Plaintiff, 

V. 

NEORA, LLC, formerly known as NERIUM 

INTERNATIONAL, LLC, a Texas 

limited liability company, 

SIGNUM BIOSCIENCES, INC., a Delaware 

corporation, 

SIGNUM NUTRALOGIX, a Delaware 

corporation and subsidiary of SIGNUM 

BIOSCIENCES, INC., and 

JEFFREY OLSON, individually and as Chief 

Executive Officer ofNEORA, LLC, 

formerly known as NERIUM 

INTERNATIONAL, LLC, 

_

Defendants. 

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CaseNo. 19-19699 

STIPULATED ORDER FOR PERMANENT INJUNCTION AS TO DEFENDANTS 

SIGNUM BIOSCIENCES, INC., AND SIGNUM NUTRALOGIX 

Plaintiff, the Federal Trade Commission ("Commission" or "FTC"), filed its Complaint 

For Permanent Injunction and Other Equitable Relief ("Complaint"), pursuant to Section 13(b) 

of the Federal Trade Commission Act ("FTC Act"), 15 U.S.C. § 53(b). The Commission and 

Defendants Signum Biosciences, Inc., and Signum Nutralogix ( collectively, "Stipulating 

Defendants"), stipulate to the entry of this Stipulated Order for Permanent Injunction ("Order") 

to resolve all matters in dispute in this action between them. 
2. The Complaint charges that Stipulating Defendants participated in deceptive acts 

or practices that violate Section 5 of the FTC Act, 15 U.S.C. § 45(a) by: 

a. making false, misleading, or unsubstantiated health claims about 

eicosanoyl-5-hydroxytryptamide ("EHT") and products containing EHT; and 

b. making false claims that scientific studies prove the effects of EHT and 

products containing EHT. 

3. Stipulating Defendants neither admit nor deny any of the allegations in the 

Complaint, except as specifically stated in this Order. Only for purposes of this action, 

Stipulating Defendants admit the facts necessary to establish jurisdiction. 

4. Stipulating Defendants waive any claim that they may have under the Equal 

Access to Justice Act, 28 U.S.C. § 2412, concerning the prosecution of this action through the 

date of this Order, and agree to bear their own costs and attorney fees. 

5. Stipulating Defendants waive all rights to appeal or otherwise challenge or contest 

the validity of this Order. 

DEFINITIONS 

For purposes of this Order, the following definitions apply: 

1. "Covered Product" means any Dietary Supplement, Food, or Drug, and includes 

Nerium EHT, ME Sports, and EHT or any product purporting to contain EHT. 

2 
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. 

3. "Defendants" means all of the Defendants, individually, collectively, or in any 

combination. 

4. "Stipulating Defendants" means Signum Biosciences, Inc., Signum Nutralogix, 

and their successors and assigns. 

5. "Drug" means: 

a. articles recognized in the official United States Pharmacopoeia, official 

Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any 

supplement to any of them; 

b. articles intended for use in the diagnosis, cure, mitigation, treatment, or 

prevention of disease in humans or other animals; 

c. articles ( other than food) intended to affect the structure or any function of 

the body of humans or other animals; and 

3 
6. "Essentially Equivalent Product" means a product that contains the 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 Product; provided that the Covered Product may contain additional ingredients if 

reliable scientific evidence generally accepted by experts in the relevant 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. 

7. "Food" means: (a) any article used for food or drink for humans or other animals; 

(b) chewing gum; and ( c) any article used for components of any such article. 

I. PROHIBITED REPRESENTATIONS REGARDING HEALTH-RELATED 

CLAIMS REQUIRING HUMAN CLINICAL TESTING FOR SUBSTANTIATION 

IT IS ORDERED that Stipulating Defendants, Stipulating Defendants' officers, agents, 

employees, and independent contractors, 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, offeting for sale, sale, or disttibution of 

any Covered Product, 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: 

A. cures, mitigates, or treats Alzheimer's, Parkinson's disease, or brain injury or 

4 
unless the representation is non-misleading and, at the time of making such representation, they 

possess and rely upon competent and reliable scientific evidence substantiating that the 

representation is true. For purposes of this Section, competent and reliable scientific evidence 

shall consist of human clinical testing of the Covered Product, 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 placebocontrolled; 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. 

