Case 1:20-cv-10249 Document 1 Filed 02/10/20 Page 1 of 33 

UNITED STATES DISTRICT COURT 

FOR THE DISTRICT OF MASSACHUSETTS 

BOSTON DIVISION 

FEDERAL TRADE COMMISSION, 

 Plaintiff, 

 v. 

ZYCAL BIOCEUTICALS HEALTHCARE 

COMPANY, INC., a corporation, 

JAMES J. SCAFFIDI, individually and as an 

officer of ZYCAL BIOCEUTICALS 

HEALTHCARE COMPANY, INC., 

EXCELLENT MARKETING RESULTS, INC., a 

corporation, 

and 

MICHAEL MCGAHEE, individually and as an 

officer of EXCELLENT MARKETING 

RESULTS, INC., 

 Defendants. 

Case No. ____________ 

COMPLAINT FOR PERMANENT 

INJUNCTION AND OTHER 

EQUITABLE RELIEF 

Plaintiff, the Federal Trade Commission (“FTC”), for its Complaint alleges: 

1. The FTC brings this action under Section 13(b) of the Federal Trade Commission 

Act (“FTC Act”), 15 U.S.C. § 53(b), to obtain permanent injunctive relief, rescission or 

reformation of contracts, restitution, the refund of monies paid, disgorgement of ill-gotten 

monies, and other equitable relief for Defendants’ acts or practices in violation of Sections 5(a) 

and 12 of the FTC Act, 15 U.S.C. §§ 45(a), 52. 
Case 1:20-cv-10249 Document 1 Filed 02/10/20 Page 2 of 33 

JURISDICTION AND VENUE 

2. This Court has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331, 1337(a), 

and 1345. 

3. Venue is proper in this District under 28 U.S.C. § 1391(b)(1), (b)(2), (b)(3), 

(c)(1), and (c)(2), and 15 U.S.C. § 53(b). 

PLAINTIFF 

4. The FTC is an independent agency of the United States Government created by 

statute. 15 U.S.C. §§ 41-58. The FTC enforces Section 5(a) of the FTC Act, 15 U.S.C. § 45(a), 

which prohibits unfair or deceptive acts or practices in or affecting commerce. The FTC also 

enforces Section 12 of the FTC Act, 15 U.S.C. § 52, which prohibits false advertisements for 

food, drugs, devices, services, or cosmetics in or affecting commerce. 

5. The FTC is authorized to initiate federal district court proceedings, by its own 

attorneys, to enjoin violations of the FTC Act and to secure such equitable relief as may be 

appropriate in each case, including rescission or reformation of contracts, restitution, the refund 

of monies paid, and the disgorgement of ill-gotten monies. 15 U.S.C. § 53(b). 

DEFENDANTS 

6. Defendant ZyCal Bioceuticals Healthcare Company, Inc. (“ZyCal”) is a Delaware 

corporation that has multiple locations from which it does business, including Shrewsbury, 

Massachusetts and Tom’s River, New Jersey. ZyCal transacts or has transacted business in this 

District and throughout the United States. At times material to this Complaint, acting alone or in 

concert with others, ZyCal has advertised, marketed, distributed, or sold the ingredient 

Cyplexinol or oral products containing Cyplexinol to trade customers throughout the United 

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States. At times material to the Complaint, acting alone or in concert with others, ZyCal also has 

advertised, marketed, distributed, or sold its own Cyplexinol products under the brand name 

Ostinol to health professionals and consumers throughout the United States. 

7. Defendant James J. Scaffidi is the president of ZyCal. At times material to this 

Complaint, acting alone or in concert with others, he has formulated, directed, controlled, had the 

authority to control, or participated in the acts and practices of ZyCal set forth in this Complaint. 

Defendant Scaffidi and his family trust together own approximately eighty-six percent of ZyCal. 

Scaffidi runs the daily operations of the company, including creating and approving advertising 

content, hiring and firing employees, and entering into contracts on behalf of ZyCal. Defendant 

Scaffidi resides in this District and, in connection with the matters alleged herein, transacts or 

has transacted business in this District and throughout the United States. 

8. Defendant Excellent Marketing Results, Inc. (“EMR”) is a Delaware corporation 

with its principal place of business at 2055 Range Road, Clearwater, Florida 33765. EMR 

transacts or has transacted business in this District and throughout the United States. At times 

material to this Complaint, acting alone or in concert with others, EMR has advertised, marketed, 

distributed, or sold the orally-administered product StimTein, containing the active ingredient 

Cyplexinol, to consumers throughout the United States. 

9. Defendant Michael McGahee is the president of EMR. At times material to this 

Complaint, acting alone or in concert with others, he has formulated, directed, controlled, had the 

authority to control, or participated in the acts and practices of EMR set forth in this Complaint. 

Defendant McGahee and his wife are EMR’s sole shareholders. He holds a fifty percent share of 

the company and runs its daily operations, including creating and approving infomercial and 

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Case 1:20-cv-10249 Document 1 Filed 02/10/20 Page 4 of 33 

internet advertising content, and securing radio and television advertising spots. He personally 

appears in the StimTein infomercial, during which he makes many of the deceptive statements 

alleged in this Complaint. Defendant McGahee, in connection with the matters alleged herein, 

transacts or has transacted business in this District and throughout the United States. 

COMMERCE 

10. At times material to this Complaint, Defendants have maintained a substantial 

course of trade in or affecting commerce, as “commerce” is defined in Section 4 of the FTC Act, 

15 U.S.C. § 44. 

SUMMARY OF DEFENDANTS’ BUSINESS ACTIVITIES 

11. Since at least 2009 and continuing until at least August 2018, EMR and McGahee 

(“the EMR Defendants”) have marketed StimTein, an ingestible capsule, through nationally 

advertised infomercials and other means. The EMR Defendants have represented that StimTein, 

taken as directed, grows bone and cartilage and thereby provides substantial and long-lasting 

relief from pain associated with debilitating joint ailments, including arthritis, and that these 

benefits are clinically proven. The active ingredient in StimTein that purportedly provides the 

advertised health benefits is Cyplexinol, which is manufactured and supplied by ZyCal and 

Scaffidi (“the ZyCal Defendants”). 

