Department of Health and Human Services' logo Department of Health and Human Services

Public Health Service
Food and Drug Administration
  Silver Spring, MD 20903


TO: (b)(6)
FROM: United States Food and Drug Administration
RE: Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus
DATE: May 3, 2009

This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address on May 2, 2009. The FDA has determined that your website offers a product for sale that is intended to mitigate, prevent, treat or cure the H1N1 Flu Virus in people. This product, the Swine Flu Protection Kit, has not been approved, cleared, or otherwise authorized by FDA for use in the mitigation, prevention, treatment, or cure of the H1N1 Flu Virus or any other human or animal disease. The marketing of this product violates the Federal Food, Drug, and Cosmetic Act (FFDC Act). 21 U.S.C. §§ 331, 351, 352. You must immediately cease marketing unapproved, uncleared, or unauthorized products for the diagnosis, mitigation, prevention, treatment, or cure of the H1N1 Flu Virus or any other human or animal disease.

Some examples of the claims on your website include:

Text on the page that is masked 1 because the text is white on a white background, examples of which include:

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, under 21 U.S.C. § 360bbb-3, the emergency use of certain unapproved and un-cleared products or unapproved or un-cleared uses of approved or cleared products. The marketing and sale of unapproved or un-cleared products in connection with the H1N1 Flu Virus, which 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.

FDA is taking urgent measures to protect consumers from products that, without approval, authorization, or clearance by FDA, claim to diagnose, mitigate, prevent, treat or cure H1N1 Flu Virus. You should take immediate action to ensure that your firm is not marketing such products and does not market them in the future. 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 violate the FFDC Act’s approval, adulteration, or misbranding provisions.

Within 48 hours, please send an email to describing the actions that you have taken or plan to take to address your firm's violations and to prevent their recurrence. Additionally, if another firm manufactures the products identified above, your reply should include the name and address of the manufacturer. If the firm from which you receive the products is not the manufacturer, please include the name of your supplier in addition to the manufacturer.

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.

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 unapproved, un-cleared, and unauthorized H1N1 Flu Virus-related products marketed in violation of the FFDC Act. Once the violative claims and/or products have been removed from your website, and these corrective actions have been confirmed by 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, un-cleared, 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 may advise the appropriate regulatory officials in the country from which you operate that FDA considers the products listed above to be unapproved, uncleared, or unauthorized products that cannot be legally sold to consumers in the United States.

Please direct any inquiries to FDA at

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This page was posted on January 31, 2010.

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