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H1N1 Flu: FDA Responds Quickly to Protect the Public's Health

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Working as part of a team led by the U.S. Department of Health and Human Services (HHS), the Food and Drug Administration (FDA) stood ready with a plan in place as soon as the spread of the 2009 H1N1 flu virus became evident.

HHS is coordinating efforts of the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), FDA, and other federal health agencies to mobilize against the H1N1 influenza (flu) outbreak. As the situation developed, FDA instituted an H1N1 incident management system to protect the public's health.

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Teamwork is Key

Through the incident management system, FDA is ensuring effective coordination in the areas of operations, logistics, and communications—as well as among several cross-cutting teams involving the agency's centers.

"Among us are laboratory scientists, medical reviewers, epidemiologists, product experts, and field inspectors," says FDA Acting Commissioner Joshua M. Sharfstein, M.D. "We are fully committed and engaged in protecting the nation during this difficult time."

The system made it possible for FDA to quickly

  • initiate close collaboration with CDC and other HHS agencies, the World Health Organization (WHO), and foreign governments
  • issue several emergency use authorizations
  • provide timely updates on a Web page devoted to the outbreak.
  • partner with the U.S. Federal Trade Commission (FTC) to alert the public about fraudulent products claiming to diagnose, prevent, treat, or cure the H1N1 flu virus

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FDA's Cross-Cutting Teams

  • The Vaccine Team focuses on making a safe and effective vaccine for the H1N1 flu available as soon as possible.
  • The Antiviral Team works on issues regarding antiviral drugs that can be used to prevent and treat illness caused by this novel flu virus.
  • The In Vitro Diagnostics Team identifies and evaluates diagnostics that can help test for the H1N1 virus.
  • The Personal Protective Equipment Team works to identify and evaluate personal protective equipment such as respirators, face masks, and gloves that may help reduce the risk of exposure to the H1N1 virus, and to increase the availability of such equipment.
  • The Blood Team is dedicated to the safety and availability of blood and blood products needed for transfusion by the public during this flu outbreak. (The H1N1 flu outbreak has not affected the U.S. blood supply, but FDA is monitoring the situation for any developments.)
  • The Drug Shortage Team works to ensure the availability of medical products such as antiviral drugs.
  • The Consumer Protection Team focuses on fraudulent and potentially dangerous products.

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Emergency Use Authorization

Through an Emergency Use Authorization (EUA), the Project BioShield Act of 2004 gives FDA authority to make promising drugs, biologics, and devices quickly available in emergencies.

This Act allows FDA, based on an evaluation of available data, to

  • authorize the emergency use of unapproved or uncleared medical products
  • authorize the unapproved or uncleared use of approved or cleared medical products

The authorization may remain in effect for the duration of the declaration justifying the emergency use (up to one year). The declaration may be terminated prior to one year or renewed at the end of one year. FDA can revoke an EUA if, for example, the criteria for issuance are no longer met.

Soon after HHS declared a nationwide public health emergency on April 26, 2009, FDA issued authorizations for the emergency use of certain influenza medicines, diagnostic tests, and certain personal respiratory protection devices.

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A Warning Against Fraud

On May 1, 2009, FDA and the FTC warned that consumers who purchase products which claim to protect against or treat the 2009 H1N1 virus, but are not approved by FDA for the treatment or prevention of influenza, are risking their health and the health of their families.

These fraudulent products come in all varieties and could include dietary supplements, medical foods, or products that claim to prevent or cure the 2009 H1N1 influenza.

FDA announced that it has initiated an aggressive strategy to identify, investigate, and take regulatory or criminal action against individuals and businesses that wrongfully promote purported 2009 H1N1 influenza products in an attempt to take advantage of the current flu public health emergency.

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This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

Date Posted: May 12, 2009

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