FDA, CDC lift nationwide romaine consumer advisory, announce voluntary labeling agreement

Following the onset of an E. coli O157:H7 outbreak linked to romaine lettuce announced by the CDC and the FDA on Nov. 20, the agencies have lifted a nationwide consumer advisory that said romaine is unsafe to eat. However, the CDC is telling consumers and those in the produce supply chain not to eat, sell or serve romaine lettuce harvested from the Central Coast in central and northern California, according to a CDC food safety alert.

The FDA has also announced a voluntary labeling agreement with the leafy green industry to help customers determine where their romaine lettuce came from, the agency’s commissioner, Dr. Scott Gottlieb, said in a statement.

Resulting from its investigations over the Thanksgiving holiday, FDA has found that the outbreak likely came from “end of season” romaine lettuce grown in the Central Coast growing region, Gottlieb said.

(Related: Romaine lettuce not safe to eat, says the CDC)

The CDC has confirmed 43 cases of E. coli in 12 states, with illnesses starting between Oct. 8 and Oct. 31. Sixteen people were hospitalized, but no deaths have been reported as of 4 p.m., Nov. 27. The Public Health Agency of Canada has confirmed 22 cases of E. coli in Quebec, Ontario and New Brunswick.

Currently, the FDA does not believe that romaine grown in other regions, nor hydroponic romaine lettuce or greenhouse-grown romaine, have been contaminated, Gottlieb said.

With its new voluntary labeling initiative, the FDA aims to make clear to consumers where their lettuce was grown and the date it was harvested, Gottlieb said. Labels should also note whether romaine was grown hydroponically or in a greenhouse. If information is missing, the FDA encourages consumers and the supply chain not to use or eat romaine.

Dr. Bob Whitaker, chief science and technology officer at the Produce Marketing Association (PMA), sent an email to produce industry members and stakeholders on Nov. 26, providing an update on the lift of the consumer advisory and the establishment of the voluntary labeling agreement. PMA, United Fresh and other industry partners are offering support to the FDA and CDC in the traceback investigation, and PMA is working to help implement voluntary labeling.

“PMA has agreed to support this initiative and are recommending that all industry members throughout the supply chain follow this labeling program,” Whitaker said in the email. “We recognize that voluntary source labeling is not true traceability, but it is a mechanism to ensure consumers have access to romaine that was not implicated in the outbreak.”

PMA and United Fresh created a Question & Answer (Q&A) document that addresses the labeling agreement.

Creighton Magid, a partner at the international law firm Dorsey & Whitney and head of its Washington, D.C., office, stressed in a statement the need for a voluntary labeling agreement in light of the recent nationwide consumer advisory not to eat romaine lettuce, when the E. coli-contaminated greens came from a specific region.

“The FDA’s announcement is important in that it addresses, for the first time, the need for place-of-origin labeling for fresh produce,” Magid said.