12. The ZyCal Defendants first recruited the EMR Defendants as trade customers in 

or about 2009. In particular, the ZyCal Defendants encouraged the EMR Defendants to market a 

Cyplexinol product via an infomercial. The EMR Defendants agreed, branding the finished 

product as StimTein. At times material to the Complaint, the ZyCal Defendants supplied to the 

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EMR Defendants either the finished StimTein product or the ingredient Cyplexinol for use in 

StimTein. 

13. The ZyCal Defendants also supplied the EMR Defendants with product 

information, clinical studies, and other promotional materials about the purported health benefits 

of Cyplexinol. The EMR Defendants incorporated the ZyCal Defendants’ health benefit claims 

into their promotional materials for StimTein. For example, in 2009, the ZyCal Defendants 

provided talking points to the EMR Defendants about Ostinol, a ZyCal product with a 

Cyplexinol formulation similar to that of StimTein. The talking points emphasized that the 

product “stimulate[s] cells to grow bone tissue,” “stimulate[s] cells to grow cartilage,” and 

“contains a biologically active protein complex proven for 40 years and used clinically for 20 

years to grow bone.” These claims appeared prominently in StimTein advertising. 

14. Since at least 2011, the ZyCal Defendants also have marketed the Cyplexinol 

ingredient or oral products containing Cyplexinol to other trade customers. The ZyCal 

Defendants provide to those trade customers product information and promotional materials with 

bone and joint claims substantially similar to the claims they have provided to the EMR 

Defendants. 

15. Since at least 2014, the ZyCal Defendants also have advertised and marketed their 

own line of Cyplexinol products under the brand name Ostinol directly to consumers and health 

professionals (primarily chiropractors). The ZyCal Defendants sell Ostinol products in varying 

strengths and formulations. They have made, and continue to make, claims that Ostinol products 

grow bone and cartilage and thereby substantially reduce joint pain and discomfort, and that 

these benefits are clinically proven. 

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16. In truth and in fact, Defendants possess no competent and reliable scientific 

evidence that any Cyplexinol product, taken as directed, provides any of the health benefits 

advertised by Defendants, nor are any of the advertised benefits clinically proven. 

DECEPTIVE ADVERTISING OF STIMTEIN 

17. At times material to the Complaint, the EMR Defendants have advertised, offered 

for sale, sold, and distributed the oral product StimTein, containing the active ingredient 

Cyplexinol. For the purposes of Section 12 of the FTC Act, 15 U.S.C. § 52, StimTein is either a 

“food” or a “drug” as defined in Sections 15(b) and (c) of the FTC Act, 15 U.S.C. §§ 55(b), (c). 

18. The EMR Defendants have advertised StimTein mainly through long- and shortform infomercials and internet marketing, including the website www.stimtein.com. They have 

represented directly and through consumer endorsements that StimTein grows new bone, 

including in persons with osteoporosis or osteopenia; that StimTein grows new cartilage; that 

StimTein provides substantial and long-lasting relief from joint pain, including pain caused by 

arthritis, bursitis, and stenosis; and that these benefits are clinically proven. 

19. The EMR Defendants used the testimonial of a then-employee of EMR and the 

testimonial of the mother of another then-employee of EMR, as consumer endorsements of 

StimTein without disclosing their connections to the company. Both testimonialists claimed that 

StimTein eliminated their debilitating joint pain. 

20. The EMR Defendants sold StimTein for approximately $30-$60 for a 30-day 

supply. From 2015 to 2018, Defendants generated approximately $3.6 million in gross sales 

minus returns of StimTein. 

 6 
Pain 

Arthritis 

Bursitis 

Stenosis 

Case 1:20-cv-10249 Document 1 Filed 02/10/20 Page 7 of 33 

21. To induce consumers to purchase StimTein, the EMR Defendants have 

disseminated or caused to be disseminated advertisements, packaging, and promotional 

materials, including, but not limited to, advertisements containing the following statements and 

depictions, among others: 

a. StimTein infomercial excerpt (Jan. 2017) 

[VOICEOVER]: If you have pain from arthritis, bursitis, stenosis 

Or any other type of joint pain, and that includes back pain 

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Case 1:20-cv-10249 Document 1 Filed 02/10/20 Page 8 of 33 

In the next [sic], find out how to free yourself from that pain in a way you never dreamed 

possible! With a new scientific breakthrough that only uses an all natural non-drug 

supplement. 

* * * 

[Testimonialist Cindy Butler]: I couldn’t pick up my kids. Literally, could not pick them 

up. And they’re young and didn’t understand why momma couldn’t pick them up. This 

one little supplement changed my life. I run with my kids. I’m able to swim and play 

with my kids. 

* * * 

[Testimonialist Elaine M.]: I got out of bed and I didn’t feel any pain. So that’s when 

the lightbulb went off saying this product is really working. 

* * * 

[Dr. Donald C. DeFabio]: First time I saw these proteins come across my desk, I said, 

“ah here’s another supplement.” Once I started to see results, now it’s one of my routine 

recommendations for people with joint pain or who have bone health concerns. 

 8 
Bone Acthating Proteins· 

.. o 11 l' or I h l' 111 '" 1 d r l' r Ii, l' . 

dinirall~ ll·,ll· d 111111-dru;.! 

,uppll' llll' llh 1111 lhl· 

marJ..l'I Inda~. " 

Period 

Case 1:20-cv-10249 Document 1 Filed 02/10/20 Page 9 of 33 

* * * 

[VOICEOVER]: The bone activating proteins in StimTein are backed by 40 years of 

research. They have been reviewed in prestigious medical publications such as Arthritis, 

Research, and Therapy, The Journal of Biological Chemistry, and Arthritis and 

Rheumatism from the American College of Rheumatology. They have 20 years of 

clinical use in over 500,000 medical procedures along with clinical trials that proves [sic] 

they do in fact work. 

* * * 

When the bone activating proteins are present they activate replenishing cells around the 

bones so that they can actually use the existing building blocks to form new bone and 

cartilage. The end result is when you replace the missing bone activating proteins you 

get long term bone and joint health, and most importantly you get your life back. 

