Ozone Therapy Can Be Deemed Both Legal And Illegal
Yes, you read that right. Thanks to a maze of laws, rules, and regulations, many of which contradict each other, one can now credibly make the case that ozone therapy is both legal and illegal.
Examples: on the one hand the FDA declares ozone a toxic gas with no known medical properties.
On the other hand, it allowed at least two different trials to be conducted with this allegedly toxic substance, seehere andhere. And word on the street has it that it may approve a third one very soon. This implies that the FDA did have to consider ozone to be a drug with potentially therapeutic properties, or at least harmless.
On the one hand, section801.415 of FDA regulations pertaining to medical devices says that any device which produces ozone and is used in any medical condition is to be branded as adulterated and/or misbranded, and hence presumably illegal.
On the other hand, section 801.65 implies that any device used by licensed practitioners, including physicians, dentists, and optometrists in their practice is exempt from registration, meaning its legal to use it.
And although section 801.415 says that devices which produce ozone are not medical devices, they nevertheless satisfy theFDA definition of medical devices.
Having fun yet? Good, because there is more:
The FTC does not allow you to advertise that
But at the same time there is the Right to Try legislation which allows exactly that: to try drugs for which there are no human clinical studies available yet.
What Are The Different Types Of Ozone Therapy
Using medical ozone treatments for certain conditions may include the following methods:
- Autohemotherapy or self blood therapy is a procedure where some amount of blood is collected from your body and medical graded ozone gas is combined with the blood.
- The two types of autohemotherapies are:
- Major autohemotherapy : Some amount of blood is collected in an intravenous bag and after combining it with ozone gas, the blood is administered back to the patient as an intravenous drip.
- Minor autohemotherapy: Very small amount of blood is collected from the vein, which is readily combined with ozone, and injected back instantly.
Antibacterial Antifungal And Antiviral Abilities
Over time bacteria has learned and adapted to resist antibiotics. Scientists constantly seek ways to prevent and find better treatments for fungal, viral, and bacterial infections.
Continued studies of ozone found that they contain a layer of infection control properties. Ozone therapy can solely resolve some acute bacterial infections. In the case of a tick bite Ozone cures the infection within 48 hours.
Viral infections such as the flu harass people every year, especially in December. The good news, Ozone therapy may help these infections as well.
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Ozone Therapy Is A Near Perfect Example Of Pseudoscience
Vintage quackery is quaint, but modern quackery is evil, and it’s clear that ozone therapy is a chefs kiss example of dangerous medical pseudoscience:
- Banned by the FDA. Obviously unsafe if used incorrectly.
- Elaborate, superficially plausible biological rationale. Strong seeds of truth.
- Powerful links to rank quackery , of course
- but also vigorous support from superficially credible proponents: doctors, dentists, veterinarians.
- A growing body of literature, small but too large to dismiss out of hand, consisting almost exclusively of crappy little clinical trials with off-the-charts risk of bias.
Acute And Chronic Infections
Ozone therapy has helped people get relief from various types of acute and chronic infections caused by a wide range of microorganisms. Medical ozone therapy is effective against skin infections, wound infections, organ infections, sores, lesions, and delayed healing after any surgical procedure.
Dental or oral infections and pneumology-specific infections are also corrected by the ozone administration.
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Is Ozone Therapy Harmful Or Notthe Answer Is No
Ozone therapy treatment is not at all harmful, especially when done under expert medical supervision. The cases where people get any damages or health concerns, stem from the fact that they are not able to get the right professional help, or they are using faulty ozone generators for ozone therapy at home.
Now, you might ask Why is ozone therapy illegal in the US?
Well, in 2019, the FDA released a statement indicating that ozone is a toxic gas and has no known application in preventive or supportive medicine with known results.
However, a number of health practitioners are using ozone therapy for treating a number of diseases in the US and all over the world.
So, is ozone therapy FDA approved? No, but it is being used all over the globe for treating various health conditions and as a supplement for boosting the effect of other treatment procedures.
Ozone Therapy For Lyme: A Dangerous Scam
The FDA is quite clear about ozone:
Ozone is a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy.
In fact, ozone is the primary ingredient of the air pollution known as smog. Its a highly reactive gas that can do harm to the human body.
When breathed in, ozone can cause damage that has been called a sunburn inside your lungs.
In 2015, a woman named Dejay Cartwright died after being sold injected ozone treatment by long time Lyme literate charlatan Henry Childers, MD of Delaware Integrative Medicine.
According to a malpractice lawsuit, Childers diagnosed Cartwright with a host of maladies without testing: encephalopathy, chronic pain syndrome, chronic fatigue syndrome, babesiosis, toxoplasmosis, Lyme disease and common variable immune deficiency. Bloomberg Businessweek reported on the horrific story.
In 2019, emergency medicine doctors in Kentucky reported on a 50-year-old woman who suffered a heart attack after receiving intravenous ozone therapy to treat so-called chronic Lyme disease.
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I Cannot Find Any Double
Phase 3 double-blind studies are only conducted and financed by Big Pharma Corporations.
