September 28, 2020

Volume X, Number 272

September 28, 2020

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September 25, 2020

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FDA Publishes Statement on the Salinas-Linked Romaine Lettuce E. Coli 0157:H7 Outbreak and Status Update on Investigations

  • On December 12, 2019, the Food and Drug Administration (FDA), in conjunction with the Centers for Disease Control and Prevention (CDC) and state and local partners, reported an update of its investigation tracking three separate outbreaks linked to romaine lettuce caused by three different strains of E. coli O157:H7.  FDA reported that, through its traceback investigation (pursuant to which investigators from FDA, CDC, the California Department of Food and Agriculture (CDFA), and California Department of Public Health (CDPH) reviewed hundreds of supply chain records, visited several fields, and took a variety of samples from water, soil, soil amendments/compost, scat, and swabs), the agency was able to identify a common grower linked to the outbreaks in Salinas, California, based on available supply chain information.  FDA noted, however, that romaine from this particular grower does not appear to account for all of the illnesses in these outbreaks.

  • On January 15, 2020, FDA provided an update on the status of the investigation, as well as recent findings by the agency based on its further investigation of fields linked to the common grower it had previously identified.

  • In the January 15 statement, FDA officially lifted its November 22, 2019 consumer advisory (to avoid romaine lettuce grown in Salinas), as the growing season for this region has concluded, and FDA found there was no longer a need for consumers to avoid it.  Additionally, FDA and CDC had been tracking two multi-state romaine lettuce outbreaks (one that sickened 167 people in 27 states, and another, linked to salad kits, that sickened 10 people in five states), as well as a third outbreak in Washington State (that sickened 11 people).  In its January 15 statement, FDA also declared each of these outbreaks to be officially over.

© 2020 Keller and Heckman LLPNational Law Review, Volume X, Number 24


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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...