The makers of ZyCal, a supplement that supposedly relieves joint pain by growing new bone have agreed to stop making that claim, as part of a settlement with the Federal Trade Commission.
The FTC today announced an order settling a 2020 federal lawsuit against ZyCal Bioceuticals Healthcare Company, Inc., 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.
“This settlement is an important reminder that health-related advertising claims require rigorous substantiation in the form of competent and reliable scientific evidence," said Samuel Levine, Director of the FTC’s Bureau of Consumer Protection.
Supreme Court blocked refunds to consumers
While ZyCal will be barred from continuing its health claims if the settlement is approved by a federal court, it won't have to make refunds to consumers thanks to a recent Supreme Court decision involving another company, AMG Capital Management.
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 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.