Bottled Water Production Shut Down by Decree: Violations & Link to Outbreak
A federal court permanently enjoined a Henderson, NV, company 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 AffinityLifestyles.com Inc. and Real Water Inc., along with company 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 and concentrate 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 consumption of “Real Water” brand alkaline water was the only known common link between the five cases of acute liver failure in children that occurred in November and December 2020 and were reported to the FDA in March, according to a statement released by the Food and Drug Administration.
“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.”
Acting Assistant Attorney General Brian M. Boynton of the Justice Department’s Civil Division said: “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.”
“As consumers, we count on bottled water companies to take appropriate measures in ensuring their water doesn’t make our families sick, particularly children,” said Acting U.S. Attorney Christopher Chiou for the District of Nevada.
“The permanent injunction imposed on Real Water reflects the Department of Justice’s and FDA’s commitment to protecting the health of Nevadans and consumers across the country.”
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.
“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, aggressively pursued this injunction and we will continue to take swift action to protect consumers.”
The defendants agreed to settle the suit and be bound by a consent decree of the 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.
Trial Attorneys Brianna Gardner and Sarah Williams of the Civil Division’s Consumer Protection Branch are handling the case with the assistance of Assistant U.S. Attorney Troy Flake of the U.S. Attorney’s Office for the District of Nevada and Associate Chief Counsel Jennifer Argabright of the FDA’s Office of the Chief Counsel.
From Food Safety News, 6/2/21, “Consent decree shuts down production of Real Water because of violations and link to outbreak.”
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