CDC tied HIV infections to spa facials, so score risky treatments before you pay

Key takeaways

• A legitimate clinical trial rarely charges you: under federal rules, a drug sponsor needs written FDA permission to charge and can recover only direct costs.
• In May 2026, FDA reviewers found just five small human studies of the peptide BPC-157 and advised against letting pharmacies compound it; as of October 2026, it wasn’t on the federal list of allowed ingredients.
• When researchers tested 44 products sold online as SARMs in a 2017 study, only 23 contained one, and in 8 the labeled ingredients couldn’t be found at all, CNN reported.
• The FDA has linked IV vitamin infusions mixed in unsanitary clinics to infections, including a woman hospitalized with suspected septic shock in 2021.
• Score any offer on evidence, reversibility, oversight, cost and who profits before you pay, and report problems to the FDA’s MedWatch program.

In the spring and summer of 2018, an unlicensed spa in New Mexico offered “vampire facials.” Staff drew a client’s blood, separated out the plasma, and worked it back into the face with tiny needles¹.

When health inspectors visited that fall, they found unlabeled tubes of blood in a kitchen refrigerator, next to food and injectable drugs¹. Unwrapped syringes turned up in drawers and on counters, and some in the household trash. There was no sterilizer on site¹.

Five people ended up with closely related strains of HIV: four spa clients and the sexual partner of one¹. In April 2024, the Centers for Disease Control and Prevention called it the first report linking HIV transmission to nonsterile cosmetic injections¹.

The idea behind the facial was not what made it dangerous. The setting was. No license, no sterile technique, no records to trace clients.

That is the pattern in many “cutting-edge” offers: peptides labeled for research, muscle drugs sold as supplements, gene therapy in a charter city, IV drips mixed in a back room. This guide explains how to tell regulated care from an experiment you’re paying to be part of, and gives you a five-question score to use before you hand over a card.

Approved, compounded, off-label: words that mean different things

FDA-approved means the agency found a drug safe and effective for the specific uses on its label². Medical devices have their own system of clearance and approval, covered in our buyer’s map to wellness devices.

Off-label means a doctor prescribes an approved drug for a different condition, dose or form than its label lists². Doctors generally may do this when they judge it medically appropriate, and it may be the only option when no approved drug exists². But the FDA hasn’t judged whether the drug works and is safe for that new purpose².

Compounded means a pharmacist or doctor mixed a drug for an individual patient. The FDA states plainly that compounded drugs are not FDA-approved, so it does not check their safety, effectiveness or quality before they’re sold³.

Traditional compounding pharmacies, known as 503A pharmacies, are overseen mainly by state pharmacy boards and don’t have to follow federal manufacturing rules. “Outsourcing facilities,” called 503B, do follow those rules and get FDA inspections³.

Unapproved covers everything else: a vial labeled “research use only,” a powder from an overseas website, a gene therapy in another country. Here, no one has checked the product before it reaches you.

A real clinical trial has a review board, a consent process and rarely a bill

A clinical trial is a research study that tests whether a treatment is safe and works. The National Institutes of Health describes the phases⁴:

• Phase I: about 20 to 80 people, testing safety for the first time.
• Phase II: about 100 to 300 people, looking at whether it works.
• Phase III: about 1,000 to 3,000 people, confirming benefit and comparing with standard care.

Most U.S. trials are reviewed by an institutional review board (IRB), an independent committee of doctors, statisticians and community members that protects participants⁴. Informed consent is an ongoing conversation about the purpose, risks and benefits, and you can leave at any time⁴.

Then there’s money. Under federal rules, a sponsor needs prior written FDA permission to charge for an experimental drug in a trial. Even then, it can recover only direct costs, such as making and shipping the drug, backed by an independent accountant’s review⁵.

That’s why a “trial” with a price tag deserves suspicion. The NIH suggests asking up front whether you will pay for any part of a study, such as tests or the study drug⁴.

