The FDA Just Shut Down This Entire Bottled Water Company
The brand was potentially linked with 16 cases of of acute non-viral hepatitis.
Reaching for a bottle of water is usually not one of the moments when your brain might suspect you're in danger. But after one water brand's products were linked to serious illnesses, a major recall was issued to remove them from shelves. Now, the U.S. Food and Drug Administration (FDA) has ordered that the troubled bottled water company shut down for violating federal regulations. Read on to see which brand is being forced to fold for safety's sake.
The FDA ordered that bottled water company Real Water Inc. shut down immediately.
On June 1, the FDA announced that Real Water Inc., a Nevada-based bottled water manufacturer, would cease operations and shut down due to its violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act). According to a judge's ruling, the company cannot process, distribute, or promote its products until its manufacturing operations comply with federal regulations and a list of other specific requirements. It must also destroy any remaining product it has in stock.
According to the FDA's announcement, the company's products—which are drawn from a municipal water source in Las Vegas—are in breach of the FD&C Act "because they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or may have been rendered injurious to health." In addition, part of the court order stipulates that the company must hire an independent expert to ensure its manufacturing practices comply with federal standards if they plan to restart operations.
"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, FDA Associate Commissioner for Regulatory Affairs, said in a statement. "The FDA, together with our federal counterparts at the U.S. Department of Justice (DOJ), aggressively pursued this injunction and we will continue to take swift action to protect consumers."
The company's bottled alkaline water was recalled in March for sickening customers.
The court order represents the latest development since Real Water Inc. voluntarily recalled all sizes of their alkaline bottled water and their concentrate on March 24 due to an FDA investigation. At the time, the company said in an announcement that "distributors have been notified of the recall and instructed to immediately remove recalled products from all store shelves, distribution, and other inventories to ensure they are no longer available for sale or consumption."
According to the FDA, anyone who still has Real Water alkaline water products "should not drink, cook with, sell, or serve it," including to pets. The products include 5-gallon containers that were delivered to homes in Hawaii, California, Utah, Arizona, and Nevada, 3-gallon containers that were sold nationwide through home delivery and subscription service, other various sized bottles that were sold online and in stores nationwide, and "Real Water" concentrate that was sold online.
Real Water has been potentially linked to liver disease.
Real Water products have potentially been linked to multiple cases of non-viral hepatitis, which is inflammation of the liver that can lead to cirrhosis on the liver, liver cancer, liver failure, and even death. The FDA first sent out a warning about Real Water on March 16 after learning of five cases of non-viral hepatitis in infants and young children in Nevada in November, resulting in acute liver failure.
"All patients were reported to have consumed 'Real Water' brand alkaline water. The consumption of 'Real Water' brand alkaline water is the only common link identified between all of these cases to date," the FDA noted.
According to the FDA, adults in the households with these children who also drank Real Water reportedly experienced symptoms as well, but they were less severe.
16 cases of illness have been linked to the bottled water since the initial recall, including one death.
Since the FDA's original warning in March, the number of reported illnesses has grown to 16 cases of acute non-viral hepatitis in adults, including one death of a woman with underlying medical conditions. In a recently posted notice, the agency says the common symptoms associated with hepatitis include "fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, dark urine, clay or gray-colored bowel movements, joint pain, yellow eyes, and jaundice." The FDA urges anyone who begins experiencing these symptoms to "contact their doctor."