MYTH-BUSTED: The Dangerous Truth About "Breathable Ozone" Wellness Products
- Rebecca Nolan Harris, PhD
- 5 days ago
- 11 min read
I Read Something Terrifying Today:
Breathable Ozone
I was browsing a wellness site and came across a product that made my blood run cold: the TheraO3 Ozone Module, marketed as a portable device that produces "safe, breathable ozone" for use in saunas, cars, offices, and hotel rooms. The product claims to enhance oxygen delivery, support immune health, kill airborne pathogens, and promote "vibrant skin, hair, and nails."
Here's the problem: There is no such thing as "safe, breathable ozone."
As someone committed to evidence-based health information, I felt compelled to break down the dangerous myths being perpetuated by products like this. Let's separate fact from fiction.
MYTH 1: "Low-Level Ozone is Safe to Breathe"
THE TRUTH:
Every major federal health agency in the United States explicitly warns against breathing ozone at ANY level.
The FDA's Position: The Food and Drug Administration has stated unequivocally that "ozone is a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy" and that "when inhaled, ozone is a toxic gas that has no demonstrated safe medical application."[1] The FDA prohibits all medical uses of ozone where there is no proof of safety and effectiveness.
The EPA's Warning: The Environmental Protection Agency makes it crystal clear: "NO agency of the federal government has approved these devices for use in occupied spaces."[2] The EPA further warns that manufacturers often use misleading terms like "energized oxygen" or "pure air" to make ozone sound healthy, when in reality, "ozone is a toxic gas with vastly different chemical and toxicological properties from oxygen."[2]
MYTH 2: "Ozone Therapy is Well-Researched and Proven"
THE TRUTH:
While some medical ozone therapies exist (typically involving injections, NOT inhalation), the evidence is limited and controversial.
A 2022 systematic review published in Frontiers in Public Health found that while some studies showed benefits for pain management, the research quality was mixed. Of 26 systematic reviews analyzed, only 9 were rated as high-level evidence, while 11 were rated as low-level and 3 as critically low.[3]
Important Distinction: Medical ozone therapy studied in clinical settings typically involves:
Injections for localized pain (herniated discs, osteoarthritis)
Topical applications for wounds
Blood treatments (autohemotherapy)
These are NOT the same as breathing ozone gas into your lungs. The American Cancer Society warned in 2010 that evidence for ozone therapy's efficacy is inconclusive for many claimed applications, and the therapy may be dangerous.[4]
MYTH 3: "Ozone Just Purifies the Air Around You"
THE TRUTH:
When you breathe ozone, it causes immediate chemical damage to your respiratory system.
The Science of How Ozone Harms Your Lungs:
Immediate Effects: According to EPA research, even relatively low amounts of ozone exposure can cause:[5]
Chest pain, coughing, and throat irritation
Shortness of breath and difficulty breathing deeply
Inflammation and damage to airways
Pain when taking a deep breath
Chronic Effects: Regular exposure can lead to:[5,6]
Increased susceptibility to respiratory infections
Aggravation of lung diseases (asthma, emphysema, chronic bronchitis)
Increased frequency of asthma attacks
Long-term lung damage
Increased hospital admissions and daily mortality
Who's Most at Risk? The EPA identifies these vulnerable populations:[5]
Children (whose lungs are still developing)
People with asthma or other respiratory conditions
Older adults
People who exercise outdoors
Outdoor workers
A study on ground-level ozone exposure found that "breathing ground-level ozone can result in health effects observed in broad segments of the population, including respiratory symptoms, reduced lung function, and airway inflammation."[7]
MYTH 4: "It's Like Getting Extra Oxygen"
THE TRUTH:
Ozone (O₃) is NOT oxygen (O₂). They are chemically and toxicologically different substances.
Ozone is composed of three oxygen atoms instead of two. That third oxygen atom is highly reactive and can detach to react with other molecules, which is exactly what makes it dangerous to living tissue.[2]
When ozone enters your respiratory system, that reactive oxygen atom attacks the organic material that makes up your lung tissue, causing inflammation, cellular damage, and oxidative stress. This is the opposite of the "enhanced oxygen delivery" being marketed.
The Regulatory Reality
Federal Safety Standards:
Multiple agencies have established exposure limits that demonstrate just how toxic ozone is:[8]
FDA: Requires ozone output of indoor medical devices to be no more than 0.05 ppm
OSHA: Workers cannot be exposed to an average concentration of more than 0.10 ppm for 8 hours
NIOSH: Recommends an upper limit of 0.10 ppm, not to be exceeded at any time
EPA: National Ambient Air Quality Standard considers levels above these thresholds dangerous
These ultra-low thresholds exist because ozone is that dangerous to human health.