II. PROIDBITED REPRESENTATIONS: OTHER HEALTH-RELATED CLAIMS 

IT IS FURTHER ORDERED that Stipulating Defendants, Stipulating Defendants' 

officers, agents, employees, and independent contractors, and all other persons in active concert 

or participation with any of them, who receive actual notice of this Order, whether acting directly 

5 
program name, endorsement, depiction, or illustration, any representation, other than 

representations covered under the section of this Order entitled "Prohibited Representations 

Regarding Health-Related Claims Requiring Human Clinical Testing for Substantiation," about 

the health benefits, perfonnance, or efficacy of any Covered Product, including any 

representation that such product lowers the risk of or prevents Alzheimer's, Parkinson's disease, 

brain injury or diseases, including Chronic Traumatic Encephalopathy, or any other disease, 

they unless the representation is non-misleading, and, at the time of making such representation, 

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) 

generally accepted by such experts to yield accurate and reliable results; and (3) that are 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 

6 
Persons covered by this Section have the burden of proving that a product satisfies the definition 

of Essentially Equivalent Product. 

III. PROHIBITED REPRESENTATIONS REGARDING TESTS, STUDIES, OR 

OTHER RESEARCH 

IT IS FURTHER ORDERED that Stipulating Defendants, Stipulating Defendants' 

officers, agents, employees, and independent contractors, 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 product are permanently restrained and enjoined from misrepresenting, or 

assisting others in misrepresenting, expressly or by implication, including through the use of any 

product name, endorsement, depiction, or illustration: 

A. That any Covered Product is scientifically or clinically proven to lower the risk 

of, prevent, cure, mitigate, or treat any disease, including Alzheimer's, Parkinson's disease, or 

brain injury or diseases, including Chronic Traumatic Encephalopathy; 

B. That any Covered Product is scientifically or clinically proven to lower the risk 

of, prevent, or treat concussions; 

C. That the performance or benefits of any product are scientifically or clinically 

proven or otherwise established; or 

D. The existence, contents, validity, results, conclusions, or interpretations of any 

7 
IT IS FURTHER ORDERED that, with regard to any human clinical test or study 

Order, ("test") upon which Stipulating Defendants rely to substantiate any claim covered by this 

Stipulating Defendants shall secure and preserve all underlying or supporting data and 

documents generally accepted by experts in the field as relevant to an assessment of the test, 

including: 

A. All protocols and protocol amendments, reports, articles, write-ups, or other 

accounts of the results of the test, and drafts of such documents reviewed by the test sponsor or 

any other person not employed by the research entity; 

B. All documents referring or relating to recruitment; randomization; instructions, 

including oral instructions, to participants; and participant compliance; 

C. Documents sufficient to identify all test participants, including any participants 

who did not complete the test, and all communications with any participants relating to the test; 

all raw data collected from participants enrolled in the test, including any participants who did 

not complete the test; source documents for such data; any data dictionaries; and any case report 

forms; 

D. All documents referring or relating to any statistical analysis of any test data, 

including any pretest analysis, intent-to-treat analysis, or between-group analysis performed on 

any test data; and 

E. All documents referring or relating to the sponsorship of the test, including all 

8 
by: (1) any Stipulating Defendant; (2) any Stipulating Defendant's officers, agents, 

representatives, or employees; (3) any other person or entity in active concert or participation 

with any Stipulating Defendant; ( 4) any person or entity affiliated with or acting on behalf of any 

Stipulating Defendant; (5) any supplier of any ingredient contained in the product at issue to any 

of the foregoing or to the product's manufacturer; or (6) the supplier or manufacturer of such 

product. 

For purposes of this Section, "reliably reported test" means a report of the test has been 

published in a peer-reviewed journal, and such published report provides sufficient information 

about the test for experts in the relevant field to assess the reliability of the results. 