The FDA also warns that a listing on ClinicalTrials.gov, the federal trial registry, or an FDA registration does not mean a product is legally marketed. For stem cell products, the agency goes further: if someone charges you or offers one outside a clinical trial, you are probably being misled and sold something illegally⁶.

Right to Try and expanded access are narrow doors

Some people hear that federal law lets anyone try an experimental drug. The real rules are tight.

Under the federal Right to Try Act, a patient must have a life-threatening disease, have used up approved options, and be unable to join a trial of the drug. A doctor must certify this, and the patient must give written consent⁸.

The drug must have finished a Phase 1 trial and still be in active development under an FDA permit⁸. The FDA doesn’t review these requests, no IRB is required, and makers don’t have to provide the drug⁸.

The FDA’s separate Expanded Access program serves people with serious or immediately life-threatening conditions who can’t get a drug through a trial⁸.

Neither path covers a healthy person who wants to build muscle or slow aging. If a clinic says Right to Try lets it sell you an experimental product for wellness, that’s a misreading of the law.

Research peptides and SARMs: “not for human use” isn’t a safety label

BPC-157 is a short chain of amino acids, called a peptide, sold by websites, med spas and some pharmacies¹⁰. Its rules shifted repeatedly in 2026.

Until early 2026, BPC-157 sat in the FDA’s Category 2, a group of compounding ingredients the agency had flagged for significant safety risks⁹¹¹. On February 27, Health Secretary Robert F. Kennedy Jr. announced that about 14 of those peptides, including BPC-157, would move to Category 1, which would allow compounding with a prescription, the trade journal AJMC reported. That would not be FDA approval, AJMC noted¹¹.

The FDA’s own records are more tangled. Its May 2026 list of nominated ingredients no longer showed BPC-157 in Category 2, but it didn’t show it in Category 1 either⁹. Instead, the agency asked its advisory committee whether to add BPC-157 to a separate list of ingredients that standard compounding pharmacies may use¹⁰.

In a May 2026 briefing for that committee, FDA reviewers found five human studies of BPC-157¹⁰. The biggest randomized 53 people in an ulcerative colitis study known only from a meeting abstract. The smallest involved two people¹⁰.

The reviewers said the FDA’s criteria weighed against adding it to the list¹⁰. They flagged possible immune reactions and found no testing for bacteria or toxins in the quality certificates that supporters submitted. They also noted that the World Anti-Doping Agency prohibits it¹⁰.

At the July 2026 meeting, the committee voted to recommend BPC-157 and five other peptides anyway, AJMC reported¹¹. The vote is advisory. As of AJMC’s August report, the FDA hadn’t decided, and formal rulemaking could take 12 to 24 months¹¹. As of October 2026, the list in federal regulations held six substances, and BPC-157 wasn’t one of them⁷.

Meanwhile, many vials sold online carry a “research use only” label¹⁰¹¹. That label doesn’t make a product safe for you. It means nobody has promised it is.

SARMs, or selective androgen receptor modulators, are experimental drugs that act like testosterone on muscle. In a 2017 study in the journal JAMA, researchers including Shalender Bhasin of Brigham and Women’s Hospital bought 44 products sold online as SARMs and tested them, CNN reported¹².

Only 23 contained a SARM. Seventeen held another unapproved drug, and in 8, the ingredients on the label couldn’t be found at all¹². According to CNN, the FDA had just warned three companies selling SARMs as supplements, and the agency linked SARMs to liver toxicity and a possible higher risk of heart attack and stroke¹².

IV drips and injections: where it’s mixed matters

In October 2021, the FDA warned about sterile drugs mixed under unsanitary conditions at medical offices, IV hydration clinics, medical spas and mobile IV services¹³. It said the true extent was unknown and harms were likely underreported¹³.

One case shows why. In February 2021, a 50-year-old woman was hospitalized with suspected septic shock and organ failure after an IV vitamin infusion at home¹³. Her blood grew a bacterium, Pseudomonas fluorescens.

