Case 4:20-cv-10249-TSH Document 84 Filed 02/06/23 Page 1 of 20 

UNITED STATES DISTRICT COURT 

FOR THE DISTRICT OF MASSACHUSETTS 

FEDERAL TRADE COMMISSION, 

Plaintiff, 

v. 

ZYCAL BIOCEUTICALS HEALTHCARE 

COMPANY, INC., a corporation, and 

JAMES J. SCAFFIDI, individually and as an 

officer of ZYCAL BIOCEUTICALS 

HEALTHCARE COMPANY, INC., 

Defendants. 

Case No. 4:20-CV-10249__________ 

[PROPOSED] STIPULATED 

ORDER FOR PERMANENT 

INJUNCTION AND OTHER 

RELIEF 

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

for Permanent Injunction and Other Equitable Relief (“Complaint”), for a permanent injunction, 

and other relief in this matter, pursuant to Section 13(b) of the Federal Trade Commission Act 

(“FTC Act”), 15 U.S.C. § 53(b). The Commission and Defendants stipulate to the entry of this 

Stipulated Order for Permanent Injunction and Other Relief (“Order”) to resolve all matters in 

dispute in this action between them. 

THEREFORE, IT IS ORDERED as follows: 

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FINDINGS 

1. This Court has jurisdiction over this matter. 

2. The Complaint charges that Defendants participated in deceptive acts or practices 

in violation of Sections 5 and 12 of the FTC Act, 15 U.S.C. §§ 45 and 52, in the marketing and 

sale of one or more Cyplexinol Products. 

3. Nothing in this Order alters Defendants’ rights or obligations under any other 

statute, including the Dietary Supplement Health and Education Act, 21 U.S.C. § 343(r)(6). 

4. 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, Defendants admit the facts 

necessary to establish jurisdiction. 

5. 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. 

6. Defendants and the Commission waive all rights to appeal or otherwise challenge 

or contest the validity of this Order. 

DEFINITIONS 

For the purpose of this Order, the following definitions apply: 

A. “Covered Product” means any Dietary Supplement, Food, or Drug, including 

any Cyplexinol Product. 

B. “Cyplexinol Product” means any Dietary Supplement, Food, or Drug containing 

the ingredient Cyplexinol, including Ostinol, Pro-Stiminol, and Chondrinol. 

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C. “Defendants” means the Individual Defendant and Corporate Defendant, 

individually, collectively, or in any combination. 

1. “Corporate Defendant” means ZyCal Bioceuticals Healthcare Company, 

Inc. and its successors and assigns. 

2. “Individual Defendant” means James J. Scaffidi. 

D. “Dietary Supplement” means: (1) any product labeled as a dietary 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. 

E. “Drug” means: (1) articles recognized in the official United States 

Pharmacopoeia, official Homeopathic 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. 

F. “Essentially Equivalent Product” means a product that contains the identical 

ingredients, except for inactive ingredients (e.g., binders, colors, fillers, excipients), in the same 

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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 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. 

G. “Food” means: (1) any article used for food or drink for humans or other animals; 

(2) chewing gum; and (3) any article used for components of any such article. 

ORDER 

I. 

PROHIBITED REPRESENTATIONS REGARDING HEALTH-RELATED CLAIMS 

REQUIRING HUMAN CLINICAL TESTING FOR SUBSTANTIATION 

IT IS 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, promoting, offering for sale, sale, or distribution 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. Grows bone tissue or is osteoinductive; 

B. Grows cartilage tissue; 

C. Improves bone density or slows bone loss; 

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D. Cures, treats, or mitigates any orthopedic condition, including osteoarthritis, 

arthritis, osteoporosis, degenerative joint conditions, joint pain, and pain resulting from 

inflammation; or 

E. Cures, mitigates, or treats any disease 

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

Defendants 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 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. 

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II. 

