Case 8:20-cv-01431-PSG-KES Document 214 Filed 04/22/22 Page 1 of 26 Page ID #:8536
`Case 8:20-cv-01431-PSG-KES Document 213-1 Filed 04/20/22 Page 2 of 55 Page ID
`#:8423
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`04/22/22
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`Plaintiff,
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`
`
`v.
`
`UNITED STATES DISTRICT COURT
`CENTRAL DISTRICT OF CALIFORNIA
`
`FEDERAL TRADE COMMISSION,
`Case No. 8:20-cv-01431-PSG-KES
`
`JS-6
`
`
`
`
`[PROPOSED] FINAL ORDER FOR
`
`PERMANENT INJUNCTION AND
`
`MONETARY JUDGMENT
`QYK BRANDS LLC d/b/a Glowyy, et
`al.
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`Defendants.
`
`On August 4, 2020, Plaintiff, the Federal Trade Commission (“FTC”), filed
`its Complaint for Permanent Injunction and Other Equitable Relief pursuant to
`Sections 13(b) and 19 of the Federal Trade Commission Act (“FTC Act”), 15
`U.S.C. §§ 53(b) and 57b, and the FTC’s Trade Regulation Rule Concerning the
`Sale of Mail, Internet, or Telephone Order Merchandise (“MITOR” or the “Rule”),
`16 C.F.R. Part 435. Plaintiff filed its First Amended Complaint on May 19, 2021
`(ECF No. 73, “FAC”). On February 14, 2022, Plaintiff filed its Motion for
`Summary Judgment (“Motion”), as well as its Statement of Undisputed Facts, as
`supported by declarations, stipulation, admissions, interrogatory answers, or other
`materials submitted in support of the Motion. Having considered the Motion and
`supporting materials in the record and any oppositions thereto, the Court finds
`there is no genuine dispute of material fact, and the FTC is entitled to judgment
`against all Defendants as a matter of law. The Court’s reasoning and specific
`findings are detailed in the Minute Order dated April 6, 2022 (ECF No. 212).
`
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`Case 8:20-cv-01431-PSG-KES Document 214 Filed 04/22/22 Page 2 of 26 Page ID #:8537
`Case 8:20-cv-01431-PSG-KES Document 213-1 Filed 04/20/22 Page 3 of 55 Page ID
`#:8424
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`THEREFORE, IT IS ORDERED as follows:
`FINDINGS
`A.
`This Court has jurisdiction over the subject matter of this case, and
`there is good cause to believe that it will have jurisdiction over all parties hereto
`and that venue in this district is proper.
`B.
`The Complaint alleges that Defendants participated in deceptive and
`unfair acts or practices in violation of Sections 5 and 12 of the FTC Act, 15 U.S.C.
`§ 45 and § 52, and of the Commission’s Trade Regulation Rule Concerning the
`Sale of Mail, Internet or Telephone Order Merchandise, 16 C.F.R. Part 435
`(“MITOR”), by representing they would ship goods, including Personal Protective
`Equipment (“PPE”) and hand sanitizer, within certain timeframes but having no
`reasonable basis to expect to ship the goods within the advertised timeframes;
`failing to ship goods within the timeframe required by MITOR; failing to offer
`consumers the opportunity to consent to a delay in shipping or to cancel their order
`and receive a prompt refund upon becoming aware of their inability to ship goods
`within the time advertised; and, after receiving cancellation and refund requests,
`failing to provide consumers with a prompt refund. The Complaint also charges
`that Defendants participated in deceptive acts or practices in violation of Section 5
`of the FTC Act, 15 U.S.C. § 45, by misrepresenting that they: (1) would ship
`orders “Today”; or would ship within 7 days; (2) had certain PPE and hand
`sanitizer in stock and ready to ship; and (3) would ship the goods consumers
`ordered; and that they further violated Sections 5 and 12 of the FTC Act by
`participating in deceptive acts and practices by misrepresenting that their product,
`Basic Immune IGG, could treat, prevent, or reduce risk of contracting COVID-19,
`and that it was clinically shown and approved by the FDA to do so.
`C. Defendants’ activities are in or affecting commerce, as defined in
`Section 4 of the FTC Act, 15 U.S.C. § 44.
