Obama’s New Safety Cops

On July 31, 12 federal agents raided a facility in the suburbs of Salt Lake City, seizing $2.7 million dollars worth of finished product and numerous 55-gallon barrels of raw materials. These were not narcotics officers taking down a meth lab, however. The raid was led by the Food and Drug Administration, and they were after skin-care products.

Actually, it was hand sanitizer manufactured by Clarcon Biological Chemical Laboratory Inc., including the brands CitruShield Barrier Lotion and Mom Nature Vastly Superior Sanitizer for Hands. In June, Clarcon voluntarily recalled several of its brands when the FDA discovered that they included "extremely high" levels of bacteria that could cause serious infections that might require "medical or surgical attention." But Clarcon refused to destroy the products after the recall, so the FDA sent in U.S. Marshals to ensure that the recalled sanitizer didn't find its way back onto the market. (Clarcon did not return messages seeking comment.)

Then, on Aug. 7, the FDA sent U.S. Marshals out yet again, this time to seize tuna-salad sandwiches manufactured by Southern Belle Sandwich Co. of Baton Rouge, La., whose Web site describes the company as a family-owned business that supplies convenience stores along the Gulf Coast. (Southern Belle also did not respond to a request for comment.) According to the agency's press release, "Recent FDA inspections found evidence of widespread and active rodent and insect infestation, filthy conditions, and poor employee practices, such as allowing food-processing utensils to lie on the floor near live insects."

The FDA only made eight such raids in all of fiscal year 2008, so executing two within one week is something of an enforcement bonanza. Under the previous administration, FDA enforcement actions of all kinds declined by roughly 50 percent, even though the number of problems identified by field inspectors remained steady, according to a report by the Democratic staff of the House Government Reform Committee. To underscore just how serious the FDA is about cracking down on offenders, President Obama's new FDA commissioner, Dr. Margaret Hamburg, made a speech last week putting manufacturers on notice.

"That … is a stronger speech on the need for enforcement than I've ever heard from an FDA commissioner," says Dr. Sidney Wolfe, acting president of the consumer watchdog group Public Citizen. Michael Druckman, who spent seven years in the FDA's Office of Chief Counsel under President George W. Bush, similarly remarked he could not recall a commissioner ever devoting an entire speech to enforcement.

It may be more alarming than reassuring to learn that Hamburg's speech was so remarkable to veteran FDA observers. Though she laid out some procedural changes to streamline enforcement, the core message of her speech was that, "a strong FDA enforces the law" by regularly inspecting food and drug manufacturers and taking swift and visible action when violators endanger the public health. One would like to think this has always been the standard operating procedure for the country's top consumer safety agency, not a radical new idea from a commissioner just confirmed in May.