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FDA Update on Non-viral Hepatitis and “Real Water”

 On April 16, 2021, the FDA issued an update on its investigation of an outbreak reported March 13, 2021 in Nevada of acute non-viral hepatitis of unknown cause, and associated with consumption of “Real Water” brand alkaline water.  According to the Centers for Disease Control and Prevention (CDC), which is also investigating the outbreak, acute non-viral hepatitis is inflammation of the liver from a cause other than a virus, such as drugs, alcohol, or toxins.

Thus far, five hospitalized pediatric patients from four households have recovered, as have two adults and three children from two of the four households, after experiencing less severe symptoms, including fever, vomiting, nausea, loss of appetite, and fatigue.  As the investigation continues, FDA is working to locate any remaining “Real Water” products, particularly products sold on-line, to ensure they are no longer available to consumers.  FDA recommends that consumers, including pets, avoid the recalled alkaline water products until more information is known about the cause of the illnesses.

Since FDA’s previous, March 31 update, which indicated a lack of cooperation from the firm, FDA has completed inspections at “Real Water” Inc.’s facilities and has received some requested records.  FDA is also sampling and analyzing Real Water products and will provide updates as the investigation continues.

© 2021 Keller and Heckman LLPNational Law Review, Volume XI, Number 109
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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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