Editor’s note: U.S. Rep Rosa DeLauro sent this letter to FDA Commissioner Scott Gottlieb on Friday.

Dear Commissioner Gottlieb:

I write out of concern about the current outbreak of cyclosporiasis as well as the transparency and timeliness of your agency’s ongoing investigation.

As of this week, the Centers for Disease Control and Prevention (CDC) has reported a total of 395 infections, across 15 states, in people who consumed Fresh Express supplied salads at McDonald’s restaurants. To date, there have been 16 hospitalizations.

Although once rare in the United States, parasitic outbreaks caused by Cyclospora have become more common over the last several decades. Many of these outbreaks have continually been found to be associated with imported fruits and vegetables.

Earlier last month, several Midwest state public health departments announced investigations linked to salad consumed at McDonald’s. On July 13, 2018, McDonald’s announced it would voluntarily stop selling salads at 3,000 of its restaurants until it could procure product from another supplier.

However, it was not until July 26 that the Food and Drug Administration (FDA) completed analysis showing that an unused package of product distributed to McDonald’s by the supplier, Fresh Express, was contaminated with Cyclospora. Fresh Express was notified of the analysis the following day, and, according to FDA, “Fresh Express committed to using recall procedures to inform those companies that received this romaine about the sample result.”

Sometime between July 27 and July 30, Fresh Express notified Caito Foods, LLC that they had received recalled product, prompting the Department of Agriculture’s Food Safety and Inspection Service (FSIS) to issue a July 30 public health alert on beef, pork and poultry wraps distributed by Caito Foods.

This timeline of events does not instill confidence that the FDA has acted within the best interests of consumers in order to get potentially contaminated product out of the marketplace. As such, I seek specific, written responses to the following questions by September 7, 2018.

  1. When did FDA learn that Fresh Express was the supplier of the implicated lettuce blend used in McDonald’s salads?
  2. To date, what records has FDA requested from Fresh Express related to the ongoing investigation? When were these records originally requested? For records that have been obtained, when did FDA receive them?
  3. Did FDA receive a list from Fresh Express containing companies who received potentially contaminated product? Other than McDonald’s and Caito Foods, LLC, has any other fast food chain or food distributor received similar, potentially contaminated product from Fresh Express? If so, what is the status of removing this product from the supply chain, and why have those companies not be named in this investigation?
  4. Has FDA received any information from Fresh Express that would indicated where the contaminated product was grown and processed? Specifically, was the contaminated product grown in the United States or imported from a foreign country? If the contaminated product was grown and processed in the United States, has FDA (or its state partners) visited and inspected the farms/processing facilities that may currently be implicated?
  5. Given that McDonald’s and Caito Foods, LLC both received similar, potentially contaminated product from Fresh Express, what explains the 18-day difference between each company’s recall? Following statement by McDonald’s on July 13, was there any consideration given to notifying and working with other companies that were supplied similar, potentially contaminated product from Fresh Express?

Thank you for your attention, and I look forward to your response.

Rosa L. DeLauro
Member of Congress

Rosa DeLauro

About the author: Rosa Delauro represents Connecticut’s 3rd Congressional District in the U.S. House. A Democrat, she was elected to the House in 1990 and has represented the district since then. DeLauro is the Ranking Member on the Labor, Health and Human Services, and Education Appropriations Subcommittee. She also serves on the subcommittee responsible for the U.S. Department of Agriculture and the U.S. Food and Drug Administration. DeLauro is co-chair of the Food Safety Caucus.

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