FDA Investigation of a Multistate Outbreak of Cyclospora Illnesses Linked to Fresh Express Salad Mix Served at McDonald’s Ends
The FDA, CDC, along with state and local officials investigated a multi-state outbreak of cyclosporiasis illnesses likely linked to salads from McDonald's restaurants.
Update - September 12, 2018
As of September 11, 2018, this outbreak appears to be over. A total of 511 laboratory-confirmed cases of Cyclospora infection were reported in people who consumed salads from McDonald’s restaurants; the cases were reported by 15 states and New York City.
The FDA investigated distribution and supplier information for romaine and carrots but did not identify a single source or potential point of contamination for this outbreak.
Recommendations
Consumers who have symptoms of cyclosporiasis should contact their health care provider to report their symptoms and receive care.
Case Counts
Total Illnesses: 511
Hospitalizations: 24
Deaths: 0
Last illness onset: 7/23/2018
States with Cases: CT, FL, IA, IL, IN, KY, MI, MN, MO, NE, New York City, OH, SD, TN, VA, WI
Hospitalizations: 24
Deaths: 0
Last illness onset: 7/23/2018
States with Cases: CT, FL, IA, IL, IN, KY, MI, MN, MO, NE, New York City, OH, SD, TN, VA, WI
Note: The Connecticut, New York City, Tennessee, and Virginia case-patients purchased salads while traveling in Illinois; the Florida case-patient purchased a salad while traveling in Kentucky.
Who to Contact
Consumers who have symptoms should contact their health care provider to report their symptoms and receive care.
To report a complaint or adverse event (illness or serious allergic reaction), you can:
- Call an FDA Consumer Complaint Coordinator if you wish to speak directly to a person about your problem.
- Complete an electronic Voluntary MedWatch formonline.
- Complete a paper Voluntary MedWatch form that can be mailed to FDA.
Visit www.fda.gov/fcic for additional consumer and industry assistance.
What was the Problem and What's Been Done?
- As of September 11, 2018, this outbreak appears to be over. A total of 511 laboratory-confirmed cases of Cyclospora infection were reported in people who consumed salads from McDonald’s restaurants; the cases were reported by 15 states and New York City. The FDA investigated distribution and supplier information for romaine and carrots but did not identify a single source or potential point of contamination for this outbreak.
- On July 30, 2018, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) issued a public health alert on beef, pork and poultry salad and wrap products potentially contaminated with Cyclosporathat were distributed by Caito Foods LLC, of Indianapolis, IN. The products were produced between July 15 and 18, 2018, with either “Best By,” “Enjoy by,” “Best if Sold By” or “Sell By” dates ranging from July 18 through July 23, 2018. Caito Foods had received notification from Fresh Express that the chopped romaine in these products was being recalled.
- On July 26, 2018, the FDA completed final analysis of an unused package of Fresh Express salad mix containing romaine lettuce and carrots, which had been distributed to McDonald's. The analysis confirmed the presence of Cyclospora in that sample, though the expiration date for that product, July 19, had already passed. On July 27, the FDA informed Fresh Express of the results.
- FDA instructed Fresh Express to determine whether potentially contaminated product may still be on the market. Fresh Express reported to FDA that the romaine from the same lot as the positive sample was not packaged for direct retail sale by Fresh Express and had already expired. Fresh Express committed to using recall procedures to inform those companies that received this romaine about the sample result. Fresh Express also reported that carrots used in the mix were only sent to McDonald's locations.
- As of July 13, 2018, McDonald's decided to voluntarily stop selling salads at impacted restaurants in IL, IA, IN, WI, MI, OH, MN, NE, SD, MT, ND, KY, WV, and MO. The company has since reported that it has replaced the supplier of salads in those states. More information can be found in McDonald's Statement.
- In 2015, FDA set up a multidisciplinary workgroup to prioritize the development, validation and implementation of a method for detecting Cyclospora in fresh produce. In 2018, FDA began using the newly validated Cyclospora method. The availability of this method is a significant advancement in FDA's ability to investigate outbreaks of cyclosporiasis and identify the parasite in foods.
- At this time, we do not have evidence to suggest that this cluster of illnesses is related to the ongoing Cyclospora outbreak linked to Del Monte vegetable trays.
What is Cyclospora?
Cyclospora cayetanensis is a microscopic parasite of humans. This parasite, when it contaminates food or water and is then ingested, can cause an intestinal illness called cyclosporiasis.
The Cyclospora parasite needs time (days to weeks) after being passed in a bowel movement to become infectious for another person. Therefore, it is unlikely that cyclosporiasis is passed directly from one person to another.
What are the Symptoms of Cyclosporiasis?
Most people infected with Cyclospora develop diarrhea, with frequent, sometimes explosive, bowel movements. Other common symptoms include loss of appetite, weight loss, stomach cramps/pain, bloating, increased gas, nausea, and fatigue. Vomiting, body aches, headache, fever, and other flu-like symptoms may be noted. Some people who are infected with Cyclospora do not have any symptoms. If not treated, the illness may last from a few days to a month or longer. Symptoms may seem to go away and then return one or more times (relapse).
What Do Restaurants and Retailers Need To Do?
Based on current information available Cyclospora may be resistant to routine chemical disinfection methods such as those using chlorine. However, restaurants and retailers should still follow basic food safety practices:
- Retailers, restaurants, and other food service operators should always practice safe food handling and preparation measures. It is recommended that they wash utensils, and surfaces with hot, soapy water before and after handling food. Wash and sanitize display cases and refrigerators where potentially contaminated products were stored.
- Wash and sanitize cutting boards, surfaces, and utensils used to prepare, serve, or store potentially contaminated products.
- Wash hands with warm water and soap following the cleaning and sanitation process.
- Regular frequent cleaning and sanitizing of food contact surfaces and utensils used in food preparation may help to minimize the likelihood of cross-contamination.
What Do Consumers Need To Do?
Consumers who have symptoms of cyclosporiasis should contact their health care provider to report their symptoms and receive care. Most people infected with Cyclospora develop diarrhea, with frequent, sometimes explosive, bowel movements. Other common symptoms include loss of appetite, weight loss, stomach cramps/pain, bloating, increased gas, nausea, and fatigue. Vomiting, body aches, headache, fever, and other flu-like symptoms may be noted.
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