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The �鶹��ý Trade Commission today announced an order settling a 2020 federal lawsuit against defendants ZyCal Bioceuticals Healthcare Company, Inc. (ZyCal) and its president James J. Scaffidi, which charged them with deceptively claiming that their products grow bone and cartilage and relieve joint pain.

The order bars the ZyCal defendants from making these claims unless supported by randomized controlled clinical trials. It also bars them from providing anyone else with the means to make false or misleading claims. The FTC filed the order in the U.S. District Court for the District of Massachusetts, and it must be approved and signed by a judge to become final.

“The Commission sued these defendants to halt bogus claims that their products grow bone and cartilage and relieve joint pain,” said Samuel Levine, Director of the FTC’s Bureau of Consumer Protection. “This settlement is an important reminder that health-related advertising claims require rigorous substantiation in the form of competent and reliable scientific evidence. Unfortunately, the Supreme Court decision in AMG Capital Management prevented us from obtaining refunds for consumers in this case. The Commission has urged Congress to enact legislation to restore the agency’s ability to obtain critical relief for consumers through federal court actions.”

The FTC’s February 2020 complaint alleged the ZyCal defendants marketed oral products containing the ingredient Cyplexinol, which they touted was a stem cell activator that could grow bone and cartilage in users and relieve joint pain, including for people with osteoporosis and osteoarthritis. They also claimed that these health benefits were clinically or scientifically proven. The ZyCal defendants marketed Cyplexinol products directly to consumers under the brand name Ostinol, and indirectly through health practitioners and third-party distributors.

The complaint further alleged that the ZyCal defendants supplied a company, Excellent Marketing Results, Inc. (EMR), with the means and instrumentalities to deceptively market a copycat Cyplexinol product called StimTein. While the Commission announced a settlement with the EMR defendants when the complaint was announced in early 2020, litigation continued against the ZyCal defendants. The consent order announced today resolves the agency’s complaint against ZyCal and Scaffidi.

The settlement bars the ZyCal defendants from making bone and cartilage growth and joint pain claims for any food, drug, or dietary supplement, unless they are not misleading and are substantiated by competent and reliable scientific evidence, including randomized clinical trials. It also prohibits them from making other health benefit claims for the same products unless they are supported by reliable scientific evidence.

Finally, the order prohibits the defendants from misrepresenting that bone and cartilage growth claims, pain claims, and related claims are clinically or scientifically proven; from misrepresenting the existence, contents, or results of any scientific test or study; and from providing anyone else with the means to make false or misleading statements. ZyCal also must send a notice of the settlement with the FTC to a number of consumers, health practitioners, and other purchasers who bought Cyplexinol products from the company on or after January 1, 2018.

The Commission vote approving the stipulated final order was 4-0. The staff attorney handling the case is Mary L. Johnson in the FTC’s Bureau of Consumer Protection.

NOTE: Stipulated final orders or injunctions have the force of law when approved and signed by the District Court judge.