A federal court permanently enjoined a Henderson, NV, company from making prepared, processing, and distributing adulterated and misbranded bottled water.
In a criticism filed on Can even 19, on the seek files from of the U.S. Meals and Drug Administration (FDA), the US alleged that AffinityLifestyles.com Inc. and Accurate Water Inc., alongside with company officers Brent A. Jones and his son, Blain K. Jones, violated the Federal Meals, Drug, and Cosmetic Act by distributing adulterated and misbranded bottled water.
The firms beforehand distributed bottled water and pay attention below the emblem names “Re2al Water Drinking Water” and “Re2al Alkalized Water.” While the firms marketed their products as a healthy alternative to tap water, the authorities alleged that the products really consisted of municipal tap water that the defendants processed with diverse chemical substances in violation of unique excellent manufacturing practices, connected meals security standards, and hazard prevention measures.
According to the criticism filed within the U.S. District Court docket for the District of Nevada, the FDA bought files that no much less than 5 kids skilled acute non-viral hepatitis leading to acute liver failure after drinking Re2al Water. The FDA documented varied particular person complaints of illness, alongside side nausea and vomiting, connected to the Re2al Water. Therefore, the agency warned patrons, restaurants, distributors, and outlets no longer to drink, cook with, promote or lend a hand the product.
The consumption of “Accurate Water” brand alkaline water used to be the preferrred recognized accepted hyperlink between the 5 circumstances of acute liver failure in kids that happened in November and December 2020 and had been reported to the FDA in March, per an announcement launched by the Meals and Drug Administration.
“Since then, 11 additional circumstances of acute non-viral hepatitis in adults, alongside side one death of a lady with underlying scientific circumstances, had been identified as possibly linked to the consumption of Accurate Water brand alkaline water.”
Performing Assistant Authorized loyal Fashioned Brian M. Boynton of the Justice Department’s Civil Division mentioned: “Meals and water sold to patrons have to be safe. The Department of Justice will proceed to work intently with the Meals and Drug Administration to be determined that bottled water and varied products we exhaust and drink are manufactured in compliance with the law.”
“As patrons, we rely on bottled water firms to recall relevant measures in guaranteeing their water doesn’t produce our households sick, specifically kids,” mentioned Performing U.S. Authorized loyal Christopher Chiou for the District of Nevada. “The eternal injunction imposed on Accurate Water reflects the Department of Justice’s and FDA’s dedication to retaining the health of Nevadans and patrons all over the country.”
The criticism alleges that FDA inspections came all over: (a) multiple regulatory violations within the firms’ manufacturing processes, alongside side major deviations from preventative abet watch over requirements supposed to manipulate the risk of hazards in meals; and (b) multiple failures to be conscious unique excellent manufacturing be conscious requirements for water bottling companies and products.
“We’re committed to struggling with unhealthy products from coming into the nation’s meals offer, and we are in a position to recall enforcement action when a company fails to be conscious the law,” mentioned FDA Companion Commissioner for Regulatory Affairs Judy McMeekin, Pharm.D. “The FDA, alongside with our federal counterparts on the U.S. Department of Justice, aggressively pursued this injunction and we are in a position to proceed to recall swift action to give protection to patrons.”
The defendants agreed to resolve the scoot neatly with and be dash by a consent decree of the eternal injunction. The whine entered by the federal court permanently enjoins the defendants from violating the Meals, Drug, and Cosmetic Act and requires that they extinguish any meals, alongside side any bottled water products, serene of their possession. As allotment of the settlement, the defendants represented that they are no longer engaged in processing, making prepared, packing, or distributing water or any varied vogue of meals. Sooner than processing or distributing any meals sooner or later, the defendants first have to sigh the FDA in advance, comply with particular remedial measures space forth within the injunction, and allow the FDA to peek their companies and products and procedures.
Trial Attorneys Brianna Gardner and Sarah Williams of the Civil Division’s Consumer Safety Department are handling the case with the assist of Assistant U.S. Authorized loyal Troy Flake of the U.S. Authorized loyal’s Place of work for the District of Nevada and Companion Chief Counsel Jennifer Argabright of the FDA’s Place of work of the Chief Counsel.
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