressed to:
Pamela B. Schweikert
Director, Compliance Branch
U.S. Food & Drug Administration
Irvine, CA 92612
Alonza E. Cruse