Case 2:21-cv-00959-JAD-BNW Document 1 Filed 05/19/21 Page 1 of 19
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`BRIANNA GARDNER
`SARAH WILLIAMS
`Trial Attorneys
`Consumer Protection Branch
`U.S. Department of Justice, Civil Division
`PO Box 386
`Washington, DC 20044-0386
`202-532-4786 (Gardner)
`202-616-4269 (Williams)
`Fax: 202-514-8742
`brianna.m.gardner@usdoj.gov
`sarah.williams@usdoj.gov
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`Counsel for Plaintiff
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`UNITED STATES DISTRICT COURT FOR THE
`DISTRICT OF NEVADA
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`UNITED STATES OF AMERICA
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` Plaintiff,
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`v.
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`AFFINITYLIFESTYLES.COM, INC., and REAL
`WATER, INC., corporations, and BRENT A.
`JONES and BLAIN K. JONES, individuals.
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` Defendants.
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`Case No. 21-cv-959
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`COMPLAINT FOR A PERMANENT
`INJUNCTION
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`Plaintiff, the United States of America, on behalf of the United States Food and Drug
`Administration (“FDA”) alleges:
`1.
`This statutory injunction proceeding is brought under the Federal Food, Drug, and
`Cosmetic Act, 21 U.S.C. § 332(a), to halt the manufacture and distribution of adulterated and/or
`misbranded bottled drinking water and chemical concentrate. Defendants’ bottled drinking water has
`been associated with five cases of acute liver failure in children. Plaintiff seeks an injunction to restrain
`and enjoin Defendants from directly or indirectly doing or causing the following acts:
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`Case 2:21-cv-00959-JAD-BNW Document 1 Filed 05/19/21 Page 2 of 19
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`Violating 21 U.S.C. § 331(uu), by operating a facility that manufactures,
`A.
`processes, packs, or holds food for sale in the United States, and not doing so in compliance with the
`hazard analysis and risk-based preventive controls requirements in 21 U.S.C. § 350g;
`B.
`Violating 21 U.S.C. § 331(a), by introducing or delivering for introduction into
`interstate commerce articles of food that are adulterated within the meaning of 21 U.S.C. § 342(a)(4)
`and/or misbranded within the meaning of 21 U.S.C. § 343(i)(2); and
`C.
`Violating 21 U.S.C. § 331(k), by causing articles of food that are held for sale
`after shipment of one or more of their components in interstate commerce to become adulterated within
`the meaning of 21 U.S.C. § 342(a)(4) and/or misbranded within the meaning of 21 U.S.C. § 343(i)(2).
`JURISDICTION AND VENUE
`This Court has jurisdiction over the subject matter and all parties to this action pursuant
`2.
`to 28 U.S.C. §§ 1331, 1337, and 1345, and 21 U.S.C. § 332(a).
`3.
`Venue in this district is proper under 28 U.S.C. § 1391.
`THE PARTIES
`Plaintiff, the United States of America, brings this action on behalf of FDA, the agency
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`mandated to protect the public health by, among other things. ensuring the safety of the U.S. food
`supply, including, but not limited to, bottled drinking water.
`5.
`Defendant AffinityLifestyles.com, Inc. (“Affinity”) is a Nevada corporation operating
`under Nevada Business ID, NV19981130088, and located at 3773 Howard Hughes Parkway, Suite
`500S, Las Vegas, Nevada 89169. Affinity is the majority shareholder of Defendant Real Water, Inc.
`6.
`Defendant Real Water, Inc. (“Real Water”) is a Delaware corporation, doing business in
`Nevada, under Nevada Business ID, NV20181191189, with addresses at 3208 W. Desert Inn Rd, Las
`Vegas, NV 89102 and 6018 E. Main Street, Mesa, Arizona 85205.
`7.
`Real Water manufactures bottled drinking water and a proprietary chemical concentrate
`(“E2 Concentrate”) at 1180 Center Point Drive, Suite 200, Henderson, Nevada 89102 (the “Henderson
`Facility”), within the jurisdiction of this Court.
