FDA Regulations
Cookie dough. Pistachios. Lead-laced baby toys. These are just a few recent examples of the many food, household and other products that are recalled from the U.S. market each year because of potential health hazards. But while voluntary industry recalls help protect against future harm, each successive safety warning inevitably leaves the American public wondering who in the Federal Government is looking out for our well-being.
The answer in most cases is the U.S. Food and Drug Administration (FDA), which is tasked with "protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics and products that emit radiation," according to the agency's website. But in the past several years, the traditionally underfunded and understaffed organization has sometimes been slow to react, or taken no protective action at all, in response to potential dangers.
Take, for instance, the recent consumer-safety warning against Zicam, a popular over-the-counter homeopathic cold remedy. The FDA first began receiving reports of patients' losing their sense of smell after using Zicam nasal products in 1999. Zicam's maker, Matrixx Initiatives, paid $12 million in 2006 to settle hundreds of lawsuits brought by Zicam users who claimed to have lost their olfactory sense.
The FDA finally reacted on June 16, issuing a warning to consumers to stop using Zicam nasal gel and swabs. (The FDA does not regulate homeopathic, nondrug products like Zicam, nor does it have the authority to enforce a product recall; Matrixx continues to sell its products in stores.) Observers say the move is indicative of the new Obama Administration FDA — whose commissioner, Margaret Hamburg, sworn in last month, has promised to pursue enforcement more swiftly and aggressively.
Indeed, just three days after its warning against Zicam, the FDA advised consumers to throw away all prepackaged, refrigerated Nestlé Toll House cookie dough — which Nestlé USA also recalled — because of a risk of E. coli contamination. The recall came after the Centers for Disease Control and Prevention received reports of 66 cases of illness in people who have eaten the dough raw since March 2009.
Following is a look at just what the FDA does and doesn't regulate — and what efforts are being made to toughen the agency's enforcement powers.