Attorney General Chris Carr and the Federal Trade Commission (FTC) filed a joint enforcement action against Superior Healthcare, LLC, Regenerative Medicine Institute of America, LLC d/b/a Stem Cell Institute of America, LLC, Physicians Business Solutions, LLC, Steven Peyroux, and Brent Detelich for allegedly violating the Georgia Fair Business Practices Act (FBPA) and the FTC Act by making false and misleading claims about the regenerative medicine products they offered to consumers in Georgia.
“At best, the use of unproven products or therapies can cost consumers thousands of dollars without affording them any results,” said Attorney General Chris Carr. “At worst, it can be harmful to their health. Our office will continue to hold accountable businesses that make unsubstantiated claims and violate the law – especially those that target our older or at-risk adults.”
The Complaint alleges that the Defendants, operating as a common enterprise, aggressively marketed, offered, and sold expensive regenerative medicine products to consumers, most of whom were older adults. Through various channels, including seminars, social media platforms, an infomercial, websites, YouTube channels, email blasts, and print media, Defendants advertised to the public and to healthcare practitioners that these products cure, treat, or mitigate a variety of orthopedic diseases and health conditions, and that they are comparable or superior to conventional treatments for these diseases and health conditions. The Complaint alleges that these claims are false and/or misleading because they are not substantiated by competent and reliable scientific evidence. In fact, not only did the Defendants allegedly fail to conduct any randomized clinical testing of the treatments they advertise demonstrating that they are effective in curing, treating, or mitigating any orthopedic condition, disease, or health condition, there are no studies in the scientific literature that support their advertised claims.
Defendants Physicians Business Solutions, LLC (PBS) and Stem Cell Institute of America, LLC (SCIA) generated millions of dollars in revenue by training and advising chiropractors and other healthcare practitioners on how to add stem cell therapy to their practices. Superior Healthcare, LLC (SHC) generated revenues by selling the products directly to consumers and by contracting with third-party clinics throughout Georgia to administer injections in exchange for a fee. From 2017 until 2019, SHC sold regenerative medicine products to no less than 444 consumers, 70 percent of whom were over the age of 59. According to the complaint, the regenerative medicine products cost approximately $5,000 per joint injection, with patients often receiving more than one injection.
The Defendants allegedly engaged in their unlawful acts and practices repeatedly over a period of at least five years and continued to do so despite knowledge that the U.S. Food and Drug Administration (FDA) had issued a public warning about stem cell therapy in 2012, as well as a series of guidance documents and warning letters in 2017 stating that stem cell therapy is a drug subject to the agency’s full drug approval requirements.
The Georgia Attorney General’s Office is seeking injunctive relief, consumer restitution, disgorgement of ill-gotten gains, and civil penalties of up to $5,000 per violation of the FBPA and up to $10,000 per FBPA violation committed against elderly and/or disabled consumers.
Warnings and Tips for Consumers
The U.S. Food and Drug Administration (FDA) regulates regenerative medicine products. There continues to be broad marketing of unapproved products considered regenerative medicine therapies that are intended for the treatment or cure of a wide range of diseases or medical conditions. These products require FDA licensure/approval to be marketed to consumers. Before approval, these products require FDA oversight in a clinical trial. These unapproved products, whether recovered from your own body or another person’s body, include stem cells, stromal vascular fraction (fat-derived cells), umbilical cord blood and/or cord blood stem cells, amniotic fluid, Wharton’s jelly, ortho-biologics, and exosomes.
If you are being offered any of these products outside of a clinical trial for which the FDA has oversight, please contact the FDA at firstname.lastname@example.org. Additionally, contact the FDA if you are considering treatment with any of these products and have questions, or if you have been treated with these products and wish to report any adverse effects or file a complaint.