ON MAY 23, FDA INSPECTORS visited the Sargento plant in Plymouth, Wis., and took some cheese samples for bacteria testing. Such visits are relatively routine–two or three a year, according to a company spokeswoman. Sargento took its own samples from the same lot of cheese and sent them off for independent testing. At the end of May, the independent test showed no bacteria, and the FDA called back and said its samples, too, were bacteria-free. Sargento shipped the cheese. Then, at the end of July, the FDA called again and said there was a problem. The regulatory agency had found traces of listeria, a bacteria that causes flu-like symptoms or fevers in most people, but can be fatal if ingested by someone with a weak immune system. That finding triggered further investigation, with both Sargento and the FDA retesting their samples, and the Wisconsin Department of Agriculture conducting a test of its own. The results? The FDA said the cheese was fine. The Wisconsin Agriculture Department said the cheese was fine. The Sargento-commissioned tests said the cheese was fine. But the FDA was not satisfied. It has a “zero tolerance” policy on listeria, and it recommended a recall. Sargento officials were obviously concerned, especially because the cheese had been tested and retested, each time showing no signs of listeria. “We had a lot of discussions with all sorts of FDA officials, because we knew what the potential harm to our reputation could be,” says Barbara Gannon, a spokeswoman for Sargento. “The FDA said, ‘If you don’t issue the recall, we will.'” On July 27, Sargento issued a “voluntary” recall of 108,000 pounds of cheese. The press coverage was overwhelming. The recall was reported on 269 local radio and television stations and in more than 200 newspapers, according to a Sargento study. “Pretty much every major metro area had it,” says Gannon. Even worse, CNN put the recall in its half-hour Headline News loop. Sargento phones lit up. In the day after the CNN report aired–and aired, and aired, and aired–Sargento operators answered 1,800 calls from consumers. The switchboard was overwhelmed, so the company set up an automated recording to help with the staggering number of calls. Another 9,000 went to the recording. Then, on August 24, everything changed. FDA Regional Food and Drug director Gary Pierce sent a letter to Sargento CEO Lou Gentine. The finding of bacteria, he wrote, was “incorrect.” The FDA regrets “the difficulties this has caused your company.” Early estimates of the “difficulty” Sargento has experienced run to several hundred thousand dollars. But Sargento’s Gannon allows that the real-dollar cost of recalling, securing, and destroying the cheese could be much higher. The more serious damage, of course, is the incalculable, fuzzy cost of brand injury–the shopper’s pause in the grocery store aisle after reaching for any Sargento product. “Hmmm, wasn’t this the company…can’t remember. Oh well, I’ll get Lucerne instead.” Aside from sending the letter and removing the recall announcement from its website, the FDA has done nothing to correct the mistake. The FDA website makes no mention of it, and there are no press releases indicating that the FDA has attempted to ameliorate this costly error. Worse, though, is that FDA representatives will not speak publicly about it. Repeated calls to Carrie Ainsworth-Wright in the FDA office of public affairs, and to Gary Pierce, the author of the letter to Sargento, have gone unreturned. Sargento, of course, could sue. But Gannon calls that “highly unlikely.” “We are regulated by the FDA,” she explains. “Everything we do.” In fact, both Gannon and Gentine, the CEO, say they understand the mistake and even praise the FDA. “It’s a big job they have, and they don’t make this kind of mistake very often,” says Gannon. “Although there was a lab error in this unusual case, we continue to be supportive of FDA’s important role to ensure the wholesomeness of the food supply,” said Gentine, in a statement. All indications are that the Sargento folks are right: Such grievous errors are rare. But what does it say about our regulatory state that companies are so afraid of the government that they do not attempt to recover their losses when its mistakes do serious damage to their business? And what does it say about the regulators that they take no positive action to mitigate the losses a mistake has caused? Indeed, that they won’t even discuss what led to the error, or ways to prevent similar errors in the future? Stephen F. Hayes is staff writer at The Weekly Standard.
