Following the December reveal of its Health Products Compliance Guidance, the Federal Trade Commission announced an order settling a 2020 lawsuit against ZyCal Bioceuticals Healthcare Company, Inc. and its president which charged them with deceptively claiming that their products grow bone and cartilage and relieve joint pain.

The FTC’s complaint alleged that the ZyCal defendants marketed a line of joint pain relief products containing an active ingredient which they touted as a stem cell activator that could grow bone and cartilage and thereby provide substantial and long-lasting relief from pain associated with joint ailments, including arthritis.  According to the FTC, the defendants also claimed that these health benefits were clinically or scientifically proven, and further, supplied another company with the means to deceptively market a copycat product.

Among other things, the settlement bars the ZyCal defendants from making health benefit claims—including bone and cartilage growth and joint pain relief claims—for any food, drug or dietary supplement unless they are not misleading and are substantiated by competent and reliable scientific evidence, including randomized controlled clinical trials.  The order also prohibits them from misrepresenting that such 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 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.  “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.”

This action underscores the recent Health Products Compliance Guidance issued by the FTC in December, which provides updated guidance from FTC staff on how to ensure that health-related advertising claims are truthful, not misleading and adequately supported.