PROHIBITED REPRESENTATIONS REGARDING 

OTHER HEALTH-RELATED CLAIMS 

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, promoting, offering for sale, sale, or distribution 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 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, performance, efficacy, 

safety, or side effects of any Covered Product, 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, 

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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 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. 

III. 

PROHIBITED MISREPRESENTATIONS REGARDING 

TESTS, STUDIES, OR OTHER RESEARCH 

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, promoting, offering for sale, sale, or distribution of any 

Covered Product, are permanently restrained and enjoined from misrepresenting, in any manner, 

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

product name, endorsement, depiction, or illustration: 

A. That any Covered Product is clinically or scientifically proven to: 

1. Grow bone tissue or is osteoinductive; 

2. Grow cartilage tissue; 

3. Improve bone density or slow bone loss; or 

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4. Cure, treat, or mitigate any orthopedic condition, including osteoarthritis, 

arthritis, osteoporosis, degenerative joint conditions, joint pain, and pain resulting from 

inflammation; 

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

proven or otherwise established; or 

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

test, study, or other research, including by misreporting the number of study participants and 

their demographic information or by failing to disclose potential conflicts of interest between the 

study sponsors or authors and the study participants. 

IV. 

MEANS AND INSTRUMENTALITIES 

IT IS FURTHER ORDERED that Defendants, Defendants’ officers, agents, employees, 

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, promoting, offering for sale, sale, or distribution of any 

Covered Product, are permanently restrained and enjoined from providing to others the Means 

and Instrumentalities with which to (1) make, directly or indirectly, expressly or by implication, 

including through the use of endorsements or trade names, any false or misleading statement of 

material fact, including the representations covered by Sections I through III, above. For 

purposes of this Section, “Means and Instrumentalities” means any information, including any 

advertising, labeling, promotional, sales, training, or purported substantiation materials, 

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contracts, or other agreements, for use by others in their marketing or sale of any product, 

package, or service, in or affecting commerce. 

V. 

FDA-APPROVED CLAIMS 

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, 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 the Food and Drug Administration Modernization Act of 1997. 

VI. 

PRESERVATION OF RECORDS RELATING TO COMPETENT AND 

RELIABLE HUMAN CLINICAL TESTS OR STUDIES 

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

(“test”) upon which Defendants rely to substantiate any claim covered by this Order, 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: 

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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 

communications and contracts between any sponsor and the test’s researchers. 

Provided, however, the preceding preservation requirement does not apply to a reliably 

reported test, unless the test was conducted, controlled, or sponsored, in whole or in part by: (1) 

any Defendant; (2) any Defendant’s officers, agents, representatives, or employees; (3) any other 

person or entity in active concert or participation with any Defendant; (4) any person or entity 

affiliated with or acting on behalf of any 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. 

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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 any Defendant, 

Defendant 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 the Defendant’s size and complexity, the nature and scope of 

the Defendant’s activities, and the sensitivity of the personal information collected from or about 

the participants. 

VII. 

NOTICE TO CUSTOMERS 

IT IS FURTHER ORDERED that, within 30 days of the entry of this Order: 

A. Corporate Defendant shall send by first-class mail or by electronic mail a notice 

in the exact wording and format shown in Attachment A, showing the date of the mailing or 

transmission, to any consumer, health professional, licensee, distributor, and wholesaler, who, as 

of the date of entry of this Order, is or has been a direct purchaser of Corporate Defendant’s 

Cyplexinol Products from January 1, 2018 to the present. For consumers and health 

professionals, the notice will be sent to those purchasers who bought Cyplexinol Products from a 

ZyCal website. The subject line of the notice must state “FTC SETTLEMENT ABOUT 

CYPLEXINOL (OSTINOL) ADVERTISING.” The notice must not contain any other message 

concerning Corporate Defendant’s goods or services, or include any attachments. 

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B. For any notice sent by first-class mail, Corporate Defendant’s name and return 

address must appear on the front of the envelope, and the customer’s name and address must be 

printed on the front of the envelope or be visible through a window in the envelope. 

