Advertising regenerative medicine and stem cell treatments: what the FDA, FTC and Google say

Regenerative treatments are often sold to practices as an add-on service: a supplier, a training company or a marketing package promises a new cash-pay line with seminars, ads and patient handouts ready to use. Chiropractic, orthopedic, pain, integrative and aesthetic practices all get these offers. Before any of that material goes public, it helps to know how federal regulators and Google treat the claims involved, because this is one of the few areas of healthcare marketing where the product, the advertising and the advertiser have all been the subject of recent federal enforcement and court rulings.

This guide covers what FDA says about regenerative products, what two federal court decisions settled, what the FTC has done about stem cell marketing, what Google Ads allows, and what a practice can say honestly. Our guide to orthopedic and sports medicine practice marketing has a shorter section on these treatments; this one goes further. Platelet-rich plasma has its own rules; see our guide to PRP injection marketing. Stem cell offers aimed at people with MS are covered in MS center marketing.

What FDA says about regenerative products

FDA regulates human cells, tissues and cellular and tissue-based products, which it abbreviates as HCT/Ps. Some are regulated only under section 361 of the Public Health Service Act and 21 CFR Part 1271; 21 CFR 1271.10 sets the criteria, such as minimal manipulation and homologous use. Products that do not meet those criteria are regulated as drugs or biological products and need FDA approval before they can be marketed.

FDA’s consumer page on regenerative medicine therapies is direct about the market. It says:

• There continues to be broad marketing of unapproved products considered regenerative medicine therapies, and these products require FDA licensure or approval to be marketed to consumers.
• The unapproved products include stem cells, stromal vascular fraction (fat-derived cells), umbilical cord blood and cord blood stem cells, amniotic fluid, Wharton’s jelly, ortho-biologics and exosomes, whether recovered from the patient’s own body or another person’s.
• Regenerative medicine therapies have not been approved to treat a long list of conditions, including any orthopedic condition, chronic pain, fatigue, neurological disorders, and cardiovascular or lung diseases.
• Including a product in the clinicaltrials.gov database, or registering a firm and listing its product with FDA, does not mean the product is legally marketed.
• As of that page’s last update, the only FDA-approved stem cell products were blood-forming stem cells derived from umbilical cord blood, approved for disorders affecting blood production and not for other uses. FDA keeps a current list of approved cellular and gene therapy products.

FDA also ended a period of enforcement discretion. Its question and answer page says that after May 31, 2021, FDA no longer intends to exercise enforcement discretion with respect to the investigational new drug and premarket approval requirements for these products. It says a product that requires but lacks premarket approval may not be lawfully marketed, including when a sponsor has an IND or is pursuing one, and that anyone who keeps marketing such a product does so at their own risk.

For marketing, the point is simple. Phrases such as “FDA registered”, “FDA compliant lab” or “listed on clinicaltrials.gov” can create an impression of approval that FDA itself says is often false. If a product is not approved, the ad should not suggest otherwise.

What the courts have settled

Some clinics argued that treatments using a patient’s own cells, removed and returned the same day, fall outside FDA regulation under the same surgical procedure exception in 21 CFR 1271.15(b). That exception covers an establishment that removes HCT/Ps from an individual and implants such HCT/Ps into the same individual during the same surgical procedure.

In an opinion filed September 27, 2024 (No. 22-56014), the Ninth Circuit reversed a district court judgment in favor of doctors who create and administer a stem cell mixture called stromal vascular fraction. According to the court staff summary, the panel held that the stromal vascular fraction at issue is a drug under the Food, Drug, and Cosmetic Act, and that the same surgical procedure exception applies only if the removed HCT/P and the implanted HCT/P are the same. Because the procedure removed fat tissue but implanted a cell mixture made from it, it was not exempt. The Supreme Court denied review on October 14, 2025 (No. 24-1189).

