AffinityLifestyles.com Inc. and Real Water Inc., Henderson, Nevada, companies have been enjoined by a federal court from preparing, processing, and distributing adulterated and misbranded bottled water.
In a complaint filed on May 19, at the request of the U.S. Food and Drug Administration (FDA), the United States alleged that the company and its officers Brent A. Jones and his son, Blain K. Jones, violated the Federal Food, Drug, and Cosmetic Act by distributing adulterated and misbranded bottled water. The companies formerly distributed bottled water under the brand names “Re2al Water Drinking Water” and “Re2al Alkalized Water.” While the companies marketed their products as a healthy alternative to tap water, the government alleged that the products in fact consisted of municipal tap water that the defendants processed with various chemicals in violation of current good manufacturing practices, relevant food safety standards and hazard prevention measures.
According to the complaint filed in the U.S. District Court for the District of Nevada, the FDA received information that at least five children experienced acute non-viral hepatitis (resulting in acute liver failure) after drinking Re2al Water. The FDA documented other consumer complaints of illness, including nausea and vomiting, related to the Re2al Water. Subsequently, the agency warned consumers, restaurants, distributors and retailers not to drink, cook with, sell or serve the product.
The complaint alleges that FDA inspections found: (a) multiple regulatory violations in the companies’ manufacturing processes, including significant deviations from preventative control requirements intended to control the risk of hazards in food; and (b) multiple failures to follow current good manufacturing practice requirements for water bottling facilities.
The defendants agreed to settle the suit and be bound by a consent decree of permanent injunction. The order entered by the federal court permanently enjoins the defendants from violating the Food, Drug, and Cosmetic Act and requires that they destroy any food, including any bottled water products, still in their possession. As part of the settlement, the defendants represented that they are no longer engaged in processing, preparing, packing or distributing water or any other type of food. Before processing or distributing any food in the future, the defendants first must notify the FDA in advance, comply with specific remedial measures set forth in the injunction, and permit the FDA to inspect their facilities and procedures.