Department of Health and Human Services
Public Health Service
Irvine, CA 92612-2506
February 2, 2006
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED
3959 E Speedway Blvd #316
Tucson, AZ 85712
Ref. No. 15-06
Dear Sir or Madam:
The Food and Drug Administration (FDA) has reviewed your website at the Internet address 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 USC 321(g)(1)(B)]. You can find the Act and FDA's regulations through links on FDAÕs Internet homepage: 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 prevention and treatment of avian flu and other forms of influenza.
The Internet labeling of your product 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 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 drug is also misbranded within the meaning of section 502(a) of the Act [21 USC 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 is not an all-inclusive review of your website and the products 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 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 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. 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
US Food and Drug Administration
Irvine, CA 92612
Alonza E. Cruse
This page was posted on February 12, 2008.