| Public Health Service Food and Drug Administration |
| 5100 Paint Branch Parkway College Park, MD 20740 |
Department of Health and Human ServicesTO: www.fludefence.org C/O Whois Protection, domains@safe-whois.info, legal@CASHBURNERS.com, support@securebill.org
PO Box 76 Belfast, Christchurch, NZ 8030
Registrant ID: 627b589ee1370b5e
From: Food and Drug Administration
RE: Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus
DATE: June 2, 2010
WARNING LETTER
This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address http://www.fludefence.org on April 28, 2010. The FDA has determined that your website offers a product for sale that is intended to diagnose, mitigate, prevent, treat or cure the H1N1 Flu Virus in people. This product has not been approved, cleared, or otherwise authorized by FDA for use in the diagnosis, mitigation, prevention, treatment, or cure of the H1N1 Flu Virus. This product is: "Flu Defence." The marketing of this product violates the Federal Food, Drug, and Cosmetic Act (FFDC Act). 21 U.S.C. §§ 331, 351, 352 We request that you immediately cease marketing unapproved, uncleared, or unauthorized products for the diagnosis, mitigation, prevention, treatment, or cure of the H1N1 Flu Virus.
Some examples of the claims on your website include:
• On a page titled "Flu Defence - Your Natural Flu Remedy"
o "Flu defence is the first 100% natural general-purpose flu remedy that attacks the virus..."
o "[W]ill also neutralize various viruses."
o "[E]xhibits strong antiviral action against influenza A & B, birdflu, herpes, swine flu, and even HIV."
• On a page titled "Frequently Asked Questions?"
o "How Does it Work?...Flu defence will neutralize the activity of the hemagglutinin spikes found on the surface of some types of viruses. When these hemagglutinin spikes are deactivated the viruses can no longer pierce cell walls or enter the cell and replicate. Flu defence also minimizes any symptoms like body aches, cough, and fever and can be taken both as a preventer or as a treatment."
o "What's the difference between Flu Defence and Tamiflu? Tamiflu is a synthetic drug which interferes with viral reproduction ... [w]hile Flu defence is 100% natural and neutralizes the virus completely and increases your natural bodily defences [sic] against viruses."
o "How do I take it? 1 pill daily to prevent flu, with a 1 week break each 4 weeks, or 6 pills daily during acute symptoms (throughout the day)."
• On a page titled "Customer's Testimonials"
o "This is the first year where I haven't had the flu. Thanks to Flu Defence."
o "I had a bad case of the Flu and I thought I was going to die! Incredibly the Flu Defence pills had one feeling better within 2 hrs of consumption and completely cured the following day."
o "I've been taking Flu Defence to keep me safe from the recent pandemic of swine flu. I'm an Air hostess so protecting myself against such as virus is a necessary, since im [sic] at such risk."
The claims quoted above are supplemented by metatags used to bring consumers to your website through Internet searches. These metatags include: ''''flu, flu defense... natural flu remedy, herbal tamiflu."
The Secretary of Health and Human Services, under section 319 of the Public Health Service Act, 42 U.S.C. § 247d, has determined that a public health emergency exists nationwide involving the H1N1 Flu Virus that affects or has the significant potential to affect national security. Following this determination and in response to requests from the U.S. Centers for Disease Control and Prevention, FDA issued letters authorizing the emergency use of certain unapproved and uncleared products or unapproved or uncleared uses of approved or cleared products, provided certain criteria are met, under 21 U.S.C. § 360bbb-3. The marketing and sale of unapproved or uncleared H1N1 Flu Virus related products that are not authorized by and used in accordance with the conditions of an Emergency Use Authorization, is a potentially significant threat to the public health. Therefore, FDA is taking urgent measures to protect consumers from products that, without approval or authorization by FDA, claim to diagnose, mitigate, prevent, treat or cure H1N1 Flu Virus in people.
You should take immediate action to ensure that your firm is not marketing, and does not market in the future, products intended to diagnose, mitigate, prevent, treat or cure the H1N1 Flu Virus that have not been approved, cleared, or authorized by the FDA. The above is not meant to be an all-inclusive list of violations. It is your responsibility to ensure that the products you market are in compliance with the FFDC Act and FDA's implementing regulations. We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that the claims you make for your products do not adulterate or misbrand the products in violation of the FFDC Act. 21 U.S.C. §§ 331, 351, 352. Within 48 hours, please send an email to FDAFLUTASKFORCECFSAN@fda.hhs.gov, describing the actions that you have taken or plan to take to address your firm's violations. If your firm fails to take corrective action immediately, FDA may take enforcement action, such as seizure or injunction for violations of the FFDC Act without further notice. Firms that fail to take corrective action may also be referred to FDA's Office of Criminal Investigations for possible criminal prosecution for violations of the FFDC Act and other federal laws.
FDA is advising consumers not to purchase or use H1N1 Flu Virus-related products offered for sale that have not been approved, cleared, or authorized by FDA. Your firm will be added to a published list on FDA's website of firms and websites that have received warning letters from FDA concerning marketing unapproved/uncleared, and unauthorized H1N1 Flu Virus-related products in violation of the FFDC Act. This list can be found at http://www.accessdata.fda.gov/scripts/h1n1flu/. Once the violative claims and/or products have been removed from your website, and these corrective actions have been confirmed by the FDA, the published list will be updated to indicate that your firm has taken appropriate corrective action.
If you are not located in the United States, please note that unapproved, uncleared, or unauthorized products intended to diagnose, mitigate, prevent, treat, or cure the H1N1 Flu Virus offered for importation into the United States are subject to detention and refusal of admission. We will advise the appropriate regulatory or law enforcement officials in the country from which you operate that FDA considers your product(s) listed above to be unapproved, uncleared, or unauthorized products that cannot be legally sold to consumers in the United States.
Please direct any inquiries concerning this letter to FDA at FDAFLUTASKFORCECFSAN@fda.hhs.gov or by contacting Quyen Tien at 215-717-3705.
Sincerely,
/S/
Donald Kautter
Acting Director
Office of Compliance
Center for Food Safety
And Applied Nutrition
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