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`Case 2:21-cv-00959-JAD-BNW Document 1 Filed 05/19/21 Page 3 of 19
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`Real Water also manufactures bottled drinking water at 6018 E. Main Street, Mesa,
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`Arizona 85205 (the “Mesa Facility”).
`9.
`Defendants distribute bottled drinking water from the Henderson Facility and the Mesa
`Facility under the brands “Re2al Water Drinking Water” and “Re2al Alkalized Water,” respectively.
`“Re2al Water” is used herein to refer to either brand of Defendants’ bottled drinking water.
`Defendants repackage E2 Concentrate at the Mesa Facility and distribute it under the
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`brand “Re2al Alkalized Water Concentrate.”
`11.
`Defendant Brent A. Jones is the President and Director of Affinity and Real Water. He is
`responsible for purchasing, marketing, and sales at Real Water. Brent A. Jones is a resident of Nevada,
`who performs his duties at the Henderson Facility, within the jurisdiction of this Court.
`12.
`Defendant Blain K. Jones is the Vice President, Secretary, and Treasurer of Real Water,
`and the Secretary and Treasurer of Affinity. He is responsible for manufacturing, distribution, and
`employee training at Real Water. Blain K. Jones is a resident of Nevada, who performs his duties at the
`Henderson Facility, within the jurisdiction of this Court.
`13.
`Upon information and belief, Defendants Brent A. Jones and Blain K. Jones are the only
`individuals who know the formula for E2 Concentrate.
`14.
`Upon information and belief, Defendant Blain K. Jones is the sole individual responsible
`for manufacturing E2 Concentrate.
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`DEFENDANTS’ PRODUCTS
`Defendants manufacture, process, prepare, bottle, pack, label, hold, and distribute articles
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`of food within the meaning of 21 U.S.C. § 321(f), namely Re2al Water and E2 Concentrate.
`Defendants manufacture E2 Concentrate at the Henderson Facility using materials
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`shipped from outside Nevada, including potassium hydroxide provided by a chemical company located
`in Arizona.
`To manufacture E2 Concentrate, Defendants first process municipal tap water by carbon
`17.
`filtration, reverse osmosis filtration, ultraviolet light filtration, and ozone filtration, and then Defendants
`mix this processed water with potassium hydroxide, potassium bicarbonate, and magnesium chloride.
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`Case 2:21-cv-00959-JAD-BNW Document 1 Filed 05/19/21 Page 4 of 19
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`Next, Defendants claim to use a proprietary “ionizer” apparatus to apply an electrical current to this
`mixture, which allegedly creates positively-charged and negatively-charged solutions. Defendants then
`discard the positively-charged solution and store the negatively-charged solution as E2 Concentrate.
`Defendants use E2 Concentrate for manufacturing Re2al Water at the Henderson Facility.
`18.
`Defendants also send E2 Concentrate to the Mesa Facility for manufacturing Re2al Water there, and for
`repackaging the E2 Concentrate into retail bottles.
`Defendants manufacture Re2al Water by adding E2 Concentrate and potassium hydroxide
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`to municipal tap water that has been processed as described in paragraph 17. Defendants mix these
`ingredients in a large tank, and then fill containers with this mixture for distribution as Re2al Water.
`Defendants distribute 5-gallon containers of Re2al Water from the Henderson Facility
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`both to customers within Nevada and to customers located outside of Nevada, including Arizona and
`California. Defendants distribute 500-milliliter (mL), 1-liter (L), 1.5-L, and 1-gallon containers of Re2al
`Water from the Mesa Facility to distributors in Arizona, California, and Nevada. Defendants distribute
`4-ounce (oz) bottles of E2 Concentrate from the Mesa Facility to online consumers throughout the
`United States.
`Defendants market Re2al Water as “premium” drinking water that is a “clean,” “healthy”
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`alternative to tap water.
`Defendants market E2 Concentrate as a taste enhancer that consumers can add to liquids,
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`including, but not limited to, tea, coffee, and wine.
`Defendants intend for Re2al Water and E2 Concentrate to be consumed with no further
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`processing. It is therefore crucial for Defendants to properly manufacture, process, prepare, bottle, pack,
`hold, and distribute Re2al Water and E2 Concentrate to minimize the potential for chemical and
`microbial contamination and reduce the risk of illness to consumers.
