Investigation of Acute Non-Viral Hepatitis of Unknown Etiology Potentially Associated with an Alkaline Water Product

Background

CDC and the FDA were notified of five cases of acute non-viral hepatitis of unknown etiology (unknown cause) in children by the Southern Nevada Health District (SNHD) in Nevada on March 13, 2021. CDC, FDA, and state and local partners worked together to investigate a potential link between these cases of acute non-viral hepatitis and the consumption of an alkaline water product called “Real Water” and other possible etiologies (causes).

Investigation Overview

There have been 21 probable cases and four suspect cases of acute non-viral hepatitis linked to the consumption of “Real Water” alkaline water. Eighteen probable cases and four suspect cases have been identified in Nevada and three probable cases have been identified in California. There are no confirmed cases because a causative agent for the illnesses has not been identified. Information from the epidemiologic investigation supports that there is a link between these cases of acute non-viral hepatitis and “Real Water” alkaline water.

Illnesses started on dates ranging from August 2020 to November 2020. Most patients became sick in November 2020. All people with probable cases were hospitalized. One probable case was in a woman in her 60s with underlying health conditions who died of hepatitis of unknown etiology–related complications.

Real Water, Inc. is not currently in operation. On June 1, 2021, FDA announcedexternal icon that Real Water, Inc. has agreed to cease operations until they can comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements listed in a consent decree. Consumers, restaurants, distributors, and retailers should not drink, cook with, sell, or serve “Real Water” alkaline water per FDA recommendationsexternal icon. Further, FDA advises that “Real Water” not be given to pets. Real Water, Inc. issued a recall on their products.

As of 11/23/2021, this outbreak appears to be over.

What is acute non-viral hepatitis?

Acute non-viral hepatitis is inflammation of the liver that occurs suddenly and can lead to liver failure. It can be caused by exposure to some medications, drugs, alcohol, and toxins. It can also be caused by autoimmune disease. Other possible causes of non-viral hepatitis include contaminated water or food, dietary and herbal supplements, traditional or home remedies, wild-growing mushrooms and plants, and chemicals such as metals, solvents, paint thinners, or pesticides.

What caused the illness?

Information from the epidemiologic investigation supports that there is a link between these cases of acute non-viral hepatitis and “Real Water” alkaline water. No causative agent has been identified. FDA collected consumer and non-consumer alkaline/non-alkaline water, chemicals, and concentrates. Laboratory analyses did not identify the contaminant that could have led to the illnesses. For more information about the FDA investigation, visit the FDA websiteexternal icon.

What are the symptoms of acute non-viral hepatitis?

Although hepatitis can have many causes, symptoms are often the same. Symptoms of hepatitis can include

If you are currently experiencing these symptoms or have other symptoms that concern you, contact your healthcare provider to report your symptoms and receive care.

What is alkaline water?

The pH level is used to describe how acidic or alkaline a substance is on a scale of 0-14. Alkaline drinking water often contains additives that increase the pH. Something is defined as alkaline if it has a pH higher than 7.

Information for consumers

Consumers, restaurants, distributors, and retailers should not drink, cook with, sell, or serve “Real Water” alkaline water per FDA recommendationsexternal icon. FDA also advises that this water shouldn’t be given to pets. Real Water, Inc. issued a recall on their products.

Contact your healthcare provider if you are experiencing symptoms of acute non-viral hepatitis, such as fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, dark urine, light-colored stools, joint pain, or yellow skin or eyes.

Information for clinicians

Active case finding for this investigation has concluded. However, it is important for clinicians to be aware of the signs and symptoms of acute non-viral hepatitis and to report any unusual illnesses to public health authorities.