Nevada-based Real Water stops production for failure to comply
Source U.S. Food and Drug Administration
The U.S. Food and Drug Administration said this week that Real Water Inc., a Nevada-based bottled water manufacturer, agreed to cease operations until it can comply with the Federal Food, Drug and Cosmetic Act (FD&C Act) and other requirements listed in a consent decree.
U.S. District Judge Jennifer A. Dorsey entered a consent decree of permanent injunction on June 1 between the U.S. and AffinityLifestyles.com Inc., the majority shareholder of Real Water Inc.; Brent A. Jones, president of Real Water; and Blain K. Jones, vice president of Real Water.
According to a complaint filed by the U.S. Department of Justice on behalf of the FDA, the defendants violate the FD&C Act by operating facilities that fail to meet preventive controls requirements to control food hazards. The complaint also alleges that defendants violate the FD&C Act by failing to follow current good manufacturing practice (CGMP) requirements for bottled water.
The consumption of Real Water brand alkaline water was the only known common link to five cases of acute liver failure in children that occurred in November and December which 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.
The consent decree requires the defendants to cease operations until they complete corrective actions, including the hiring of a qualified independent expert to inspect their facilities to ensure compliance with the FD&C Act.
