In March 2021, Real Water, a bottled water company operating in Mesa, Ariz., and Henderson, Nevada, issued a recall of all sizes of its Real Water brand drinking water and concentrate, when five cases of non-viral hepatitis occurred in children, prompting an FDA investigation. However, the company continued to sell its product through online retailers, and by the end of April 2021, six additional cases were reported, including one fatality.
In federal court, FDA argued that Real Water violated the Federal Food, Drug, and Cosmetic Act by distributing adulterated and misbranded bottled water. On June 1, the court acted and Real Water was required shut down production and agreed to cease operations until it could comply with the legislation.
“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 Christopher Chiou, acting U.S. attorney for the District of Nevada, in a statement. “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 FDA noted that it’s crucial for consumers, restaurants, distributors, and retailers to not drink, cook with, sell, or serve this water.
Bryan Armentrout, founder of The Food Leadership Group/Food Safety Foundation, tells Food Quality & Safety that when a recall such as this occurs, FDA pays attention. “Moving forward, [FDA] will take the lessons learned and incorporate them into their water bottler assessments,” he says. “It appears to me that Real Water was not cooperative, which was absolutely the wrong thing to do. FDA has the tools under the Food Safety Modernization Act to respond quickly in such situations, and they did.”
Armentrout expects FDA to take the next steps in the process soon, which may include additional actions against the company and the leadership team. This may also include actions under the Department of Justice via the Park Doctrine.
“Food Safety is a continuous process and, as we learn new lessons, they need to be shared,” Armentrout adds. “What was the root cause of the issue at Real Water? What can other bottled water manufacturers learn from their failure? In order to prevent a repeat, the industry needs to know what happened and take steps to prevent a recurrence. This is what their food safety plans are meant to accomplish.”
The water bottle industry isn’t expected to be impacted much, if at all, with Armentrout noting that consumer impressions regarding the safety of bottled water isn’t expected to change. “It’s a big part of how people hydrate, and alternatives such as tap water are considered to be inferior by consumers,” he says. “Recent activity and testing of bottled water from organizations such as Consumer Reports has raised awareness around the issue of contamination. If these issues continue, confidence can quickly erode.”