`PREVENTIVE CONTROLS REQUIREMENTS
`The Federal Food, Drug, and Cosmetic Act requires that the owner, operator, or agent in
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`charge of a facility evaluate the hazards that could affect food manufactured, processed, packed, or held
`by such facility, and identify and implement preventive controls to significantly minimize or prevent the
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`occurrence of those hazards and provide assurances that such food is not adulterated. See 21 U.S.C.
`§ 350g (Hazard analysis and risk-based preventive controls).
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`The hazard analysis and risk-based preventive controls requirements set forth at 21
`C.F.R. Part 117, Subpart C (“Human Food Preventive Control Regulations”), implement 21 U.S.C.
`§ 350g, and were promulgated to better protect the public health by, among other things, ensuring the
`production of safe and sanitary food through hazard analysis and risk-based preventive controls. See 21
`U.S.C. § 350g(n)(1)(A). Failure to comply with the Human Food Preventive Control Regulations
`violates the Federal Food, Drug, and Cosmetic Act. See 21 U.S.C. § 331(uu) and 21 C.F.R. § 117.1(b);
`see also Final Rule, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive
`Controls in Human Food, 80 Fed. Reg. 55,908 (Sept. 17, 2015).
`26.
`The hazard analysis requirements require the owner, operator, or agent in charge of a
`food facility to “conduct a hazard analysis to identify . . . known or reasonably foreseeable hazards . . .
`to determine whether there are any hazards requiring a preventive control” for each type of food
`manufactured, processed, packed, or held at the facility. 21 C.F.R. § 117.130(a) (Requirement for a
`hazard analysis); 21 U.S.C. § 350g(b). Hazards can be biological, chemical, or physical, and they can be
`naturally occurring, unintentionally introduced, or intentionally introduced for purposes of economic
`gain. See 21 U.S.C. § 350g(b); 21 C.F.R. § 117.130(b) (Hazard identification).
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`The owner, operator, or agent in charge of a food facility must, among other things,
`identify and implement preventive controls to provide assurances that any hazards requiring a preventive
`control are significantly minimized or prevented, and the food manufactured, processed, packed, or held
`by a facility is not adulterated under 21 U.S.C. § 342. See 21 U.S.C. § 350g(c); 21 C.F.R. § 117.135
`(Preventive controls).
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`Preventive controls include, as appropriate to the food and facility, process controls,
`sanitation controls, supply-chain controls, a recall plan, as well as any other controls necessary to
`provide assurances that the food is not adulterated under 21 U.S.C. § 342. 21 U.S.C. § 350g(c); 21
`C.F.R. § 117.135(c).
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`The preventive controls requirements require monitoring procedures to provide assurance
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`that the preventive controls are being consistently performed, see 21 U.S.C. § 350g(d) and 21 C.F.R.
`§ 117.145 (Monitoring); corrective action procedures to be taken if preventive controls are not properly
`implemented or found to be ineffective, see 21 U.S.C. § 350g(e) and 21 C.F.R. § 117.150 (Corrective
`actions and corrections); and procedures to verify that the preventive controls are consistently
`implemented and are effectively and significantly minimizing or preventing hazards, see 21 U.S.C.
`§ 350g(f) and 21 C.F.R. § 117.165 (Verification of implementation and effectiveness).
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`The preventive controls requirements additionally require documentation of monitoring
`and corrective actions in accordance with 21 C.F.R. §§ 117.145 and 117.150 in records that are subject
`to review in accordance with 21 C.F.R. § 117.165. See 21 U.S.C. § 350g(g) (Recordkeeping).
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`The preventive controls requirements further require that the owner, operator, or agent in
`charge of a food facility prepare a written food safety plan that includes the hazard analysis, preventive
`controls, supply-chain program, recall plan, and monitoring, corrective action, and verification
`procedures described above. See 21 U.S.C. § 350g(h) (Written Plan and Documentation); 21 C.F.R.
`§ 117.126 (Food safety plan).