Our [StimTein] Bone and Joint Restore is clearly one of the most effective clinically 

tested non-drug supplements on the market today. Period. 

[Infomercial Host (Michael McGahee)]: There are two university studies, one from 

Oxford, that show as we get older many of us stop making these bone activating proteins 

and that’s when our bone and joint problems begin. Now they’ve been studied for over 

40 years, with 20 years of clinical use, but we’re bringing this medical breakthrough new 

to the public for the first time. 

 9 
 

Case 1:20-cv-10249 Document 1 Filed 02/10/20 Page 10 of 33 

* * * 

[Dr. Richard Garian]: That joint starts to decrease. That cartilage cushion between the 

joints. And when that happens we irritate the surrounding connective tissue, we irritate 

the surrounding blood supply. In order to restore the normal cushioning to that joint you 

need the raw ingredients. So these proteins provide the raw ingredients and as the tissue 

itself becomes healthier the pain becomes less and less and the function becomes higher 

and higher. 

* * * 

[Steven Lund]: ... With this product it helps rebuild it. It also sets the groundwork so 

now your calcium, phosphorous, other things you’re taking will have something to land 

in. It’s going to stimulate these cells to work properly so that they will build bone, they 

will build joints, they’ll build the cartilage that you need to rebuild to stop the negative 

impact like you did when you were young. 

 10 
 

um'Rin 

!l!ill~,lll!l 

l!illlli~~ 

Case 1:20-cv-10249 Document 1 Filed 02/10/20 Page 11 of 33 

* * * 

[Infomercial Host (Michael McGahee)]: ... this is the picture that started the whole 

thing. These are actual x-rays of bone growing across a half inch gap in a person’s leg. 

And guess what? Calcium had nothing to do with this. It was the proteins that produced 

the result. And it was a verification that they could do the same thing with cartilage and 

joints. 

Now of course this was surgically done, but we wanted to see if the oral version of these 

natural proteins would produce an effect. So that’s why we performed clinical tests and 

what you’re seeing on this program are the amazing results. And it’s something that 

could happen for you. 

* * * 

[Dr. DeFabio]: Osteoporosis ... and osteopenia, huge, huge problems today. It is so nice 

to be able to give my patients an option where they can stimulate their body to grow more 

bone. ... And I’ve seen these proteins improve people’s bone density results – their 

DEXAs they’re called – extremely well. One patient went from osteopenia to normal 

lumbar spine bone density in 14 months. 14 months! That’s unheard of. 

* * * 

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Case 1:20-cv-10249 Document 1 Filed 02/10/20 Page 12 of 33 

[Testimonialist Beverly Murray]: The main problem is my knees and pain and burning 

and the burning has been a real issue because you can feel that all the time. And the first 

thing I noticed was that the burn was gone. It was really gone. 

* * * 

[Testimonialist Kimberly Troop]: It hurt. If I lifted to get something out of the cupboard 

it, I would go to my knees and have to crawl to the table or to the chair and just sit there 

until that pain went away. And now, I noticed everytime I go to get something out the 

cupboard I don’t have that pain anymore. ... 

b. StimTein website excerpt (www.stimtein.com captured Mar. 13, 2017) 

Free Yourself From Pain In A Way 

You Never Dreamed Possible 

Joint Pain, Arthritis Pain, Bursitis Pain, Stenosis 

Pain, Back Pain 

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Case 1:20-cv-10249 Document 1 Filed 02/10/20 Page 13 of 33 

* * * 

Case Histories 

I started having pain all over my body, mainly my shoulders, knees and back. ... I 

had to get help out of bed in the morning and back in bed at night. And I literally 

couldn’t pick up my kids. ... 

It was debilitating to me. ... I used two different kinds of injectables, and then 

they put me on a medicine that required an IV for four hours. Plus I was up to 

3,200 milligrams of over the counter medication a day .... 

Then I tried StimTein® and it’s changed my life. I pick up my kids, throw them 

around and play in the pool with them as well as give them piggy back rides to 

bed at night. I can step up stairs without a cane and I even work out now. 

I’m completely free of all the medications. I only take the supplement three times 

a day. This one little supplement has changed my life .... 

Cindy Butler 

Owner Paradise Press 

Results will vary. 

* * * 

Doctors Report Amazing Pain Relief Results 

. . . 

As a physician I get approached constantly. I’m inundated with products that are 

supposed to be the latest greatest thing. It gets frustrating for me to hear all the 

hype and not see the results... until I tried Stimtein [sic]. And I was very 

impressed. I was having transitory joint pain, which means that it moved around. 

... It is quite surprising to me that I’ve noticed a big change in the joint pain that I 

was experiencing. I am not having pain now. And that was in a very short period 

of time; in less than two weeks. 

* * * 

Dr. Deborah Springer 

Springer Chiropractic 

Results will vary. 

* * * 

 13 
                                 

                             

                             

                 

                                 

                           

                             

      

                       

                             

                               

                       

     

Case 1:20-cv-10249 Document 1 Filed 02/10/20 Page 14 of 33 

Long Term & Short Term Relief 

Long-term relief with StimTein comes about because the body is forming 

cartilage and there is less pain since it is going through its natural re-building 

cycle. 

* * * 

Clinical Results 

While there is no claim to heal or cure anything, the results of our clinicals speak 

for themselves. In one of the trials performed over a four-week period, 70% said 

they had a 50% decrease in pain and an amazing 100% said they experienced 

some relief. 

22. In addition, the ZyCal Defendants supplied the EMR Defendants with advertising, 

packaging, and promotional materials, including, but not limited to, advertisements containing 

the following statements and depictions, among others: 

a. Ostinol Talking Points excerpt (Aug. 2009) 

OstinolTM Bone and Cartilage Stimulating Proteins 

... 

How does OstinolTM work in bone health? 

“The proteins in OstinolTM naturally stimulate cells to grow bone tissue so calcium can bind to it.

OstinolTM is the only product[,] which contains these proteins that are proven to activate stem

cells which build bone tissue – a natural process known as osteoinduction. Then calcium can

bind to the tissue to make strong, healthy bones.”

How is OstinolTM different from other bone products? 