Historical Perspective: We've Known This For Over a Century
This isn't new information. The Wikipedia entry on ozone therapy notes that "for almost a century, health professionals have refuted" claims that ozone generators are safe and effective for occupied spaces, citing sources dating back to 1913.[4]
During World War I, when ozone was tested on wounds at Queen Alexandra Military Hospital in London, applying the gas directly for just 15 minutes resulted in damage to both bacterial cells AND human tissue.[4]
Documented Adverse Events
Between 1975 and 1983 in Germany, research on ozone therapy documented:[4]
Six deaths
Four cases of visual disturbance
Three cases of paraplegia
Four gas embolisms in the pulmonary system
Two myocardial infarctions
Four pulmonary embolisms
Two cases of stroke paralysis
Two cases of cardiac arrhythmia
The most common adverse effect of ozone treatment is pulmonary edema (fluid in the lungs). As of 2012, at least five deaths had been reported specifically due to ozone therapy's use in cancer patients.[4]
How Therasage Misrepresents the Science
After reading Therasage's "Understanding Ozone" page, I've identified multiple dangerous misrepresentations of scientific facts. Let's break them down:
Misrepresentation 1: Ozone = "Extra Oxygen"
What They Say: "When ozone (extra oxygen) is introduced into the area, it attacks microbes without a coating and diseased cells with deficient cell wall enzymes."
The Scientific Reality: Ozone is NOT "extra oxygen." This is like calling carbon monoxide "extra air" because it contains oxygen. Ozone (O₃) is a completely different molecule from oxygen (O₂) with vastly different—and toxic—properties. The EPA explicitly warns that manufacturers use misleading terms to make ozone sound healthy when it's actually a toxic gas.[2]
Misrepresentation 2: Conflating Different Biological Processes
What They Say: "In the body's immune defense, hydrogen peroxide is produced and released by T-cells to destroy invading bacteria, viruses and fungi... Hydrogen peroxide is formed in the body by micro-bodies called peroxisomes, which combine water with free oxygen."
The Scientific Reality: They're describing the body's NATURAL immune processes that happen INTERNALLY at the cellular level, then using this to justify EXTERNALLY breathing toxic ozone gas. This is a classic bait-and-switch. Yes, your immune cells produce reactive oxygen species internally as part of their function, but that doesn't mean breathing a toxic gas externally is safe or beneficial. It's like saying, "Your stomach produces hydrochloric acid to digest food, so drinking hydrochloric acid must be healthy!"
Misrepresentation 3: Selective Targeting Myth
What They Say: "It oxidizes them [microbes and diseased cells], allowing them to be cleared from the body as part of normal detoxification."
The Scientific Reality: Ozone doesn't selectively target only bad cells—it damages ALL organic tissue it comes into contact with. The EPA clearly states: "The same chemical properties that allow high concentrations of ozone to react with organic material outside the body give it the ability to react with similar organic material that makes up the body."[2] Your healthy lung tissue IS organic material. When you breathe ozone, it attacks your airways, causing inflammation, damage, and pain.[5]
Misrepresentation 4: Ignoring All Safety Warnings
What's Missing: Nowhere on this page do they mention:
The FDA's prohibition on ozone for medical use
The EPA's explicit warnings against breathing ozone
The documented adverse effects (respiratory damage, deaths, etc.)
That NO federal agency has approved ozone generators for occupied spaces
The established safety thresholds that demonstrate ozone's toxicity
The Pattern: This page cherry-picks information about oxygen and the body's natural processes, then deceptively connects it to their ozone product without disclosing the serious health risks documented by every major federal health agency.
Misrepresentation 5: "Enhanced Cellular Oxygenation"
What They Imply: That breathing ozone improves oxygen delivery to your cells and tissues.
The Scientific Reality: Breathing ozone DAMAGES your respiratory system, making it HARDER for your body to absorb oxygen efficiently. According to EPA research, ozone exposure causes:
Inflammation and damage to airways[5]
Reduced lung function[7]
Airway constriction[5]
Decreased ability to breathe deeply and vigorously[5]
This is the opposite of "enhanced oxygenation"—it's respiratory impairment.
How Therasage Misrepresents the Science
After reading Therasage's "Understanding Ozone" page, I've identified multiple dangerous misrepresentations of scientific facts. Let's break them down:
Misrepresentation 1: Ozone = "Extra Oxygen"
What They Say: "When ozone (extra oxygen) is introduced into the area, it attacks microbes without a coating and diseased cells with deficient cell wall enzymes."
