Booming IV hydration spa industry needs more oversight, researchers say

Intravenous hydration spas are a booming business, likely bringing in hundreds of millions per year, marketing saline drips, sometimes mixed with drugs, electrolytes, or vitamins, as cures for hangovers, colds, and other conditions. Yet despite safety concernsflagged by the Food and Drug Administration, the industry has little in the way of either federal or state-level regulation or oversight, according to a mixed-methods analysis of the industry published today in JAMA Internal Medicine. These facilities largely evade federal regulation under section 503A of the Food, Drug, and Cosmetic Act, which consigns most oversight to the states.

The researchers analyzed state laws and statements related to the IV hydration industry for all 50 states and the District of Columbia to determine whether states address four oversight aspects: governance, provider credentials, dispensing practices, and compounding practices. As of June 2024, no state, nor DC, had enacted any legislation regulating IV hydration spas specifically and only four states, Alabama, North Carolina, South Carolina, and Vermont, had issued policies or statements addressing all four oversight aspects.

The researchers also reviewed five IV hydration clinic websites for all 50 states and DC to ascertain product offerings, product claims, and spa staffing. They found that hydration therapy was most commonly combined with magnesium (used for muscle recovery; 57.3 percent of clinics), glutathione (used for immune support; 53.7 percent), and nicotinamide adenine dinucleotide (used to boost energy levels; 51 percent). Pharmaceuticals such as ketorolac, a pain-reliever (25.5 percent), and the anti-nausea medicine ondansetron (26.3 percent) were administered with hydration therapy less frequently. Besides hydration therapy, IV spas offered vitamin injections (63.5 percent) and GLP-1 weight-loss drugs (27.5 percent).

Researchers also used secret shoppers to telephone two facilities per state, reaching 85, which were able to answer all questions in the shoppers' scripts. Callers were transferred to a registered nurse during 45 calls (51.7 percent) or a licensed health professional during seven calls (8 percent). Twenty-four facilities (27.6 percent) explained that a consultation with a medical professional was required prior to the provision of therapy, while 52 facilities (59.6 percent) described necessary waiver or consent forms, or asked about the prospective patient's medical history. Seventy-five facilities (86.2 percent) suggested specific therapies to combat the headache and cold symptoms volunteered by the shoppers, with 33 spas (38.4 percent) claiming the therapy would help with the described symptoms. When asked about risks of IV hydration, 21 facilities (24.4 percent) disclosed risks such as bruising, infection, or bleeding at the site.

The FDA issued a warningin 2021 following a report of septic shock after a patient received IV hydration at a clinic and physicians have voiced concerns that the hydration spa industry may have contributed to a shortage of IV fluids in 2024.

"America's strip malls and Main Streets are filling up with IV hydration spas, yet there's little evidence of health benefit from the practice, little regulation at the state and federal levels, and unnecessary risk," said Dr. Peter G. Lurie, president of the Center for Science in the Public Interest and a co-author of the study. "Clearly, the existing patchwork of state-level policies is insufficient protection for most consumers."

"IV hydration spas might be diverting some patients from getting the real healthcare they need, while diverting valuable IV fluids away from hospitals that need them," said Dr. Joseph S. Ross, co-author of the paper and professor at Yale University School of Medicine and Yale's Collaboration for Regulatory Rigor, Integrity, and Transparency. "Given their rising use, more evidence is needed to understand the benefits of these hydration therapies, particularly given their costs and potential risks for consumers."

Dr. Annisha Sivakumar, Dr. Howard P. Forman, and Isabel Wang, also from Yale University School of Medicine are co-authors with Lurie and Ross on the paper published today.

Since the acceptance of the JAMA Internal Medicine paper, one state, Texas, passed a lawthat elective IV therapy be only administered by physicians, physician assistants, advanced practice registered nurses, or registered nurses. The law, HB 3749, was passed after a Texas woman, Jennifer Cleveland, died after receiving an IV infusion from an unlicensed and improperly supervised provider. That law went into effect on September 1.

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Tags

• Food and Drug Administration
• Hydration

Topics

• CSPI
• Government Accountability
• Industry Accountability

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