FDA sends warning notices to those exploiting H1N1; enforcement imminent says experts

Dietary supplement companies that are making online claims to cure, or even promise to treat H1N1, known as the swine flu, run the risk of being criminally charged by the U.S. Food and Drug Administration, the agency has warned.

The FDA began issuing warning letters in April. Recently, warnings were received by the makers of Extreme Immunity 100% Pure Immunolin, Amazon A-V, Four Thieves Spray, and Swine Flu Formula. Unless corrective action is taken within 48 hours of receipt of the warning letter, the FDA will seize, sanction and file criminal charges against the manufacturers.

Within hours of announcements from the Center for Disease Control that the swine flu might reach dangerous proportions, hundreds of Web sites and URLs began touting cures and treatments for H1N1. Both the FDA and the Federal Trade Commission sent out a general forewarning to cease making false claims. Apparently some companies didn't get the memo, or at the very least, they failed to take the federal warning seriously.

"Over the past several years there has been a tendency in the supplement industry to treat warning letters almost as suggestions that you might want to consider changing your marketing," said Marc Ullman, an industry expert and law partner in New York City-based Ullman, Shapiro and Ullman. "Under the current regime at FDA that approach would probably be a large mistake. FDA enforcement appears to have taken on a new vigor with the Obama administration, and I would expect that failure to adequately respond to (a) warning letter would put the recipient at significant risk of serious enforcement action."

The Federal Trade Commission also warned Web site operators who made claims that their products can prevent, treat, or cure H1N1 virus, that they must have scientific proof to support any claims. This included dietary supplements, air filtration devices, and cleaning agents.

"Scam artists follow the headlines, trying to make a fast buck with products that play off the news — and prey on concerned people," said Eileen Harrington, acting director of the FTC's Bureau of Consumer Protection, in a statement. "We're online and telling e-marketers their sites must comply with the law."

According to the FTC, the agency has identified at least 10 Web sites making suspect flu treatment, prevention, or cure claims. A handful of domestic Web sites have already complied with requests to remove questionable Web pages. The others are under review by the FDA, FTC and FTC international counterparts.

The four major industry trade associations issued a statement that said they are unaware of any scientific data supporting the use of dietary supplements to treat swine flu.

"Furthermore, federal law does not allow dietary supplements to claim to treat any diseases, including swine flu," according to the American Herbal Products Association, the Consumer Healthcare Products Association, the Council for Responsible Nutrition and the Natural Products Association.

The only products recommended for use are the prescription antiviral drugs, Oseltamivir (brand name Tamiflu) and Zanamivir (brand name Relenza).