Outbreak of E. coli O157:H7 Linked to Romaine Lettuce

The U.S. Food and Drug Administration, along with the Centers for Disease Control and Prevention and state authorities, continues to investigate a multistate outbreak of E. coli O157:H7 infections associated with consumption of romaine lettuce in the U.S. As of Nov. 26, 2018, this outbreak has resulted in 43 people becoming ill in 12 states, with the last reported illness onset date being Oct. 31, 2018. An additional 22 people in Canada have become ill, and the FDA and our partners are also coordinating the investigation with Canadian health and food safety authorities.

As we continue to investigate this outbreak, today the FDA is announcing new steps to help consumers better identify where their romaine is grown through voluntary labeling.

To learn more visit the FDA’s website.


Knowing the growing origin of produce will continue to play an important role in allowing consumers to avoid contaminated products and facilitating market withdrawals and tracebacks. That’s why we previously called on the romaine lettuce industry to provide unambiguous and clear information to consumers regarding where their lettuce was grown and when it was harvested.

To this end, the FDA recently participated in discussions with the major producers and distributors of romaine lettuce in the U.S. and with the major trade associations representing the produce industry regarding product labeling and dating to assure consumers that any romaine lettuce that will come onto the market is not associated with the current outbreak of E. coli O157:H7. The labeling will identify the origin of the romaine based on harvest region, along with the date of harvest. This can improve the ability of the FDA to provide more targeted information to consumers in the event of a future outbreak of illness. The FDA also has commitments from the romaine lettuce industry that such labeling will continue into the future and become the standard for their products.

The FDA has urged growers, processors, distributors and retailers to:

  • clearly and prominently label all individually packaged romaine products to identify growing region and harvest date for romaine; and
  • clearly and prominently label at the point of sale the growing region when it is not possible for romaine lettuce suppliers to label the package (e.g. individual unwrapped whole heads of romaine lettuce available in retail stores).

We hope that growers, processors, distributors and retailers will join us in our effort to protect consumers by applying these labeling recommendations to their products.

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FDA Statement November 26, 2018, Statement from FDA Commissioner Scott Gottlieb, M.D., on the current romaine lettuce E. coli O157:H7 outbreak investigation


NGA and FMI have developed set of anticipated questions and answers to provide recommendations for this new voluntary labeling system. Additionally, there is a set of best practices created by FMI and its outside law firm for companies that wish to adopt the voluntary labeling recommendations.

Those interested in learning more or receiving a copy of these documents are encouraged to reach out to MGFPA.