Adrianne DeLuca
Last week, the U.S. Food and Drug Administration (FDA) filed a lawsuit in the United States District Court for the District of Nevada against Las Vegas-based alkaline water brand Real Water, Inc. after an investigation revealed that unsanitary conditions and unregulated practices at the company’s bottling facility led to a non-viral strain of hepatitis contaminating the bottled water late last year. The contamination is linked to five cases of acute liver failure in children, the death of a 69-year-old woman, and several other cases of hepatitis and acute liver failure among Real Water consumers during November and December 2020. At least a dozen additional civil suits have been filed against the company since March.
How did this happen?
After Southern Nevada health officials alerted the FDA about the illnesses in March, the agency began an investigation and audit of Real Water Inc. Investigators found the company had violated the Federal Food, Drug, and Cosmetic Act in multiple ways. The facilities producing “Real Water” alkaline water were found to have “no written process control and/or supply-chain control procedures” to monitor the amount of chemical ingredients and environmental pathogens, or to identify biological hazards in the water produced at its Henderson, Nevada and Mesa, Arizona plants.
Initially, Real Water failed to provide any records of water samples or test results to the FDA; however, they eventually turned over a pair of oxidation meters that are now exhibits in the suit. The FDA was forced to issue a Demand for Records after Real Water didn’t cooperate with the investigation and audit in a timely manner.
The failure to regularly test their water likely led to additional contamination, according to the complaint. Although the origin of the contamination has not yet been identified, investigators also observed the company using recycled detergent and sanitizer water to clean 5-gallon water containers used for home and office delivery. The recycled detergent was not tested to ensure it was not carrying additional contaminants.
Additionally, the FDA found the company had no record of inspections of the condition, performance or effectiveness of the equipment used in either facility.
Real Water issued a voluntary recall on March 16, 2021 after the FDA notified the company of the outbreak linked to the product. Once the investigation was underway, the FDA discovered the company failed to identify units bottled at the plants with a production code, meaning that when the product was recalled, there was no systematic way of identifying where units had been distributed. Real Water was still being sold and distributed over a month after the recall was issued and is still listed online at Naturewoo.com.
What is Real Water?
The water brand creates its trademarked E2 Concentrate, which is essentially potassium bicarbonate, using municipal tap water. According to the product’s description that still remains on a few local distributor’s sites, the water is filtered through reverse osmosis, undergoes treatment with a UV light and is charged with an electrical current to separate out the positive and negative ions – creating the E2 Concentrate. The concentrate is created in the Henderson facility and then shipped to the Mesa facility to be mixed into bottles for distribution, but does not undergo a treatment to destroy any environmental pathogens that may be present.
Real Water, which has marketed its product as “the healthiest drinking water available,” launched in 2013. The product has a pH level of 9.0 and is “infused with negative ions” to increase cellular hydration. None of these statements have been evaluated by the FDA. Real Water was sold in RTD bottles nationwide at retailers such as Whole Foods, Sprouts and Publix, and was available for 5-gallon home and office delivery in the Las Vegas area. The company also sold the E2 concentrate in 4 oz. bottles that could be added to any purified water source.
Blaine Jones, Vice President, Secretary, and Treasurer of Real Water, and the Secretary and Treasurer of AffinityLifestyles.com Inc., the majority shareholder of Real Water Inc. was responsible for manufacturing, distribution, and employee training at Real Water and is the sole individual responsible for making the E2 concentrate, according to the complaint.
In a videotaped deposition obtained by the Las Vegas Review-Journal, Casey Aiken, a former Lead Water Technician at Real Water, Casey Aiken, said he had been promoted from the warehouse last fall after working on the distribution end for only a few months. He said he had no prior chemistry experience aside from a few hours of hands-on training instructed by Blaine Jones. Aiken was in charge of mixing the concentrate into the water, but in his deposition, he claimed he was never instructed on how much concentrate should be added.
Aiken claims he did not know what was in the concentrate, but explained that his thinking was if someone is already ingesting it, “I would think that it’s safe no matter what.”
The investigation found that Real Water had no documentation to ensure excessive amounts of the chemical ingredients were not added or that the E2 Concentrate had not been contaminated.
The ingredients listed on Real Water’s label only identify purified water and potassium bicarbonate are present in the product. The FDA complaint cites that the label fails to list potassium hydroxide and magnesium chloride which they found to be ingredients in the water.
What Happens Now?
Real Water’s website is currently down “for maintenance.” In its place is a statement from the company on March 24, 2021 about the inquiry, a video from Brent Jones apologizing for any illness caused related to the product and two water test reports.
The five children who had experienced acute liver failure have recovered and avoided liver transplants according to the Southern Health District of Nevada. Additionally, Aiken stated in his deposition that he had been giving the water to his dog who subsequently needed medication to reduce the swelling of his liver. The civil suits filed against the company are still ongoing and are seeking class-action status.
According to the Mayo Clinic, hepatitis can be caused by a viral infection, or from the presence of an increased level of toxins which cause the liver to swell. Symptoms of hepatitis include fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, joint pain, yellow eyes, and jaundice. The investigation found that the source of the outbreak was likely propelled by the use of the concentrate either not being added in the appropriate proportions or as a recontamination agent in the water it was mixed into.
In April the FDA issued a statement saying “it is crucial that consumers, restaurants, distributors, and retailers not drink, cook with, sell, or serve “Real Water” alkaline water. FDA also advises that this water not be served to pets.”
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