The U.S. Food and Drug Administration (FDA) says Real Water Inc. is refusing to cooperate with its investigation of a non-viral hepatitis outbreak that includes five cases of liver failure associated with the company’s alkaline water product. Because the company has not provided the FDA with access to its facilities in Henderson, NV and Mesa, AZ or any records, the agency issued a formal Demand for Records under section 414 of the Federal Food, Drug, and Cosmetic Act yesterday.

This request would allow the FDA to see records pertaining to manufacturing, materials, inventory, distribution, inventory, testing, complaints, and more. If Real Water 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.


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Liver Failure from Non-viral Hepatitis

In 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 patients come from different households. The only common link identified in all cases was consumption of “Real Water” brand alkaline water.

Alkaline water has a higher pH than regular drinking water which has a neutral pH of 7. Companies that make these products tout their health benefits but there isn’t a body of scientific evidence to support these claims.

Real Water alkaline water is 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 to residential and commercial locations. The smaller sizes were sold at grocery stores including Whole Foods and Costco,  the gas station/ convenience store Terrible Herbst and online at Amazon.com.

The FDA warns consumers, restaurants, and retailers not to drink, serve or sell Real Water alkaline water at this time.

Related

Real Water Alkaline Water Recall for Non-viral Hepatitis Risk

Real Water Hepatitis

Real Water Lawsuits

Real Water is owned by Affinity Lifestyles.com Inc. of Las Vegas. Several customers have filed lawsuits against the company to cover their extensive medical bills.

Acute cases of non-viral hepatitis occur when toxins cause an inflammation of the liver. This inflammation can also be triggered by drinking too much alcohol or by an autoimmune disease.

Symptoms of viral and non-viral hepatitis are similar. They include fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, dark urine, gray or clay-colored stools, joint pain, and yellow eyes and skin. Anyone who drank this water and is experiencing these symptoms should contact their doctor.

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.

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