C. For any notice sent by electronic mail: 

1. One to three days after sending any initial notice, Corporate Defendant 

shall resend such notice by electronic mail in the form shown in Attachment A to those 

customers who did not open the initial notice. 

2. Corporate Defendant must collect and maintain the following metrics on 

the initial and subsequent emailed notices: 

a. Unique open-rate (unique opens divided by number of emails 

successfully delivered); 

b. Click-to-open rate (unique clicks divided by the number of emails 

opened); and 

c. Unique click rate (unique clicks divided by the number of emails 

successfully delivered). 

3. Corporate Defendant must report to the Commission the metrics listed in 

this Subsection within 30 days of sending the second notice. 

VIII. 

ORDER ACKNOWLEDGMENTS 

IT IS FURTHER ORDERED that Defendants obtain acknowledgments of receipt of 

this Order: 

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A. Each 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 10 years after entry of this Order, Individual Defendant for any business that 

such Defendant, individually or collectively with any other Defendant, is the majority owner or 

controls directly or indirectly, and Corporate Defendant, must deliver a copy of this Order to: (1) 

all principals, officers, directors, and LLC managers and members; (2) all employees having 

managerial responsibilities for the manufacturing, labeling, advertising, promoting, offering for 

sale, sale, or distribution of any Covered Product and all agents and representatives who 

participate in the manufacturing, labeling, advertising, promoting, offering for sale, sale, or 

distribution of any Covered Product; 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 Defendant delivered a copy of this 

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

receipt of this Order. 

IX. 

COMPLIANCE REPORTING 

IT IS FURTHER ORDERED that Defendants make timely submissions to the 

Commission: 

A. 60 days after entry of this Order, each Defendant must submit a compliance 

report, sworn under penalty of perjury: 

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1. Each Defendant must: (a) 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 Defendant; (b) identify all of that Defendant’s 

businesses by all of their names, telephone numbers, and physical, postal, email, and Internet 

addresses; (c) describe the activities of each business, including the goods and services offered, 

the means of advertising, marketing, and sales, and the involvement of any other Defendant 

(which Individual Defendant must describe if he knows or should know due to his own 

involvement); (d) describe in detail whether and how that Defendant is in compliance with each 

Section of this Order; and (e) provide a copy of each Order Acknowledgment obtained pursuant 

to this Order, unless previously submitted to the Commission. 

2. Additionally, Individual Defendant must: (a) identify all telephone 

numbers and all physical, postal, email and Internet addresses, including all residences; (b) 

identify all business activities, including any business for which such Defendant performs 

services whether as an employee or otherwise and any entity in which such Defendant has any 

ownership interest; and (c) describe in detail such Defendant’s involvement in each such 

business, including title, role, responsibilities, participation, authority, control, and any 

ownership. 

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

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

1. Each Defendant must report any change in: (a) any designated point of 

contact; or (b) the structure of any Corporate Defendant or any entity that Defendant has any 

ownership interest in or controls directly or indirectly that may affect compliance obligations 

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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. 

2. Additionally, Individual Defendant must report any change in: (a) name, 

including aliases or fictitious name, or residence address; or (b) title or role in any business 

activity, including any business for which such Defendant performs services whether as an 

employee or otherwise and any entity in which such Defendant has any ownership interest, and 

identify the name, physical address, and any Internet address of the business or entity. 

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

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

E. Unless otherwise directed by a Commission representative in writing, all 

submissions to the Commission pursuant to this Order must be emailed to DEbrief@ftc.gov or 

sent by overnight courier (not the U.S. Postal Service) to: Associate Director for Enforcement, 

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

Washington, DC 20580. The subject line must begin: FTC v. ZyCal Bioceuticals Healthcare Co., 

Inc., et al. File No. X200017. 

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X. 