The practical lesson for marketing teams: “it is your own cells” or “same-day procedure” is not a regulatory status, and it should not be used in ads to imply that a treatment is exempt from FDA oversight.

What the FTC has done about stem cell marketing

FDA looks at the product. The FTC looks at the advertising. Three FTC announcements show how it treats regenerative claims.

1. October 18, 2018. The FTC settled charges against a physician and two companies over advertising that amniotic stem cell therapy could treat serious diseases, including Parkinson’s disease, autism, multiple sclerosis, macular degeneration and osteoarthritis. The order prohibits claims that any product or service cures, mitigates or treats any disease, or is comparable to or better than conventional treatment, unless the claims are true and supported by competent and reliable scientific evidence. It imposed a $3.31 million judgment, partially suspended after payment of $525,000, and required the defendants to notify current and former patients of the order within 30 days.
2. August 17, 2021. The FTC and the Georgia Attorney General sued the co-founders of a company that trained chiropractors and other practitioners to add stem cell therapy to their practices. The complaint alleged the company taught client clinics to recruit patients through advertising, free educational seminars and consultations, and gave them a library of sample advertisements. It alleged false or unsubstantiated claims that stem cell therapy treats arthritis, joint pain and other orthopedic conditions and is comparable or superior to surgery, steroid injections and painkillers. The agencies said seminars targeted seniors and retirement communities.
3. January 8, 2025. The FTC announced the outcome. In March 2024 the federal court granted summary judgment for the FTC and Georgia on all counts, finding the defendants created and published false and misleading ads about the efficacy and approval of stem cell injections. Orders issued December 26, 2024 permanently ban the defendants from marketing regenerative medicine treatments, prohibit them from providing others with the means of making false or misleading statements about these treatments, and require payment of $5,155,146 in refunds and civil penalties under Georgia law.

Two points matter for any practice that is offered a turnkey program. First, the FTC pursued the company that supplied the ads and training, not only a clinic, so templated claims do not become safe because a vendor wrote them. Second, once a practice publishes a vendor’s ad, the claims in it are the practice’s claims, and the practice needs its own evidence for them.

The evidence standard is high. The FTC Health Products Compliance Guidance says that, as a general matter, substantiation of health-related benefits will need to be randomized, controlled human clinical testing. And under 16 CFR 255.2(b), a patient story that conveys a particular result implies that result is what people can generally expect, unless the ad clearly and conspicuously discloses the generally expected performance. Patient stories about pain relief after a regenerative injection carry that implication. Our guide to patient testimonials and before-and-after photos covers the rest of the testimonial rules.

What Google Ads allows

Google’s policy on speculative and experimental medical treatment, cell therapies, and gene therapies does not allow the promotion of speculative or experimental medical treatments, or the promotion of cell or gene therapies. Its examples of cell or gene therapies include stem cell therapy, cellular (non-stem) therapy, gene therapy and similar forms of regenerative medicine, and platelet rich plasma (PRP) therapies.

There are two exceptions. In the United States, Google allows the promotion of FDA licensed or approved cell or gene therapies by the entities that hold the license or approval, after applying to Google. And Google allows ads for cell or gene therapies that are exclusively educational or informational, regardless of approval status; its examples are academic papers and tickets for medical conferences. A practice ad inviting patients to a free seminar about a treatment the practice sells is promotion, not the kind of educational material those examples describe.

Google does not issue an immediate suspension for this policy; it says it will warn at least 7 days before suspending an account. Repeated disapprovals still cost time, and the same landing page content can cause problems with other policies. Our Google Ads for practices service builds campaigns around the consultation and the conditions you evaluate rather than around products the policy does not allow.

