What are FDA requirements for opening an oxygen spa bar in the U.S.? Can industrial grade oxygen or oxygen concentrators be substituted for medical oxygen in such use?
Oxygen spa bars have been operating in Japan for many years, and are starting to appear in Canada. These establishments don’t administer oxygen for medical or emergency use in the traditional sense. We have received inquiries as to U.S. Food and Drug Administration’s requirements regarding this type of operation. This is a very interesting business concept; however, medical oxygen is defined as a prescription drug which requires a prescription in order to be dispensed, except as described above, for emergency use. Oxygen spa bar advertising that makes unproven medical claims, e.g., a skin care treatment, anti-aging, hangovers, fatigue, migraine headaches, etc. would render the oxygen a new drug. Further, we would strongly discourage the use of industrial grade oxygen due to the lack of control exercised over industrial high pressure cylinders and the possibility of contamination occurring. As for the use of oxygen concentrators, these are prescription devices and as such would require
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