Inspections, Compliance, Enforcement, and Criminal Investigations
Hamrick's LLC 14-Aug-06
Department of Health and Human Services
Public Health Service
Los Angeles District
August 14, 2006
17216 Saticoy St., Suite 345
West Van Nuys, CA 91406
The Food and Drug Administration (FDA) has reviewed your web sites at the Internet addresses http:/www.avn36.com and http://www.birdflustopper.com and has concluded that claims in your labeling cause your product "avn 36" 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 sites claim that your product is useful in the prevention and treatment of avian flu.
The Internet labeling of your products bears the following claims:
"With the rising concern about the spread of Avian Influenza (Bird Flu), daily consumption of avn 36 will give you a great defense and help your body resist this fatal influenza."
"Introducing a Powerful Immune System Booster to Help Protect Your Family Against Bird Flu"
"Did you know that boosting your immune system is a great way to fight off bird flu? All-natural avn36 is a special supplement which strengthens your body's immune system defenses. From the very first tablet, you'll help your family remain healthy - regardless of the pathogens they may be exposed to. By using avn36 you'll have a better chance of avoiding the coming bird flu pandemic . . . . We're so confident in the effectiveness of avn36 that we even offer a 60-day, 100% money back guarantee."
In addition, the use of "birdflustopper" in the name of your website suggests that avn 36, which is pictured and offered for sale on the home page of the website, is intended to prevent or treat influenza.
These claims cause your product to be a drug, as defined in section 201(g)(1)(B) of the Act. 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. 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 this drug is effective for the prevention and treatment of avian flu when, in fact, these claims are not supported by competent and reliable scientific evidence.
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.
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. 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. Include any documentation necessary to show that correction has been achieved. 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
Irvine, CA 92612
Alonza E. Cruse