What a practice can say

None of this stops a practice from talking about its care honestly. Some practices take part in FDA-regulated clinical trials; others offer approved products or decide not to offer these treatments at all. Whatever your situation, these principles keep the website and ads accurate:

• State the regulatory status plainly. If a product is not FDA approved for the use you describe, do not imply that it is. Avoid “FDA registered” or similar wording as a selling point.
• Describe, do not promise. Explain what the procedure involves, what it costs, what risks FDA has reported and what is not known. Leave out cure, repair, regrow, reverse and avoid-surgery claims unless you have the approval and the evidence.
• No comparisons to surgery or other treatments. Both FTC cases above involved claims that stem cell therapy was comparable or superior to conventional treatment.
• No results testimonials. A story about pain relief implies typical results under 16 CFR 255.2(b).
• Be careful with seminars. A free seminar is still advertising. Everything said there and in the invitation needs the same evidence as a printed ad.
• Read vendor materials as your own. Ask the supplier or training company for the evidence behind every claim in the kit before you publish any of it.

Illustration: a practice that offers a joint injection procedure could replace “Regrow cartilage and avoid knee replacement with your own stem cells” with “Learn what this procedure involves, its cost, its FDA status and the risks FDA has reported, and talk with a physician about whether it is appropriate for you, alongside other options.” The second version can be supported; the first cannot.

Approved blood and bone marrow transplants and gene therapies for blood disorders are a different subject from unapproved stem cell offers. Our guide to hematology practice marketing covers how to word them.

A review list before you publish

Illustration: an integrative clinic receives a marketing kit from a product supplier with seminar slides, newspaper ads and a landing page. The owner could review it this way, with counsel.

1. Identify every product named or implied. Ask the supplier for its FDA status in writing, and check FDA’s list of approved cellular and gene therapy products.
2. Mark every health claim. Treats, heals, regenerates, repairs, reduces pain, avoids surgery. For each one, ask for the randomized, controlled human clinical evidence. If none exists, cut the claim.
3. Remove approval signals. FDA registered, FDA compliant, clinicaltrials.gov listing, same-day exemption language.
4. Remove comparisons and testimonials. Better than surgery, safer than steroids, and patient stories about outcomes.
5. Check Google Ads. Do not run ads that promote cell therapies or PRP unless you hold an FDA license or approval and Google has approved the exception.
6. Review seminar invitations and scripts. Apply the same evidence test to what will be said in the room.
7. Keep a file. Save the evidence, the supplier’s written statements and the final approved copy.

How we handle this

We help practices market the consultation, the conditions they evaluate and the care they provide. When a practice offers regenerative treatments, we write accurate, descriptive pages and flag product, approval and outcome claims for the practice and its counsel before anything is published, and we do not build Google Ads campaigns that promote therapies Google’s policy does not allow. Our work is built with HIPAA in mind, and we confirm in writing what a BAA covers before any patient information flows through a tool; if it is not covered, we do not route patient information through it. See our integrative medicine marketing service and our guide to integrative medicine marketing claims.

Sources

• FDA: Important Patient and Consumer Information About Regenerative Medicine Therapies
• FDA: Questions and Answers Regarding the End of the Compliance and Enforcement Policy for Certain HCT/Ps
• FDA: Approved Cellular and Gene Therapy Products
• eCFR: 21 CFR 1271.10, criteria for HCT/Ps regulated solely under section 361 of the PHS Act
• eCFR: 21 CFR 1271.15, exceptions (including the same surgical procedure exception)
• U.S. Court of Appeals for the Ninth Circuit: opinion in No. 22-56014 (filed September 27, 2024)
• Supreme Court of the United States: docket No. 24-1189 (petition denied October 14, 2025)
• FTC press release, October 18, 2018: deceptive health claims by a stem cell therapy clinic
• FTC press release, August 17, 2021: FTC and Georgia Attorney General complaint over stem cell joint pain marketing
• FTC press release, January 8, 2025: court orders ban defendants from marketing stem cell treatments
• FTC: Health Products Compliance Guidance (December 2022)
• eCFR: 16 CFR Part 255, Endorsement Guides (255.2(b))
• Google Ads policy: Speculative and experimental medical treatment, cell therapies, and gene therapies

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