FDA Outbreak Investigation
FDA Investigates Outbreak of Hepatitis A Illnesses Linked to Frozen Strawberries
November 3, 2016
The U.S. Food and Drug Administration, the Centers for Disease Control and Prevention (CDC) and state and local officials are investigating an outbreak of hepatitis A illnesses linked to frozen strawberries.
Fast Facts
Update 11/3/2016: The FDA has learned that frozen strawberry products subject to recall by The International Company for Agricultural Production and Processing (ICAPP), including but not limited to whole, sliced and sugared, and diced strawberries, may have been served in food service operations as recently as October 27, 2016.
The FDA recommends that institutions and food service operations supplied by any of the five companies identified below immediately reach out to their suppliers and determine if they received frozen strawberry product recalled by ICAPP. Then, if needed, institutions and food service operations that find they served any recalled product within the last two weeks should contact their local health department and communicate to their customers regarding possible exposure to hepatitis A virus and the potential benefit of post exposure prophylaxis.
The FDA and CDC are not currently aware of any illnesses related to any recalled products other than whole frozen strawberries. However, because hepatitis A can have serious health consequences, CDC advises post exposure prophylaxis (PEP) for unvaccinated persons who have consumed any of the recalled frozen strawberry products in the last 2 weeks. PEP offers no preventive benefit to persons whose exposure occurred more than 2 weeks ago.
The five consignees who received recalled frozen strawberry products from ICAPP are:
- C.H. Belt of Lake Forest, Ca. (sold under CH World Brand)
- Jetro/Restaurant Depot of College Point, N.Y. (sold under James Farm brand and unbranded “Bits & Pieces”)
- Sysco Corporation of Houston, Tex. (sold under Sysco brand)
- Patagonia Foods of San Luis Obispo, Ca. (sold under Patagonia brand)
- Reddy Raw of Woodridge, N.J. (sold under Regal brand).
The FDA is working with these firms to help identify further downstream customers who may have received the recalled frozen strawberry products. More product information in table below.
The FDA, CDC and state and local officials are investigating hepatitis A virus (HAV) infections linked to frozen whole strawberries in smoothies served in Tropical Smoothie Cafe restaurant locations.
On October 19, 2016 the FDA placed frozen strawberries from ICAPP on Import Alert 99-35 after multiple positive samples confirmed hepatitis A in the product.
As of October 20, 2016, CDC reports 134 people with hepatitis A linked to this outbreak have been reported from 9 states (AR, CA, MD, NC, NY, OR, VA, WI and WV).
129 of these cases reported eating a smoothie containing strawberries from Tropical Smoothie Café. There have been no cases reporting illness from this same exposure since September 23, 2016.
5 cases had no exposure to Tropical smoothie café. The latest illness onset date among these cases was 10/1/2016.
The investigation into these cases is ongoing.
According to the CDC, information available at this time does not indicate an ongoing risk of acquiring hepatitis A virus infection at Tropical Smoothie Café’s. Tropical Smoothie Café reported that they removed these strawberries from their Cafés nationwide on August 19.
On October 25, 2016, ICAPP recalled all frozen strawberries and frozen strawberry products that it has imported into the United States since January 1, 2016. These include whole, sliced and sugared, and diced frozen strawberries.
What is the Problem and What is Being Done About It?
The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention, state and local officials are investigating an outbreak of hepatitis A illnesses linked to frozen Egyptian strawberries in smoothies served at Tropical Smoothie Café locations.
The FDA’s investigation in connection with this outbreak identified five samples of ICAPP’s frozen strawberries that tested positive for hepatitis A. ICAPP recalled all frozen strawberries and frozen strawberry products that it imported into the United States since January 1, 2016. ICAPP’s recalled frozen strawberries were distributed to food service establishments nationwide. The products were not offered for retail sale to consumers. Frozen strawberry products subject to recall include whole, sliced and sugared, and diced strawberries.
