Florida is the latest state to sidestep the authority of the Food and Drug Administration by allowing patients to access certain stem-cell treatments that have not been rigorously evaluated and approved.

Under a new law that went into effect July 1, doctors in Florida can administer unapproved stem-cell therapies for wound care, pain management, or orthopedic purposes. The law comes amid growing support for medical freedom in the United States, an idea espoused by Health and Human Services secretary Robert F. Kennedy Jr., and it could prompt other states to follow. Supporters say the law helps protect patients, while critics argue it opens the door for physical and financial harm.

“There is interest in various states in enabling the sale of stem-cell products that have not been approved by the FDA,” says Leigh Turner, a bioethicist and professor of health, society, and behavior at the University of California, Irvine, who has been tracking the stem-cell industry. “I think we’re going to see more of that.”

Last year, Utah passed a law allowing health care providers in the state to offer placental stem-cell therapies, which are often marketed for treating wounds and injuries, so long as they clearly note their unapproved status and get written informed consent from patients before administering them. And a 2017 law in Texas permits clinics and companies to offer unapproved stem-cell therapies to people with chronic or terminal diseases when conventional treatment options have been exhausted.

Stem cells have been of immense interest for the past 30 years because of their ability to produce copies of themselves indefinitely and form more specialized cells in the body. Stem cells are central to human development during pregnancy and can be found in embryos, placental tissue, and umbilical cord blood, and are also produced naturally by adults, particularly in bone marrow, to allow the body to repair itself. They have been studied as treatments for a wide variety of ailments over the years, including arthritis, diabetes, heart failure, multiple sclerosis, and Parkinson’s disease.

But despite decades of research, stem cells have not produced the kinds of cures that scientists had hoped for. The only products the FDA has approved are blood-forming stem cells sourced from umbilical cord blood. They are used in transplants to treat patients with certain cancers and blood and autoimmune disorders who have had their own blood-forming stem cells destroyed by high doses of chemotherapy or radiation.

The Florida law prohibits stem-cell therapies derived from embryos and classifies the use of embryonic stem cells as a third-degree felony. It also bans the use of cells taken from umbilical cords following abortions, although it allows cells to be sourced from discarded umbilical cords and placentas after live births.

The FDA regulates stem cell therapies as drugs unless they are “minimally manipulated,” meaning that any processing of the cells does not significantly alter their original relevant biological characteristics. This loophole has allowed clinics and companies to circumvent the years-long drug approval process and offer treatments of stem cells that have not been thoroughly tested for safety and efficacy. The Florida law does not specify whether stem cells offered in the state must be minimally manipulated, presumably allowing cells that are manipulated beyond that standard.

Stem cells are already big business in Florida. In a 2021 study, Turner identified nearly 2,800 clinics in the US selling purported stem-cell treatments, a significant increase from the 570 clinics that he and a coauthor recorded when conducting a study five years before. In the more recent study, California, Texas, and Florida led the nation in terms of numbers of clinics.

In recent years, the FDA has warned consumers about the risks of unapproved stem-cell products and issued warning letters to businesses marketing them. In 2018, President Donald Trump’s then FDA head Scott Gottlieb sought to permanently shut down two stem-cell clinics, one of them in Florida, citing “serious and permanent harm” they caused. At the Florida clinic, three patients were blinded after receiving eye injections of stem cells for age-related macular degeneration. The clinic charged $5,000 for the injections and sourced the stem cells from the patients’ own fat tissue.

However, Trump’s new health leadership is expected to take a different approach from what was seen during the president’s first term. Secretary Kennedy has been a proponent of stem cells and said on a recent podcast that he received an unproven stem-cell therapy at a clinic in Antigua for his vocal condition. He has also promised to end what he sees as the FDA’s suppression of stem-cell therapies. With Kennedy overseeing the FDA, the new Florida law will likely go unchallenged for the foreseeable future.

Sean Morrison, a stem-cell biologist and chair of the International Society for Stem Cell Research’s public policy committee, says there is “no chance” the Florida law will help people.

“The premise of the law is that there are stem-cell therapies that are effective for the treatment of things like orthopedic conditions that have not been approved by the FDA. That’s not true. What we do know is that there are hundreds of companies in the United States, including Florida, that are selling fake stem-cell therapies,” he says, referring to products that are likely to have little or no effect on the condition they’re marketed to treat.

At worst, these products can cause serious complications. Morrison points to the case of Liveyon, a company that marketed its cord-blood-derived stem cells for autoimmune disorders, Alzheimer’s, Parkinson’s, and lung and heart diseases. In 2018, the FDA received several reports of patients needing hospitalization for bacterial infections after receiving stem-cell injections manufactured by an associated company and distributed by Liveyon. The Department of Justice brought a lawsuit against Liveyon’s founder and CEO, John Kosolcharoen, claiming the company’s advertising for a series of products contained multiple false and misleading statements. Kosolcharoen pleaded guilty to introducing an unapproved new drug into interstate commerce with the intent to defraud and mislead.

Supporters of the Florida law, however, say it will establish guardrails for the industry and make stem-cell therapies safer for patients. “Florida law will now require that these procedures be delivered with transparency, scientific rigor, and patient protections with informed consent through their physician,” Florida state representative James Buchanan, who sponsored the bill, said in a June 26 Facebook post. “This legislation will positively impact the medical and tourism industries as this State becomes a hub for regenerative medicine,” he said.

The law also sets certain standards for stem-cell manufacturing. Stem cells used in these therapies must be retrieved, manufactured, and stored in a facility that is registered and regulated by the FDA. Facilities must also comply with the FDA’s so-called good manufacturing practices, which ensures that drugs are consistently produced with certain quality standards. In addition, physicians must obtain patient informed consent prior to administering treatments authorized under the Florida law.

“This law is providing responsible, domestic access,” says George Shapiro, chief medical officer at ZEO ScientifiX, a South Florida company that supplies ​​stem cells. “There are a lot of patients who currently travel outside the US to get this for pain, for inflammation, and for wound care. Now, they’re able to get it here.”

Turner says these measures could potentially root out some of the worst actors in the space, depending on how strictly Florida chooses to enforce the law and whether it will levy any disciplinary action or criminal penalties against businesses that don’t comply with the law. But he still worries about the risks that unproven stem cells pose to patients.

“There are a lot of problems that can flow from a marketplace like this and from legislation that essentially operates as an enabler,” he says. “People do get harmed. People do get scammed.”