The clinic that mixed it had no certified clean area for sterile work. Inspectors found peeling paint, carpeting that was hard to clean, standing water in refrigerated storage, and expired ingredients¹³.

The New Mexico spa fits the same lesson¹. Before any injection or drip, ask who prescribed it, where it was mixed, and whether the clinic is licensed. A clinic that can’t answer is telling you something.

Ozone, offshore gene therapy and stem cells: where oversight runs out

Ozone. If you’re offered ozone injections or ozone-treated blood, know that federal regulations take a blunt position: “Ozone is a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy”¹⁴. A device used to treat a medical condition with ozone, without proof of safety and effectiveness, is considered adulterated or misbranded¹⁴.

Offshore gene therapy. In 2023, MIT Technology Review reported on Minicircle, a startup testing a follistatin gene therapy, meant to boost muscle, in Próspera, a private charter city on Honduras’s island of Roatán¹⁵. A 2022 recruiting ad asked people to buy an NFT, a crypto token, to join¹⁵.

Próspera’s health rules rely on what it calls “closely monitored self-regulation”¹⁵. Gene therapy experts questioned the science, and the company had shared little about its trial design or results¹⁵. At the time of that report, Honduras’s government had voted in 2022 to repeal the law that created zones like Próspera, pending ratification¹⁵.

Stem cells. The only FDA-approved stem cell products come from umbilical cord blood and are approved only for disorders of blood production⁶. The FDA has received reports of blindness, tumors and infections from unapproved products⁶. Our article on miracle-cure scams covers those clinics in more detail.

Score the risk before you pay

This is our own tool, not a validated medical test. It won’t tell you whether something works. It shows how many safety nets have been removed. Score each question 0, 1 or 2.

Question	0 points	1 point	2 points
Evidence: What human research supports this use?	Approved for this use, or large trials	A few small human studies	Animal or lab work only, or none
Reversibility: Can you undo it?	Stop anytime; effects fade	Injected or infused; effects last days to weeks	Permanent or hard to undo, like genes or cells
Oversight: Who checked the product and the setting?	FDA-approved product, licensed clinician and facility	Compounded by a licensed pharmacy, or off-label	“Research use only,” offshore, unlicensed or no IRB
Cost: How do you pay?	Insurance, or a trial that doesn’t charge	Cash for a standard service	You pay to join a “study,” prepay packages or buy tokens
Who profits: Does the person recommending it sell it?	No financial tie	Sells it, and says so	Sells or owns it and doesn’t disclose

0 to 3: lower risk. Still check interactions.
4 to 6: pause. Get an independent opinion from a clinician who doesn’t sell it.
7 to 10: high risk. Walk away, or get an independent review before going further.

Picture a gym that sells prepaid packages of BPC-157 injections from vials marked for research use. Evidence scores 1, since FDA reviewers found only five small human studies¹⁰. Reversibility scores 1, and oversight scores 2.

Cost scores 2, because you pay up front. Who profits scores 1, since the gym openly sells what it recommends. The total is 7: high risk.

Natural-health readers are often first to question drug company research and government assurances. That same skepticism belongs here. A seller who profits from an unproven injection, and avoids the oversight that drug companies face, deserves at least as much scrutiny as any pharmaceutical firm.

What the evidence says, offer by offer

Offer	Evidence level	Why
Cord-blood stem cells for blood-forming disorders	Strong evidence	FDA-approved for that narrow use6
BPC-157 injections	Not enough evidence	Five small human studies; FDA reviewers found too little safety data10
Offshore follistatin gene therapy	Not enough evidence	Little public detail on trial design or results15
SARMs bought online	Evidence says no, or unsafe	Contents often didn’t match labels in a 2017 study; FDA cited liver and heart risks, CNN reported12
Unapproved stem cell injections	Evidence says no, or unsafe	Reports of blindness, tumors and infections6
Ozone therapy	Evidence says no, or unsafe	Federal rule: toxic gas with no known medical use14
IV drips mixed in unsanitary settings	Evidence says no, or unsafe	Documented infections, including septic shock13

Where to report a problem, and when to get help

If something goes wrong, get care first. Call 911 for trouble breathing, chest pain, fainting, or a high fever with confusion after an injection or infusion. For a suspected poisoning or bad reaction to a product, call Poison Control at 1-800-222-1222.