The Scientific Reality: Ozone is NOT "extra oxygen." This is like calling carbon monoxide "extra air" because it contains oxygen. Ozone (O₃) is a completely different molecule from oxygen (O₂) with vastly different—and toxic—properties. The EPA explicitly warns that manufacturers use misleading terms to make ozone sound healthy when it's actually a toxic gas.[2]
Misrepresentation 2: Conflating Different Biological Processes
What They Say: "In the body's immune defense, hydrogen peroxide is produced and released by T-cells to destroy invading bacteria, viruses and fungi... Hydrogen peroxide is formed in the body by micro-bodies called peroxisomes, which combine water with free oxygen."
The Scientific Reality: They're describing the body's NATURAL immune processes that happen INTERNALLY at the cellular level, then using this to justify EXTERNALLY breathing toxic ozone gas. This is a classic bait-and-switch. Yes, your immune cells produce reactive oxygen species internally as part of their function, but that doesn't mean breathing a toxic gas externally is safe or beneficial. It's like saying, "Your stomach produces hydrochloric acid to digest food, so drinking hydrochloric acid must be healthy!"
Misrepresentation 3: Selective Targeting Myth
What They Say: "It oxidizes them [microbes and diseased cells], allowing them to be cleared from the body as part of normal detoxification."
The Scientific Reality: Ozone doesn't selectively target only bad cells—it damages ALL organic tissue it comes into contact with. The EPA clearly states: "The same chemical properties that allow high concentrations of ozone to react with organic material outside the body give it the ability to react with similar organic material that makes up the body."[2] Your healthy lung tissue IS organic material. When you breathe ozone, it attacks your airways, causing inflammation, damage, and pain.[5]
Misrepresentation 4: Ignoring All Safety Warnings
What's Missing: Nowhere on this page do they mention:
The FDA's prohibition on ozone for medical use
The EPA's explicit warnings against breathing ozone
The documented adverse effects (respiratory damage, deaths, etc.)
That NO federal agency has approved ozone generators for occupied spaces
The established safety thresholds that demonstrate ozone's toxicity
The Pattern: This page cherry-picks information about oxygen and the body's natural processes, then deceptively connects it to their ozone product without disclosing the serious health risks documented by every major federal health agency.
Misrepresentation 5: "Enhanced Cellular Oxygenation"
What They Imply: That breathing ozone improves oxygen delivery to your cells and tissues.
The Scientific Reality: Breathing ozone DAMAGES your respiratory system, making it HARDER for your body to absorb oxygen efficiently. According to EPA research, ozone exposure causes:
Inflammation and damage to airways[5]
Reduced lung function[7]
Airway constriction[5]
This is the opposite of "enhanced oxygenation"—it's respiratory impairment.
Disclaimer: This article is for informational purposes only and is not intended as medical advice. Always consult with qualified healthcare professionals regarding your health concerns. If you've been using ozone-generating devices and are experiencing respiratory symptoms, please seek medical attention immediately.
"But They Have a Patent!" - The Patent Deception
One of the most common defenses people offer when I raise safety concerns is: "But doesn't Therasage have a patent? Doesn't that mean it's legitimate?"
This is a critical misunderstanding that wellness companies exploit. Let me be crystal clear:
Patents ≠ FDA Approval ≠ Safety
After thoroughly reviewing Therasage's website and product claims, here's what I found:
What They Actually Have Patented: Therasage repeatedly states they have "patented Full Spectrum Infrared Portable Saunas." Their patent is for their infrared sauna technology—NOT for their ozone products (TheraO3 Module and TheraO3 Bubbler).
What Their Ozone Products Are: The TheraO3 products appear to be standard ozone generators with no unique patented technology. They're similar to many other ozone generators on the market.
The Patent vs. Safety Distinction
The U.S. Patent and Trademark Office (USPTO) and the FDA are completely separate agencies with entirely different purposes:
USPTO (Patent Office):
Reviews inventions for novelty and non-obviousness
Asks: "Is this new and different?"
Does NOT evaluate safety or efficacy
Does NOT approve medical uses
Grants legal monopoly rights to inventors
FDA (Food and Drug Administration):
Reviews products for safety and effectiveness
Asks: "Is this safe and does it work?"
Requires clinical evidence for medical claims
Protects public health
Has explicitly stated ozone has "no known useful medical application"
Why This Matters
A patent simply means you've invented something new—it could be a new way to generate ozone, a new shape for a device, or a new combination of technologies. You can patent something that's dangerous, ineffective, or even deadly. The patent office doesn't care if your invention is harmful; they only care if it's novel.
