One week after Real Water Inc. recalled all of its alkaline water products after non-viral hepatitis illnesses including cases of liver failure were associated with them, the products are still being sold and marketed, the U.S. Food and Drug Administration (FDA) said in its most recent update on the outbreak. What’s more, the agency said, the Las Vegas-based company is still refusing to cooperate with the FDA investigation of the outbreak. Consumers, restaurants, and retailers should not drink, serve or sell Real Water alkalized water at this time, the FDA warns.
Contact the Pritzker Hageman Hepatitis Team
Phone: 1-888-377-8900 | Text: 1-612-261-0856
Alkaline water is water that has been altered so that it has a higher pH than regular drinking water which has a neutral pH of 7. Although companies that make alkalized water products tout their health benefits, there isn’t scientific evidence to support these claims.
Real Water issued the recall last week after state and federal health officials revealed that they had identified at least 10 cases of non-viral hepatitis among people who consumed the product including five cases of liver failure among children and infants. In its recall, the company stated that it had notified its distributors and ceased production and distribution of the products. But today, the FDA said it has identified “a number” of distributors that the company had not contacted directly about the recall, that the products are still being sold online and that Real Water continues to promote them on social media.
Non-viral Hepatitis and Liver Failure
Hepatitis is an inflammation of the liver. Often a virus is the trigger for these infections. But chemicals such as alcohol, medications, or other toxins including herbal and dietary supplements can also cause the liver to become inflamed and in some cases cease to function.
Symptoms of viral and non-viral hepatitis include fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, dark urine, gray or clay-colored stools, joint pain and yellowing of eyes and skin. Anyone who drank Real Water alkalized water and is experiencing these symptoms should contact their doctor immediately.
Real Water Hepatitis Outbreak Timeline
November 2020 The Southern Nevada Health District received 10 reports of acute non-viral hepatitis including five infants and children who suffered liver failure. The only common link identified among all of these patients in all cases was consumption of “Real Water” brand alkaline water.
March 13, 2021 The Southern Nevada Health District notifies the Centers for Disease Control and Prevention (CDC) and FDA of the non-viral hepatitis cases seeking care at hospitals between November 10, 2020, and December 3, 2020. These patients included five children ranging in age from seven months to five years old. Lab tests on these infants and children, who were experiencing symotoms of vomiting, poor intake, and fatigue, showed “elevated hepatic transaminases, hyperbilirubinemia, coagulopathy, and a negative viral hepatitis serology panel,” according to a CDC Health Action Alert. They all required transfers to a pediatric tertiary-care specialty liver unit due to concerns of acute liver failure and the possible need for liver transplantations, the alert states.
March 17, 2021 The FDA announced the outbreak but there is no recall.
March 23, 2021 The FDA issues a formal Demand for Records under section 414 of the Federal Food, Drug, and Cosmetic Act which would allow the FDA to see records pertaining to manufacturing, materials, inventory, distribution, inventory, testing, complaints, and more. If the company refuses the demand, the FDA can suspend the company’s food facility’s registration to prevent it from operating, seize inventory, order a mandatory recall or issue an injunction against the company.
March 24, 2021 In an outbreak update, the FDA says that its investigation has been stymied by the company’s refusal to cooperate. In the absence of a recall, the FDA warns consumers, restaurants, and retailers not to drink, serve or sell Real Water alkaline water. It reveals that it has issued a Demand for Records.
Later that day Real Water issues a recall for all of its products, states that it has contacted its distributors and ceased production.
The recall includes Real Water alkaline water sold in 5-gallon, 1-gallon, 500-mL (16.9oz.), 1-liter, and 1.5-liter plastic bottles and in 750-mL glass bottles. The 5-gallon sizes were delivered by distributors to residential and commercial locations. The smaller sizes were sold at grocery stores including Whole Foods, Costco Publix and Cub Foods; the gas station/ convenience store Terrible Herbst and online at Amazon.com.
March 25, 2021 The FDA issues a second Demand for Records.
March 31, 2021 The FDA announces that Real Water is still refusing to cooperate with the investigation, that the company is still marketing the product on social media, that retailers are still selling the products, and that some distributors have not been notified about the recall.
The FDA discovered these issues while conducting an audit of the company’s recall without information or cooperation from the company. The agency issues a second Demand for Records.
The CDC issues a Health Action Alert providing background information and recommendations for clinicians. (See link in March 13, 2021entry.)
Visitors to the company’s website will be greeted by a message that it is “down for maintenance.” But links to the recall, two water tests and a YouTube video from Real Water CEO, majority owner and founder Brent Jones are available.
Real Water Lawsuits
Real Water’s parent company is Affinity Lifestyles.com Inc. of Las Vegas. Several customers have filed lawsuits against the company to cover their extensive medical bills.
If you have been sickened in this outbreak and would like a free consultation with the hepatitis lawyers at Pritzker Hageman, please contact our team by calling 1-888-377-8900 sending a text to 1-612-261-0856 or completing the form below.