“OstinolTM works with your favorite calcium or bone product to address both parts of bone loss –

the mineral (calcium) loss and the tissue loss. Only OstinolTM contains a biologically active

protein complex proven for 40 years and used clinically for 20 years to grow bone.”

. . .

How does OstinolTM work in joint health? 

“The proteins in OstinolTM naturally stimulate stem cells which absorb glucosamine and

chondroitin to put them together to make cartilage. OstinolTM is the only product which contains

these proteins that are proven to activate stem cells which make cartilage – a natural process

known as osteoinduction. These cells absorb glucosamine and chondroitin to form cartilage,

building strong, healthy joints.”

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Case 1:20-cv-10249 Document 1 Filed 02/10/20 Page 15 of 33 

23. The EMR Defendants incorporated bone- and cartilage-building claims described 

in Paragraph 22 into their own advertising for StimTein and continued to make those claims until 

August 2018. The StimTein infomercial heavily emphasizes the bone- and cartilage-growth 

claims and that decades of medical research purportedly backed those claims. According to 

infomercial host Defendant McGahee, “the bone activating proteins in StimTein are backed by 

40 years of research. They have been reviewed in prestigious medical publications ... [and] have 

20 years of clinical use in over 500,000 medical procedures along with clinical trials that proves 

[sic] they do in fact work.” These proteins “activate replenishing cells around bones so that they 

can actually use the existing building blocks to form new bone and cartilage.” 

DECEPTIVE PRACTICES BY ZYCAL DEFENDANTS 

FOR OSTINOL PRODUCTS 

24. At times material to the Complaint, the ZyCal Defendants have advertised, 

offered for sale, sold, and distributed Ostinol products and other oral Cyplexinol products to 

trade customers, health professionals, and consumers. For the purposes of Section 12 of the FTC 

Act, 15 U.S.C. § 52, these products are either “foods” or “drugs” as defined in Sections 15(b) 

and (c) of the FTC Act, 15 U.S.C. §§ 55(b), (c). 

25. The ZyCal Defendants have sold Ostinol products to consumers and health 

professionals for approximately $45-$135 for a 30-day supply. From 2014 to 2017, they 

generated gross sales minus returns for Ostinol products of more than $3.1 million to health 

professionals and more than $1.5 million to consumers. During that time, they also made 

approximately $1.9 million in sales of the ingredient Cyplexinol and Cyplexinol products to 

trade customers, including $467,325 in sales to EMR. 

 15 
 

Case 1:20-cv-10249 Document 1 Filed 02/10/20 Page 16 of 33 

ZyCal Defendants’ Marketing to Health Professionals 

26. At times material to the Complaint, the ZyCal Defendants have marketed Ostinol 

products to health professionals, primarily chiropractors, through internet and print marketing, 

including the website https://rts.ostinol.com. They have represented that Ostinol products grow 

bone or cartilage tissue and thereby substantially reduce joint pain and discomfort, and that these 

benefits are clinically proven. 

27. To induce health professionals to purchase Ostinol products, the ZyCal 

Defendants have disseminated or caused to be disseminated advertisements, packaging, and 

promotional materials, including, but not limited to, advertisements containing the following 

statements and depictions, among others: 

a. ZyCal health professionals brochure excerpt (Feb. 2018) 

Help your patients get 

Image of older Their joints kicking again man and boy Try OstinolTM in 2018_________ playing soccer This revolutionary safe and natural product grows new cartilage 

tissue and works on inflammatory pathways, so joints feel a 

difference in 7 days! 

b. Regenerative Tissue Science health professionals website excerpt 

(https://rts.ostinol.com captured Oct. 31, 2019) 

10 Years And Going Strong! 

... As the world’s creator of osteoinductive supplements, RTS is committed to 

leading the nutritional industry through biologically active products which turn on 

stem cells, affecting a paradigm shift in regenerative health and medicine. RTS, 

backed by experts from medicine and surgery, setting a new standard in natural 

medicine and nutritional health. 

* * * 

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BONE HEALTH SUPPLEMENTS 

 ... 

Cyplexinol® is an all-natural stem cell signaling protein complex[,] which 

uniquely stimulates key pathways to support your body’s ability to create new 

bone and cartilage tissue! This new class of nutrition provides health benefits no 

other product has ever delivered! 

* * * 

Ostinol® Advanced 250 mg 

... 

Ostinol® is a breakthrough in bone and joint health. ... 

Ostinol® is: 

o FAST – In a recent clinical study people reported less discomfort in as fast 

as 7 days* 

o POWERFUL – New class of proteins used by doctors for years 

Ostinol® is powered by Cyplexinol® Pro a complex of proteins naturally found 

in bones and joints which are functionally involved in the formation of bone and 

cartilage tissue. ... 

Bioactive protein complexes are backed by over 50 years of scientific and medical 

research. Before being used as a nutritional supplement, this class of proteins was 

used clinically for years to grow bone and cartilage tissue postoperatively. Natural healthcare professionals have been using this powerful 

bioactive protein complex in Ostinol® as an oral supplement for bone and joint 

health with great clinical success and it is now available directly 

to you as the ultimate supplement in bone and joint health. ... 

* * * 

JOINT HEALTH SUPPLEMENTS 

... 

Ostinol® is powered by Cyplexinol®, a new class of nutritional ingredient. 

Cyplexinol® is an all-natural stem cell signaling protein complex which uniquely 

stimulates key pathways to support your body’s ability to create new bone and 

cartilage tissue!* Once the new tissue begins to grow, it can absorb important 

nutrients (e.g., Glucosamine, Chondroitin, MSM, SAMe, HA) that are necessary 

for the continued maintenance of strong joint cartilage. ... 

* * * 

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Case 1:20-cv-10249 Document 1 Filed 02/10/20 Page 18 of 33 

Ostinol® Advanced 5X 

... 

o FAST – In a recent clinical study people reported less discomfort in as fast 

as 7 days 

o POWERFUL – New class of proteins used by doctors for years* 

Ostinol® Advanced 5X is powered by Cyplexinol® Pro a complex of proteins 

naturally found in bones and joints which are functionally involved in the 

formation of bone and cartilage tissue.* ... 

