Why Is Ozone Therapy Illegal?

​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, it’s 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 therapy's legality.

Let’s try to untangle this red tape mess:

Does the FDA say that ozone therapy is illegal?

In general, the FDA does not make determinations about the legality or illegality of single therapies, since its scope is to regulate drugs, biological products, and medical devices. It does not regulate what doctors do in their practice.

But it does declare ozone a

“toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy”.

Critics of ozone therapy use this as “proof” that the use of ozone in medicine is prohibited.

But, this is not entirely correct.

In fact, there are many FDA unapproved substances which are nevertheless legally administered in the US every day.

For example: homeopathic products are not FDA approved, and yet are legally sold and used by practitioners by the thousands every day. 

The same is true for vitamin C. The FDA did not approve ascorbic acid as a viable cancer treatment, and yet there are many doctors who administer high dose vitamin C IVs to cancer patients without losing their licenses. The only provision: they are not allowed to promote the vitamin infusions as cancer cures.

Dietary supplements are also not FDA approved, and yet they are legally sold by the millions, without vitamin shop owners being hunted down as criminals.

So, there are many things, including ozone, which are not FDA approved and yet are legally practiced on a large scale with the full knowledge of the regulators.

License: Creative Commons 3 – Nick Youngson 

Is the reason why ozone is not FDA approved because it can’t be patented?

Ozone is a naturally occurring gas in our atmosphere, like oxygen or nitrogen. Hence, it can't be patented. Hence, there are no big bucks to be made. Hence, there is no powerful ozone lobby which could influence FDA officials in its favor, like what the pharmaceutical lobby is doing.

At least that's the argument many ozone enthusiasts make.

And there is something to it, but it does not necessarily have to do with the fact that ozone can't be patented. There are products which can't be patented, but which make up huge markets, are highly profitable, and the manufacturers of which have formed powerful associations.

Case in point: vitamins and supplements can't be patented, yet they constitute a global 200 billion dollar market. Consequently, they can afford to have a powerful lobby, namely the Council for Responsible Nutrition (CRN). Already years ago the CRN had enough cash on hand to hire Mel Gibson to make a snazzy commercial. The goal: to keep the government off their backs. Mel's charm seems to have worked, for now at least.

Theoretically, the same could be done for ozone therapy even though it's not as profitable as easily packaged and marketed vitamins. Still, ozone practitioners could organize and seek to influence law makers in ozone therapy's favor.

Whether this would be a good thing is another matter though.

Because the same vitamin lobby which years ago sought to keep the regulators away, is now the number one driver for more regulation. They have recently proposed to “allow FDA to know when new products are introduced, quickly identify and act against dangerous or otherwise illegal products (…).”

Translated: Established vitamin manufacturers want to use government power to be automatically shielded from new innovative products and consequently new competitors. Crony capitalism at its best, or rather its worst. There is no reason to believe that an ozone lobby would be exempt from going down the same path.

Bottom line: the reason why the FDA hasn't changed its stance on ozone has more to do with the lack of a special interest group than with the fact that ozone can't be patented.

Does the FDA have a vested interest in declaring ozone toxic and useless?

Another often quoted argument about why the FDA is opposed to ozone is the fact that the agency is majorly funded by pharmaceutical corporations. According to FDA critics, this creates a conflict with its official mandate, namely to “protect the public”. 

We know that most advisors on whose recommendations the FDA commissioners base their rulings, receive million dollar kickbacks from drug manufacturers. According to the FDA's own website, the “human drug” division alone is financed more than 60% with fees from the corporations the FDA is supposed to regulate. In addition, there is a constant revolving door between the FDA and the pharmaceutical industry.

Many ozone experts maintain that ozone is better for certain conditions than drugs. Dr. Olmedo, a Spanish oncologist, claimed in the past that ozone therapy was more effective against cancer than chemotherapy. Although he seems to have changed his opinion since, he does admit that no one ever investigated in earnest the question whether ozone could be an effective cancer treatment or not. 

But, let's play this crazy idea through for a moment: Let’s assume that his original statement was right and that ozone therapy is indeed a more powerful approach for cancer than chemotherapy. (Which would not be that difficult, given that chemotherapy was found to increase the 5-year survival rate by only 2.3% or less.)

And let’s say that the FDA approved ozone. Who would lose in this scenario and how much?

Chemotherapy can cost hundreds of thousands of dollars per year per patient. The cancer drug market is a 100 billion dollar industry. If ozone therapy was approved as an anti-cancer drug, it would bankrupt many pharmaceutical companies. And, as a consequence, it would shrink the FDA's budget dramatically.

