Updated May 20, 2021 - 5:47 pm
The Department of Justice has sued Las Vegas-based Real Water, alleging a series of sanitation and labeling failures that led to an outbreak of liver illnesses tied to the product.
In response to the lawsuit, company president Brent Jones, a former Nevada legislator, agreed to recall and destroy any Real Water products.
Food and Drug Administration investigators found that the company did not test processed tap water before it was bottled at plants in Henderson and Mesa, Arizona, “potentially leading to impure and unsafe water,” according to the federal complaint filed Wednesday.
A plan to recall the product must be submitted to the FDA within three days and “include customer notifications, public warning, methods for conducting effectiveness checks, and plans for product disposition,” according to an order filed in connection with the lawsuit.
At the Henderson and Mesa facilities, “FDA investigators observed that Defendants have not properly cleaned and sanitized the water tanks in which they mix processed municipal tap water with E2 Concentrate, potentially leading to chemical and microbial contamination,” the lawsuit states, citing violations of the Food, Drug and Cosmetic Act.
Real Water also did not “record the results of any inspections of the equipment used for these processes, conditions found, and the performance or effectiveness of the equipment,” according to the complaint.
Attorneys for Real Water could not be reached for comment on the government’s lawsuit.
The suit is among at least a dozen filed against Real Water since the outbreak was reported, and also names Jones and his son, Blain — the company’s vice president, secretary and treasurer — as defendants.
Real Water had “no written process control and/or supply-chain control procedures to ensure that the correct type and amount of chemicals are added to each batch of product water,” the suit alleges. “Defendants also do not have written sanitation controls at the Henderson and Mesa Facilities to control the risk of re-contamination with environmental pathogens during the mixing and bottling processes.”
One suit filed last week linked a Nevada woman’s death to the bottled water, pointing to a series of outbreaks throughout the last six years.
According to the DOJ lawsuit, Real Water failed to:
■ Develop a written food safety plan.
■ Adequately clean and sanitize containers, utensils, pipes and equipment.
■ Sample and test cleaning solutions.
■ List all ingredients on bottles.
Investigators observed the company use untested and recycled detergent and sanitizer to clean reusable 5-gallon containers, according to the suit.
The product loaded with concentrate and touted as “alkalized water infused with negative ions” and “the healthiest drinking water available” never underwent a “lethal treatment,” which meant that “any biological contamination would be passed on to the consumer,” the DOJ alleges.
Health officials have said they were first alerted in March to five cases of acute nonviral hepatitis, which causes liver failure, in infants and children from late last year.
“No other common exposures, including medications, food, supplements, activities, travel history, or ill contacts have been reported or linked to the illnesses,” the DOJ suit states.
Last month, the Southern Nevada Health District said it had linked at least six additional cases of severe liver disease to Real Water.
On Thursday, local health officials reported five more cases of serious liver disease in connection with its investigation into Real Water, also linking the woman’s death to the alkaline water.
Brent Jones has apologized to customers, while the company’s lawyers have said they were cooperating with ongoing investigations.
DOJ lawyers allege in their suit that Blain Jones initially lied to investigators about where 5-gallon containers were manufactured in November, when the Henderson plant was the only facility capable of bottling the jugs.
He also said that a concentrate introduced into the product had been used only at a Las Vegas plant before August, but investigators found that the concentrate also was used in Henderson.
Blain Jones “denied any change in the formulation of Defendants’ Real Water, but FDA investigators later determined that Defendants had changed the formulation in November 2020 because of customer complaints regarding taste and possible illness,” the DOJ suit alleges.