The FDA does not regulate or approve OTC oxygen and recommends seeing a health care provider to determine how much oxygen you should take.
The AARC cited concerns about the safety of OTC oxygen for people other than healthy athletes or those traveling in areas with high altitudes.
The AARC’s review of OTC oxygen highlighted an important warning label on canisters that reads “This product is not intended to diagnose, treat, cure, or prevent any disease. For Recreational Purposes Only. This product is NOT for Medical or Prescription use.”
The ALA also issued a warning about using non-prescription oxygen concentrators to treat respiratory conditions.
“You may have seen online advertisements for non-prescription, portable oxygen concentrators. While these are often more affordable, if you have a lung disease like COPD or pulmonary fibrosis, which requires you to use prescription oxygen, these OTC devices may not meet your oxygen needs, and it would be important to speak with your health provider before purchasing,” the ALA said in a statement.
The Pulmonary Fibrosis Foundation (PFF) recommends patients only use FDA-approved devices and warns canned oxygen may provide an inadequate flow.
The PFF acknowledges people may opt for OTC oxygen to save money because medical-grade oxygen is more expensive. To address this issue, PFF joined 23 other patient, professional, and industry groups to advocate for legislative changes to supplemental oxygen supply, education, and reimbursement.
Additionally, health care providers warn about purchasing OTC oxygen concentrators instead of prescription models. In a test of three different OTC oxygen concentrators, researchers found two were not suitable for people with pulmonary conditions.
“Though these [OTC] devices are not explicitly advertised for this purpose, the marketing material and documentation associated with these devices may suggest the possibility of medical use, which may be confusing and/or misleading to consumers,” the study concluded.
While OTC oxygen may be safe for some people, the lack of regulation makes it an unsafe alternative to prescription devices.