Disability Law

ABC World News (6/16, story 5, 2:05, Stephanopoulos) reported, "The Food and Drug Administration today told the makers of one of the country's most popular cold medications, Zicam, to stop selling its nasal spray and swabs. In the last ten years, about 130 consumers have filed complaints, saying they permanently lost their sense of smell after using Zicam."

The CBS Evening News (6/16, story 6, 1:30, Ashton) reported that "the FDA is not responsible to regulate" the safety of products like Zicam, "an over-the-counter remedy containing some natural ingredients" before it "comes to market," but the agency is "responsible to regulate its safety after it's been on the shelf." NBC Nightly News (12/6, story 4, 0:25, Williams) added that Zicam manufacturer Matrixx "has suspended shipments of the products, but says the warning is not supported by scientific evidence and is asking the FDA for a review."

Wall Street Journal reports that William Hemelt, Matrixx's acting president and chief operating officer, said, "This isn't a new issue for us. We've certainly studied it for many years, and we think our products are safe." The agency warned against the use of "nasal zinc-containing products, which are sold as Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Gel Swabs." Regulators "also warned against Zicam Cold Remedy Swabs, Kids Size." But, "the FDA's action doesn't affect other Zicam products."

Commenting on the products, Dr. Margaret Hamburg, FDA commissioner, "said the incidence of anosmia associated with Zicam 'strikes us as a fairly large problem,'" the New York Times reports. The company "paid $12 million to settle 340 lawsuits from Zicam users who claimed that the product destroyed their sense of smell" in 2006, and "hundreds more such suits have since been filed."

The Los Angeles Times reports that the company will be required to "receive FDA approval" if it "wants to market the products in the future," Deborah Autor, director of compliance for the FDA's Center for Drug Evaluation and Research, explained. The company may have received 800 reports "of anosmia...associated with the use of the products from doctors and consumers," but has failed to "forward such reports to the FDA." Autor said that the agency has "asked Matrixx to provide" regulators with the reports.

The AP reports that the company said "it will consider withdrawing the products." Meanwhile, "government scientists say they are unaware of any data supporting Zicam's labeling, which claims the drug reduces cold symptoms, including 'sore throat, stuffy nose, sneezing, coughing and congestion.'"

From the American Association for Justice news release.