Frequently Asked Quetsions
This requires knowledge of anatomy, injectables, and ozone and is a hands-on training.
- CFR – Code of One of my patients showed me this 2019 FDA article stating that Ozone therapy should not be used or marketed for any medical conditions. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=801.415 CFR – Code of Federal Regulations Title 21 The information on this page is current as of April 1 2019. For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). Sec. 801.415 Maximum acceptable level of ozone. (a) Ozone is a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy. www.accessdata.fda.gov Were you guys aware of this? None of the educational presentations mention this, except for the old FDA statement from 1976 of unknown effect on humans. I was really excited about the Ozone therapy knowing its effectiveness but I’m really concerned about the legal aspects of this business. Is it legal to use Cumulus Ozone Generator considering the following statement: In such a manner that it generates ozone at a level in excess of 0.05 part per million by volume of air circulating through the device or causes an accumulation of ozone in excess of 0.05 part per million by volume of air (when measured under standard conditions at 25 deg. C (77 deg. F) and 760 millimeters of mercury) in the atmosphere of enclosed space intended to be occupied by people for extended periods of time, e.g., houses, apartments, hospitals, and offices. This applies to any such device, whether portable or permanent or part of any system, which generates ozone by design or as an inadvertent or incidental product. b. This statement is assuming the ozone is being vented into the air where breathing and lung irritation can occur.