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`Case 8:20-cv-01431-PSG-KES Document 214 Filed 04/22/22 Page 3 of 26 Page ID #:8538
`Case 8:20-cv-01431-PSG-KES Document 213-1 Filed 04/20/22 Page 4 of 55 Page ID
`#:8425
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`D. Corporate Defendants violated Section 5 of the FTC Act, 15 U.S.C. §
`45, and MITOR, 16 C.F.R. Part 435, by representing they would ship goods,
`including hand sanitizer and PPE, within certain timeframes but having no
`reasonable basis to expect to ship the goods within the advertised timeframes;
`failing to ship goods within the timeframe required by MITOR; failing to offer
`consumers the opportunity to consent to a delay in shipping or to cancel their order
`and receive a prompt refund upon becoming aware of their inability to ship goods
`within the time advertised; and, after receiving cancellation and refund requests,
`failing to provide consumers with a prompt refund. Corporate Defendants further
`violated Section 5 of the FTC Act, 15 U.S.C. § 45, by misrepresenting that they:
`(1) would ship orders “Today”; or would ship within 7 days; (2) had certain PPE
`and hand sanitizer in stock and ready to ship; and (3) would ship the goods
`consumers ordered; and that they further violated Sections 5 and 12 of the FTC Act
`by participating in deceptive acts and practices by misrepresenting that their
`product, Basic Immune IGG, could treat, prevent, or reduce risk of contracting
`COVID-19, and that it was clinically shown and approved by the FDA to do so.
`E.
`Individual Defendants Rakesh Tammabattula and Jacqueline Thao
`Nguyen participated in and had authority to control the Corporate Defendants’
`deceptive marketing and sale of hand sanitizer, PPE products, and Basic Immune
`IGG.
`
`F.
`In light of Defendants’ conduct, there is a cognizable danger that they
`will continue to engage in activities that violate the FTC Act unless enjoined from
`such acts and practices.
`
`DEFINITIONS
`For the purpose of this Order, the following definitions apply:
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`Case 8:20-cv-01431-PSG-KES Document 214 Filed 04/22/22 Page 4 of 26 Page ID #:8539
`Case 8:20-cv-01431-PSG-KES Document 213-1 Filed 04/20/22 Page 5 of 55 Page ID
`#:8426
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`“Applicable Time Period” means the time stated in Defendants’
`A.
`solicitation or within 30 days of Receipt of a Properly Completed Order if no time
`is stated in the solicitation.
`“Clearly and Conspicuously” means that a required disclosure is
`B.
`difficult to miss (i.e., easily noticeable) and easily understandable by ordinary
`consumers, including in all of the following ways:
`1.
`In any communication that is solely visual or solely audible, the
`disclosure must be made through the same means through which the
`communication is presented. In any communication made through both
`visual and audible means, such as a television advertisement, the disclosure
`must be presented simultaneously in both the visual and audible portions of
`the communication even if the representation requiring the disclosure is
`made in only one means.
`2.
`A visual disclosure, by its size, contrast, location, the length of
`time it appears, and other characteristics, must stand out from any
`accompanying text or other visual elements so that it is easily noticed, read,
`and understood.
`3.
`An audible disclosure, including by telephone or streaming
`video, must be delivered in a volume, speed, and cadence sufficient for
`ordinary consumers to easily hear and understand it.
`4.
`In any communication using an interactive electronic medium,
`such as the Internet or software, the disclosure must be unavoidable.
`5.
`The disclosure must use diction and syntax understandable to
`ordinary consumers and must appear in each language in which the
`representation that requires the disclosure appears.
`6.
`The disclosure must comply with these requirements in each
`medium through which it is received, including all electronic devices and
`face-to-face communications.
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`Case 8:20-cv-01431-PSG-KES Document 214 Filed 04/22/22 Page 5 of 26 Page ID #:8540
`Case 8:20-cv-01431-PSG-KES Document 213-1 Filed 04/20/22 Page 6 of 55 Page ID
`#:8427
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`7.
`The disclosure must not be contradicted or mitigated by, or
`inconsistent with, anything else in the communication.
`8. When the representation or sales practice targets a specific
`audience, such as children, the elderly, or the terminally ill, “ordinary
`consumers” includes reasonable members of that group.
