On June 1, the FDA published a press release announcing that Real Water Inc., a Nevada-based bottled water manufacturer, 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.

As our readers may recall, the FDA has been investigating an outbreak of acute non-viral hepatitis of unknown cause in Nevada. 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. An additional 11 cases of acute non-viral hepatitis in adults, including one death, have since been identified as possibly linked to the consumption of Real Water brand alkaline water.

According to a complaint filed by the Department of Justice (DOJ) on behalf of the FDA, defendants violated the FD&C Act by operating facilities that failed to meet preventive controls requirements to control food hazards, and also failed to follow current good manufacturing practice (cGMP) requirements for bottled water. The Real Water Inc. products were also deemed adulterated within the meaning of the FD&C Act because they were prepared, packed, or held under insanity conditions whereby they may have become contaminated with filth or may have been rendered injurious to health.

U.S. District Judge Jennifer A. Dorsey entered a consent decree of permanent injunction between the US and AffinityLifestyles.com Inc. (a majority shareholder of Real Water Inc.), Real Water Inc., Brent A. Jones (president of Real Water Inc.), and Blain K. Jones (vice president of Real Water Inc.). The consent decree requires defendants to cease operations until they complete corrective actions, including hiring a qualified independent expert to inspect their facilities. Further, defendants may not resume operations until procedures are implemented to ensure continuing compliance with food safety requirements.