Ozone Therapy’s therapeutic properties and effects have a direct conflict of interest with pharmaceutical drugs that have a mediocre effect on treating pathologies and conditions that Ozone Therapy treats and manages without any adverse reactions.
Therefore, the suppression of Ozone Therapy by Big Pharma corporations means that Phase 3 double-blind studies will never be conducted and have not been conducted in the last 60 years.
There are hundreds of peer review studies that have been conducted that repeatedly indicate the properties of ozone therapy. There is no doubt that further research needs to be done, however, funding and investment in the field of Ozone Therapy is limited.
We recommend the following video Medical Ozone Introduction | Intropsrection so that you have an better overview of the State of Play of Ozone Therapy
The Pictures That Piqued My Interest
For decades consumers could buy ozone generators for self-treatment, like this bizarre vintage medical device of unknown provenance. It still works: it produces a strong ozone odour & the paddle causes the sensation of little sparks when applied to the skin. Photos by neon collector Jenny Beatty, used with permission. .
I got those great photo from Jenny from a post in a Facebook discussion group, Skeptical Revival, which I will take a moment to promote. The groups intro:
Scientific Skepticism is many things. Its an approach to evaluating claims , a worldview, a movement to promote critical thinking, a movement to protect people from the harms of pseudoscience, and a community. Lets rebuild that community. Share links, post thoughts, discuss ideas.
Rebuild? The skeptical community suffered some schisms over the last decade. Skepticism is not a hive mind. There are factions separated by chasms. There are members I dont want to be associated with. The group is all about trying to heal, trying to get back on the same page.
And anti-quackery activism is something almost all skeptics can get behind.
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How To Prepare For Ozone Therapy
Talk with your healthcare provider about the best way to prepare for your treatment. They may provide ozone therapy by drawing blood from your body, then mixing it with ozone gas and replacing it.
If ozone therapy will be administered with your blood, prepare for your blood draw by getting plenty of sleep the night before and eating a healthy breakfast that day. Also, make sure to drink plenty of water.
There are many different ways to receive ozone therapy. Your healthcare provider will discuss the best options for you and your treatment.
Three main forms of treatment include administering ozone:
- Directly to the tissue. If you undergo ozone therapy for an extremity problem or wound, the ozone gas will most likely be applied directly to the tissue of the affected body part. The gas is administered in a protective covering.
- Intravenously. To treat internal disorders, such as HIV, the ozone gas is usually dissolved into blood that was taken from you. Then, the blood with the dissolved gas is injected back into you through an IV. Intravenous use can carry the risk of causing an embolism through the formation of air bubbles.
- Intramuscularly. Ozone therapy is also available as an intramuscular injection. For this injection, the ozone gas is often mixed with oxygen before administration.
Research from 2018 indicated that ozone therapy may help with knee osteoarthritis by improving range of motion and delaying decline.
Whats The Point The Rationale For Ozone Therapy
Why use ozone medically? Other than that nice fresh smell? Anything with the power to harm might also have the power to heal. The dose makes the poison or the medicine.
A seed of truth is a standard feature of all successful quackeries, and the legitimate antibiotic powers of ozone are the seed of truth that has powered its medical reputation for one hundred and twenty years, a perennially popular snake oil hurting and killing many people rather than curing anyone of anything, making it one of the best ever examples of popular but dangerous quackery.
Ozone therapy was particularly prominent in the era of patent medicines and peak electrical quackery, and it has a colourful history literally.
For decades consumers could buy ozone generators for self-treatment, like this bizarre vintage medical device of unknown provenance. It still works: it produces a strong ozone odour & the paddle causes the sensation of little sparks when applied to the skin. Photo by neon collector Jenny Beatty, used with permission. .
Incredibly, ozone generators are still for sale as air purifiers, just as the Tesla Ozone Company intended even leveraging Teslas reputation for the marketing! For more about ozones strange history, I strongly recommend this superb article from ScienceHistory.org: A Killer of a Cure: For more than a century ozone therapy has been a source of false hope for the sick and ill-gotten gains for the crooked.
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Claims That Ozone Therapy Is Dangerous
The Food and Drug Administration is a weighty organization. They hold the power to decide what can be considered medicine in the United States.
They take a very strong stance on ozone when they say, âOzone is a toxic gas with no known useful medical application.â
To me, it makes complete sense why the FDA makes this statement regarding ozone. Why would they give any other opinion?
Ozone therapy has very little chance of FDA approval. FDA approval is an incredibly expensive process and requires millions of dollars. Ozone therapy cannot generate much revenue because it runs on oxygen, which only cost a few cents.
The other issue is that ozone therapy is not patentable.
Pretend that a company spent millions of dollars to get FDA approval for ozone therapy. Letâs call this company ACME. Usually, ACME would acquire a patent to protect their product and avoid competition from other companies. Afterall, they just spent millions to get a new treatment approved, so they can sell a product. However, with ozone therapy, itâs not possible to get a patent. So ACME would risk millions of dollars just to compete with all the other companies in the industry.