`“Corporate Defendant(s)” means QYK Brands LLC d/b/a Glowyy,
`C.
`DrJsNatural LLC, Theo Pharmaceuticals, Inc., and EASII, Inc., and each of their
`subsidiaries, affiliates, successors, and assigns.
`“Covered Dietary Supplement” means any Dietary Supplement,
`D.
`Food, or Drug, including Basic Immune IGG.
`“Defendants” means all of the Individual Defendants and the
`E.
`Corporate Defendants, individually, collectively, or in any combination.
`“Dietary Supplement” means: (1) any product labeled as a dietary
`F.
`supplement or otherwise represented as a dietary supplement; or (2) any pill, tablet,
`capsule, powder, softgel, gelcap, liquid, or other similar form containing one or
`more ingredients that are a vitamin, mineral, herb or other botanical, amino acid,
`probiotic, or other dietary substance for use by humans to supplement the diet by
`increasing the total dietary intake, or a concentrate, metabolite, constituent, extract,
`or combination of any ingredient described above, that is intended to be ingested,
`and is not represented to be used as a conventional food or as a sole item of a meal
`or the diet.
`“Document” is synonymous in meaning and equal in scope to the
`G.
`usage of “document” and “electronically stored information” in Federal Rule of
`Civil Procedure 34(a), Fed. R. Civ. P. 34(a), and includes writings, drawings,
`graphs, charts, photographs, sound and video recordings, images, Internet sites,
`web pages, websites, electronic correspondence, including e-mail and instant
`messages, contracts, accounting data, advertisements, FTP Logs, Server Access
`Logs, books, written or printed records, handwritten notes, telephone logs,
`
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`5
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`Case 8:20-cv-01431-PSG-KES Document 214 Filed 04/22/22 Page 6 of 26 Page ID #:8541
`Case 8:20-cv-01431-PSG-KES Document 213-1 Filed 04/20/22 Page 7 of 55 Page ID
`#:8428
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`telephone scripts, receipt books, ledgers, personal and business canceled checks
`and check registers, bank statements, appointment books, computer records,
`customer or sales databases and any other electronically stored information,
`including Documents located on remote servers or cloud computing systems, and
`other data or data compilations from which information can be obtained directly or,
`if necessary, after translation into a reasonably usable form. A draft or non-
`identical copy is a separate Document within the meaning of the term.
`“Drug” means: (1) articles recognized in the official United States
`H.
`Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or
`official National Formulary, or any supplement to any of them; (2) articles
`intended for use in the diagnosis, cure, mitigation, treatment, or prevention of
`disease in humans or other animals; (3) articles (other than food) intended to affect
`the structure or any function of the body of humans or other animals; and (4)
`articles intended for use as a component of any article specified in (1), (2), or (3);
`but does not include devices or their components, parts, or accessories.
`“Essentially Equivalent Product” means a product that contains the
`I.
`identical ingredients, except for inactive ingredients (e.g., binders, colors, fillers,
`excipients) in the same form and dosage, and with the same route of administration
`(e.g., orally, sublingually), as the Covered Dietary Supplement; provided that the
`Covered Dietary Supplement may contain additional ingredients if reliable
`scientific evidence generally accepted by experts in the field indicates that the
`amount and combination of additional ingredients is unlikely to impede or inhibit
`the effectiveness of the ingredients in the Essentially Equivalent Product.
`“Food” means: (1) any article used for food or drink for humans or
`J.
`other animals; (2) chewing gum; and (3) any article used for components of any
`such article.
`“Individual Defendants” means Rakesh Tammabattula and
`K.
`Jacqueline Thao Nguyen.
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`Case 8:20-cv-01431-PSG-KES Document 214 Filed 04/22/22 Page 7 of 26 Page ID #:8542
`Case 8:20-cv-01431-PSG-KES Document 213-1 Filed 04/20/22 Page 8 of 55 Page ID
`#:8429
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`“Option” means an offer made Clearly and Conspicuously and
`L.
`without prior demand.
`“Personal Protective Equipment” means protective clothing,
`M.
`helmets, gloves, face shields, goggles, facemasks, respirators, or other equipment
`designed, intended or represented to protect the wearer from the spread of infection
`or illness.
