FDA Issues Final Rule on Detaining Adulterated Food

On February 4, the FDA issued a final rule expanding its authority to detain food that may be adulterated or misbranded. The old threshold required the agency to have “credible evidence” that the food product in question posed a threat of adverse consequences to human health; under the new standard, the FDA need only have “reason to believe” that a food product is adulterated.

The agency specifically refused requests from industry to define more specifically what is meant by “reason to believe,” saying that decisions about detaining suspect foods would be made on a case-by-case basis.

That’s a reasonable approach, said Francis (Frank) F. Busta, PhD, senior science advisor and director emeritus with the National Center for Food Protection and Defense at the University of Minnesota. “If your standards for detention are too explicitly defined, someone can figure out how to circumvent those requirements.”

Judging possible adulterated food on a case-by-case basis also keeps the FDA from hamstringing itself with dated information. “There are always new situations, new data sources and new information coming in,” said Karen Everstine, PhD, MPH, a research fellow at the National Center for Food Protection and Defense. “If there’s a case that comes up and the particular circumstance hasn’t arisen before, the agency isn’t held to explicit standards that didn’t anticipate this situation.”

A key focus of Dr. Everstine’s work is economically motivated adulteration of food productions, known as EMA. “That’s getting a lot more attention lately, particularly with the horse meat scandal in European beef products,” she said. “We know that EMA can result in public health consequences.” It also costs the food and consumer products industry between 10 and 15 billion annually.

“This issue [EMA] is just starting to be well recognized, and with the new authority, the FDA really has an opportunity to protect the public,” said Dr. Busta. “Some people in industry have raised concerns that the FDA might overreach their authority, but I’m not sure that the agency has the resources to overextend it even if they wanted to. They’ve got so much to do that I don’t think industry is going to suffer from them seizing too many items.”