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`Defendants’ Violations
`Defendants violate the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 331(uu), by
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`operating a facility that manufactures, processes, packs, or holds food for sale in the United States, in a
`manner that does not comply with the hazard analysis and risk-based preventive controls requirements
`of 21 U.S.C. § 350g.
`33.
`Defendants fail to comply with the hazard analysis and preventive controls requirements
`by, among other things, their:
`A.
`Failure to identify and evaluate any known or reasonably foreseeable hazards for
`each type of food manufactured, processed, packed, or held at Defendants’ facilities to determine
`whether there are hazards requiring a preventive control, in violation of 21 U.S.C. § 350g(b) and 21
`C.F.R. § 117.130;
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`Failure to identify and implement preventive controls to provide assurances that
`B.
`the food manufactured, processed, packed, or held at Defendants’ facilities is not adulterated under 21
`U.S.C. § 342, in violation of 21 U.S.C. § 350g(c) and 21 C.F.R. § 117.135;
`C.
`Failure to monitor the effectiveness of preventive controls to provide assurances
`that the food manufactured, processed, packed, or held by Defendants’ facilities is not adulterated under
`21 U.S.C. § 342, in violation of 21 U.S.C. § 350g(d) and 21 C.F.R. § 117.145;
`D.
`Failure to establish appropriate corrective action procedures to ensure that the
`food manufactured, processed, packed, or held by Defendants’ facilities and introduced into interstate
`commerce is not adulterated, in violation of 21 U.S.C. § 350g(e) and 21 C.F.R. § 117.150(b);
`E.
`Failure to verify that preventive controls identified and implemented to provide
`assurances that the food manufactured, processed, packed, or held by Defendants’ facilities is not
`adulterated under 21 U.S.C. § 342 are adequate to control the hazards so identified, in violation of 21
`U.S.C. § 350g(f) and 21 C.F.R. § 117.165(a);
`F.
`Failure to establish and implement a risk-based supply-chain program for those
`raw materials and other ingredients for which the receiving facility has identified a hazard requiring a
`supply-chain-applied control, in violation of 21 U.S.C. § 350g(c) and 21 C.F.R. §§ 117.135(c)(4) and
`117.405; and
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`Failure to develop a written food safety plan, in violation of 21 U.S.C. § 350g(h)
`G.
`and 21 C.F.R. § 117.126.
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`FOOD ADULTERATION
`Food is adulterated within the meaning of the Federal Food, Drug, and Cosmetic Act “if
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`it has been prepared, packed, or held under insanitary conditions whereby it may be have become
`contaminated with filth, or whereby it may have been rendered injurious to health.” 21 U.S.C.
`§ 342(a)(4).
`35. Manufacturers that process, bottle, hold, or ship bottled drinking water must comply with
`FDA’s current good manufacturing practice (“CGMP”) requirements for bottled drinking water at 21
`C.F.R. Part 129 (“Bottled Water CGMP Regulations”). See 21 C.F.R. § 129.1. The Bottled Water
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`CGMP Regulations were promulgated to ensure that bottled drinking water is safe for human
`consumption and that it has been processed, bottled, held, and transported under sanitary conditions. 21
`C.F.R. § 129.1. Manufacturing according to Bottled Water CGMP Regulations means that the facilities,
`methods, practices, and controls used in the processing, bottling, holding, and transporting of bottled
`drinking water are administered in conformity with CGMP. 21 C.F.R. § 129.1.
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`Among other things, failure to follow Bottled Water CGMP Regulations can render
`bottled drinking water adulterated within the meaning of 21 U.S.C. § 342(a)(4). See 21 C.F.R. § 129.1.
`Defendants’ Violations
`Defendants violate the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 331(a), by
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`introducing or delivering for introduction into interstate commerce, or causing the introduction or
`delivery for introduction into interstate commerce, articles of food that are adulterated within the
`meaning of 21 U.S.C. § 342(a)(4).
`38.
`Defendants violate the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 331(k), by
`causing articles of food that are held for sale after shipment of one or more of their components in
`interstate commerce to become adulterated within the meaning of 21 U.S.C. § 342(a)(4).
