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Blumenthal Urges FDA to Enforce Recalls of E. Coli Tainted Lettuce

(Hartford, CT)—Today, U.S. Senator Richard Blumenthal (D-Conn.) released a letter to Food and Drug Administration (FDA) Commissioner Scott Gottlieb urging the FDA to expedite its investigation to identify the source of the multi-state E. coli outbreak and immediately work with retailers and food producers to conduct sweeping recalls to prevent further sickness amongst the public.

“After weeks of Americans continuing to be hospitalized from this outbreak, the CDC and FDA have failed to identify the source of this contamination. Instead of issuing recalls, FDA has placed the burden on consumers to try to identify the source of the lettuce they order in a restaurant or purchase from a grocery store. In many instances, product labels may not disclose where a product is grown, or the leaves may be mixed from several different sources, making it nearly impossible to be sure that individuals are eating uncontaminated lettuce,” Blumenthal writes.

On March 13, 2018, the first reports of people sickened by this E. coli strain linked to tainted romaine lettuce surfaced. Since then, the strain has infected healthy adults, children, and the elderly alike—seventy-five percent of which have been female—leading to hospitalization and, in some cases, severe, potentially life threatening, kidney failure.  While the Centers for Disease Control and Prevention (CDC) have traced this outbreak to the greater Yuma, Arizona region, the precise source of this outbreak has yet to be identified, making Americans across the country vulnerable to sickness. According to the CDC, 53 people from 16 states, including 2 in the state of Connecticut, have reportedly been infected with this E. coli strain.

“Consumers deserve to go to the grocery store or restaurants knowing that the federal government is protecting them from poisonous food products. As such, I urge the FDA to work with food producers to conduct voluntary, and in necessary instances mandatory recalls, to expeditiously remove tainted romaine lettuce from store shelves,” Blumenthal continues.

The full text of the letter is below.

 

April 24, 2018

The Honorable Scott Gottlieb, M.D.

Commissioner

Food and Drug Administration

Department of Health and Human Services

10903 New Hampshire Avenue

Silver Spring, MD 20993

 

Dear Commissioner Gottlieb:

As the Food and Drug Administration (FDA) continues to respond to the Shiga toxin-producing Escherichia coli (E. coli) strain O157:H7 multi-state foodborne illness outbreak, I strongly urge FDA to expedite its investigation to identify the source of this preventable disaster and immediately work with retailers and food producers to conduct sweeping recalls to prevent further sickness among the public.

On March 13, 2018, the first reports of people sickened by this E. coli strain linked to tainted romaine lettuce surfaced. Since then, the strain linked to romaine lettuce has infected healthy adults, children, and the elderly alike—seventy-five percent of which have been female—leading to hospitalization and, in some cases, severe, potentially life threatening, kidney failure.[1] While the Centers for Disease Control and Prevention (CDC) have traced this outbreak to the greater Yuma, Arizona region, the precise source of this outbreak has yet to be identified, making Americans across the country vulnerable to sickness. While the CDC has issued a warning to consumers to not buy or consume any romaine lettuce, including chopped, salad mixes, whole heads, and hearts, from this region, it is far from certain at this point that will contain the outbreak.

According to the CDC, 53 people from 16 states, including 2 in the state of Connecticut, have reportedly been infected with this E. coli strain.[2] After weeks of Americans continuing to be hospitalized from this outbreak, the CDC and FDA have failed to identify the source of this contamination. Instead of issuing recalls, FDA has placed the burden on consumers to try to identify the source of the lettuce they order in a restaurant or purchase from a grocery store. In many instances, product labels may not disclose where a product is grown, or the leaves may be mixed from several different sources, making it nearly impossible to be sure that individuals are eating uncontaminated lettuce. 

Section 206 of the Food Safety Modernization Act of 2011 (FSMA), now Section 423 of the Food, Drug, and Cosmetic Act, gives FDA the authority to implement a mandatory recall of food products if FDA resolves there is “reasonable probability” that a food item has been adulterated, including by E. coli, and is therefore injurious to human health.

Consumers deserve to go to the grocery store or restaurants knowing that the federal government is protecting them from poisonous food products. As such, I urge the FDA to work with food producers to conduct voluntary, and in necessary instances mandatory recalls, to expeditiously remove tainted romaine lettuce from store shelves.

Thank you for your attention to this critical public health crisis. I respectfully request a response by May 8, 2018 outlining the status of FDA’s investigation and romaine lettuce recalls.