As one legal analysis notes: "The regulatory function of the FDA is to ensure the welfare of the public by requiring that the safety and efficacy of medical devices are documented and scientifically established before a device enters the stream of commerce."[9] Patents have nothing to do with this safety evaluation.
Real-World Example
Think about it this way: Someone could patent a "novel cigarette holder design." That patent doesn't mean cigarettes are safe or FDA-approved for health benefits. The patent only means the design is new.
Similarly, Therasage may have patented aspects of their infrared sauna design (which is a legitimate heat therapy technology), but this gives zero legitimacy to their dangerous ozone products.
The Marketing Strategy
Companies like Therasage use this confusion deliberately. By prominently displaying "patented" on their website and mentioning it alongside all their products, they create a halo effect—making consumers think everything they sell has been validated by some official government process.
The reality:
Their infrared saunas may have patented design features (patents for heating technology)
Their ozone generators are NOT patented (just standard ozone generators)
Even if the ozone products WERE patented, it wouldn't make them safe
The FDA has explicitly warned AGAINST using ozone for the purposes they market
How This Gets Away With Being Sold
You might wonder: "If ozone is so dangerous and the FDA says it has no medical use, how can they legally sell this?"
The loopholes are frustrating:
They include disclaimers (in small print): "Not intended for medical use"
They market it as an air purifier/sanitizer rather than explicitly as medicine
They use weasel words like "supports," "may help," and "promotes" rather than claiming to treat diseases
They rely on the "wellness" gray area where the FDA has limited enforcement resources
They call it "low gamma ozone" (a made-up marketing term with no scientific definition or safety threshold)
But make no mistake—their marketing materials are filled with health claims that would require FDA approval if they were honest about what they're actually claiming.
The Bottom Line
Products like the TheraO3 Ozone Module that claim to produce "safe, breathable ozone" are making health claims that directly contradict the scientific consensus of every major federal health agency in the United States.
The facts are clear:
Ozone is a toxic gas when inhaled
No federal agency has approved ozone generators for use in occupied spaces
There is no safe level of ozone to deliberately breathe
The marketing uses misleading language to obscure these dangers
What You Should Do Instead:
If you're concerned about air quality:
Use HEPA air filters (genuinely effective and safe)
Ensure proper ventilation
Address sources of indoor air pollution
Consult with your healthcare provider about respiratory health
If you're seeking immune support or health improvements:
Speak with a qualified healthcare provider
Focus on evidence-based interventions (proper nutrition, exercise, sleep, stress management)
Be skeptical of wellness products making dramatic health claims
Stay safe, stay informed, and always question wellness claims that sound too good to be true—because they usually are.
References
[1] U.S. Food and Drug Administration. (2006, 2020). Statements on ozone therapy and medical devices.
[2] U.S. Environmental Protection Agency. (2014). "Ozone Generators that are Sold as Air Cleaners: An Assessment of Effectiveness and Health Consequences." EPA Publication.
[3] Scuteri, D., et al. (2022). "The role of ozone treatment as integrative medicine. An evidence and gap map." Frontiers in Public Health, 10:1112296. https://pmc.ncbi.nlm.nih.gov/articles/PMC9885089/
[4] Wikipedia contributors. (2025). "Ozone therapy." Wikipedia, The Free Encyclopedia. Retrieved October 2025.
[5] U.S. Environmental Protection Agency. (2025). "Health Effects of Ozone Pollution." https://www.epa.gov/ground-level-ozone-pollution/health-effects-ozone-pollution
[6] U.S. Environmental Protection Agency. (2025). "Health Effects of Ozone in the General Population." https://www.epa.gov/ozone-pollution-and-your-patients-health/health-effects-ozone-general-population
[7] U.S. Environmental Protection Agency. (2025). "Course Outline and Key Points - Ozone." https://www.epa.gov/ozone-pollution-and-your-patients-health/course-outline-and-key-points-ozone
[8] U.S. Environmental Protection Agency. (2014). "Ozone Generators that are Sold as Air Cleaners." https://www.epa.gov/sites/default/files/2014-08/documents/ozone_generator.pdf
Disclaimer: This article is for informational purposes only and is not intended as medical advice. Always consult with qualified healthcare professionals regarding your health concerns. If you've been using ozone-generating devices and are experiencing respiratory symptoms, please seek medical attention immediately.
Stay safe, stay informed, and always question wellness claims that sound too good to be true—because they usually are.
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