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FAQ: Non-viral Hepatitis Linked to “Real Water” Brand Alkaline Water

Case Counts

The case count lists the number of identified cases of severe acute non-viral hepatitis of unknown cause potentially associated with consumption of a Real Water product. The product has been recalled and additional cases are not anticipated. There are no confirmed cases because a causative agent was not identified. The U.S. Food and Drug Administration’s investigation into Real Water is complete, and the Centers for Disease Control and Prevention has announced the outbreak is over. The Southern Nevada Health District has also concluded its investigation into this outbreak. 

Probable: 18 (1 death)
Suspect: 4
Updated: November 15, 2021

Background

On March 16, 2021, the Southern Nevada Health District announced it was working with the U.S. Food and Drug Administration (FDA) and its state partners to investigate reports of acute non-viral hepatitis in Clark County. 

The Health District received initial reports of five cases of acute non-viral hepatitis in November 2020. The cause of their illness was unknown. All five children required hospitalization but have since recovered. The patients lived in four different households. Six additional people reported experiencing less severe symptoms that include vomiting, nausea, loss of appetite, and fatigue. These patients include three adults and three children. 

The consumption of “Real Water” brand alkaline water was found to be the only common link identified between all the cases. The FDA conducted a further investigation into the facility. Real Water products were recalled and the firm agreed to cease operations until conditions of a consent decree are met.

What type of water has been linked to the people who got sick?

Real Water brand of alkaline water was the only link identified between all the cases.   

Are other brands implicated?

Health District does not have evidence that other brands of alkaline or bottled water were affected. 

What is the status of the FDA’s investigation?

On June 1, 2021, the FDA announced that Real Water Inc. had 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. According to the complaint filed by the Department of Justice (DOJ) on behalf of the FDA, Real Water Inc. violated the FD&C Act by operating facilities that fail to meet preventive controls requirements to control food hazards. The complaint also alleges that defendants’ products are adulterated within the meaning of the FD&C Act because they have been prepared, packed or held under insanitary conditions whereby they may have become contaminated with filth or may have been rendered injurious to health. More information can be found in the press release and consent decree. 

What is acute non-viral hepatitis?

Acute non-viral hepatitis is an inflammation of the liver that can be caused by exposure to some medications, drugs, alcohol, and toxins. It can also be caused by autoimmune disease. Though hepatitis can have many causes, symptoms are often the same and can include fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, dark urine, light-colored stools, joint pain, and yellow skin or eyes. If you are currently experiencing these symptoms or have other symptoms that concern you, contact your health care provider to report your symptoms and receive care. 

What are the recommendations for the public?

Real Water products have been recalled. If people or commercial establishments have any of this product, the Health District is advising that people should not drink Real Water alkaline water. Restaurants and retailers should not serve, cook with or sell Real Water alkaline water, per FDA recommendations. Additionally, this product should not be given to pets. 

More information is available on the FDA website.

2021-11-23T15:24:41-08:00
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