*O4 Stabilized Oxygen is a dietary supplement authorized by all laws regulating dietary supplements under the Dietary and Supplement Health Education Act of the U.S. Food and Drug Administration (FDA) is regulated. (DSHEA) of 1994.
*O4 Stabilized Oxygen does not contain any substances regulated by the F.D.A. or E.P.A..
*O4 Stabilized Oxygen does not contain any substances that are subject to other regulations that restrict their sale and distribution in the United States of America and the European Union (EU).
*O4 Stabilized Oxygen has been approved by the Office of Special Nutritionals, Department of Health & Human Services, U.S. Food and Drug Administration, Washington, D.C., in accordance with the requirements of the Federal Food, Drug and Cosmetic Act (FD&C Act) and the of the Fair Packaging and Labeling Act (FPLA), a Certificate of Free Sale has been issued to.
*AntiDoping Certification: O4 Stabilized Oxygen has the internationally recognized BSCG Certified Drug Free and internationally valid BSCG Certified Drug Free® certification.
Momentary exception in Germany and thus EU:
Within the EU, O4 is currently not to be used as a food supplement because of the issue to be clarified (whether it falls under the Novel Food Regulation).