Real Water ordered to stop distributing adulterated Real Water products by a federal court. The U.S. District Court for the District of Nevada has permanently enjoined AffinityLifestyles Inc. and Real Water Inc. from preparing, processing, and distributing adulterated and misbranded bottled water. The water is allegedly the only common link between five children who developed non-viral hepatitis and acute liver failure in late 2020.
The alkaline water products may also be associated with non-viral hepatitis cases in seven adults. The water products were marketed as a healthy alternative to tap water, but the government alleges that the products consisted of municipal tap water that the defendants processed with various chemicals in violation of good manufacturing practices, relevant food safety standards, and hazard prevention measures.
After receiving reports of consumers experiencing nausea and vomiting related to Real Water, the FDA warned consumers, restaurants, distributors, and retailers not to drink, cook with, sell or serve the products. The water was still found for sale on various online retail outlets after the FDA warning.
Acting Assistant Attorney General Brian M. Boynton of the Justice Department’s Civil Division said in a statement, “Food and water sold to consumers must be safe. The Department of Justice will continue to work closely with the Food and Drug Administration to ensure that bottled water and other products we eat and drink are manufactured in compliance with the law.”
The complaint alleges that the FDA inspections found multiple regulatory violations in the company’s manufacturing processes, including significant deviations from preventative control requirements, and multiple failure to follow current good manufacturing practice requirements fo water bottling facilities.
The defendants agreed to settle the suit and be bound by a consent decree of permanent injunction. The order permanently enjoins the defendants from violating the Food, Drug, and Cosmetic Act and requires that they destroy any bottled water products still in their possession. And before processing or distributing any food or water in the future, they must notify the FDA in advance, comply with specific remedial measures, and let the FDA inspect their facilities and procedures.