`39.
`Defendants fail to comply with Bottled Water CGMP Regulations by, among other
`things, their:
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`Failure to adequately clean and sanitize product water-contact surfaces of all
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`multiservice containers, utensils, pipes, and equipment used in the transportation, processing, handling,
`and storage of product water, in violation of 21 C.F.R. § 129.37 (Sanitary operations), as those terms are
`defined by 21 C.F.R. § 129.3 (e.g., “product water” is processed water that a plant uses for bottled
`drinking water, and “multiservice containers” are containers intended to be used more than once);
`B.
`Failure to process product water under processes and controls necessary to ensure
`that Defendants’ treatment of their product water is effective and will not adulterate the bottled product,
`in violation of 21 C.F.R. § 129.80(a);
`C.
`Failure to adequately sample and test cleaning and sanitizing solutions to assure
`adequate performance in the cleaning and sanitizing operations, in violation of 21 C.F.R. § 129.80(c);
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`Failure to identify each unit package with a production code that identifies the
`D.
`batch and date produced, and record and maintain information as to the kind of product, volume
`produced, date produced, lot code used, and the distribution of product to wholesale and retail outlets, in
`violation of 21 C.F.R. § 129.80(e);
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`Failure to adequately monitor and record the performance of their filling, capping,
`and sealing process to assure that containers and closures are free from contamination, in violation of 21
`C.F.R. § 129.80(f); and
`F.
`Failure to adequately analyze product samples to assure that production of bottled
`drinking water complies with applicable standards, laws, and regulations, in violation of 21 C.F.R.
`§ 129.80(g).
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`MISBRANDED FOOD
`A food is misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act
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`if, among other things, it is fabricated from two or more ingredients and its label fails to bear the
`common or usual name of each ingredient. 21 U.S.C. § 343(i)(2).
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`Food must comply with labeling requirements that declare the ingredients by listing them
`by common or usual name in descending order of predominance by weight on either the principle
`display panel or the information panel. See 21 C.F.R. § 101.4 (Food; designation of ingredients).
`Defendants’ Violations
`Defendants violate the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 331(a), by
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`introducing or delivering for introduction into interstate commerce, or causing to be introduced or
`delivered for introduction into interstate commerce, articles of food that are misbranded under 21 U.S.C.
`§ 343(i)(2).
`Defendants violate the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 331(k), by
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`causing articles of food that are held for sale after shipment of one or more components in interstate
`commerce to become misbranded under 21 U.S.C. § 343(i)(2).
`Defendants cause their Re2al Water and E2 Concentrate to be misbranded within the
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`meaning of the Federal Food, Drug, and Cosmetic Act as follows:
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`Case 2:21-cv-00959-JAD-BNW Document 1 Filed 05/19/21 Page 10 of 19
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`Defendants’ Re2al Water product labels do not list by common or usual name all
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`ingredients, and ingredients of multi-component ingredients, including potassium hydroxide and
`magnesium chloride, in violation of 21 U.S.C. § 343(i)(2) and 21 C.F.R. § 101.4; and
`Defendants’ E2 Concentrate product labels do not list by common or usual name
`B.
`all ingredients, including potassium bicarbonate, in violation of 21 U.S.C. § 343(i)(2) and 21 C.F.R.
`§ 101.4.
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`EVIDENCE OF VIOLATIONS
`In March/April 2021, FDA inspected Defendants’ Henderson and Mesa Facilities, in
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`response to reports of five cases of acute liver failure in children and infants potentially linked to
`consumption of Defendants’ Re2al Water. During these inspections, FDA investigators documented
`significant deviations from preventive controls requirements and Bottled Water CGMP Regulations.
`Preventive Controls
`Defendants’ significant deviations from preventive controls requirements included, but
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`were not limited to, the following:
`A.
`Failure to identify and evaluate any known or reasonably foreseeable hazards for
`each type of food manufactured, processed, packed, or held at Defendants’ facilities to determine
`whether there are hazards requiring a preventive control, in violation of 21 U.S.C. § 350g(b) and 21
`C.F.R. § 117.130. Specifically, Defendants have not performed a hazard analysis of E2 Concentrate to
`identify chemical hazards requiring a preventive control due to misformulation of E2 Concentrate.
