In early 2024, a member of Howard Forman’s family visited an intravenous (IV) hydration spa, a kind of wellness clinic that administers treatment for a variety of conditions — from hangovers to fatigue — by injecting vitamins, minerals, and other chemicals directly into a customer’s bloodstream. Before that he’d never paid much attention to these clinics, although they have emerged into a booming industry, bringing in millions of dollars in the U.S. annually.
This prompted Forman, a professor at Yale School of Medicine (YSM), to begin researching these IV hydration spas — and what he discovered concerned him. While the spas market their treatments as cures for a variety of conditions, Forman says, there’s limited evidence to back up these claims; in fact, they often operate with almost no oversight.
In a new Yale study, Forman and a team of Yale researchers report that state-level policies governing IV hydration spas and facility practices vary widely, suggesting more stringent oversight may be necessary to protect public health.
“IV hydration spas are generally lightly or unregulated with regard to offerings and oversight,” said Forman, professor of radiology and biomedical imaging at YSM and of public health (health policy) at Yale School of Public Health. “They provide many therapies that are unproven — or, frankly, even risky in certain circumstances.
“Consumers should be very wary of paying often high fees for services that might appear to be clinically appropriate but generally are not offered by trained clinicians or even overseen by them,” added Forman, who also has affiliations with Yale School of Management and the Department of Economics in Yale’s Faculty of Arts and Sciences.
The study appears in the journal JAMA Internal Medicine.
The number of IV hydration spas has grown over the past decade. In 2022, the larger medical spa industry — which includes equipment such as infusion pumps and IV catheters — brought in about $15 billion in revenue, with about 10% generated from IV hydration spas themselves. These spas are defined as any commercial facility that offers IV infusion therapies to the public, including hydration solutions alone or combined with electrolytes; vitamins; compounded drugs like GLP-1s; and other supplemental amino acids and minerals.
While IV hydration spas market these treatments as cures for dehydration, hangovers, colds, and other conditions, there is little evidence that these therapies benefit consumers, coupled with rising concerns about their safety following reports of infections and contaminated products. Despite some high-profile incidents that have raised concerns about safety and oversight, there has been limited scrutiny of the IV hydration spa industry.
In medicine, we often focus on improving care within the health care system… Yet little academic attention has been given to industries operating adjacent to this system.
“In medicine, we often focus on improving care within the health care system — examining stakeholders like insurers, hospitals, and pharmaceutical companies,” said Anishaa Sivakumar, the first author of the study, who is now a resident at Massachusetts General Hospital but conducted this research while at Yale, where she earned her M.D. and M.B.A. this year. “Yet little academic attention has been given to industries operating adjacent to this system.”
She added: “Investigating this industry means that we can gain insight into the regulatory needs of the industry, which is sorely needed. It also means we can better understand why these spas burgeoned in the first place and ways that our traditional health care system might need to improve to fit the needs of our patients.”
For the new study, the researchers investigated state polices and facility practices at IV hydration spas across the country. First, they conducted a methodical review of regulatory policies related to IV hydration spas in all 50 states and Washington, D.C.. Second, they reviewed the websites for five different spas in every state and in D.C. to see what businesses exist, what they offer, what claims they make, and how they’re staffed. Third, they developed a “secret shopper” survey to query two randomly selected spas in each state and D.C., totaling 102 spas across the country.
“The IV hydration spa industry falls into a grey zone with respect to oversight,” said Joseph Ross, professor of medicine (general medicine) and of public health (health policy and management) at Yale and senior author of the study. “The [U.S. Food and Drug Administration] does not directly regulate these facilities but considers them similar to compounding pharmacies, so it only gets involved when there are serious public health safety concerns. That leaves oversight to the states, who are likely to have fewer resources and few formal rules or regulations.”
For the “secret shopper” survey, an investigator used a standardized script in which they posed as an interested consumer asking for information of IV hydration therapy services; in this case, they specifically sought information about treatment for headache and cold symptoms. The script included questions on the availability of licensed health professionals, product offerings, pricing, insurance, potential risks, and more.
People are shelling out thousands of dollars, in some cases, for unproven, sometimes risky, interventions that often lack true informed consent and often lack involvement of any trained clinician.
Through this three-part study, the researchers found enormous variation in the regulatory oversight in each state. For example, as of June 2024, they found that no U.S. state had enacted legislation specifically to regulate IV hydration spas, with only four states having guidance addressing all four spa oversight categories: governance, prescriber credentials, dispensing practices, and compounding practices.
The researchers also found huge variation in IV hydration spas offerings and oversight, as well as a general lack of clinician involvement and a very laissez faire attitude to the delivery of clinical medicine in a non-clinical environment, including many claims that were not backed by evidence.
The researchers said they hope that future investigations will raise more specific questions about different offerings.
“People are shelling out thousands of dollars, in some cases, for unproven, sometimes risky, interventions that often lack true informed consent and often lack involvement of any trained clinician,” Forman said. “Some of the products are unregulated by the FDA, even as they are perceived by most members of the lay public as actual drugs. I think consumers should ask a lot of questions and should be very cautious.”
Other authors include Isabel Wang, an M.D. candidate at Yale School of Medicine.
