Why is ozone therapy CE approved but not FDA approved?
You won’t find ozone therapy offered in the majority of doctor’s offices and medical clinics across the United States. Nor is it advertised on TV or any mainstream sources as beneficial. But if it truly does all that we and many others claim it can, shouldn’t it be touted as the answer to so many issues? Probably. But here’s why it’s not right now…
Although ozone has been in use for medical purposes since World War I, it still hasn’t gained the approval of the Food and Drug Administration (FDA) in the United States. Currently it is CE approved only.
What does it mean to be CE approved?
CE stands for the French “Conformité Européenne”, which translates to “European Conformity”. CE is the FDA’s European counterpart, and sets the standard for health, safety, and environmental protection in Europe. Any products bearing the CE marking must meet the requirements.
Ozone therapy has enjoyed CE approval for many years, which is one of the reasons why it’s more prevalent in Europe than in the United States. The other reason is that, despite a constantly increasing amount of research and users, the FDA’s official statement is still that “ozone is a toxic gas with no known medical benefit.”
Why? Ozone is defined as a “toxic gas” primarily on the basis that it’s harmful to inhale. And while it's never safe to breathe ozone in, true ozone therapy is administered safely via the bloodstream or body cavities that avoid the lungs.
Two reasons ozone therapy isn't approved by the FDA
Simply put, ozone therapy isn’t approved by the FDA for two main reasons: it isn’t patentable, and there’s not enough money to get it through the approval process.
Ozone therapy is not patentable
In order to understand why ozone therapy isn’t patentable, you need a basic understanding of what qualifies for a patent. “The USPTO defines patentable subject matter as any "new and useful" process, machine, manufacture or composition of matter. Machines or processes are patentable subject matter, but the laws of nature are not. So, you can patent a machine for sorting packages, but you can't get a patent for sunlight.”
Even though ozone generators produce ozone for medical use or otherwise, ozone is still a natural molecule, not man made. Nobody does or can own exclusive rights to ozone. So getting a patent for ozone itself would be akin to getting a patent for sunlight, something that everyone owns and can freely access.
The qualifications for patent protection are:
- The invention must meet Congress' definition of patentable subject matter, which is any "new and useful" machine, manufacture, process, or composition of matter. No patents on products or laws of nature, such as sunlight, for example.
- The subject matter must be useful, or offer "utility." This applies only to utility patents, however. Design patents and plant patents are exempt.
- The invention must be new, or "novel."
- The invention can't be obvious, which means its purpose can't simply be the logical extension of something that is already patented. This requirement is referred to as "non-obviousness."
- The inventor can't disclose the invention to the public before filing the application for the patent. In other words, the patent must be a secret at the time of filing.
#1 disqualifies ozone therapy from receiving a patent, as ozone therapy is simply the application and redirection of ozone, a naturally occurring molecule.
#3 disqualifies ozone generators from receiving a patent, as there already exists prior art (currently active patents for the same or similar inventions).
So does the FDA require something to have a patent before they will approve it?
No, but it's a good idea. Here’s why. The FDA has become a bloated bureaucracy over the years, to where getting even a single new drug approved can take up to a decade and cost nearly $3 billion. Without patent protection, an individual or organization would risk spending all that time and money getting FDA-approved, just to have somebody else make the exact same product and sell it under the same approval. That’s why it’s so important to have a patented product before attempting to get it approved by the FDA.
Lack of financial gain
But even if ozone therapy was able to be patented (a costly process in its own right), getting it through the gargantuan process of FDA approval would essentially drain all the funds of any group trying to do so.
The majority of medical companies (excepting some of the big pharmaceutical giants with close financial ties to the FDA) have too many expenses of their own to be able to afford a process like FDA approval and still survive.
But some are able to swing it, right? Absolutely. Prescription drugs are very lucrative, as they’re expensive and often require daily use. Companies selling prescription drugs are able to account for the initial dip in finances from receiving a patent and FDA approval, because they’re almost guaranteed to make that money back and then some.
But ozone therapy is at the opposite end of the spectrum cost-wise. While Americans spend an average of $1,112 on prescription drugs every year, they could be getting thousands of ozone therapy treatments for less than $1,000.
Ozone therapy is by far the most cost-effective treatment for the vast majority of people, but it’s this cost-effectiveness that also makes it unrealistic for doctors and medical companies to push for FDA approval.
Unless something big changes in the structure of medical regulation and the FDA itself, you won’t find ozone therapy on the list of things that are FDA-approved for a long, long time (if ever).
However, despite the FDA’s rigid stance on ozone therapy, the CE medical federation has deemed it safe. It’s for this reason that a good ozone generator will have the CE marking on it, meaning it has passed the test and meets the standard of European Conformity.
The CE standard for safety isn’t any lower than the FDA’S, it’s simply a much easier (and for now the only) way to show the safety and certifiability of ozone therapy machines.
"Patent Eligibility Requirements FAQ - FindLaw." https://smallbusiness.findlaw.com/intellectual-property/patent-eligibility-requirements-faq.html. Accessed 26 Jan. 2019.
"Patentable Subject Matter: Everything You Need to Know - UpCounsel." https://www.upcounsel.com/patentable-subject-matter. Accessed 28 Jan. 2019.
"Americans spend more than anyone else on ... - Financial Times." 20 Jan. 2017, https://www.ft.com/content/9338d8fc-dc17-11e6-86ac-f253db7791c6. Accessed 28 Jan. 2019.