Unapproved, uncleared, or unauthorized products that claim to diagnose, mitigate, prevent, treat or cure the 2009 H1N1 flu are illegal and a potentially significant threat to the public health.

These warning letters were the result of daily Internet surfs conducted by the FDA's Office of Enforcement, Office of Criminal Investigations, and staff from the Center for Devices and Radiological Health, the Center for Drug Evaluation and Research, and the Center for Food Safety and Applied Nutrition. The warning letters issued by e-mail and the FDA requested a response within 48 hours.

In addition, the FDA posted the offending Web sites and products on the agency's Web site.

"Taking swift action to inform unsuspecting consumers about products that could be dangerous to their health is a major priority for the FDA," said Hamburg.

The FDA will consider further civil or criminal enforcement action against those Web sites that fail to resolve the violations cited in warning letters. Actions could include seizure, injunction, and criminal prosecution.

For more information: FDA's Fraudulent H1N1 Flu Virus Product List

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