According to a Food and Drug Administration (FDA) press release on Tuesday, Real Water Inc. has agreed to stop production of bottled water until it comes into compliance with the Federal Food, Drug, and Cosmetic Act, and other requirements contained in a consent decree which was granted on Tuesday by the Nevada District Court.
“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,” said FDA Associate Commissioner for Regulatory Affairs Judy McMeekin in the press release. “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.”
According to the FDA, consumption of “Real Water” brand alkaline water is the only link between five cases of acute liver failure in children, 11 cases of non-viral hepatitis in adults, and the death of one individual who had other underlying medical conditions.
The FDA initially announced its investigation into reports of non-viral hepatitis resulting in liver failure for infants and children associated with the bottled water company on March 16, 2021, after five individuals were hospitalized. The Southern Nevada Health District and Centers for Disease Control also participated in the investigation. A recall of Real Water brand drinking water was issued on March 24 for facilities in Henderson, NV and Mesa, AZ although the FDA had not completed investigations due to “a lack of cooperation by the firm.” The FDA said consumers and businesses should not “drink, cook with, sell, or serve” the Real Water brand alkaline water.
The FDA reported that it had completed the inspections in an April 26 update, and that it identified six additional cases in adults. The legal complaint in the matter was filed on May 19, 2021. The FDA claimed that the defendants did not meet requirements for preventative control or controlling food hazards, and did not follow good manufacturing practice requirements specific to bottled water and the water was either packaged or held in unsanitary conditions.
In addition to the contamination, the complaint further claimed that the labels on Real Water were misleading and that the defendants should have declared the common names of ingredients.
According to the FDA, Real Water Inc. will be able to resume operations after the company comes into compliance with the conditions in the consent decree.
