Chiropractors all over the country are promoting new therapies that promise to good health back to the body’s essential systems—a promise reminiscent of past chiropractic claims that have often landed that profession in hot water legally.
Stem cell therapy is heavily regulated because it implicates many legal issues, from the ethical use of human tissue to concerns about patients’ health and safety. To offer it and stay out of the regulatory crosshairs, chiropractors need to be vigilant and fastidious in navigating stem cells’ murky legal waters.
Serious consequences can follow when chiropractors don’t adhere to the laws and regulations that govern their practice. These consequences can include:
- Receiving warning letters from the FDA.
- Paying fines to the FTC for false and misleading advertising.
- Facing disciplinary action from state boards.
To stay on the right side of these laws, it’s critically important to know what they’re supposed to do.
This article explores the FDA’s stance on stem cell therapy, details the types of common legal traps one can fall into when offering stem cell therapy, and presents a few best practices to follow to avoid those traps.
Understanding FDA Regulations: Are Stem Cell Therapies Approved?
The use of human cells, tissues, and cellular and tissue-based products (HCT/Ps) are regulated by the FDA under 21 CFR Part 1271. This includes stem cell therapies. The FDA states that only a limited category of stem cell treatments are currently approved—those atypically involving blood-forming stem cells for conditions like leukemia. The agency does not approve stem cell therapies marketed for use in treatment of pain, arthritis, or other orthopedic conditions.
The entire set of regulations from the FDA can be read at this web address: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-L/part-1271
Chiropractors are not allowed to promote therapies that have not been approved as safe or effective medical treatments. Even if the therapies in question were safe and effective, chiropractors wouldn’t be able to administer them, unless they were working directly with a medical doctor. And it turns out that the FDA has been pretty active in enforcing these rules. If you’re interested in the particulars of how they’re doing it, check out this link.
Chiropractors and Stem Cell Therapy: What’s Legal?
Chiropractic scope of practice laws in most states prevent chiropractors from conducting procedures like stem cell injections. They are typically deemed medical—not chiropractic—services.
Consider California, for example—state laws say that stem cell therapy is a medical procedure, so the people who make up California cannot have their spines realigned by someone who is not a physician. Texas has physicians who can perform the same function. Yet state regulations capping the kinds of procedures a chiropractor can perform mean that if you flood Texas with stem cells, your chiropractor there cannot use them. And if you’re in Florida? Sorry, but unless your licensed chiropractor is under the supervision of a licensed physician, you cannot have those cells in your spine.
To check the rules of your state, consult your state board: https://fclb.org/chiropractic-licensing-boards.php.
Nevertheless, chiropractors can have a role in this. They can refer patients to medical doctors licensed to provide these treatments. They can work directly with these medical professionals in a compliant business model. They can participate in a structure where a medical practice is supported by a Management Services Organization (MSO). And it’s absolutely necessary to have disclaimers in all marketing materials. These materials should clearly state when a therapy is not FDA-approved.
Advertising and the FTC: Avoiding False Claims
Chiropractors must also follow the Federal Trade Commission (FTC) guidelines, which require that any health-related claims be backed by solid scientific evidence. Stem cell therapy is not scientifically proven to cure or treat specific conditions, especially if it is suggested that the treatment is approved by the Food and Drug Administration (FDA). Consequently, making that claim is very likely to provoke enforcement action against chiropractors.
Don’t make statements such as these: “Stem cells regenerate cartilage and cure arthritis” or “FDA-approved therapy eliminates pain permanently.” These kinds of statements are not only misleading; they’re against the law.
To fully understand the FTC regulations governing healthcare marketing, see the guide at: https://www.ftc.gov/business-guidance/resources/health-products-compliance-guidance.
In one significant case from 2021, the FTC penalized a chiropractic clinic that promoted its stem cell procedures as being FDA-approved and effective for curing joint pain. The order accompanying the 2021 enforcement action explained that the stem cell clinic had made misleading and unsubstantiated claims that their procedures were not only safe but also effective—a claim that is backed by very questionable evidence, if any exists at all. Here are some details from the enforcement action.
Chiropractors must keep in line with legalities by using accurate disclaimers, avoiding any unsubstantiated medical claims, and steering clear of testimonials that might exaggerate treatment results.
FTC enforcement can be found here, in even more examples: https://www.ftc.gov/enforcement/cases-proceedings.
Building a Compliant Business Model
Chiropractors who desire involvement in regenerative medicine need to establish their business in a way that complies with state laws and rules governing the corporate practice of medicine (CPOM). They have several legal paths to take, two of which I will outline here. One option is to refer patients to a medical clinic that provides FDA-approved treatments. The other is to form a management services organization (MSO) in which the chiropractor handles business operations while licensed physicians do the treating.
This division is of central importance. For example, in a compliant MSO framework, a chiropractor can run a wellness center and supply nonsurgical, supportive services, while a physician (certified and operating under a separate legal mantle) can administer the risky, unproven stem cell treatments. This kind of separation of powers makes sure that laws against the corporate practice of medicine are not broken and that the tricky business of regenerative medicine—and the even trickier business of telling which cells are regenerative and which are plain old fat or bone—stays firmly in the hands of medical professionals.
Recent Enforcement Trends: What Chiropractors Should Know
In recent years, increased scrutiny has been applied to stem cell marketing by regulators. For example, the FDA has taken action against clinics that offer unapproved stem cell products. Meanwhile, the FTC remains busy pursuing deceptive advertising cases.
- Stem cell clinics in 2022. Several stem cell clinics were shut down for offering stem cell injections that had not yet been approved.
- Chiropractic clinics in 2021. The FTC fined some chiropractic clinics a few years ago for marketing their services with false claims.
- Stem cell treatments in 2020. A company marketed their products as cures for COVID-19, which led to a lawsuit. They were not FDA-approved treatments.
To monitor the enforcement actions taken by the FDA, go to: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters
To dodge legal trouble, chiropractors should not promote stem cell therapies as FDA-approved unless they really are. They should not inject anything unless state law clearly says they can. They should not get involved with regenerative medicine unless it’s through a properly structured MSO or with licensed medical professionals.
Chiropractors who promote or participate in stem cell therapy join a sphere where the rules are tight—and where the wrong moves can bring unwelcome consequences. We have seen that the FDA wants to regulate these kinds of therapies, even when the exact nature of the therapy might lead one to believe that the therapy could be considered safe and effective. We have seen that the FTC wants to regulate the kinds of advertising claims that get made about the therapy. And we have also seen that state regulatory agencies want to make sure that the people practicing in their states are following the law.
The lawyers at Cohen Healthcare Law Group can help you if you want direction on how to structure your practice legally, on how to advertise your services lawfully, or on how to work with licensed providers in a mutually beneficial way.
Contact us today to make an appointment for a consultation and take the necessary steps to ensure that your practice is on the correct legal path.
Contact our healthcare law and FDA attorneys for legal advice relevant to your healthcare venture.
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