`Defendants have no documentation of the ingredients or manufacturing process for E2 Concentrate to
`ensure that excessive amounts of chemical ingredients are not added or improperly mixed, or that the E2
`Concentrate is not contaminated with environmental pathogens during processing. Defendants have also
`not performed a hazard analysis to identify biological hazards, including environmental pathogens,
`requiring a preventive control due to recontamination during the formulating or mixing of the E2
`Concentrate. The E2 Concentrate sold directly to consumers does not undergo a lethal treatment,
`meaning a treatment that will significantly minimize any environmental pathogen prior to packaging,
`thus any biological contamination would be passed on to the consumer;
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`Failure to identify and implement preventive controls to provide assurances that
`B.
`the food manufactured, processed, packed, or held by Defendants’ facilities is not adulterated under 21
`U.S.C. § 342, in violation of 21 U.S.C. §350g(c) and 21 C.F.R. § 117.135. For example, FDA
`investigators observed at the Henderson and Mesa Facilities that Defendants have no written process
`control and/or supply-chain control procedures to ensure that the correct type and amount of chemicals
`are added to each batch of product water. Defendants also do not have written sanitation controls at the
`Henderson and Mesa Facilities to control the risk of recontamination with environmental pathogens
`during the mixing and bottling processes;
`C.
`Failure to monitor the effectiveness of preventive controls to provide assurances
`that the food manufactured, processed, packed, or held at Defendants’ facilities is not adulterated under
`21 U.S.C. § 342, in violation of 21 U.S.C. § 350g(d) and 21 C.F.R. § 117.145. Specifically, Defendants
`do not have any monitoring records documenting Defendants’ formulation and mixing steps of their E2
`Concentrate at the Henderson Facility, and do not have any monitoring records documenting
`Defendants’ formulation and mixing steps of their Re2al Water at the Henderson and the Mesa Facilities;
`D.
`Failure to establish appropriate corrective action procedures to ensure that the
`food manufactured, processed, packed, or held by Defendants’ facilities from and entering interstate
`commerce is not adulterated in violation of 21 U.S.C. § 350g(e) and 21 C.F.R. § 117.150(b).
`Specifically, Defendants did not implement or record appropriate corrective actions in response to
`illness complaints and equipment failure;
`E.
`Failure to verify that preventive controls identified and implemented to provide
`assurances that the food manufactured, processed, packed, or held by Defendants’ facilities is not
`adulterated under 21 U.S.C. § 342 are adequate to control the hazard so identified, in violation of 21
`U.S.C. § 350g(f) and 21 C.F.R. § 117.165(a). Specifically, Defendants failed to collect and test
`environmental samples that verify the effectiveness of their sanitation controls to prevent contamination
`by environmental pathogens;
`F.
`Failure to establish and implement a risk-based supply-chain program for those
`raw materials and other ingredients for which the receiving facility has identified a hazard requiring a
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`supply-chain-applied control, in violation of 21 U.S.C. § 350g(c) and 21 C.F.R. §§ 117.135(c)(4) and
`117.405. Specifically, FDA investigators observed that Defendants do not have preventive controls at
`the Mesa Facility for the E2 Concentrate received from the Henderson Facility to verify that the
`Henderson Facility is controlling the chemical hazard that could result due to misformulation of the E2
`Concentrate. Defendants also do not have records documenting the Mesa Facility’s receipt of the E2
`Concentrate, which is needed for a valid supply-chain program; and
`G.
`Failure to develop a written food safety plan, in violation of 21 U.S.C. § 350g(h)
`and 21 C.F.R. § 117.126. Defendants are required to have a written food safety plan that contains a
`hazard analysis, preventive controls, a supply-chain program, a recall plan, procedures for monitoring
`the preventive control implementation, corrective action procedures, and verification procedures, but
`they do not have such a plan for their E2 Concentrate. Thus, Defendants have not taken adequate
`measures to protect against the hazards of chemical contamination in E2 Concentrate or in Re2al Water
`that contains E2 Concentrate and is distributed directly to consumers.