For any test conducted, controlled, or sponsored, in whole or in part, by Stipulating 

Defendants, Stipulating Defendants must establish and maintain reasonable procedures to protect 

the confidentiality, security, and integrity of any personal information collected from or about 

participants. These procedures must be documented in writing and must contain administrative, 

technical, and physical safeguards appropriate to Stipulating Defendants' size and complexity, 

the nature and scope of Stipulating Defendants' activities, and the sensitivity of the personal 

information collected from or about the participants. 

9 
all other persons in active concert or participation with any of them from: 

A. For any drug, making a representation that is approved in labeling for such drug 

under any tentative final or final monograph promulgated by the Food and Drug Administration, 

or under any new drug application approved by the Food and Drug Administration; and 

B. For any product, making a representation that is specifically authorized for use in 

labeling for such product by regulations promulgated by the Food and Drug Administration 

pursuant to the Nutrition Labeling and Education Act of 1990 or permitted under Sections 303-

304 of f 1997. the Food and Drug Administration Modernization Act o

VI. COOPERATION 

IT IS FURTHER ORDERED that Stipulating Defendants must fully cooperate with 

representatives of the Commission in this case and in any investigation related to or associated 

with the transactions or the occurrences that are the subject of the Complaint. Stipulating 

Defendants must provide truthful and complete information, evidence, and testimony. 

Stipulating Defendants must cause Stipulating Defendants' officers, employees, agents, and 

independent contractors, to appear for interviews, discovery, hearings, trials, and any other 

proceedings that a Commission representative may reasonably request upon 5 days written 

notice, or other reasonable notice, at such places and times as a Commission representative may 

designate, without the service of a subpoena. 

10 
A. Each Stipulating Defendant, within 7 days of entry of this Order, must submit to 

the Commission an acknowledgment of receipt of this Order sworn under penalty of perjury. 

B. For 3 years after entry of this Order, each Stipulating Defendant, must deliver a 

copy of this Order to: (1) all principals, officers, directors, and LLC managers and members; (2) 

all employees, agents, independent contractors, and representatives who participate in conduct 

related to the subject matter of the Order; and (3) any business entity resulting from any change 

in structure as set forth in the Section titled Compliance Reporting. Delivery must occur within 

7 days of entry of this Order for current personnel. For all others, delivery must occur before 

they assume their responsibilities. 

C. From each individual or entity to which a Stipulating Defendant delivered a copy 

of this Order, that Defendant must obtain, within 30 days, a signed and dated acknowledgment of 

receipt of this Order. 

VIII. COMPLIANCE REPORTING 

IT IS FURTHER ORDERED that Stipulating Defendants make timely submissions to 

the Commission: 

A. One year after entry of this Order, Stipulating Defendants must submit a 

compliance report, sworn under penalty of pe1jury: each Stipulating Defendant must: (1) identify 

the primary physical, postal, and email address and telephone number, as designated points of 

contact, which representatives of the Commission may use to communicate with Stipulating 

11 
and sales, and the involvement of any other Defendant; ( 4) describe in detail whether and how 

that Stipulating Defendant is in compliance with each Section of this Order; and (5) provide a 

copy of each Order Acknowledgment obtained pursuant to this Order, unless previously 

submitted to the Commission. 

B. For 10 years after entry of this Order, each Stipulating Defendant must submit a 

compliance notice, sworn under penalty of perjury, within 14 days of any change in the 

following: (1) any designated point of contact; or (2) the structure of any Stipulating Defendant 

or any entity that Stipulating Defendant has any ownership interest in or controls directly or 

indirectly that may affect compliance obligations arising under this Order, including: creation, 

merger, sale, or dissolution of the entity or any subsidiary, parent, or affiliate that engages in any 

acts or practices subject to this Order. 

C. Each Stipulating Defendant must submit to the Commission notice of the filing of 

any bankruptcy petition, insolvency proceeding, or similar proceeding by or against such 

Stipulating Defendant within 14 days of its filing. 

D. Any submission to the Commission required by this Order to be sworn under 

penalty of perjury must be true and accurate and comply with 28 U.S.C. § 1746, such as by 

concluding: "I declare under penalty of perjury under the laws of the United States of America 

that the foregoing is true and correct. Executed on: __ " and supplying the date, signatory's 

full name, title (if applicable), and signature. 