I wonder how many FDA officials would look forward to forgo their salaries in order to “protect the public” in such a case?

I'll go out on a limb here, and assume: not many. Wouldn't it be more in the interest of FDA bureaucrats to create the current anti-ozone spin instead? And to convince consumers that they are “protecting them” by declaring ozone to be a toxic and useless gas? This would then allow them to keep their government jobs and keep cashing in lucrative pharma industry kickbacks. 

But hey, this is only a crazy idea, since everyone knows that ozone does not cure cancer.

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, see here and here. 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, section 801.415 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 it's legal to use it.

And although section 801.415 says that devices which produce ozone are not medical devices, they nevertheless satisfy the FDA definition of medical devices.

Having fun yet? Good, because there is more:

The FTC (Federal Trade Commission) does not allow you to advertise that

“a product or service can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made.”

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.

But, you may say, ozone is not a drug, so the “Right to Try” act does not apply. Well, not quite, since according to the act's definition an “investigational drug” is one “that has not been approved or licensed by the FDA for any use”, which does apply to ozone.

One could also argue that ozone falls under FDA's “Expanded Access” policy which allows access to an investigational medical product for or anyone with a serious or life-threatening disease “when no comparable or satisfactory alternative therapy options are available”. 

Fact is, that the right to use ozone therapy, like essentially everything in our lives, is at the bureaucrats’ mercy. Just like politicians were able to ban a drug with a 65 years long safety track record when it came to protecting the interests of big corporations, they could easily do the same to ozone therapy, probably even without going through the trouble of introducing new legislation. 

Is the use of ozone therapy illegal when treating patients with Coronavirus? Not in Texas, said the head of the state medical board.

Are doctors who practice ozone therapy acting legally?

In spite of the onslaught of rules and regulations, doctors wield wide ranging authorities about what drugs and treatments they can use in their practice. Although there may be differences in how the state medical boards rule when dealing with violations, in general they do not regulate specific practice procedures.

So, when the government sent a warning letter to Dr. David Brownstein who was using intramuscular ozone injections (among other alternative methods) to treat Covid-19 patients, it was because he was advertising it as a possible cure, not because he was administering ozone therapy.

The same applied to a wellness center in Dallas, Texas, which was offering ozone treatments for Covid patients. They did not get in trouble for offering ozone services, but for making what the FTC deemed unsubstantiated claims about them.

And that although the state medical board in Texas went even so far as to interpret their CAM legislation to mean that doctors are explicitly allowed to treat Covid-19 patients with ozone therapy.

In addition, many states have passed so called health freedom or CAM (complimentary and alternative medicine) laws to make it easier for naturopaths and other alternative health care providers to legally treat patients, some of whom use ozone therapy.

So, in spite of Wikipedia trying its best to manipulate the public into thinking that doctors who practice ozone therapy engage in criminal activity, I could not find a single case in the past 30 years where a legally practicing, licensed doctor was arrested or had his license revoked specifically for using ozone therapy in the US.

Is ozone therapy illegal in other countries?

Ozone therapy is being practiced nearly all over the world. It's estimated that worldwide there are around 30,000 ozone therapy practitioners.

A growing number of countries have passed legislation, have implemented rules or regulations, enacted decrees of their health authorities, or have set precedents in courts which protect the medical practice of ozone therapy.

Ozone therapy appears to be widely practiced in India, a country with 1.4 billion people.

It's also well represented in China, another country with nearly 1.5 billion inhabitants and an estimated 5,000 practicing ozone doctors. China regularly engages in and publishes research in ozone therapy.

When I visited Russia a few years ago I visited two of the largest hospitals in Nizhny Novgorod, a city with over a million people. Both clinics had their own ozone departments. Ozone therapy has received the blessing of the Russian Health Ministry and is practiced there legally although it's not covered by state mandated health insurance.

There are several thousand ozone practitioners in Europe. Nearly every European country has its own association of ozone doctors. A medical university in Rome, Italy, offers a Master's degree in ozone therapy.

There appears to be only one country which has gone against the trend towards ozone therapy legalization, namely Malaysia. Three years ago the Malaysian authorities have banned ozone therapy, and that although there was not a single documented case of an accident due to ozone therapy.

Ozone therapists are represented on every continent (except the South Pole) and in nearly every country where their use of ozone is either peacefully tolerated or legally protected. For now …

Featured image: license: designer491, bigstockphoto.com

Related reading

Which countries use ozone therapy for Coronavirus infections?

Does drinking ozonated water damage the gut biome?

How to get the benefit of ozone therapy for US$ 100 or less?

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