Bioactive protein complexes are backed by over 50 years of scientific and medical 

research. Before being used as a nutritional supplement, this class of proteins was 

used by surgeons for years to grow bone and cartilage tissue post-operative. 

Now, natural healthcare professionals have this new class of powerful bioactive 

protein complex available in Ostinol® Advanced 5X as an oral supplement for 

bone and joint health. 

... 

For people who: 

o need extreme single joint support 

o suffer from severe problems in multiple joints 

* * * 

RTS PROFESSIONAL’S ADVANTAGE 

POWERFUL PRODUCTS! 

We run shoulder-to-shoulder with traditional allopathic medicine. Our patented 

proprietary active ingredient, Cyplexinol® has been clinically studied with 

amazing results! Providing more benefits than pharmaceuticals, Cyplexinol® is 

all-natural, safe, offers no side effects and has better results! 

LASER FOCUS AREA OF SPECIALIZATION! 

... Our active ingredient, Cyplexinol® is a new class of nutritional ingredient that 

can grow de novo tissue while patients are living their day to day lives. 

... 

ZyCal Defendants’ Consumer-Directed Marketing 

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28. At times material to the Complaint, the ZyCal Defendants have advertised, 

offered for sale, sold, and distributed Ostinol products to consumers mainly through internet 

marketing, including the websites www.ostinol.com and www.zycalbio.com. They have 

represented directly, and through consumer endorsements and the endorsement of registered 

dietician Katherine Spinks, that Ostinol products grow bone or cartilage tissue and thereby 

substantially reduce joint pain and discomfort, and that these benefits are clinically proven. They 

also used Spinks’ endorsement without disclosing that she was a ZyCal sales representative at 

the time her endorsement was made. 

29. To induce consumers to purchase Ostinol products, the ZyCal Defendants have 

disseminated or caused to be disseminated advertisements, packaging, and promotional 

materials, including, but not limited to, advertisements containing the following statements and 

depictions, among others: 

a. Ostinol consumer website excerpt 

(www.ostinol.com captured on Oct. 23, 2019) 

BONE SUPPLEMENTS 

... 

Ostinol® is a breakthrough in bone and joint health. ... Ostinol® is powered by 

Cyplexinol®, a new class of nutritional ingredient. Cyplexinol® is an all-natural 

stem cell signaling protein complex[,] which uniquely stimulates key pathways to 

help support your body’s ability to create new bone and cartilage tissue! This 

new class of nutrition provides health benefits no other product has ever 

delivered! 

* * * 

Ostinol Standard 150 mg 

... 

Ostinol® is: 

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Case 1:20-cv-10249 Document 1 Filed 02/10/20 Page 20 of 33 

o FAST – In a clinical study people had reported less discomfort in as fast as 

7 days* 

o POWERFUL – New Class of protein complexes used clinically to grow 

new bone and cartilage for over thirty years* 

Ostinol® is powered by Cyplexinol®, a new class of nutritional ingredient. 

Cyplexinol® is an all-natural stem cell signaling protein complex which uniquely 

stimulates key pathways to help support your body’s ability to create new bone 

and cartilage tissue! ... 

* * * 

Ostinol® Insta Joint 

 POWERFUL! CLINICALLY TESTED, SCIENTIFICALLY PROVEN 

... 

o FAST - In a recent clinical study people reported improved 

comfort in as fast as 7 days 

o POWERFUL - New class of protein complex used clinically to 

grow new bone and cartilage tissue for years.* 

Ostinol® Insta Joint is powered by Cyplexinol®, a new class of nutritional 

ingredient. Cyplexinol® is an all-natural stem cell signaling protein complex 

which uniquely stimulates key pathways to help support your body’s ability to 

create new bone and cartilage tissue! ... 

* * * 

WHAT OUR CUSTOMERS ARE SAYING! 

Two years ago, I started taking Ostinol® 350s. I had a DEXA scan this week, 

and I was ecstatic because my numbers were so much better – my score increased 

8%! The only thing I added or changed since 2015 was to start taking Ostinol®. 

 ... 

I have been taking Ostinol® 450s for several weeks, and have already seen 

improvement in my knees! I wasn’t able to stand for very long periods due to my 

knee pain. Now I am able to be on my feet for several hours at a time. 

... 

I needed to let you know that I am a nutritionist caring for a 97-year-old patient 

who has experienced extensive reversal in bone condition since starting OstinolTM 

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Case 1:20-cv-10249 Document 1 Filed 02/10/20 Page 21 of 33 

just 3 1⁄2 months ago! No other product I have worked with has shown anything 

even close to these results. 

... 

WHO NEEDS OSTINOL® FOR JOINT HEALTH? 

There are over 60 million Americans struggling with joint problems and if you are 

one of them, then Ostinol® is the supplement for you! 

Ostinol® products are the only supplements available on the market today that 

stimulate the body to grow healthy, new cartilage tissue. 

 ... 

WHO NEEDS OSTINOL® FOR BONE HEALTH? 

If you are one of the 54 million Americans suffering from troublesome bone 

health, then Ostinol® is just right for you. 

Ostinol® 450mg, 350mg, and 150mg are the only supplements available on the 

market today that stimulate the body to grow healthy, new bone tissue. These 

supplements provide a range of strengths for individuals who have mild, 

moderate, or severe bone loss. 

Ostinol® dramatically improves the quality of life for people with troublesome 

bone health. ... Each supplement is powerful, safe, and effective, and takes only 7 

days to work. 

* * * 

CLINICAL TRIALS & STUDIES 

... 

JOINT HEALTH SUPPORT 

A 2013 clinical trial with 87 participants (55+ years old) who had moderate to 

severe joint discomfort involved the administration of 150 mg Ostinol® alone, 

once daily for 12 weeks. ... The statistically significant onset of action occurred 

by day 7. ... By week twelve 90% of participants experienced positive results and 

improved quality of life. 

 View Study 

JOINT HEALTH SUPPORT 

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Case 1:20-cv-10249 Document 1 Filed 02/10/20 Page 22 of 33 

A 2015 clinical trial with 44 participants (55+ years) who had self-reported joint 

problems were enrolled in this trial. . . . The participants showed a 49% 

improvement in discomfort by week 4, 57% improvement in activity levels by 

week 4, and 80% improvement in affected joint strength after 4 weeks. 

View Study 

b. Ostinol consumer website excerpt 

(www.ostinol.com/pages/clinical-trial-studies captured on Oct. 23, 2019) 

CLINICAL TRIALS & STUDIES 

ZyCal Bioceuticals Healthcare Co. [video clip] 

[VOICEOVER] . . . Now ZyCal Bioceuticals ushers in a paradigm shift in 

molecular nutrition, bridging the gap between allopathic and natural medicine, 

manufacturing the only all natural ingredient proven to turn on stem cells and 

regenerate bone and cartilage tissue. ... 

And in 2006, specialists from surgery joined forces with leaders from J&J, P&G, 

and Unilever to create the first stem cell activating supplement and launched 

ZyCal Bioceuticals. This natural complex is the only substance, which provides 

the biochemical signal capable of turning on stem cells, transforming them into 

osteoblasts and chondrocytes, and producing new bone and cartilage tissue, a 

process known as osteoinduction. Today, ZyCal Bioceuticals presents this 

signaling ingredient to the natural medicine community as Cyplexinol®. ... 

Science, research, and quality are the hallmarks of ZyCal Bioceuticals as 

Cyplexinol is backed by multiple clinical trials. With each batch undergoing 

more than 30 rigorous tests by three independent laboratories. Guaranteeing 

results for you and your patients. 

ZyCal is proud to be at the forefront of stem cell technology and tissue 

regeneration. Helping lead a future where proven medical science found in nature 

impacts so many lives. ... OstinolTM, stem cell activating proteins, from surgery 

to supplement. 

... 

c. ZyCal consumer website excerpt 

(www.zycalbio.com captured on Dec. 28, 2017) 

OstinolTM Standard contains 150mg of Cyplexinol® .90 Standard – Nature’s 

BMP-Complex which activates stem cells to grow bone tissue so calcium and 

minerals can stick. 

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Case 1:20-cv-10249 Document 1 Filed 02/10/20 Page 23 of 33 

* * * 

OstinolTM Standard contains 350mg of Cyplexinol® .90 Standard – Nature’s 

BMP-Complex which activates stem cells to grow cartilage tissue so glucosamine 

and chondroitin can bind. 

* * * 

OstinolTM Standard contains 450mg of Cyplexinol® bio-active protein-complex, 

which is clinically proven to activate your body’s natural cells to grow healthy 

new bone and cartilage tissue. 

d. ZyCal 2016 consumer website excerpt 

(www.ostinol.com/take-charge/in-their-own-words 

captured from https://archive.org/web/ on Sept. 9, 2019) 

In Their Own Words 

... 

“Two weeks after starting the product, the arthritis in my feet was better and after 

three weeks, I could rotate my hands to play the piano again. Thank you for 

adding pain-free years to my life.” Nell T., Austin Texas 

... 

“In the 20 plus years that I have been working as a dietitian, I haven’t been as 

excited and eager to share a product with my patients as I am yours. The results 

have been remarkable and have enabled individuals to enjoy activities that they no 

longer thought were possible. ... Being able to prescribe these Bioceuticals to 

patients has brought them both increased mobility and hope for a healthier future. 

I encourage all healthcare practitioners to become knowledgeable about your 

product and how it can benefits their patients.” Katherine Spink [sic], RD, 

South Carolina 

“The supplements are wonderful. I was able to postpone knee replacement 

surgery thanks to improved mobility after two weeks... and then I cancelled the 

surgery altogether after two months of taking your product. I may not be able to 

run a foot race, but I am off the cane totally and very comfortable with no pain 

and I am getting around beautifully. ...” Sara Jo M. 

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Case 1:20-cv-10249 Document 1 Filed 02/10/20 Page 24 of 33 

e. 2016 ZyCal consumer website excerpt 

(www.ostinol.com/take-charge/two-problems-one-solution 

captured from https://archive.org/web/ on Sept. 9, 2019) 

 ... 

 Two Problems, One Solution 

Two health conditions, one breakthrough solution. That’s the promise OstinolTM 

makes to those struggling with poor bone and joint health. 

Unlike all other products on the market, OstinolTM is the first all-natural protein 

complex proven to grow new bone and cartilage tissue while helping fight 

inflammation. That’s right, OstinolTM doesn’t just fortify like traditional 

supplements do, such as calcium, glucosamine and chondroitin ... we stimulate 

the cells that grow new, healthy tissue, helping improving YOUR bone and joint 

health. 

As some people age, they lose the ability to produce enough of the vital, bioactive proteins found in OstinolTM, resulting in poor bone and joint health. These 

natural, key bio-active proteins are required, on a daily basis, to activate and 

transform key cells in our bones and joints so that new, healthy bone and cartilage 

tissue can be replenished. 

Just one OstinolTM capsule a day allows you to take charge of your body, 

recapturing that youthful feeling with healthier joints and stronger bones for a 

better quality of life. 

The natural, bio-active proteins in OstinolTM are so powerful that they have been 

clinically used for more than 25 years by orthopedic surgeons to safely grow bone 

tissue post-operative. Through a recent breakthough, these powerful proteins are 

now available in an oral formulation that healthcare professionals have used for 

nearly 10 years while addressing a wide array of patients with bone and joint 

problems. 

Today, these powerful bio-active proteins are available directly to you the 

consumers in three convenient strengths to address a variety of bone loss and joint 

health conditions. 

Two chronic problems. One breakthrough solution. That’s our OstinolTM promise 

to you. 

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Case 1:20-cv-10249 Document 1 Filed 02/10/20 Page 25 of 33 

30. Based on the facts and violations of law alleged in this Complaint, the FTC has 

reason to believe that Defendants are violating or are about to violate laws enforced by the 

Commission. The ZyCal Defendants continue to disseminate deceptive advertisements and 

promotional materials representing that Ostinol products grow bone or cartilage tissue and 

thereby substantially reduce joint pain and discomfort, and that these benefits are clinically 

proven. The EMR Defendants were engaged in their deceptive advertising of StimTein for more 

than eight years and only stopped their unlawful conduct months after they received a Civil 

Investigative Demand from the FTC. 

VIOLATIONS OF THE FTC ACT 

31. Section 5(a) of the FTC Act, 15 U.S.C. § 45(a), prohibits “unfair or deceptive acts 

or practices in or affecting commerce.” 

32. Misrepresentations or deceptive omissions of material fact constitute deceptive 

acts or practices prohibited by Section 5(a) of the FTC Act. 

33. Section 12 of the FTC Act, 15 U.S.C. § 52, prohibits the dissemination of any 

false advertisement in or affecting commerce for the purpose of inducing, or which is likely to 

induce, the purchase of food, drugs, devices, services, or cosmetics. For the purposes of Section 

12 of the FTC Act, 15 U.S.C. § 52, StimTein and Ostinol products are either a “food” or “drug” 

as defined in Sections 15(b) and (c) of the FTC Act, 15 U.S.C. §§ 55(b), (c). 

Count I 

 StimTein: False or Unsubstantiated Efficacy Claims by the EMR Defendants 

34. In numerous instances in connection with the advertising, marketing, promotion, 

offering for sale, or sale of StimTein, including through the means described in Paragraph 21, the 

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Case 1:20-cv-10249 Document 1 Filed 02/10/20 Page 26 of 33 

EMR Defendants have represented, directly or indirectly, expressly or by implication, that 

StimTein, taken as directed: 

A. Grows new bone, including in persons with osteoporosis and osteopenia; 

B. Grows new cartilage; and 

C. Provides substantial or long-lasting relief from joint pain and discomfort, 

including chronic or severe pain caused by arthritis, bursitis, and stenosis. 

35. The representations set forth in Paragraph 34 are false or misleading or were not 

substantiated at the time the representations were made. 

36. Therefore, the making of the representations as set forth in Paragraph 34 

constitutes a deceptive act or practice and the making of false advertisements in violation of 

Sections 5(a) and 12 of the FTC Act, 15 U.S.C. §§ 45(a), 52. 

Count II 

StimTein: False Establishment Claims by the EMR Defendants 

37. In numerous instances in connection with the advertising, marketing, promotion, 

offering for sale, or sale of StimTein, including through the means described in Paragraph 21, the 

EMR Defendants have represented, directly or indirectly, expressly or by implication, that 

StimTein, taken as directed, is: 

A. Clinically proven to grow new bone, including in persons with 

osteoporosis and osteopenia; 

B. Clinically proven to grow new cartilage; and 

 26 
Case 1:20-cv-10249 Document 1 Filed 02/10/20 Page 27 of 33 

C. Clinically proven to provide substantial or long-lasting relief from joint 

pain and discomfort, including chronic or severe pain caused by arthritis, 

bursitis, and stenosis. 

38. The representations set forth in Paragraph 37 are false. 

39. Therefore, the making of the representations as set forth in Paragraph 37 

constitutes a deceptive act or practice and the making of false advertisements in violation of 

Sections 5(a) and 12 of the FTC Act, 15 U.S.C. §§ 45(a), 52. 

Count III 

StimTein: Deceptive Endorsement Claim by the EMR Defendants 

40. In numerous instances in connection with the advertising, marketing, promotion, 

offering for sale, or sale of StimTein, including through the means described in Paragraph 21, the 

EMR Defendants have represented, directly or indirectly, expressly or by implication, that the 

endorsements of Kimberley Troop and Beverly Murray reflect the experiences and opinions of 

ordinary impartial users of StimTein. 

41. In fact, the endorsements of Kimberley Troop and Beverly Murray do not reflect 

the experiences and opinions of ordinary impartial users of StimTein because Kimberley Troop 

was an employee of Defendant EMR at the time her endorsement was made and Beverly Murray 

was the mother of a then-employee of Defendant EMR at the time her endorsement was made. 

Therefore, the representation set forth in Paragraph 40 is false or misleading in violation of 

Section 5(a) of the FTC Act, 15 U.S.C. § 45(a). 

 27 
Case 1:20-cv-10249 Document 1 Filed 02/10/20 Page 28 of 33 

Count IV 

StimTein: Deceptive Failure to Disclose Material Connections by the EMR Defendants 

42. In numerous instances in connection with the advertising, marketing, promotion, 

offering for sale, or sale of StimTein, including through the means described Paragraph 21, the 

EMR Defendants have represented, directly or indirectly, expressly or by implication, that the 

endorsements of Kimberley Troop and Beverly Murray reflect the experiences and opinions of 

users of StimTein. 

43. In numerous instances in which the EMR Defendants have made the 

representation set forth in Paragraph 42, the EMR Defendants have failed to disclose that 

Kimberley Troop was an employee of Defendant EMR at the time her endorsement was made 

and Beverly Murray was the mother of a then-employee of Defendant EMR at the time her 

endorsement was made. These facts would be material to consumers in evaluating the 

endorsements of StimTein in connection with a purchase or use decision. 

44. In light of the representations described in Paragraph 42, the EMR Defendants’ 

failure to disclose the material information as set forth in Paragraph 43 constitutes a deceptive 

act or practice in violation of Section 5(a) of the FTC Act, 15 U.S.C. § 45(a). 

Count V 

StimTein: ZyCal Defendants’ Provision of Means and Instrumentalities of Deception 

45. In numerous instances in connection with the advertising, marketing, promotion, 

offering for sale, or sale of StimTein, including through the means described in Paragraph 22 

above, the ZyCal Defendants have provided the EMR Defendants with advertising, marketing, 

 28 
Case 1:20-cv-10249 Document 1 Filed 02/10/20 Page 29 of 33 

and substantiation materials that contain false or misleading or unsubstantiated representations as 

set forth in Paragraphs 34 and 37 above. 

46. By furnishing the EMR Defendants with the materials described in Paragraph 45, 

the ZyCal Defendants have provided the means and instrumentalities for the commission of 

deceptive acts and practices, in violation of Sections 5 and 12 of the FTC Act, 15 U.S.C. §§ 

45(a) and 52. 