RECORDKEEPING 

IT IS FURTHER ORDERED that Defendants must create certain records for 10 years 

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

Defendant and Individual Defendant for any business that such Defendant, individually or 

collectively with any other Defendant, owns a majority of or controls directly or indirectly, must 

create and retain the following records: 

A. A copy of each unique advertisement or other marketing material; 

B. Accounting records showing the revenues from all goods or services sold; 

C. Personnel records showing, for each person providing services, whether as an 

employee or otherwise, that person’s: name; addresses; telephone numbers; job title or position; 

dates of service; and (if applicable) the reason for termination; 

D. Records of all consumer complaints and refund requests, whether received 

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

E. All records necessary to demonstrate full compliance with each provision of this 

Order, including all submissions to the Commission. 

XI. 

COMPLIANCE MONITORING 

IT IS FURTHER ORDERED that, for the purpose of monitoring Defendants’ 

compliance with this Order: 

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

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

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

documents for inspection and copying. The Commission is also authorized to obtain discovery, 

without further leave of court, using any of the procedures prescribed by Federal Rules of Civil 

Procedure 29, 30 (including telephonic depositions), 31, 33, 34, 36, 45, and 69. 

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

directly with each Defendant. Defendant must permit representatives of the Commission to 

interview any employee or other person affiliated with any Defendant who has agreed to such an 

interview. The person interviewed may have counsel present. 

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

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

individual or entity affiliated with Defendants, without the necessity of identification or prior 

notice. Nothing in this Order limits the Commission’s lawful use of compulsory process, 

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

D. Upon written request from a representative of the Commission, any consumer 

reporting agency must furnish consumer reports concerning Individual Defendant, pursuant to 

Section 604(1) of the Fair Credit Reporting Act, 15 U.S.C. § 1681b(a)(1). 

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Case 4:20-cv-10249-TSH Document 84 Filed 02/06/23 Page 18 of 20 

XII. 

RETENTION OF JURISDICTION 

IT IS FURTHER ORDERED that this Court retains jurisdiction of this matter for 

purposes of construction, modification, and enforcement of this Order. 

SO ORDERED this day of ___________, 20__. 

UNITED STATES DISTRICT JUDGE 

SO STIPULATED AND AGREED: 

FOR PLAINTIFF FEDERAL TRADE COMMISSION: 

Anisha Dasgupta 

General Counsel 

__/s/ Mary L. Johnson_______________ Date: _02/03/2023__ 

MARY L. JOHNSON 

EDWIN RODRIGUEZ 

SARAH BOTHA 

KRISTIN M. WILLIAMS 

Federal Trade Commission 

600 Pennsylvania Avenue, N.W., Mailstop CC-6316 

Washington, D.C. 20850 

202-326-3115, mjohnson1@ftc.gov 

202-326-3147, erodriguez@ftc.gov 

202-326-2036, sbotha@ftc.gov 

202-326-2619, kwilliams2@ftc.gov 

202-326-3259 (facsimile) 

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Case 4:20-cv-10249-TSH Document 84 Filed 02/06/23 Page 20 of 20 

ATTACHMENT A 

[On ZyCal letterhead if mailed or with ZyCal logo if sent by email] 

[On envelope if mailed or the “re” line if sent by email:] 

FTC SETTLEMENT ABOUT CYPLEXINOL (OSTINOL) ADVERTISING 

[content of letter or email, 16-point font] 

Dear [End Users, Wholesalers, Distributors, Licensees, and Health Practitioners]: 

We’re writing because you bought Cyplexinol products, such as Ostinol. According to 

the Federal Trade Commission (FTC), ZyCal doesn’t have scientific evidence to support 

advertising claims that Cyplexinol grows bone, grows cartilage, or relieves joint pain. 

To settle the case, ZyCal has agreed to stop making these claims, unless it has adequate 

scientific evidence. 

Learn more about the FTC’s lawsuit at [URL]. 

Sincerely, 

[ZyCal signatory]