FDA action against false H1N1 claims swift and substantial

Any public health crisis brings out the best and the worst in Americans. The best include the public health workers who work tirelessly to contain the crisis, and of course the countless cases of neighbors helping neighbors in need. Sadly, the worst include those trying to make a quick buck from a crisis, such is the case with H1N1 and selling bogus dietary supplements and other products that illegally claim to treat or prevent the disease.

Like Severe Acute Respiratory Syndrome (SARS), avian flu, anthrax in the mail, and others crises before it, the 2009 H1N1 Influenza (H1N1) (also known as "swine flu") is no different with respect to the spike in fraudulent products being sold on the internet to frightened consumers.

What is different about the H1N1 crisis is the speed and effectiveness with which the Food and Drug Administration (FDA) has acted to protect the public from these illegal products. On April 17, 2009, the first two cases of H1N1 flu virus were confirmed in the U.S. Less than two weeks later, on May 1, 2009, the FDA and the Federal Trade Commission (FTC) issued a warning to consumers about fraudulent H1N1 products being sold online. In the warning, FDA announced that it had "developed an aggressive strategy to identify, investigate, and take regulatory or criminal action against individuals or businesses that wrongfully promote purported 2009 H1N1 influenza products in an attempt to take advantage of the current flu public health emergency."

FDA's strategy resulted in fast and significant results. Shortly after the May 1, announcement, FDA started issuing Warning Letters to companies selling these products. According to FDA, as of June 15, 2009, it had issued more than 50 warning letters. To put that number into context, in all of 2008, FDA issued less than 50 warning letters in total to the entire dietary supplement industry. While it can be very difficult to actually identify the entity selling a product over the internet, much less get it to comply, FDA reports that more than 66 per cent of these Web sites have removed the offending H1N1 claims and/or products.

Another way to put the speed and magnitude of FDA's efforts against illegal H1N1 products into perspective is to compare it to FDA's response in the case of SARS products. On March 17, 2003, the Centers for Disease Control and Prevention (CDC) first announced that 14 suspected SARS cases were being investigated in the U.S. FDA and FTC first warned consumers about online companies selling illegal SARS treatment and prevention products two months later, on May 9, 2003. FDA took action against only 10 of those companies.

The wild world of the internet poses a daunting challenge to anyone trying to police it. Despite their best efforts, no regulator can identify all of the bad actors, nor can it expect that every company it does target will voluntarily comply. That said, even with its resource constraints, FDA is taking extraordinary measures to protect the public from illegal H1N1 products, and should be applauded for its efforts. This crisis has brought out the best in FDA.

Ivan J. Wasserman is a partner at Mannatt Phelps and Phillips law firm. Manatt is a national law firm with range of specialized capabilities typically found only in boutique firms. Its practice in the nutraceutical industry includes FDA and FTC compliance, trademarks and patents, and litigation. www.manatt.com, 202.585.6529

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