Bottled water manufacturer ordered to cease production after reports of liver failure, hepatitis [View all]

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A Nevada-based bottled water manufacturer, Real Water, Inc, has agreed to cease operations until it can comply with federal regulations after the U.S. Food and Drug Administration found the water was the only “common link” among cases of acute liver failure in five children. A federal judge yesterday entered a consent decree of permanent injunction against AffinityLifestyles.com, the owner of Real Water, Inc. The firm violated the federal Food, Drug and Cosmetic Act.

According to the FDA, the water was the “only known common link between five cases of acute liver failure in children that occurred in November and December 2020 that was reported to the FDA in March. Since then, 11 additional cases of acute non-viral hepatitis in adults, including one death of a woman with underlying medical conditions, have been identified as linked to the consumption of Real Water brand alkaline water.”

According to the complaint, Real Water operated “facilities that fail to meet preventive controls requirements to control food hazards.” The complaint alleges the company manufactured the water “under insanitary conditions whereby they may have been contaminated with filth or may have been rendered injurious to health.

Real Water was distributed through the United States and sold on Amazon.com. The FDA said that anyone who thinks they may have been sickened by Real Water Drinking Water, Real Alkalized Water and Real Alkalized Water Concentrate, should see a doctor and report the problem to the FDA.

https://www.pennlive.com/food/2021/06/bottled-water-manufacturer-ordered-to-cease-production-after-reports-of-liver-failure-hepatitis.html