As of October 20, 2016, CDC reports 134 people with hepatitis A linked to this outbreak have been reported from 9 states (AR, CA, MD, NC, NY, OR, VA, WI and WV). Among people with available information, 52 people have been hospitalized. Nearly all ill people reported drinking a smoothie from Tropical Smoothie Café in the month before illness started. Of the 54 ill people who were interviewed about the type of smoothie, all reported eating a smoothie containing strawberries. These ill people purchased smoothies at cafés located in a limited geographical area, including Virginia and neighboring states. The ill person in Oregon had purchased smoothies containing strawberries from a Tropical Smoothie Café location in Virginia while traveling.
The FDA’s traceback investigation indicates that the strawberries served in Tropical Smoothie Café locations where ill people reported drinking smoothies were from ICAPP, imported from Egypt. Tropical Smoothie Café reported that they stopped using Egyptian frozen strawberries in their locations in Virginia and neighboring states by August 8, 2016. Additionally, on August 19, 2016, the firm reported that they removed Egyptian frozen strawberries from all cafes nationwide.
The agency has been in touch with the Egyptian International Health Regulations National Focal Point to discuss the investigation, and has placed frozen strawberries from ICAPP on Import Alert 99-35 after multiple positive samples confirmed hepatitis A in the product.
The FDA recommends that institutions and food service operations supplied by any of the five companies identified below immediately reach out to their suppliers and determine if they received frozen strawberry product recalled by ICAPP. Then, if needed, institutions and food service operations that find they served any recalled product within the last two weeks should contact their local health department and communicate to their customers regarding possible exposure to hepatitis A virus and the potential benefit of post exposure prophylaxis. The FDA and CDC are not currently aware of any illnesses related to any recalled products other than whole frozen strawberries. However, because hepatitis A can have serious health consequences, CDC advises post exposure prophylaxis (PEP) for unvaccinated persons who have consumed any of the recalled frozen strawberry products in the last 2 weeks. PEP offers no preventive benefit to persons whose exposure occurred more than 2 weeks ago.
What is Hepatitis A?
Hepatitis A is a contagious liver disease that results from infection with the hepatitis A virus (HAV). It can range in severity from a mild illness lasting a few weeks to a severe illness lasting several months. Hepatitis A is usually spread when a person ingests fecal matter — even in microscopic amounts — from contact with objects, food, or drinks contaminated by the feces of an infected person.
What are the Symptoms of Hepatitis A?
Illness occurs within 15 to 50 days of exposure and in adults includes fatigue, abdominal pain, jaundice, abnormal liver tests, dark urine and pale stool.
Who is at Risk?
Hepatitis A, and especially the strain found in the clinical samples already tested, is a virus that originates in and is spread by people, rather than animals. Contamination can occur when an infected food handler prepares food without appropriate hand hygiene. Food (as is suspected in this outbreak) or water contaminated with HAV can also cause outbreaks of disease.
In rare cases, particularly in patients with pre-existing severe illness or who are immunocompromised, HAV infections can progress to liver failure and death.
People with hepatitis A may not have symptom until 15 to 50 days after consuming a contaminated food or drink.
What Can be Done to Prevent Infection with Hepatitis A?
Because hepatitis A can have serious health consequences, CDC recommends providing post exposure prophylaxis (PEP) for unvaccinated people who have eaten any of the recalled frozen strawberry products in the last 2 weeks. PEP consists of:
Hepatitis A vaccine for people between the ages of 1 and 40 years
Hepatitis A virus-specific immunoglobulin (IG) for people outside of this age range, but the hepatitis A vaccine can be substituted if IG is not available.
Those with evidence of previous vaccination do not require PEP
If you are unsure if you have been vaccinated against hepatitis A, contact your health professional to check your immunization records. If you have been vaccinated, no further action is needed. If you have never received the hepatitis A vaccine, getting a single dose within two weeks of exposure can protect against illness. If you are unable to determine whether you have already been vaccinated, receiving an additional dose of vaccine is not harmful if you have already been vaccinated.
Who Should Receive the Hepatitis A Vaccine?
In general, CDC recommends the following groups be vaccinated for hepatitis A:
All children at age 1 year
Travelers to countries that have high rates of hepatitis A
Family members and caregivers of recent adoptees from countries where hepatitis A is common
Men who have sexual contact with other men
Users of injection and non-injection illegal drugs
People with chronic (lifelong) liver diseases, such as hepatitis B or hepatitis C
People who are treated with clotting-factor concentrates
People who work with hepatitis A infected animals or in a hepatitis A research laboratory
What Specific Products Were Recalled?
