Key takeaways
- FDA said in 2016 that no whole-body cryotherapy device had been cleared or approved for the health claims spas make.
- A 2015 Cochrane review found insufficient evidence that whole-body cryotherapy reduces muscle soreness or improves recovery after exercise.
- FDA named asphyxiation, loss of consciousness, frostbite, burns and eye injury as whole-body cryotherapy hazards.
- Localized fat freezing (cryolipolysis, such as CoolSculpting) is a cleared device category, separate from whole-body and facial cryotherapy.
- Our sources have no reliable national price for spa cryotherapy, so get the total in writing before you pay.
What is cryotherapy?
Cryotherapy is the use of extreme cold as a treatment.
At a spa it comes in three formats: whole-body cryotherapy (WBC) in a cold chamber, facial cryotherapy — often listed on menus as a “cryofacial” — and localized cold treatments aimed at one small area.
Whole-body cryotherapy is the format FDA has warned consumers about, and the one our sources include a systematic review of.
The three spa formats
| Format | Where the cold goes | FDA clearance for health claims |
|---|---|---|
| Whole-body (WBC) | Chamber or enclosure with cold vapors | None, per FDA's 2016 update |
| Facial (“cryofacial”) | Skin of the face | None |
| Localized (cryolipolysis) | One small area | Cleared device (CoolSculpting) |
FDA's 2016 consumer update describes whole-body cryotherapy as exposure to vapors at about minus 200 to minus 300 degrees Fahrenheit for two to four minutes, and it flagged asphyxiation from oxygen deficiency as a hazard, especially where liquid nitrogen is used.
The fact that anchors the regulatory picture comes from that same update: FDA said not a single whole-body cryotherapy device had been cleared or approved to support the medical claims spas were making — its examples were arthritis, fibromyalgia, anxiety and weight loss — and that the agency found very little evidence of WBC safety or effectiveness.
One note on scope: cryotherapy also describes the freezing treatments used on skin lesions such as warts and skin tags.
That is a different service from the spa treatments in this guide — our guide to skin tag removal covers it instead.
Whole-body vs facial vs localized cryotherapy
The three formats share little beyond cold.
What each one is, and what each one is cleared for, differ sharply.
- Whole-body cryotherapy (WBC): you stand in a chamber or enclosure while cold vapors circulate. FDA's description is exposures of two to four minutes at about minus 200 to minus 300 degrees Fahrenheit. As of FDA's 2016 update, no WBC device had been cleared or approved for health claims.
- Facial cryotherapy (“cryofacial”): cold applied to the skin of the face. Like whole-body cryotherapy, facial cryotherapy has no FDA clearance for health claims, and we did not find published safety or effectiveness evidence for cryofacial devices in the sources we reviewed.
- Localized cryo (cryolipolysis): cold applied to one spot — “cold-assisted lipolysis,” the breakdown of fat, in the clearance wording. This is the one format with a cleared device: CoolSculpting was first cleared through the De Novo pathway in 2010, and the current CoolSculpting Elite clearance is dated September 12, 2024, with BMI limits written into the labeling.
That distinction matters when you read a spa menu: fat freezing is a cleared device category with defined areas and BMI limits, while whole-body and facial cryotherapy carry no FDA clearance for the health claims.
The CoolSculpting guide covers the cleared fat-freezing category in depth.
Does cryotherapy work? What the evidence shows
Start with the claims.
FDA's 2016 update was written because spas were marketing whole-body cryotherapy for conditions including arthritis, fibromyalgia, anxiety and weight loss; the agency said no device had been cleared or approved to support those claims, and that it found very little evidence of WBC safety or effectiveness.
The published research is thin.
The review in our sources, a 2015 Cochrane review, found only four small trials — 64 participants, most of them young adult males — and concluded there was insufficient evidence that whole-body cryotherapy reduces self-reported muscle soreness or improves recovery after exercise, compared with passive rest or no WBC.
The review also noted a lack of adverse-event data.
FDA consumer update (July 2016)
- No whole-body device cleared or approved for spa health claims
- Example claims: arthritis, fibromyalgia, anxiety, weight loss
- Very little evidence of safety or effectiveness
Cochrane review (2015)
- Four small trials, 64 participants, mostly young adult males
- Insufficient evidence on muscle soreness or recovery after exercise
- Lack of adverse-event data
What that means in practice: on the evidence we reviewed, the benefits advertised for whole-body cryotherapy are not established in these sources.
The Cochrane review covered muscle soreness and recovery in active young men — not weight, skin, mood or the other outcomes on spa menus — and FDA's statement is from 2016, so a studio may point to studies published since.
Whether later research changes the picture is not something our sources settle; a licensed provider who follows the literature is the right person to ask.
FDA's 2016 statement and the 2015 Cochrane review are the two pillars: one says no cleared device and very little evidence; the other says insufficient evidence from four small trials. Neither source shows a benefit, and neither claims to have tested every version of the treatment.
Find cryotherapy providers near you
Compare Google ratings, reviews and posted prices at med spas in your city.
What a cryotherapy session is like
For whole-body cryotherapy, the FDA description is the concrete anchor: exposure to cold vapors at about minus 200 to minus 300 degrees Fahrenheit for two to four minutes.
Beyond that, the honest answer is that session details vary by studio and device, and our research did not turn up a reliable source for them: how many sessions studios recommend, what a cryofacial involves step by step, or how studios screen people before a first visit.
