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EQUINE OXYGEN
CERTIFICATIONS & STANDARDS

ABOUT OXYGEN
HORSES NEED OXYGEN
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F.D.A. Regulations:
H2O-BOO2STŪ EQUINE OXYGEN is a dietary supplement regulated by all laws governing dietary supplements under the U.S. Food and Drug Administration's (FDA) Dietary and Supplement Health Education Act. H2O-BOO2STŪ EQUINE OXYGEN contains no substances regulated by the F.D.A. or E.P.A. The F.D.A. has recently determined that supplements may no longer be classified and regulated as food additives. H2O-BOO2STŪ EQUINE OXYGEN contains no substances subject to any other regulations which would prohibit its sale and distribution in the United States of America.

H2O-BOO2STŪ EQUINE OXYGEN has been issued a Certificate of Free Sale by the Office of Special Nutritionals, Department of Health & Human Services, U.S. Food and Drug Administration, Washington D.C. pursuant to the requirements of the Federal Food, Drug and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). (Certificate on file with Area International. Copies can be provided upon written request.)  F.D.A:  “…we can state that such a product may be freely marketed in the United States or exported provided that the product conforms to all applicable United States laws and regulations.”
 

GMO Certification
(Genetically Modified Organism)

H2O-BOO2STŪ EQUINE OXYGEN is not derived from genetically modified starting raw materials, or additives that are derived from genetically modified organisms, and does not contain detectable levels of genetically modified materials, (known as PCR negative). It is our understanding that the EU labeling requirements are based on the presence of detectable levels of transgenic material. Based on this information, H2O-BOO2STŪ EQUINE OXYGEN will not, on its own, require the labeling of these foodstuffs and food ingredients as indicated in (EC) No. 1829/2003 and (EC) No. 1830/2003, (which came into law on the 7th of November, 2003) on the authorization, labeling, and traceability of genetically modified organisms in food and feed.

 

BSE Certification
(Bovine Spongiform Encephelitis)

H2O-BOO2STŪ EQUINE OXYGEN is completely free from any beef, chicken, fish or pork derivatives, natural or synthetic hormones, hormone residues, antibiotics, insecticides, rodenticides, radioactive substances, alcohols, peroxides, chlorindioxit, food additives which are internationally banned for human consumption, or any substances which are banned by ministerial decrees, and does not contain any natural substances which may harm the physiological and/or behavioral functioning of the human body. H2O-BOO2STŪ EQUINE OXYGEN is not known to cause any side affects or any harm to the human body or tissues.


TOXICITY
Independent analysis of H2O-BOO2STŪ EQUINE OXYGEN further supports the conclusions that the Sodium levels of the concentrated solution (25% oxygen by volume) were found to be 6,400 mg/L or approximately 4.8 mg per serving. At the daily dose of 2.25 mL of H2O-BOO2STŪ, sodium consumption from the concentrated solution of H2O-BOO2STŪ EQUINE OXYGEN was well below the recommended daily reference safety standards established by the U.S. Government.

Toxic metals, including Lead, Mercury and Arsenic, are undetectable. Nitrate levels and other trace minerals are also undetectable by all normal testing standards.

The current formulation of H2O-BOO2STŪ EQUINE OXYGEN has been found to be "...totally safe to the human body."

Lab assays and analysis of H2O-BOO2STŪ EQUINE OXYGEN are available upon written request.

Hazardous Polymerization:
Will not occur.

Respiratory Protection:
None Required

Carcingenicity:
NTP: NO
IARC: NO
OSHA: NO

LD50/LC50 MIXTURE:
None Specified by Manufacture
Hazard Ratings: Health = 0
(0=NONE, 4=EXTREME)
Flammability = 0
Contact = 0
Reactivity = 1


Statement of Quality Control Standards
and Good Manufacturing Practices (GMP)

This is to certify that H2O-BOO2STŪ EQUINE OXYGEN's manufacturing facility has received a Processed Food Registration Certification from the State of California, Department of Health Services, Food and Drug Branch, Registration Number 0022118. H2O-BOO2STŪ EQUINE OXYGEN's  manufacturing facility is registered with the State of California, U.S.A. to manufacture, pack or hold processed food, including dietary food supplements, in accordance with the provisions of California Department of Health Services Division 104, Section 110461, of the California Health and Safety Code. This facility maintains an approved and certified food-quality clean-room processing facility that complies to all local, state and federal GMP practice guidelines.

 


NOTICE: This information is intended for educational purposes only and should not be construed as medical advice. These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease. Consult a qualified veterinarian before using any nutritional supplements on your horses.

This information may not be reproduced or utilized in any form or by any means, in whole or in part, electronic or mechanical, including photocopying, recording, or by any information storage and retrieval system, without prior written permission of Area International, Inc. 

Racing picture above is called “GALLOWAY & COMPANY”  from the Collection of Randy Galloway and Don Walker.

 

 
 

Đ 2009 H2O-BOO2STŪ AQUACEUTICALS