Lack of regulation in growing IV therapy, hydration industry potentially puts patients at risk
Lack of oversight has boards, industry groups nationwide taking action to set best practices and prevent tragedies
(InvestigateTV) — If you look on the internet, you’ll find a virtually endless menu of ailments that can supposedly be helped by a health trend that’s growing in popularity across the nation - IV hydration therapy and treatments:
- Hangover help following a night of partying
- Immunity boosts touted to help avoid the common cold
- Assistance with the symptoms of Alzheimer’s and even cancer cures
Websites and clinics from coast to coast claim they’ve got what you need to feel better – in the bag. However, experts say a lack of regulatory oversight in this rapidly emerging industry has put consumers at risk.
IV hydration and therapy is a multi-billion-dollar industry. But InvestigateTV discovered it’s operating in a medical gray area, with questions raised about the claims made about what these drips can treat or cure, the sanitation and hygiene practices surrounding the solutions that are created, and who’s keeping an eye on clinic owners, operators and the medical providers involved – if there are any.
“I think the problem is that it’s become so prevalent that consumers make the assumption well, surely if it’s all out here, then it must be okay,” said Dr. Sherif Zaafran, president of the Texas Medical Board. “The way it is right now, it really is kind of a free-for-all.”
Zaafran, who authored a bulletin on the issue of IV therapy clinics in an October 2023 newsletter, reminded physicians that these services – even just providing IV fluids - constitute the practice of medicine and should be administered by a doctor or a qualified medical practitioner under the delegation and supervision of a physician.
“The main worry is actually who is staffing them? Who is deciding what kind of hydration therapy is being given?” Zaafran said.
It’s concern that was amplified following a tragedy in Texas in July 2023, when Jenifer Cleveland, 47, died following an IV therapy injection at the Luxe Med Spa in Wortham, about an hour east of Waco.
Attorney Mark Weitz represents the owner of the clinic. He said his client has been cooperating fully with an investigation into Cleveland’s death.
In a press release from October 2023 Weitz called what happened “regretful” but said there is no criminal liability that can or should be attributed to his client.
“I haven’t seen one shred of proof that the IV is responsible for her death or that the contents of that bag in any way harmed that woman,” Weitz said in a phone interview with InvestigateTV.
‘It was a hit to the community’
Cleveland had spent time as a popular waitress at a roadside restaurant in Fairfield, Texas – not far from Wortham. She was known for her warm smile and personality. Buzz Russell was convinced her skills as a server could translate into business, so he hired her for a spot on the sales team at the country music station he owns, KNES.
“She had that personality, and she was very quick, very smart,” he said. “She picked up all this very, very quickly. And she was quirky. She fit right in with the rest of us.”
In an ironic twist of fate – Luxe Med Spa would be one of Cleveland’s first sales clients and her last. She had been in the job less than a year when she scheduled an appointment for an IV infusion at the clinic – a gesture of support for the business that had helped her kick-start her new career.
Records from the Texas Medical Board show Cleveland visited the med spa on July 10, 2023. The documents say she got an IV infusion from the owner of the clinic – a phlebotomist according to her attorney. Phlebotomists are not licensed by the state of Texas.
Board records say the IV that Cleveland was given contained vitamins and a mix of electrolytes it labeled “dangerous,” saying one of the ingredients was known to cause complications. Just moments after the needle went in, the mother and wife were unresponsive.
Despite CPR attempts by the clinic owner, Cleveland died within hours from sudden cardiac arrest. Her death is now being investigated by the Texas Attorney General’s office.
“The shock factor was pretty big for me. I’m like, no - people do this all the time. But again, it’s not as casual as we think it is,” Russell said in an interview with InvestigateTV. “In these situations where you literally have someone’s life in your hands, there has to be a procedure. What were the steps that should have been taken? What were the steps that weren’t taken?”
There were numerous missteps according to the Texas Medical Board, which found there were not medically-licensed or experienced staff at the med spa the day Cleveland died. The medical director, records show, was an anesthesiologist located more than 100 miles away.
The board said he failed to properly supervise the owner who was “an unlicensed individual performing intravenous treatments including administering prescription pharmaceutical solutions and dangerous drugs resulting in complications that the Luxe staff were not trained or prepared to respond to or manage, resulting in the patient’s death.”
During its investigation, the medical board found the clinic had no medical protocols, policies or procedures in place – something Weitz, the med spa’s attorney, refutes.
IV industry lacks regulation, with experts calling it “the Wild West of medicine”
InvestigateTV, in collaboration with the Arnolt Center for Investigative Journalism at Indiana University, did a comprehensive analysis of state laws across the country governing the ownership of IV therapy and hydration businesses as well as the administration of this type of treatment.
We found regulations vary widely on who can own or oversee IV clinics, what licenses are required for practitioners, as well as what level of monitoring or physician oversight is required. We also discovered some states admitting they have no rules or regulations to guide the industry.
“What I fear is these clinics are kind of outpacing the regulations that are out there. So, it’s not that the legislature chose not to or ignored these types of things that are going on out there. It’s that these things are coming up faster than states have been able to come up with laws to address them specifically,” said Zaafran.
The Federation of State Medical Boards, a lobbying group representing medical boards nationwide, has acknowledged the challenges of wrangling an industry that answers to different masters.
The organization called a meeting in April to talk about the need to collaborate with stakeholders to regulate IV therapy and hydration operations, which involve doctors, nurses, pharmacists and business owners - all of which come with their own licensing, regulation and oversight.
In just the last three years InvestigateTV found medical, nursing or pharmacy boards in at least eight states including Alabama, Mississippi and Nebraska have issued specific position statements to lay out exactly who can do what when it comes to IV therapy. But those statements are not laws – they’re merely guidance that even the boards themselves admit don’t carry much weight.
IV therapy industry working to set best practices, improve overall quality of practice
IV industry insiders say those position statements from states across the country are a helpful start to road-mapping best practices.
“I think they help quite a bit. I think it empowers us as physicians and practitioners to say, ok, we see what you need and what you want. We will build around that,” said Dr. Chris Seitz, who runs Guardian MD, a company that connects providers with medical directors and has been helping businesses nationwide navigate the complex rules that come with running an IV clinic in their state.
Seitz also sits on the scientific advisory board of the American IV Association - a group created by the industry. Just weeks ago, it released a framework to raise industry standards with the goal of protecting patients.
“Done the right way, this is very safe. Not done the right way, there are risks,” said Seitz. “I think education is always the most important piece, right? We need to educate the public. We need to educate providers. We need to educate medical directors on how to do this and how to do it well. We need to educate the regulators and then they need to educate back and we need to have a lot of communication around it.”
The risks of IV therapy and hydration can get blurry, in part because of social media – where many companies advertise their services in eye-catching posts that may detract from the medical responsibilities they require. Casual beach setup posts and cheeky after-party IV pics could potentially minimize the idea that these services require a heavy degree of medical expertise.
But no matter where the drip happens, Seitz and the IV Association say that there must be clear medical protocols in place. Both emphasize that providers must be properly licensed and stick within the boundaries of their scope of practice. It’s clear from medical boards and industry experts that reputable clinics should conduct a medical evaluation on anyone seeking out IV therapy, clearly laying out the benefits and risks.
“We believe as a scientific committee that there needs to be a patient-provider relationship established. We really don’t want - and the boards don’t want this either - somebody coming in off the street looking at a menu and saying, ‘Hey, that sounds good.’ No, we need to be having a relationship,” Seitz said. “The physician or a licensed nurse practitioner or a physician’s assistant needs to see that patient and really understand what their goals of treatment are and decide in concert with that patient that this is the right therapy for them and in what capacity.”
That’s where remote medical direction and telemedicine come in. Remote care became more of an accepted medical norm during COVID. And it’s something Seitz says his company relies on as it connects medical directors to IV clinics - while limiting how many they can oversee from a distance.
But not everyone is operating to his standards. InvestigateTV looked at publicly available discipline documents from medical boards nationwide and found doctors disciplined for failures related to remote oversight of IV clinics.
We found a doctor fined thousands of dollars by Virginia’s medical board and disciplined in several other states after allowing staff at clinics he oversaw to mix and administer IV solutions without ensuring they were properly trained. The board said the physician was allowing the “unlicensed practice of medicine”.
Ohio’s medical board reprimanded a doctor last year for remotely overseeing an IV clinic where the physician admitted they failed to directly interact with most patients.
In Texas, the doctor medically directing the clinic that injected Jenifer Cleveland initially had his license suspended in October of 2023 before it was later restricted that year. In its decision, Zaafran and the board called the doctor’s failures a “continuing threat to public health and safety”. The physician did not respond to InvestigateTV’s repeated requests for comment. His license remains restricted to the practice of anesthesia.
“There has to be accountability in this because we’re talking about people’s lives,” said Buzz Russell, Jenifer Cleveland’s former boss.
Russell said Cleveland’s loved ones are now talking with local lawmakers about the possibility of lobbying for legislation in Texas to better protect IV therapy consumers. As they work toward legislative action and wait for progress on the investigation, Russell says friends and family are modeling Cleveland’s shining personality, carrying on the legacy of love she left behind.
“She loved people - very outgoing, very loving. And so yeah, if you’re going to do something - be like Jen,” he said. “Love like Jen. Be a light. That’s what she was.”
Associate producer Charlie Roth contributed to the research in this story. Additional research was done in collaboration with the Arnolt Center for Investigative Journalism at Indiana University by Yang Chao, Runtian Huang, Carson Johnson, Brookelyn Lambright, Yanai Levy, Martin Schauss, Tyler Spence, and Jacob Spudich.
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