Count VI 

Ostinol Products: False or Unsubstantiated Efficacy Claims 

by the ZyCal Defendants 

47. In numerous instances in connection with the advertising, marketing, promotion, 

offering for sale, or sale of Ostinol products, including through the means described in 

Paragraphs 22, 27 and 29, the ZyCal Defendants represent, directly or indirectly, expressly or by 

implication, that Ostinol products, taken as directed: 

A. Grow new bone; 

B. Grow new cartilage; or 

C. Provide rapid, substantial, or long-lasting relief from joint pain and 

discomfort, including joint pain and discomfort associated with arthritis or 

other degenerative bone and joint conditions. 

48. The representations set forth in Paragraph 47 are false or misleading or were not 

substantiated at the time the representations were made. 

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Case 1:20-cv-10249 Document 1 Filed 02/10/20 Page 30 of 33 

49. Therefore, the making of the representations as set forth in Paragraph 47 

constitutes a deceptive act or practice and the making of false advertisements in violation of 

Sections 5(a) and 12 of the FTC Act, 15 U.S.C. §§ 45(a), 52. 

Count VII 

Ostinol Products: False Establishment Claims by the ZyCal Defendants 

50. In numerous instances in connection with the advertising, marketing, promotion, 

offering for sale, or sale of Ostinol products, including through the means described in 

Paragraphs 22, 27, and 29, the ZyCal Defendants represent, expressly or by implication, that 

Ostinol products, taken as directed, are: 

A. Clinically proven to grow new bone; 

B. Clinically proven to grow new cartilage; or 

C. Clinically proven to provide rapid, substantial, or long-lasting relief from 

joint pain and discomfort, including joint pain and discomfort associated with 

arthritis or other degenerative bone and joint conditions. 

51. The representations set forth in Paragraph 50 are false. 

52. Therefore, the making of the representations as set forth in Paragraph 50 

constitutes a deceptive act or practice and the making of false advertisements in violation of 

Sections 5(a) and 12 of the FTC Act, 15 U.S.C. §§ 45(a), 52. 

Count VIII 

Ostinol Products: Deceptive Endorsement Claim by the ZyCal Defendants 

53. In numerous instances in connection with the advertising, marketing, promotion, 

offering for sale, or sale of Ostinol products, including through the means described in Paragraph 

 30 
Case 1:20-cv-10249 Document 1 Filed 02/10/20 Page 31 of 33 

29, the ZyCal Defendants have represented, directly or indirectly, expressly or by implication, 

that the endorsement of registered dietitian Katherine Spinks reflects her impartial experience 

and opinion of Ostinol products. 

54. In fact, the endorsement of Katherine Spinks does not reflect her impartial 

experience and opinion of Ostinol products because Katherine Spinks was a sales representative 

of Defendant ZyCal at the time her endorsement was made. Therefore, the representation set 

forth in Paragraph 53 is false or misleading in violation of Section 5(a) of the FTC Act, 15 

U.S.C. § 45(a). 

Count IX 

Ostinol Products: Deceptive Failure to Disclose Material Connection 

by the ZyCal Defendants 

55. In numerous instances in connection with the advertising, marketing, promotion, 

offering for sale, or sale of Ostinol products, including through the means described Paragraph 

29, the ZyCal Defendants have represented, directly or indirectly, expressly or by implication, 

that the endorsement of Katherine Spinks reflects her experience and opinion of Ostinol 

products. 

56. In numerous instances in which the ZyCal Defendants have made the 

representation set forth in Paragraph 55, they have failed to disclose that Katherine Spinks was a 

sales representative of Defendant ZyCal at the time her endorsement was made. This fact would 

be material to consumers in evaluating her endorsement of Ostinol products in connection with a 

purchase or use decision. 

 31 
 

Case 1:20-cv-10249 Document 1 Filed 02/10/20 Page 32 of 33 

57. In light of the representations described in Paragraph 55, the ZyCal Defendants’ 

failure to disclose the material information as set forth in Paragraph 56 constitutes a deceptive 

act or practice in violation of Section 5(a) of the FTC Act, 15 U.S.C. § 45(a). 

CONSUMER INJURY 

58. Consumers are suffering, have suffered, and will continue to suffer substantial 

injury as a result of Defendants’ violations of the FTC Act. In addition, Defendants have been 

unjustly enriched as a result of their unlawful acts or practices. Absent injunctive relief by this 

Court, Defendants are likely to continue to injure consumers, reap unjust enrichment, and harm 

the public interest. 

THIS COURT’S POWER TO GRANT RELIEF 

59. Section 13(b) of the FTC Act, 15 U.S.C. § 53(b), empowers this Court to grant 

injunctive and such other relief as the Court may deem appropriate to halt and redress violations 

of any provision of law enforced by the FTC. The Court, in the exercise of its equitable 

jurisdiction, may award ancillary relief, including rescission or reformation of contracts, 

restitution, the refund of monies paid, and the disgorgement of ill-gotten monies, to prevent and 

remedy any violation of any provision of law enforced by the FTC. 

PRAYER FOR RELIEF 

Wherefore, Plaintiff FTC, pursuant to Section 13(b) of the FTC Act, 15 U.S.C. § 53(b), 

and the Court’s own equitable powers, requests that the Court: 

A. Enter a permanent injunction to prevent future violations of the FTC Act by 

Defendants; 

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B. Award such relief as the Court finds necessary to redress injury to consumers

resulting from Defendants’ violations of the FTC Act, including rescission or reformation of 

contracts, restitution, the refund of monies paid, and the disgorgement of ill-gotten monies; and 

C. Award Plaintiff the costs of bringing this action, as well as such other and

additional relief as the Court may determine to be just and proper.

Respectfully submitted, 

ALDEN F. ABBOTT

General Counsel 

Dated: February 10, 2020 /s/ Mary L. Johnson 

Mary Johnson, DC Bar No. 455345 

Mamie Kresses, DC Bar No. 413467 

Federal Trade Commission

600 Pennsylvania Avenue, NW, CC-10528 

Washington, DC 20580 

Tel.: 202-326-3115 (Johnson), x2070 (Kresses) 

Fax: 202-326-3259 

Email: mjohnson1@ftc.gov; mkresses@ftc.gov 

Attorneys for Plaintiff

FEDERAL TRADE COMMISSION 

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