Nevada-based bottled water manufacturer Real Water Inc is ordered to stop production for failure to comply with manufacturing requirements. An investigation continues into one death and multiple cases of liver illness among people who reported drinking the water.
A court order signed by U.S. District Judge Jennifer Dorsey formalizes a settlement in which Affinity Livestyles.com Inc., Real Water Inc, Brent Jones, president of Real Water Inc., and Blain Jones, vice president of Real Water Inc. agreed to cease operations until they can comply with the Federal Food, Drug, and Cosmetic Act and other requirements listed in a consent decree.
According to the complaint filed by the U.S. Department of Justice, on behalf of the FDA, the company violate the rule by operating facilities that fail to meet preventive controls requirements to control food hazards. The company also failed to follow current good manufacturing practice requirements for bottled water.
The complaint also alleged that the company’s products 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.
Additionally, the complaint alleged the defendants’ products are misbranded because their labels fail to declare the common or usual name of each ingredient.
According to the FDA, the consumption of “Real Water” brand alkaline 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 possibly linked to the consumption of Real Water brand alkaline water.
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