FDA In Brief: FDA Investigates Source of Non-Viral Hepatitis Cases Possibly Linked to Bottled Alkaline Water
March 16, 2021
The following quote is attributed to Frank Yiannas, Deputy Commissioner for Food Policy and Response:
“The FDA is committed to protecting the health of Americans and is especially concerned when there is a food safety issue impacting our youngest, and some of the most vulnerable in the population – infants and young children. Upon learning about reports of acute non-viral hepatitis in Nevada, impacting five young children, the FDA quickly activated a team to further investigate. We are working closely with the CDC, state and local partners to complete our investigation and monitor for any additional illnesses.
“We are advising consumers, restaurants and retailers to not consume, cook with, sell or serve “Real Water” alkaline water until more information is known about the cause of the illnesses. We are working to determine how the alkaline water may be related to the illnesses. Although the investigation is ongoing, epidemiologic information currently indicates that this alkaline water product may be the cause of the illnesses. We will provide additional updates as more information becomes available.”
- On March 13, the U.S. Food and Drug Administration was alerted to five cases of acute non-viral hepatitis (resulting in acute liver failure) in infants and young children that occurred in November 2020 with an unknown cause reported to the Southern Nevada Health District. All five patients had been hospitalized but have since recovered. All patients were reported to have consumed “Real Water” brand alkaline water. These patients came from four different households. Additional people in the households were reported to have experienced less severe symptoms. Less severe symptoms included fever, vomiting, nausea, loss of appetite and fatigue.
- The consumption of “Real Water” brand alkaline water is the only common link identified between all of these cases to date. This brand of alkaline water is owned by Real Water Inc., headquartered in Mesa, Arizona.
- The FDA regulates bottled water under the Federal Food, Drug, and Cosmetic Act. Manufacturers are responsible for producing safe, wholesome and truthfully labeled food products. Health-related statements made by the firm have not been evaluated by the FDA.
- Symptoms of all types of hepatitis, including non-viral hepatitis, are similar and can include fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, dark urine, clay or gray-colored bowel movements, joint pain, yellow eyes and jaundice. Those experiencing these symptoms should contact their doctor.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.