Department of Health and Human Services
Public Health Service
Bldg 20, Denver Federal Ctr
July 19, 2006
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED
Dana Kent Hays, DO
Boulder Natural Labs
PO Box 20514
Boulder, CO 80308
Ref. No. DEN-06-20
Dear Dr Hays:
The Food and Drug Administration (FDA) has reviewed your website at the Internet address www.avaflu.com and has concluded that claims in your labeling cause your product "AvaFlu" 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 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 products bears the following implied claims:
- "Photo of the product label: "AvaFlu … Advanced Formula Flu…"
- "There is no guessing whether I have a cold or flu virus. AvaFlu helps both as well as a broad range of flu like viruses."
- "Fights Flu and Flu-like Viruses[:] … Influenza … Parainfluenza.…"
- "Weaken Drug Resistant Viruses and Slow Virus Replication with glycoprotein inhibitors."
These claims that your product prevents and treats avian flu and other forms of influenza 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 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 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.
Your reply should be addressed to Regina A. Barrell, Compliance Officer, at the above address.
B. Belinda Collins
This page was posted on February 12, 2008.