`Bottled Water CGMP
`Defendants’ significant deviations from CGMP regulations included, but were not limited
`47.
`to, the following:
`Failure to adequately clean and sanitize product water-contact surfaces of all
`A.
`multiservice containers, utensils, pipes, and equipment used in the transportation, processing, handling,
`and storage of their product water, in violation of 21 C.F.R. § 129.37. For example, during the
`inspections at the Mesa and Henderson Facilities, FDA investigators observed that Defendants have not
`properly cleaned and sanitized the water tanks in which they mix processed municipal tap water with E2
`Concentrate, potentially leading to chemical and microbial contamination;
`B.
`Failure to process product water under processes and controls necessary to ensure
`that Defendants’ treatment of their processed product water is effective and will not adulterate the
`bottled product, in violation of 21 C.F.R. § 129.80(a). For example, during the inspection at the
`Henderson Facility, FDA investigators observed that Defendants use a combination of carbon, reverse
`osmosis, ultraviolet light, and ozone filtration to process municipal tap water prior to its use as an
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`ingredient in E2 Concentrate and Re2al Water. However, Defendants fail to record the results of any
`inspections of the equipment used for these processes, conditions found, and the performance or
`effectiveness of the equipment. In addition, at the Henderson and Mesa Facilities, the investigators
`observed that Defendants do not sample the processed municipal tap water to assure the effectiveness of
`these processes, potentially leading to impure and unsafe water;
`C.
`Failure to adequately sample and test cleaning and sanitizing solutions to assure
`adequate performance in the cleaning and sanitizing operations, in violation of 21 C.F.R. § 129.80(c).
`For example, during the inspection at the Henderson Facility, FDA investigators observed that
`Defendants use recycled detergent and sanitizer water to clean and sanitize their reusable 5-gallon water
`containers that hold Re2al Water, but fail to record the results of any sampling and testing of the
`recycled detergent and sanitizer water to assure adequate performance, potentially leading to chemical
`and microbial contamination;
`D.
`Failure to identify each unit package with a production code that identifies the
`batch and date produced, and record and maintain information as to the kind of product, volume
`produced, date produced, lot code used, and the product distribution to wholesale and retail outlets, in
`violation of 21 C.F.R. § 129.80(e). For example, FDA investigators observed no production codes on
`unit packages of Re2al Water held at the Henderson Facility. Defendants were unable to provide
`production records from the Mesa Facility. These failures further complicated recall and traceback
`activities;
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`Failure to adequately monitor and record the performance of their filling, capping,
`E.
`and sealing processes to assure that containers and closures are free from contamination, in violation of
`21 C.F.R. § 129.80(f). Specifically, FDA investigators observed that Defendants do not monitor and
`record the performance of their filling, capping, and sealing operations, and they do not inspect and
`sample the containers and closures for bacteriological contamination; and
`F.
`Failure to adequately analyze product samples to assure that production of bottled
`drinking water complies with applicable standards, laws, and regulations, in violation of 21 C.F.R.
`§ 129.80(g). Specifically, Defendants fail to take and analyze representative product samples at least
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`once a week for total coliform organisms, fail to take and analyze representative product samples at least
`annually for chemical, radiological, physical, and radiological purposes, and fail to keep records of such
`analysis.
`
`Illnesses
`On March 13, 2021, FDA received information regarding five cases of acute non-viral
`48.
`hepatitis (resulting in acute liver failure) in infants and children that appeared to be associated with Re2al
`Water. The patients are from four different households, and all consumed Re2al Water prior to
`becoming ill.
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`FDA, the Centers for Disease Control and Prevention (“CDC”), and State health
`departments are investigating these illnesses and collecting additional data as part of an ongoing
`epidemiological investigation. To date, CDC has identified only one common exposure for the above
`five cases – Re2al Water. No other common exposures, including medications, food, supplements,
`activities, travel history, or ill contacts have been reported or linked to the illnesses.
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`During the 2021 Inspections, FDA investigators documented that Defendants had
`received complaints of illness from consumers, including complaints of nausea and vomiting after
`consuming Re2al