`“Prompt,” in the context of a Refund, means a Refund sent by any
`N.
`means at least as fast and reliable as first-class mail within 7 days of the date on
`which the buyer’s right to Refund vests under the provisions of this Court Order.
`Provided, however, that where a Defendant cannot provide a Refund by the same
`method payment was tendered, Prompt Refund means a Refund sent in the form of
`cash, check, or money order, by any means at least as fast and reliable as first class
`mail, within 7 days of the date on which the Defendant discovers it cannot provide
`a Refund by the same method as payment was tendered.
`“Protective Goods and Services” means any good or service
`O.
`designed, intended, or represented to detect, treat, prevent, mitigate, or cure
`COVID-19 or any other infection or disease, including, but not limited to, Personal
`Protective Equipment, hand sanitizer, and thermometers.
`“Refund” means:
`P.
`1. Where the buyer tendered full payment for the unshipped
`merchandise in the form of cash, check, or money order,
`a return of the amount tendered in the form of cash,
`check, or money order sent to the buyer;
`2. Where there is a credit sale:
`(i) And Defendant is a creditor, a copy of a credit
`memorandum or the like or an account statement
`sent to the buyer reflecting the removal or absence
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`Case 8:20-cv-01431-PSG-KES Document 214 Filed 04/22/22 Page 8 of 26 Page ID #:8543
`Case 8:20-cv-01431-PSG-KES Document 213-1 Filed 04/20/22 Page 9 of 55 Page ID
`#:8430
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`of any remaining charge incurred as a result of the
`sale from the buyer’s account;
`(ii) And a third party is the creditor, an appropriate
`credit memorandum or the like sent to the third
`party creditor which will remove the charge from
`the buyer’s account and a copy of the credit
`memorandum or the like sent to the buyer that
`includes the date that Defendant sent the credit
`memorandum or the like to the third party creditor
`and the amount of the charge to be removed, or a
`statement from Defendant acknowledging the
`cancellation of the order and representing that it
`has not taken any action regarding the order which
`will result in a charge to the buyer’s account with
`the third party;
`(iii) And the buyer tendered partial payment for the
`unshipped merchandise in the form of cash, check,
`or money order, a return of the amount tendered in
`the form of cash, check, or money order sent to the
`buyer.
`3. Where the buyer tendered payment for the unshipped
`merchandise by any means other than those enumerated
`in (1) or (2) of this definition:
`(i)
`Instructions sent to the entity that transferred
`payment to Defendant instructing that entity to
`return to the buyer the amount tendered in the form
`tendered and a statement sent to the buyer setting
`forth the instructions sent to the entity including
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`Case 8:20-cv-01431-PSG-KES Document 214 Filed 04/22/22 Page 9 of 26 Page ID #:8544
`Case 8:20-cv-01431-PSG-KES Document 213-1 Filed 04/20/22 Page 10 of 55 Page ID
`#:8431
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`the date of the instructions and the amount to be
`returned to the buyer;
`(ii) A return of the amount tendered in the form of
`cash, check or money order sent to the buyer; or
`(iii) A statement from Defendant sent to the buyer
`acknowledging the cancellation of the order and
`representing that Defendant has not taken any
`action regarding the order which will access any of
`the buyer’s funds.
`“Receipt of a Properly Completed Order” means, where the buyer
`Q.
`tenders full or partial payment in the proper amount in the form of cash, check or
`money order; authorization from the buyer to charge an existing charge account; or
`other payment methods, the time at which Defendant receives both said payment
`and an order from the buyer containing all of the information needed by Defendant
`to process and Ship the order.
`“Ship,” or any variation thereof, including Shipment or Shipping,
`R.
`means the act by which the merchandise is physically placed in the possession of
`the carrier.
`
`ORDER
`CONDUCT RELIEF
`I.
`IT IS ORDERED that Defendants are permanently restrained and enjoined
`from the advertising, marketing, promoting, or offering for sale, or assisting others
`in the advertising, marketing, promoting, or offering for sale, of any Protective
`Goods and Services.
`
`II.