Then report it:

• FDA MedWatch: for harms from drugs and other FDA-regulated products. The FDA specifically asks for reports of problems with compounded drugs¹³.
• FDA regenerative medicine office: email ocod@fda.hhs.gov about a stem cell or similar product, before treatment or after a problem⁶.
• Your state medical, nursing or pharmacy board: for an unlicensed clinic or a practitioner you think acted unsafely.
• Federal trade commission: at ReportFraud.ftc.gov, for false advertising.

Keep the vial, the label, the receipt and any consent form. They help investigators trace the source.

Questions readers ask

The bottom line

Experimental doesn’t always mean bad. Real trials, with review boards, consent and FDA oversight, are how medicine moves forward. The danger comes when the safety nets are stripped away: no license, no sterile technique, no human data, and a seller who profits.

Before you pay for any cutting-edge treatment, score it on evidence, reversibility, oversight, cost and who profits. If the score is high, get an independent opinion, and if something goes wrong, get care and report it.

Related reading

• How miracle-cure scams borrow the language you trust
• “FDA registered” isn’t “FDA approved”: a buyer’s map to wellness devices
• What a clinician must tell you before you agree
• Most health products aren’t scams, but many just haven’t been proven
• What gets into supplements that isn’t on the label

Sources

1. Centers for Disease Control and Prevention. “Investigation of Presumptive HIV Transmission Associated with Receipt of Platelet-Rich Plasma Microneedling Facials at a Spa Among Former Spa Clients — New Mexico, 2018–2023.” MMWR, 2024. cdc.gov
2. U.S. Food and Drug Administration. “Understanding Unapproved Use of Approved Drugs ‘Off Label’.” FDA, 2018. fda.gov
3. U.S. Food and Drug Administration. “Compounding and the FDA: Questions and Answers.” FDA, 2025. fda.gov
4. National Institutes of Health. “NIH Clinical Research Trials and You: The Basics.” NIH. nih.gov
5. Code of Federal Regulations. “21 CFR 312.8: Charging for Investigational Drugs Under an IND.” eCFR. ecfr.gov
6. U.S. Food and Drug Administration. “Important Patient and Consumer Information About Regenerative Medicine Therapies.” FDA, 2024. fda.gov
7. Code of Federal Regulations. “21 CFR 216.23: Bulk Drug Substances That Can Be Used to Compound Drug Products in Accordance With Section 503A.” eCFR, up to date as of October 13, 2026. ecfr.gov
8. U.S. Food and Drug Administration. “Right to Try.” FDA, 2024. fda.gov
9. U.S. Food and Drug Administration. “Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act.” Category list, updated May 14, 2026. fda.gov
10. U.S. Food and Drug Administration. “BPC-157: Briefing Document for the Pharmacy Compounding Advisory Committee.” FDA, 2026. fda.gov
11. AJMC. “5 Things to Know About the FDA’s Peptide Reversal.” AJMC, 2026. ajmc.com
12. CNN. “Study Finds Unapproved Drugs in Products Sold Online as SARMs.” CNN, 2017. amp.cnn.com
13. U.S. Food and Drug Administration. “FDA Highlights Concerns With Compounding of Drug Products by Medical Offices and Clinics Under Insanitary Conditions.” FDA, 2021.
14. Code of Federal Regulations. “21 CFR 801.415: Maximum Acceptable Level of Ozone.” eCFR. ecfr.gov
15. Clarke L. “This Biohacking Company Is Using a Crypto City to Test Controversial Gene Therapies.” MIT Technology Review, 2023. technologyreview.com