The U.S. Food and Drug Administration (FDA) has classified the recall of Taylor Farms (Taylor Fresh Foods) iceberg lettuce, the vehicle of illness in the ongoing nationwide cyclosporiasis outbreak, to Class I, accompanied by a statement clarifying what FDA’s recall classification means and why it should not be cause for public panic.

No details about the recall or FDA’s advice to the public have changed. As of August 28, the agency is "confident that all recalled iceberg lettuce related to this specific Cyclospora outbreak is off the market." 

Clarifying Taylor Farms Lettuce Recall Classification

FDA uses three classification levels—Class I, Class II and Class III—to communicate the relative degree of health risk associated with a recalled product. FDA has classified the Taylor Farms lettuce recall as Class I, meaning the agency deemed the recall to be “a situation in which there is a reasonable probability that the use of, or exposure to, a recalled product will cause serious health consequences or death.”

The classification decision was made based on the strength of the epidemiology connecting the outbreak to the recalled lettuce, along with the unprecedented scope and severity compared to previous foodborne incidents involving Cyclospora.

Typically, outbreaks involving Cyclospora are considered Class II, which indicates “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.” However, given the sheer number of ill people in this outbreak, the chances of severe health outcomes are much higher than seen in past Cyclospora contamination events.

As of August 28, a total of 11,458 illnesses across 20 states have been reported in association with the outbreak, including 495 hospitalizations and two deaths.

Recall Classifications: ‘Not a Media-Worthy Event’

Experts familiar with FDA procedures applauded the agency’s efforts to get ahead of public panic about the Taylor Farms recall classification, given the cyclosporiasis outbreak’s highly publicized nature.

For example, in a LinkedIn post, Susan Mayne, Ph.D., former Director of FDA’s Center for Food Safety and Applied Nutrition (CFSAN), explained why recall classifications “should not be a media-worthy event.”

Pointing to the “slew of headlines triggered by classification determinations,” Dr. Mayne explained that “classification is more like an administrative exercise, usually completed some weeks after a product recall, [after] the media-worthy news of a recall has already occurred.”