12 
Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue NW, 

Washington, DC 20580. The subject line must begin: FTC v. Neora, LLC,formerly known as 

Nerium International, LLC, Matter No. 1623099. 

IX. RECORDKEEPING 

IT IS FURTHER ORDERED that Stipulating Defendants must create certain records 

for 10 years after entry of the Order, and retain each such record for 5 years. Specifically, 

Stipulating Defendants for any business that such Defendant, individually or collectively with 

any other Defendant, is a majority owner or controls directly or indirectly, must create and retain 

the following records: 

A. accounting records showing the revenues from all goods or services sold; 

B. personnel records showing, for each person providing services, whether as an 

employee or othetWise, including that person's: name; addresses; telephone numbers; job title or 

position; dates of service; amounts paid to or paid by such person; and (if applicable) the reason 

for termination; 

C. records of all consumer complaints and refund requests, whether received directly 

or indirectly, such as through a third party, and any response; 

D. all records necessary to demonstrate full compliance with each provision of this 

Order, including all submissions to the Commission; and 

E. a copy of each unique advertisement or other marketing material. 

13 
receipt of a written request from a representative of the A. Within 14 days of 

Commission, each Stipulating Defendant must: submit additional compliance reports or other 

of perjury; appear for depositions; requested information, which must be sworn under penalty 

to and produce documents for inspection and copying. The Commission is also authorized 

obtain discovery, without further leave of court, using any of the procedures prescribed by 

of Civil Procedure 29, 30 (including telephonic depositions), 31, 33, 34, 36, 45, Federal Rules 

and 69, provided that Defendants, after attempting to resolve a dispute without court action, and 

motion with this Court seeking an order for one or more for good cause shown, may file a 

protections set forth in Rule 26( c ). 

B. For matters concerning this Order, the Commission is authorized to communicate 

Stipulating Defendant. Stipulating Defendants must permit representatives of directly with each 

the Commission to interview any employee or other person affiliated with any Stipulating 

interviewed may have counsel Defendant who has agreed to such an interview. The person 

present. 

posing, through its C. The Commission may use all other lawful means, including 

as consumers, suppliers, or other individuals or entities, to Stipulating Defendants representatives 

the necessity of or any individual or entity affiliated with Stipulating Defendants, without 

in this Order limits the Commission's lawful use of identification or prior notice. Nothing 

compulsory process, pursuant to Sections 9 and 20 of the FTC Act, 15 U.S.C. §§ 49, 57b-1. 

14 
p

p

, 

, 

SOORDEREDthis /Srflt\ dayof /\Ja~/ 2019. 

SO STIPULATED AND AGREED: 

FOR PLAINTIFF: 

ALDEN F. ABBOTT 

General Counsel 

~E 

Dated: Dl-~~r Z'f , 2019 

KATHARINE ROLLER 

GUYG. WARD 

Federal Trade Commission, Midwest Region 

230 South Dearborn St., Room 3030 

Chicago, Illinois 60604 

(312) 960-5634 

dotoole@ftc.gov 

kroller@ftc.gov 

gward@ftc.gov 

Attorneys for Plaintiff 

FEDERAL TRADE COMMISSION 

FOR STIPULATING DEFENDANTS: 

DEFENDANT SIGNUM BIOSCIENCES, INC. 

By: /YI Dated: October 16th, 2019 

MAXWELL STOCK, as President and Chief Executive Officer of 

SIGNUM BIOSCIENCES, INC. 

15 
By: /YI

 

MAXWELL STOCK, as Shareholder of 

SIGNUM NUTRALOGIX 

Dated: 

, 

COUNSEL FOR STIPULATING DEFENDANTS SIGNUM BIOSCIENCES, INC. AND 

SIGNUM NUTRALOGIX 

Amin Talati Wasserman, LLP 

1101 30th Street, N.W. 

Suite 500 

Washington, D. C. 20007 

(202) 496-4966 

katie@amintalati.com 

j ennifer@amintalati.com 

Dated: Oe,~ . l j , 2019 

16