According to prosecutors, the F.D.A. learned that at least five children had experienced acute non-viral hepatitis, which can lead to liver failure, after drinking the father and son’s Re²al Water products.
A father and son in Nevada were ordered on Monday to halt distribution of their branded bottled waters after five children were reportedly sickened after drinking the products, which federal prosecutors said consisted of tap water “processed with various chemicals.”
Companies run by the men, Brent A. Jones and Blain K. Jones, violated the Federal Food, Drug and Cosmetic Act “by distributing adulterated and misbranded bottled water,” the Justice Department said in a statement on Tuesday. In an order signed on Monday, Judge Jennifer A. Dorsey of the U.S. District Court for Nevada formalized a settlement in which the Joneses agreed to stop processing the products and destroy any in their possession.
According to the complaint, which was filed last month at the request of the U.S. Food and Drug Administration, the F.D.A. received information that at least five children had experienced cases of acute non-viral hepatitis, a condition that can lead to liver failure, after drinking an alkaline water product branded as Re²al Water.
Other complaints involving Re²al Water reported nausea and vomiting. As a result, the agency warned consumers, restaurants, distributors and retailers not to drink, cook with, sell or serve the product.
The Southern Nevada Health District later linked the death of at least one person who consumed the product, a woman in her 60s, to acute non-viral hepatitis.
The companies, AffinityLifestyles.com and Real Water, had distributed bottled water under the brand names Re²al Water Drinking Water and Re²al Alkalized Water from facilities in Henderson, Nev., and Mesa, Ariz., according to court records.
Federal prosecutors said that while the companies promoted their products as a healthy alternative to tap water, 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 prosecutors, inspections by the F.D.A. found “multiple regulatory violations” in the companies’ manufacturing processes and “multiple failures to follow current good-manufacturing practice requirements for water-bottling facilities.”
“Food and water sold to consumers must be safe,” Acting Assistant Attorney General Brian M. Boynton of the Justice Department’s civil division said in a statement. “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.”
J. Lee Gray, the lawyer for the Joneses, said on Wednesday that the company’s policy “is to refrain from commenting on pending litigation and investigations.”
He added, “Real Water takes customer safety and satisfaction very seriously and has worked to cooperate with F.D.A. and local health officials in their ongoing investigations of reported health issues.”
In a video posted on the company’s website in March, Brent A. Jones, the president of Real Water, apologized to customers about the federal investigation into the safety of its products, which it had voluntarily recalled.
“The lessons learned in this will drive further improvement in the brand,” the elder Mr. Jones, a former Republican lawmaker in the Nevada State Assembly, said in the video. He added that the company began over 13 years ago “with the intention to provide a healthy product that benefits and elevates people’s lifestyles.” As of Wednesday, the company’s website says it is under maintenance.
Prosecutors said that the defendants agreed to settle the suit, which calls for the defendants to destroy any food, including bottled-water products, that they may still have in their possession.
As part of the settlement, the defendants affirmed that they were no longer “processing, preparing, packing or distributing water or any other type of food.”
The settlement also stipulates that before they process or distribute any food in the future, the Joneses must first notify the F.D.A. and allow the agency to inspect facilities and procedures in advance.
“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,” Judy McMeekin, an F.D.A. associate commissioner, said in the statement.
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