Center for Food Safety and Applied Nutrition The following is an update from FDA of concern to our subscribers. Investigation of Acute Non-viral Hepatitis Illnesses – "Real Water" Brand Alkaline Water June 1, 2021 The FDA, along with the CDC and the Southern Nevada Health District, is investigating a number of reports of acute non-viral hepatitis in the state of Nevada associated with "Real Water" brand alkaline water. On June 1, 2021, FDA announced 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. 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 recently released press release and consent decree. Outside of the cases considered as part of the consent decree, additional cases have been reported. On May 20, 2021, the Southern Nevada Health District is reporting five additional probable cases linked to its investigation of acute non-viral hepatitis illness in Clark County residents and the death of one person who was identified as a probable case. The patient who died was a woman in her 60s with underlying medical conditions and is one of the five new probable cases reported. This brings the total to 16 probable and one suspect case. Please note that these new cases are not included in the DOJ complaint. Read the full update | 
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