REGULATORY COMPLIANCE    08 July 1999

In the operation of this Oxygen Bar, there are no devices, food, drugs or cosmetics regulated by the FDA, In use. The oxygen used is filtered from ambient air on sight using Pressure Swing Adsorption generator technology created exclusively for use in an oxygen bar.

We are compliant with the (CGMP Dec. 1996) the Oxygen Generator is in use it is not a medical concentrator as defined by the USP but a Pressure Swing Absorption generator specifically designed and tested for use in an oxygen bar.

The "Nose Hose" is either an aviation cannula used for passenger comfort below 18,000 feet M or an oxygen bar nasal supply hose manufactured exclusively for use in an oxygen bar. Both are unlawful for use to dispense USP (medical oxygen) by federal law. The containers bear a warning label that contains the words "Use of this product to dispense medical oxygen in the USA is a violation of Federal Law".

The oxygen bar exists to provide a new experience for any customers who choose to use it. Statements regarding the benefits of oxygen are prohibited. Written advertising bears the words "These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease".

The FDA has inspected several of our oxygen bars and has never cited or even sent a letter of non-compliance from any of the 11 inspections they have completed.

The American Lung Association has Issued a statement regarding the use of oxygen. "The prolonged use of Oxygen (in excess of 4 hours) is an irritant to the lungs. Short exposure less than 30 minutes poses little or no risk however there is probably little benefit."

The 1994 nutritional supplement act provides room for the legal existence of alternative products such as herbal supplements. Oxygen (02), Ozone (03), Vitamin 0, a stabilized form of oxygen and literally thousands of other products.