June 2 (UPI) — A federal judge on Tuesday ordered a Nevada-based bottled water manufacturer to cease operations amid a Federal Food and Drug Administration investigation into more than a dozen cases of liver illness that resulted in the death of at least one person.
Judge Jennifer Dorsey of the U.S. District Court of the District of Nevada entered a consent decree of permanent injunction with AffinityLifestyles.com Inc. and its owners to cease operations of its Real Water brand products as they have been linked to at least 16 probable cases of non-viral hepatitis illnesses.
“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,” FDA Associate Commissioner for Regulatory Affairs Judy McMeekin said.
Prosecutors filed a complaint on behalf of the FDA on May 19 against AffinityLifestyles.com, Real Water Inc. and company officers Brent Jones and his son, Blain Jones, for distributing adulterated and misbranded water.
The complaint states that while they marketed their “Re2al Water Drinking Water” and Re2al Alkalized Water” as healthy alternatives to tap water, their products were simply tap water treated with various chemicals, which violates good manufacturing practices, food safety standards and hazard prevention measures.
FDA investigators also state in the complaint that defendants committed various regulatory violations, including “significant deviations” from requirements established to prevent the risk of hazards in food and “multiple failures” to follow good manufacturing practices requirements for water bottling facilities.
“As consumers, we count on bottled water companies to take appropriate measures in ensuring their water doesn’t make our families sick, particularly children,” Acting U.S. Attorney Christopher Chiou for the District of Nevada said in a statement.
The agreement orders them to cease further violating relevant laws and to destroy any food and bottled water products in their possession. The defendants also said in the agreement that they are no longer engaged in the food or water business and that if they do intend to re-enter this line of work they must notify the FDA in advance.
The FDA said it, along with the U.S. Centers for Disease Control and Prevention, is continuing to investigate cases of liver failure linked to the bottle water.
The first five cases of acute non-viral hepatitis resulting in liver failure in infants and children were reported on March 13, with the FDA stating all five patients from four different households were hospitalized but had since recovered.
An additional two adults and three children from two of those four households reporting symptoms.
Days later, the FDA reported that the consumption of “Real water” between November and December of last year was the only common link between those cases.
Following an FDA investigation in which investigators said the company gave “a lack of cooperation,” “Real Water” issued a recall of its products on March 24.
Last month, the Southern Nevada Health District announced it had identified five more probable cases and a suspected case, all adults, including one death of a woman in her 60s who suffered from underlying medical conditions.
The new cases have not been included in the Justice Department’s complaint.