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`Case 8:20-cv-01431-PSG-KES Document 214 Filed 04/22/22 Page 10 of 26 Page ID
`Case 8:20-cv-01431-PSG-KES Document 213-1 Filed 04/20/22 Page 11 of 55 Page ID
`#:8545
`#:8432
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`IT IS FURTHER ORDERED that Defendants, Defendants’ officers,
`agents, employees, and attorneys, and all other persons in active concert or
`participation with any of them, who receive actual notice of this Order, whether
`acting directly or indirectly, in connection with the sale of any good ordered by
`mail, via the internet, or by telephone are permanently restrained and enjoined
`from:
`
`A. Representing, without a reasonable basis, that Defendants will:
`(1) Ship ordered goods within the time stated in their solicitation; or (2) Ship
`ordered goods by any revised Shipping date provided to buyers.
`B. Where the order solicitation does not Clearly and Conspicuously state
`a Shipping time, soliciting any order for the sale of merchandise without having a
`reasonable basis that the goods will Ship 30 days after Receipt of a Properly
`Completed Order.
`C.
`Informing buyers that Defendants are unable to make any
`representation regarding the length of any Shipping delay unless Defendants have a
`reasonable basis for so informing buyers.
`D.
`Failing to provide buyers with the Option either to consent to the
`delay in Shipping or to cancel the order and receive a Prompt Refund where
`Defendants cannot Ship the ordered goods within the Applicable Time Period.
`Said Option must be provided within a reasonable time after the Defendants have
`become aware of their inability to Ship within the Applicable Time Period, but in
`no event later than the Applicable Time Period.
`1.
`Provided however, that any such Option must either:
`a.
`provide a definite revised Shipping date; or
`b. where Defendants lack a reasonable basis for providing a
`definite revised Shipping date, inform the buyer that:
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`Case 8:20-cv-01431-PSG-KES Document 214 Filed 04/22/22 Page 11 of 26 Page ID
`Case 8:20-cv-01431-PSG-KES Document 213-1 Filed 04/20/22 Page 12 of 55 Page ID
`#:8546
`#:8433
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`i. the seller is unable to make any representation
`regarding the length of the delay; and
`ii. the reason(s) for the delay.
`2. Where Defendants have provided a definite revised Shipping
`date, pursuant to II.D.1.a, that is more than 30 days later than the
`Applicable Time Period, Defendants must also Clearly and
`Conspicuously inform the buyer that the buyer’s order will
`automatically be deemed to have been cancelled unless:
`a. Defendants have Shipped the merchandise within the
`Applicable Time Period, and Defendants have received no
`cancellation request prior to Shipment; or
`b.
`the buyer has specifically consented to said Shipping
`delay within the Applicable Time Period.
`3. Where Defendants have informed the buyer that they cannot
`make any representation regarding the length of the delay pursuant to
`Section II.D.1.b, Defendants must also Clearly and Conspicuously
`inform the buyer that the buyer’s order will automatically be deemed
`to have been cancelled unless:
`a. Defendants have Shipped the merchandise within 30 days
`of the Applicable Time Period, and the Defendants have
`received no cancellation request prior to Shipment; or
`b.
`the buyer has specifically consented to said Shipping
`delay within 30 days of the Applicable Time Period. Provided
`however, Defendants must also expressly inform the buyer that
`the buyer will have a continuing right to cancel the order at any
`time after the Applicable Time Period.
`E. Where the buyer has consented to a definite revised Shipping date
`pursuant to Section II.D, and Defendants become aware they are unable to Ship
`
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`Case 8:20-cv-01431-PSG-KES Document 214 Filed 04/22/22 Page 12 of 26 Page ID
`Case 8:20-cv-01431-PSG-KES Document 213-1 Filed 04/20/22 Page 13 of 55 Page ID
`#:8547
`#:8434
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`ordered goods by that date, failing to provide a renewed Option either to consent to
`a further delay or to cancel the order and receive a Prompt Refund. Said Option
`must be made within a reasonable time after the Defendants first become aware of
`their inability to Ship before the said definite revised Shipping date, but in no event
`later than the expiration of the definite revised Shipping date. Provided however,
`that any such Option must provide a new definite revised Shipping date, unless
`Defendants lack a reasonable basis for doing so. In such event, Defendants must
`also provide the notices required by Section II.D.1.b and Section II.D.3 of this
`Order.
