 The U.S. Food and Drug Administration announced that today 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. U.S. District Judge Jennifer A. Dorsey entered a consent decree of permanent injunction on June 1between the U.S. and AffinityLifestyles.com Inc. (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. "We are committed to preventing harmful products from entering the nation's food supply, and we will take enforcement action when a company fails to follow the law," said FDA Associate Commissioner for Regulatory Affairs Judy McMeekin, Pharm.D. "The FDA, together with our federal counterparts at the U.S. Department of Justice (DOJ), aggressively pursued this injunction and we will continue to take swift action to protect consumers." According to the complaint filed by DOJ on behalf of the FDA, 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 complaint further alleges that defendants' products are adulterated within the meaning of the FD&C Act because they 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 alleges the defendants' products are misbranded because their labels fail to declare the common or usual name of each ingredient. 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. The FDA issued an outbreak advisory on March 16 and continues to investigate, along with the U.S. Centers for Disease Control and Prevention and the Southern Nevada Health District. On March 24, Real Water Inc. of Mesa, Arizona, and Henderson, Nevada, issued a recall of all sizes of its Real Water brand drinking water and concentrate. The consent decree requires defendants to cease operations until they complete corrective actions, including, hiring a qualified independent expert to inspect their facilities to ensure they comply with the FD&C Act and its implementing regulations. Under the consent decree, defendants may not resume operations until they establish and implement procedures that are adequate to ensure continuing compliance with CGMP and preventive controls requirements and receive authorization from the FDA. Consumers who think they may have been sickened by defendants' products, including Real Water Drinking Water, Real Alkalized Water and Real Alkalized Water Concentrate, should seek the assistance of a health care professional and contact the FDA to report problems with this or any FDA-regulated product. Additional Information: |
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