On October 25, 2016, ICAPP recalled all frozen strawberries and frozen strawberry products that it has imported into the United States since January 1, 2016. These include whole, sliced and sugared, and diced frozen strawberries.
Company Sysco
Brand/Labeling Sysco
Type Sliced sugar added
Whole IQF
Company Jetro/Restaurant Depot
Brand/Labeling "James Farm" brand or unbranded “Bits & Pieces”
Type IQF Recipe Ready Diced strawberries
Whole IQF
Sliced with Sugar
Company Reddy Raw
Brand/Labeling Regal
Type Sliced strawberries 4+1
Company Patagonia
Brand/Labeling Patagonia
Type Strawberries IQF
Company CH BELT & Associates
Brand/Labeling C.H Worlds
Type Strawberries whole
Strawberries whole smoothie select
Strawberries diced
What Do Restaurants and Retailers Need To Do?
The FDA recommends that institutions and food service operations supplied by any of the five companies identified below immediately reach out to their suppliers and determine if they received frozen strawberry product recalled by ICAPP. Then, if needed, institutions and food service operations that find they served any recalled product within the last two weeks should contact their local health department and communicate to their customers regarding possible exposure to hepatitis A virus and the potential benefit of post exposure prophylaxis.
At this time, we do not have information to suggest that there is an ongoing risk of hepatitis A virus infection at Tropical Smoothie Cafes. The FDA and CDC are not currently aware of any illnesses related to any recalled products other than whole frozen strawberries. However, in the event that retailers and/or other food service operators are found to have handled recalled or other potentially contaminated food in their facilities, they should:
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 hot water and soap following the cleaning and sanitation process.
Retailers, restaurants, and other food service operators who have processed and packaged any potentially contaminated products need to be concerned about cross contamination of cutting surfaces and utensils through contact with the potentially contaminated products.
What Do Consumers Need To Do?
The FDA investigation is ongoing and is focused on frozen strawberries imported from ICAPP. The FDA is working with involved firms to ensure that all recalled frozen strawberries and frozen strawberry products are removed from commerce and no longer being served.
At this time, we do not have information to suggest that there is an ongoing risk of hepatitis A virus infection at Tropical Smoothie Cafes. If you think you’ve gotten sick from eating a smoothie containing strawberries from a Tropical Smoothie Café, contact your health care provider. The FDA and CDC are not currently aware of any illnesses related to any recalled products other than whole frozen strawberries. However, because hepatitis A can have serious health consequences, CDC advises post exposure prophylaxis (PEP) for unvaccinated persons who have consumed any of the recalled strawberry products in the last 2 weeks. PEP offers no preventive benefit to persons whose exposure occurred more than 2 weeks ago.
PEP consists of:
HAV vaccine for people between the ages of 1-year and 40-years.
HAV-specific immunoglobulin for people falling outside of that age range. If IG is not available, hepatitis A vaccine can be substituted.
Water, shellfish, fruit (berries) and salads are the most frequent foodborne sources of hepatitis A. Hepatitis A can be transmitted from person to person. Consumers should always practice safe food handling and preparation measures. Wash hands, utensils, and surfaces with hot, soapy water before and after handling food. Consumers should thoroughly wash their hands after using the bathroom and changing diapers to help protect themselves from hepatitis A, as well as other foodborne diseases.
Who Should be Contacted?
Contact your healthcare provider if you think you may have become ill from eating frozen strawberries, or if you believe that you have eaten any of the recalled frozen strawberry products within the last two weeks.
The FDA encourages consumers with questions about food safety to call 1-888-SAFEFOOD Monday through Friday between 10 a.m. and 4 p.m. Eastern time, or to consult http://www.fda.gov.
For questions or more information, consumers may contact ICAPP by email at customerservice@icapp.com.eg or by phone, between 9:00 am and 5:00 pm Cairo local time, at +2015411624.
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