Thomas Henry (26 October 1734 – 18 June 1816) was a surgeon, apothecary and Fellow of the Royal Society of England. In 1776 he speculated, tongue in cheek, that Joseph Priestly’s newly discovered dephlogisticated air (now called oxygen) might become “as fashionable as French wine at the fashionable taverns”. He did not expect, however, that tavern goers would “relish calling for a bottle of Air, instead of Claret”^[1]

Well to some extent that is exactly what is happening. Bring on the O² Bar, the first of which opened in Toronto, Canada, in 1996 and now we have two here in Australia and more on the way.

For around $1 per minute an O² Bar is a kiosk that offers internet access (via iPads) and “non-medical” oxygen which, in Australia, is 90% oxygen mixed with various aromas and comes complete with claims, including at least two of which are therapeutic, of:

• increased energy
• an uplifted refreshing feeling
• clearing the mind
• relief of toxic headaches such as hangovers
• relief of stress
• promotion of higher concentration levels
• detoxification
• anti-aging properties.

Of the four primary layers of atmosphere it is Earth’s troposphere which contains the air we inhale and it is roughly composed of:

• 78% nitrogen
• 21% oxygen
• 0.96% argon
• 0.04% carbon dioxide, helium, water, and other gases

Whilst oxygen is the essential component of all breathing gases the use of O2 bars may well be just an expensive way to browse the internet. According to Wikipedia, “…no long-term, well-controlled scientific studies have confirmed any of the proponents’ claims. Furthermore, the human body is adapted to 21 percent oxygen, and the blood exiting the lungs already has about 97 percent of the oxygen that it could carry bound to hemoglobin(sic). Having a higher oxygen fraction in the lungs serves no purpose, and may actually be detrimental.”^[2]

Hyperoxia results from breathing high partial pressures of oxygen causing an excess of oxygen in body tissues and can lead to oxygen toxicity. Oxygen toxicity is characterised by visual and hearing abnormalities, unusual fatigue, muscular twitching, anxiety, confusion, in-coordination, and convulsions.

In the United States of America the Federal Food, Drug, and Cosmetic Act, states that any type of oxygen used by people for breathing and administered by another person is a prescription drug. Therefore the drug oxygen is covered by Section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 321(g)(1)).^[3] and Oxygen bars are prohibited from making medical claims in relation to supplementary Oxygen.

In Canada, the Canadian Society of Respiratory Therapists simply says that “As health professionals, we cannot ethically or morally support providing oxygen therapy to those who do not require it”

In Australia the Therapeutic Goods Administration (TGA), which is part of the Australian Government Department of Health and Ageing, is responsible for regulating therapeutic goods including medicines, medical devices, blood and blood products. The TGA website states “Essentially, any product for which therapeutic claims are made must be listed, registered or included in the Australian Register of Therapeutic Goods (ARTG) before it can be supplied in Australia.”^[4]

According to the TGA document “Australian medical devices guidance document number 35”^[5] there is no mention of a division between medical or non-medical oxygen and as such it is referred to simply as “Oxygen”. The status for oxygen in the ARTG is that of “Medicine”, which certainly gives at least the appearance that regardless of its source the supply of oxygen is covered by TGA regulations and especially when any therapeutic claims are made.

When initially approached for a statement regarding Oxygen Bars a ‘spokeswoman’ for the TGA advised The Kritic that “Oxygen gas may only be considered a medicine if it is intended for therapeutic purposes.” Apropos the previously listed claims of relief of headaches and relief of stress would indeed see the oxygen supplied by an O² Bar as meeting the definition of a therapeutic good, or so you would think. The TGA have this little rider hidden within their regulations – “Some products, even though they may technically meet the definition of a therapeutic good, are declared not to be therapeutic goods under section 7 of the Therapeutic Goods Act 1989.

The ‘spokeswoman’ continued with “The oxygen bar products do not appear to use medical grade (regulated) oxygen, and would therefore be considered non-therapeutic oxygen. Even products used to deliver non-therapeutic oxygen, such as a mask or tube, would not be considered a therapeutic product, and would therefore not be regulated by the TGA.” Medical grade (regulated) oxygen?? According to their own document – “Australian medical devices guidance document number 35” there is no division between medical or non-medical oxygen or any other flavour of oxygen.

The response finished with a suggestion that The Kritic take it up with State authorities of which three were suggested:

1. NSW Health Department
2. Department of Fair Trading
3. ACCC – Australian Competition and Consumer Commission (Which is actually a federal body.)

After explaining the reason for my enquiry I had quite a lengthy discussion with a spokesperson for the NSW Health Department – Pharmserv division and he stated categorically that Oxygen is not listed as a poison therefore this matter does not fall under the purview of the NSW Health Department. Additionally he stated that “given the proponents are making quite obvious therapeutic claims that I should take the matter back to the TGA.”

Fair Trading NSW basically gave me the same run around, it is nothing to do with them unless I can prove the misleading claims and suggested it would be better if I took it up with the TGA as the governance of goods making therapeutic claims lies with that department.

The ACCC simply stated that this is not a matter for the ACCC and suggested, as with the other departments, that I take the matter with the TGA.

In a further enquiry to the TGA, The Kritic pointed out the incongruity between the statement provided and the information from the website. It was also pointed out that the above three departments, those recommended by the TGA, state that governance of this matter lies with the TGA. The following question was also included: “Is the TGA now prepared to assess, for safety or efficacy, the therapeutic benefits claimed by Oxygen Bars?” To which the following response was received: “Our original response to you stands.”

So if you decide to patronise one of these Oxygen Bars and spend $60.00 an hour on flavour infused oxygen do so with the knowledge that there is no department in Australia overseeing the use of Oxygen or Oxygen supply products and the ingredients of the various aromas in these premises and despite the fact that relevant agencies overseas have misgivings over the use of excess oxygen and the contents of some or all of the aromas nobody here seems to give a damn.

[1] Wikipedia – Thomas Henry (apothecary) – https://en.wikipedia.org/wiki/Thomas_Henry_(apothecary)
[2] O2 bar Health _benefit claims – https://en.wikipedia.org/wiki/O2_bar#Health_benefit_claims
[3] Section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 321(g)(1)) – https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm124716.htm#GLOSSARY
[4] Therapeutic Goods Administration – https://www.tga.gov.au/about/tga.htm
[5] Australian medical devices guidance document number 35 (Page 9, 5. Body fluid replacements and nutrients: Oxygen & other medical gases Status for ARTG: Medicine) – https://www.tga.gov.au/pdf/devices-guidelines-35.pdf