`F.
`Refund:
`
`Failing to cancel any order and provide the buyer with a Prompt
`
`1. When Defendants have received a cancellation and Refund
`request from the buyer pursuant to Section II of this Order;
`
`2.
`Under the circumstances prescribed in Section II.D.2 and
`II.D.3;
`
`3. When Defendants fail to provide the Option required by Section
`II.D. and have not shipped the merchandise within the Applicable
`Time Period; or
`
`4. When Defendants notify the buyer that they have decided not to
`Ship the merchandise.
`
`III.
`In any action brought by the Commission alleging a violation of Section II
`of this Order, the failure to create and maintain records establishing compliance
`with Section II creates a rebuttable presumption that Defendants violated the
`provisions of that Section.
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`Case 8:20-cv-01431-PSG-KES Document 214 Filed 04/22/22 Page 13 of 26 Page ID
`Case 8:20-cv-01431-PSG-KES Document 213-1 Filed 04/20/22 Page 14 of 55 Page ID
`#:8548
`#:8435
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`IV.
`IT IS FURTHER ORDERED that Defendants, Defendants’ officers,
`agents, employees, and attorneys, and all other persons in active concert or
`participation with any of them, who receive actual notice of this Order, whether
`acting directly or indirectly, in connection with the sale of any good or service
`ordered by mail, via the internet, or by telephone are permanently restrained and
`enjoined from, or assisting others in, expressly or by implication, misrepresenting:
`
`A.
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`B.
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`The time within which the good will ship;
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`The time within which the buyer will receive the ordered good;
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`C.
`That any costs will be refunded if the order does not arrive on time, or
`any material aspect of a Refund policy; or
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`D. Any other fact material to consumers concerning any good or service,
`such as: the total costs; any material restrictions, limitations, or conditions; or any
`material aspect of its performance, efficacy, nature, or central characteristics.
`V.
`IT IS FURTHER ORDERED that Defendants, Defendants’ officers,
`agents, employees, and attorneys, and all other persons in active concert or
`participation with any of them, who receive actual notice of this Order, whether
`acting directly or indirectly, in connection with the labeling, advertising,
`promotion, offering for sale, sale, or distribution of any Covered Dietary
`Supplement, are permanently restrained and enjoined from making, or assisting
`others in making, expressly or by implication, including through the use of a
`product or program name, endorsement, depiction, or illustration, any
`representation that such product:
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`Case 8:20-cv-01431-PSG-KES Document 214 Filed 04/22/22 Page 14 of 26 Page ID
`Case 8:20-cv-01431-PSG-KES Document 213-1 Filed 04/20/22 Page 15 of 55 Page ID
`#:8549
`#:8436
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`
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`A.
`is FDA-approved to effectively treat, prevent transmission of, or
`reduce the risk of contracting COVID-19 unless the representation is true and non-
`misleading;
`B.
`can effectively treat, prevent transmission of, or reduce risk of
`contracting COVID-19; or
`C.
`cures, mitigates, or treats any disease, unless the representation in B or
`C is true and non-misleading, and, at the time such representation is made,
`Defendants possess and rely upon competent and reliable scientific evidence that is
`sufficient in quality and quantity based on standards generally accepted in the
`relevant scientific fields, when considered in light of the entire body of relevant
`and reliable scientific evidence, to substantiate that the representation is true.
`For purposes of this Section, competent and reliable scientific evidence must
`consist of human clinical testing of the Covered Dietary Supplement, or of an
`Essentially Equivalent Product, that is sufficient in quality and quantity based on
`standards generally accepted by experts in the relevant disease, condition, or
`function to which the representation relates, when considered in light of the entire
`body of relevant and reliable scientific evidence, to substantiate that the
`representation is true. Such testing must be: (1) randomized, double-blind, and
`placebo-controlled; and (2) conducted by researchers qualified by training and
`experience to conduct such testing. In addition, all underlying or supporting data
`and Documents generally accepted by experts in the field as relevant to an
`assessment of such testing as described in the Section entitled Preservation of
`Records Relating to Competent and Reliable Human Clinical Tests or Studies must
`be available for inspection and production to the Commission. Persons covered by
`this Section have the burden of proving that a product satisfies the definition of
`Essentially Equivalent Product.
`
`VI.
`
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`Case 8:20-cv-01431-PSG-KES Document 214 Filed 04/22/22 Page 15 of 26 Page ID
`Case 8:20-cv-01431-PSG-KES Document 213-1 Filed 04/20/22 Page 16 of 55 Page ID
`#:8550
`#:8437
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`IT IS FURTHER ORDERED that Defendants, Defendants’ officers,
`agents, employees, and attorneys, and all other persons in active concert or
`participation with any of them, who receive actual notice of this Order, whether
`acting directly or indirectly, in connection with the manufacturing, labeling,
`advertising, promotion, offering for sale, sale, or distribution of any Covered
`Dietary Supplement, are permanently restrained and enjoined from making, or
`assisting others in making, expressly or by implication, including through the use
`of a product or program name, endorsement, depiction, or illustration, any
`representation, other than representations covered under the Section IV of this
`Order, about the health benefits, performance, efficacy, safety, or side effects of
`any Covered Dietary Supplement, unless the representation is non-misleading, and,
`at the time of making such representation, they possess and rely upon competent
`and reliable scientific evidence that is sufficient in quality and quantity based on
`standards generally accepted by experts in the relevant disease, condition, or
`function to which the representation relates, when considered in light of the entire
`body of relevant and reliable scientific evidence, to substantiate that the
`representation is true.
`For purposes of this Section, competent and reliable scientific evidence
`means tests, analyses, research, or studies (1) that have been conducted and
`evaluated in an objective manner by experts in the relevant disease, condition, or
`function to which the representation relates; (2) that are generally accepted by such
`experts to yield accurate and reliable results; and (3) that are randomized, double-
`blind, and placebo-controlled human clinical testing of the Covered Product, or of
`an Essentially Equivalent Product, when such experts would generally require such
`human clinical testing to substantiate that the representation is true. In addition,
`when such tests or studies are human clinical tests or studies, all underlying or
`supporting data and documents generally accepted by experts in the field as
`relevant to an assessment of such testing as set forth in the Section entitled
`
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`Case 8:20-cv-01431-PSG-KES Document 214 Filed 04/22/22 Page 16 of 26 Page ID
`Case 8:20-cv-01431-PSG-KES Document 213-1 Filed 04/20/22 Page 17 of 55 Page ID
`#:8551
`#:8438
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`Preservation of Records Relating to Competent and Reliable Human Clinical Tests
`or Studies must be available for inspection and production to the Commission.
`Persons covered by this Section have the burden of proving that a product satisfies
`the definition of Essentially Equivalent Product.
`
`
`
`VII.
`IT IS FURTHER ORDERED that Defendants, Defendants’ officers,
`agents, employees, and attorneys, and all other persons in active concert or
`participation with any of them, who receive actual notice of this Order, whether
`acting directly or indirectly, in connection with the manufacturing, labeling,
`advertising, promotion, offering for sale, sale, or distribution of any Covered
`Dietary Supplement are permanently restrained and enjoined from misrepresenting,
`in any manner, expressly or by implication, including through the use of any
`product name, endorsement, depiction, or illustration:
`A.
`That any Covered Dietary Supplement is clinically proven to treat,
`prevent the transmission of, or reduce the risk of contracting COVID-19;
`B.
`That the performance or benefits of any product are scientifically or
`clinically proven or otherwise established; or
`C.
`The existence, contents, validity, results, conclusion, or interpretations
`of any test, study, or other research.
`
`VIII.
`IT IS FURTHER ORDERED that nothing in this Order prohibits
`Defendants, Defendants’ officers, agents, employees, and attorneys, or all other
`persons in active concert or participation with any of them from:
`A.
`For any Drug product, making a representation that is approved for
`inclusion in labeling for such Drug product under a new drug application or
`biologics license application approved by the Food and Drug Administration, or,
`
`
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`Case 8:20-cv-01431-PSG-KES Document 214 Filed 04/22/22 Page 17 of 26 Page ID
`Case 8:20-cv-01431-PSG-KES Document 213-1 Filed 04/20/22 Page 18 of 55 Page ID
`#:8552
`#:8439
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