We could not confirm a standard protocol, so the studio's own answers are the main information you will get.
Ask what the session consists of, how long it runs, who supervises it, and what would end a session early.
Is cryotherapy safe?
FDA's 2016 consumer update is again the clearest source, and it is a warning.
The agency named the hazards of whole-body cryotherapy as asphyxiation from oxygen deficiency, especially where liquid nitrogen is used; loss of consciousness; frostbite; burns; and eye injury.
FDA paired that warning with an evidence gap: it found very little evidence of WBC safety, and our sources give no frequency estimates for these hazards.
The 2015 Cochrane review made the same point from the trial side — the four studies it found reported a lack of adverse-event data.
Who should avoid it is not something our sources settle: we did not find a guideline listing who should skip whole-body cryotherapy.
That is a question to put to a licensed provider who knows your health history — and to the studio, before you book.
FDA's 2016 warning lists asphyxiation and oxygen deficiency (especially with liquid nitrogen), loss of consciousness, frostbite, burns and eye injury as whole-body cryotherapy hazards, at exposures of about minus 200 to minus 300 °F for two to four minutes. FDA said then that no WBC device had been cleared or approved for the health claims spas make. Discuss your health history with a licensed provider before booking, and seek medical care if you feel unwell after a session.
How much does cryotherapy cost?
We could not confirm a reliable national price for spa cryotherapy in the sources we reviewed — we found no government or professional-body figure in them for whole-body sessions, cryofacials or cryo packages.
A per-session number quoted online may be one studio's posted price rather than a checked average.
Studios price cryotherapy in different ways — per session, in multi-session packages, or through monthly memberships — so the number to get is the total for what you actually plan to use.
What moves the quote: the format, the city, the studio and how many sessions you commit to.
Get the total in writing, including what a membership auto-renews at, before you pay.
Localized fat freezing is a separate purchase with its own pricing — see our CoolSculpting guide for how that cleared device category is priced.
Find cryotherapy near you
You may see cryotherapy at dedicated cryotherapy centers, recovery studios, gyms or day spas, so the choice comes down more to the operator than to the treatment: who runs the chamber, what device it is, and what they tell you it does.
Because FDA said in 2016 that no whole-body cryotherapy device had been cleared or approved for the claims studios make, treat a health claim in an ad or on a menu as marketing rather than a cleared use — weight-loss framing included.
- What device is this, and who makes it?
- Who supervises sessions, and what training do they have?
- Do you screen for health conditions before a first session, and who decides whether someone should not go in the chamber?
- What is the total price — per session, package or membership — and what does a membership auto-renew at?
- What happens if I feel unwell during or after a session?
Two limits hold no matter where you book: the evidence for the benefits is thin, and the hazards FDA named in 2016 do not depend on how a studio markets around them.
A studio that answers the questions above in writing, and skips the health claims, is a better place to start.
Frequently asked questions
Does cryotherapy work?
The sources we reviewed do not establish benefits.
In 2016, FDA said it found very little evidence of whole-body cryotherapy's safety or effectiveness and that no device had been cleared or approved for claims such as arthritis, fibromyalgia, anxiety or weight loss.
A 2015 Cochrane review found only four small trials (64 mostly young male participants) and concluded there was insufficient evidence that it reduces muscle soreness or improves recovery after exercise.
Ask a licensed provider about your own case.
Is cryotherapy safe?
FDA's 2016 consumer update names the hazards of whole-body cryotherapy: asphyxiation from oxygen deficiency (especially where liquid nitrogen is used), loss of consciousness, frostbite, burns and eye injury, at exposures of about minus 200 to minus 300 degrees Fahrenheit for two to four minutes.
FDA also found very little safety evidence, and the 2015 Cochrane review noted a lack of adverse-event data.
Discuss your health history with a licensed provider before booking.
Is whole-body cryotherapy FDA-approved?
Not for the health claims spas make.
In its July 2016 consumer update, FDA said no whole-body cryotherapy device had been cleared or approved in support of those claims — arthritis, fibromyalgia, anxiety and weight loss among them — and that it found very little evidence of safety or effectiveness.
The cleared exception in the cold family is localized cryolipolysis (fat freezing, such as CoolSculpting), a separate device category for specific areas.
How long does a cryotherapy session last?
For whole-body cryotherapy, FDA's description is two to four minutes of exposure to vapors at about minus 200 to minus 300 degrees Fahrenheit.
We could not confirm session lengths for cryofacials or localized treatments in our sources — those vary by device and studio, so ask before you book.
What is the difference between cryotherapy and CoolSculpting?
CoolSculpting is localized cryolipolysis — an FDA-cleared device category, with cleared areas and BMI limits written into its labeling.
Whole-body cryotherapy chambers and cryofacials are wellness uses of cold with no FDA clearance for health claims.
Different devices, different cleared status, different evidence.
Sources
Every number on this page comes from one of these sources and was checked against it.
- accessdata.fda.gov · U.S. Food and Drug Administration
- Whole Body Cryotherapy (WBC): A Trend that Lacks Evidence, Poses Risks · web.archive.org
- Whole-body cryotherapy (extreme cold air exposure) for preventing and treating muscle soreness after exercise in adults · Costello et al., Cochrane Database Syst Rev, 2015
Medical disclaimer. MedSpaStandard is for education only and is not medical advice. Talk to a licensed provider about your own health, and check any provider's license with your state board.