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FDA and CDC Will Be Lifting Consumer Advisory Not To Eat Romaine Lettuce

Nov 26, 2018

Update as of 11/26/18 at 7:00 pm (EST): Statement from FDA Commissioner Scott Gottlieb, M.D., on the current romaine lettuce E. coli O157:H7 outbreak investigation

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FDA and CDC recently let us know that later today they will be lifting their advisory for consumers not to eat any romaine lettucebased on a new voluntary labeling agreement with industry and allowing for romaine to return to the marketplace. The labeling agreement was negotiated by a number of romaine grower-shipper-processors, who have each pledged to label their romaine products with the region where grown and approximate harvest date. This will allow FDA to communicate to consumers that product coming back into the marketplace could not have been related to the outbreak earlier this fall.

A number of produce associations have also agreed to support this initiative and are recommending that all industry members throughout the supply chain follow this same labeling program. The voluntary labeling agreement is one illustration of industry and government working in partnership to ensure consumers have access to romaine that was not implicated in the outbreak. In anticipation of many “how to” questions, United Fresh and PMA have posted Questions & Answers, and provide additional details and clarification through a variety of mechanisms. A standardized approach to source labeling is new to the industry and we expect situation-specific questions that were not anticipated. All involved, including FDA, recognize that we will need to gain real-world experience as companies develop the most workable approach in different situations.

In addition to the labeling agreement, the industry and FDA have agreed to work together to continue improvement in the tracking and tracing of romaine lettuce through the supply chain. We recognize that the greatest challenge we face is motivating case identification to be retained by end customers at point of sale, thus enhancing all of our ability to quickly trace produce from point of sale to the grower. Case labeling today often provides this vital information, but too often that information is not captured and retained at point of sale, thus complicating trace back. Improved data capture at all supply chain points is a prerequisite to leveraging technology that can quickly illuminate supply chain pathways.

Our associations are committed to working with FDA in a new effort with experts from within and outside the industry, together with government, to implement improved procedures that enhance the speed and accuracy of investigations. Moving forward, our efforts to enhance strong traceability systems will be most beneficial for consumers only if coupled with expert epidemiological methodology, accelerated investigations with sufficient resources, and government-industry expert collaboration that allow us all to pinpoint the source of contaminated product resulting in more targeted recalls. 

We hope many of your questions will be answered through the ‘question and answer’ content reflecting our current understanding of the labeling initiative, and continue to rapidly provide additional detail through a variety of mechanisms.

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