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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Saurabh Overseas 6/2/10

   

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
  5100 Paint Branch Parkway
College Park, MD 20740

 

 

 

TO:        Saurabh Overseas

Email      pilldude@gmail.com.legal@CASHBURNERS.com.support@securebill.org 110015

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.f1udefence.com on May 10, 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," also referred to as "Swine Flu Defence" on your website. The marketing of this product violates the Federal Food, Drug, and Cosmetic Act (FFDC Act). 21 U.S.C. §§ §§ 331,351, 352, and/or 355. 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 the www.f1udefence.com Home page:

o "Swine Flu Defence- #1 Natural Swine Flu Cure"

o "[A]ttacks the virus"

o "We are proud to announce that finally ... general-purpose cure for swine flu is HERE! Swine Flu Defence will prevent and stop swine influenza ...."

o "[I]ncreases antiviral action against Influenza A (H1N1) & B, bird (avian) flu, herpes, swine flu and even HIV."

o "[N]ow we have a safe and effective cure for swine disease - Flu Defence. You can use it to prevent or to cure swine flu, but it also works against bird flu (avian flu)."

o "With Flu Defence, I lasted all winter with no illness. Also I haven't got Swine Flu, although all my co-workers and neighbours did."

• On a page that links from the "FAQ" tab on the Home page

o "How to prevent or cure Swine Flu (H1N1 )?"

• "[Swine Flu Defence] increases immune system amazingly, which is very important for the preventive against swine cure [sic] disease."

• "[Swine Flu Defence] works as a virus neutralizer. Swine Flu Defence neutralizes problematic hemagglutinin spikes, which are common on the surface of some types of viruses, especially of swine influenza and bird (avian) flu."

• "FluDefence stops both swine or bird flu ion [sic] a totally natural way."

• "Swine Flu Defence also helps with those symptomps [sic]: head aches, body aches, cough, fever and can be taken both as a preventer or as a treatment for all influenza viruses."

• "What's the difference between your product Swine Flu Defence and Tamiflu?" ... Swine Flu Defence is 100% natural - it stops the virus H1N1 completely and increases your immune system to become less susceptible to viruses."

• "We recommend 1 capsule of Flu Defence daily to prevent swine or avian flu."

o "What are the ingredients of Flu Defence?"

• "Elderberry extract[:] This herbs [sic] compounds will bind with viruses neutralizing the activity of the hemagglutinin spikes before they can penetrate the walls of cells, thereby inhibiting their ability to spread."

• "Vitamin C[:] This is one of the most common substances to fight and support flu symptoms. Vitamin C has been proven to boost the bacteria-killing ability of certain immune cells called macrophages and neutrophils."

• "Echinacea extract[:] Well known as a broad-spectrum immune system stimulant Echinacea is most used to protect against, and to treat, common colds, flu, and sore throat."

• "Zinc Oxide[:] ... Zinc is an important element that is required for a number of immune functions, including ... putative antiviral activity."

• On a page that links from the "Testimonials" tab on Home page:

o "Swine Flu Defence is #1 Natural Swine Flu Cure"

o "I have been using it for 1 year and I haven't had the flu!"

o "I needed something safe and effective to protect against the new swine flu pandemic...I bought Swine Flu Defence through your webshop and it really helped me! I am recommending your product to everyone who want [sic] to protect against swine flu."

o "I got swine flu (SF) 2 weeks ago and it was a very bad case. So bad that I thought i [sic] was going to die! Swine Flu Defence pills helped me ... amazingly and I felt better in only 3 hours after consumption. I was completely cured by the following day!"

o "I bought your Flu Defence to keep me safe against recent AH1N1 swine flu pandemic. I work as an air hostess so that protection was really a necessity. have to thank you because I haven't got anything since then, even a cold!"

o "With Flu Defence, I lasted all winter with no illness. Also I haven't got Swine Flu, although all my co-workers and neighbours did."

The claims quoted above are supplemented by the metatags used to bring consumers to your website through Internet searches. The metatags include: "swine flu defence, flu defence, flu defense, natural flu remedy, natural tamiflu and herbal tamiflu shop."

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/h1n1f1u/. 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 listed above to be an unapproved, uncleared, or unauthorized product 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