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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).
Documents say the commercial product is drawn from the Las Vegas-area municipal water supply, filtered and processed with potassium hydroxide, commonly called lye, the chemical potassium bicarbonate and a mineral salt, magnesium chloride.
Real Water, a premium bottled water, recalled amid death and liver illnesses
Federal authorities have ordered a complete recall of the Las Vegas-based bottled water brand Real Water and ordered the company to surrender records in investigations of at least one death and multiple cases of liver illness among people who reported drinking it.
The product is sold as premium alkalized drinking water in distinctive boxy blue bottles touting “E2 Electron Energized Technology.” Labels say it is “infused with negative ions” and offers healthy detoxifying properties.
Brent Jones, the company’s president, and attorneys for the company and the bottler, AffinityLifestyles.com, did not immediately respond Friday to email messages about a US district court order issued Wednesday.
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. . .
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.
The FDA Just Shut Down This Entire Bottled Water Company
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. . .
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. . .
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. . .
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."
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Documents say the commercial product is drawn from the Las Vegas-area municipal water supply, filtered and processed with potassium hydroxide, commonly called lye, the chemical potassium bicarbonate and a mineral salt, magnesium chloride.Real Water, a premium bottled water, recalled amid death and liver illnesses
Federal authorities have ordered a complete recall of the Las Vegas-based bottled water brand Real Water and ordered the company to surrender records in investigations of at least one death and multiple cases of liver illness among people who reported drinking it.
The product is sold as premium alkalized drinking water in distinctive boxy blue bottles touting “E2 Electron Energized Technology.” Labels say it is “infused with negative ions” and offers healthy detoxifying properties.
Brent Jones, the company’s president, and attorneys for the company and the bottler, AffinityLifestyles.com, did not immediately respond Friday to email messages about a US district court order issued Wednesday.
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