Nobody is going to spend that kind of money on FDA approval, if they can’t even patent a product, like ozone. Large companies do not take risks like this. Some would even go as far as to consider it imprudent.
In this particular paper, ISCO3 failed to cite any sources for the claims they made about DIV.
Conditions Ozone Therapy Is Used To Treat
Medical researchers suggest that ozone therapy could prove effective in remediating numerous ailments including:
Ozone therapy has been employed to treat various blood vessel disorders such as:
- Peripheral artery obstructions that inhibit proper blood flow
- Heart attacks
- Blood clots
Moreover, the gas has found some benefit in addressing coronary artery disease, which is a major contributing factor to heart attacks and other cardiovascular illnesses.
Certain individuals with chronic obstructive pulmonary disease, a serious lung problem often abbreviated as COPD, have benefitted from ozone therapy.
Ozone therapy has enjoyed relative effectiveness in remediating tissue damage precipitated by wounds. Specific examples include foot ulcers associated with diabetes and various skin ailments.
Immune System Disorders
People with various immune system conditions, especially chronic fatigue syndrome, have experienced discernible improvement after undergoing ozone therapy. Moreover, researchers have found that the remedial protocol might help those stricken with the human immunodeficiency virus, sometimes abbreviated as HIV.
Ozone therapy has enjoyed a modicum of success in addressing significant liver disorders like hepatitis and cirrhosis. Additionally, the treatment has also been employed as means of fostering liver detoxification.
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Is Ozone Therapy Safe To Use
Medical Ozone gas can be safely used by a professional qualified and trained practitioner.
Simultaneously all practitioners are trained in all areas of health and safety to conduct Ozone Therapy safely as a service to the public.
As Medical Ozone gas is an irritant to the lungs, it should not be directly breathed in. Therefore, when managed correctly medical ozone can be used safely to limit exposure.
Purpose Of The Procedure
Chronic back pain due to spine issues is managed using a number of approaches, such as physical therapy, oral medications, and local injectionsincluding nerve blocks and steroids.
Surgery is a treatment option as well, however, surgery is not recommended for low back pain that does not have a clear explanation.
Pain-inducing spine problems, which tend to be more common among people over 65, tend to limit physical activity. Often, with these spine conditions, the spinal bones or the cartilaginous discs in between the spinal vertebrae compress the spinal nerves and other structures near the spine, causing pain.
In the treatment of chronic back pain, ozone injection has been studied in the setting of herniated disks, spinal stenosis , and failed back surgery syndrome.
In research, the procedure is used as an adjunct to other back pain treatments, such as steroid or anesthetic injections.
Results of a 10-year follow-up study of patients who were treated with experimental ozone injection for disc herniation with chronic back pain suggested the procedure was safe and may have helped reduce their symptoms.
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Ozone Therapy: A Comprehensive Cure For A Wide Range Of Diseases And Conditions
Ozone therapy draws its strength from its in-built oxidizing power and ability to kill all types of microorganisms. It has a curative effect on a wide range of diseases and conditions, including the ones that are critical in nature. Medical ozone therapy has unparalleled potential to treat and cure infections, disorders, and even metabolic malfunctions.
Also, it has no serious drawbacks or reactions, unlike drugs, etc. It only requires precise medical administration in regulated amounts to ensure proper healing and cure.
Hence, it is a reliable and effective cure that is all set to revolutionize the medicine, healthcare, and well-being industry in the coming years.
One Of Many Sham Treatments Marketed For Chronic Lyme
Those who have received fake diagnoses like chronic Lyme or toxic mold illness often pursue harmful treatments in desperate attempts to feel better. In a 2015 scientific review, ozone therapy was among 30 unorthodox Lyme therapies without evidence for efficacy.
The CDC warns:
Antibiotics are the only known effective treatment for Lyme disease, but a quick search on the internet will introduce you to other untested remedies that claim to cure Lyme disease or chronic Lyme disease. These productsavailable online or from some health care providersmay be dangerous, deadly, or simply a waste of money.
Ozone therapy is at the same level of quackery as fake cancer vaccines made from urine and illegal cancer drugs imported from overseas.
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Why Is Ozone Therapy Illegal
by Paola Dziwetzki | Aug 20, 2020 |
When it comes to ozone therapy there is the perception that it is not only dangerous, but also illegal. And that although ozone therapy dates back at least 150 years, is safer than most over-the-counter drugs, and has had less documented fatalities than chiropractic. So then why would it be illegal to practice ozone therapy?
Fact is, its not. Although the FDA says that ozone is a toxic gas with no known medical use, ozone therapy is currently being legally practiced in 47 US states and most other countries in the world.
Medical doctors hold far reaching powers which authorize them to use a wide range of treatments, including those not approved by the FDA.
In addition, in the past few decades many states have passed legislation which approved the use of alternative and complimentary medical treatments by various licensed health care providers.
Still, it is true that the FDA and other regulatory agencies are sending out mixed messages when it comes to ozone therapys legality.
Lets try to untangle this red tape mess: