| |

Suntory
International performed this independent study to
determine whether the partial pressure of oxygen in
arterial blood (Pa02) in the forearm after rest would
change following the oral consumption of Aquagen®.
Three healthy males were tested before and after consuming
Aquagen® over a period of 240 minutes. The dosage
was 6 mL of Aquagen® per person.
Suntory's
conclusion:
"Each subject's partial pressure of oxygen was
relatively stable prior to Aquagen® consumption,
but then rose immediately after Aquagen® consumption.
The partial pressure of oxygen peaked 90 to 120 minutes
after Aquagen® consumption, after which it gradually
dropped, eventually reaching it's pre-Aquagen®
consumption level. In a subject with a particularly
low baseline, a significant increase was detected."
Source: Suntory International of Japan, (May 2nd,
1996)
Antimicrobial, Chemical Assay and Oxygen Test Reports
Summary (January, 1996):
1. Nelson Laboratories, Inc. of Salt Lake City, UT
completed its Antimicrobial Preservative Effect Test
(Lab Number 72984B) for Aquagen®, the Stabilized
Oxygen Supplement ( Batch SL6) at 100% concentration
on March 13, 1995 against the following organisms:
Bacteria: Staphylococcus Aureas (ATCC 6538);
Pseudomonas Aeruginosa (ATCC 9027); Escherichia
Coli (ATCC 8739)
Yeast: Candida Albicans (ATCC 10231)
Mold: Aspergillus Niger (ATCC 16404)
Organisms were assayed for surviving organisms after
0 hours (immediately after application of Aquagen®
and at 7, 14, 21 and 28 days. According to U.S. Pharmacopeia,
a preservative is considered effective if the number
of bacteria recovered is not more than 0.1% of the
initial concentration by the 14th day; the number
of molds and yeasts recovered per ml remains at or
below the initial concentration during the first 14
days; the number of organisms per ml remains at or
below the designated levels during the remainder of
the 28 day period.
Nelson
Labs reported:
"The test product reduced all of the challenge
organisms below the detectable limits at time 0 sample
interval. No organisms were recovered from the product
throughout the remainder of the test. The test product
(Aquagen®) meets the USP requirements for an effective
Antimicrobial preservative against the standard test
organisms."
2. Nelson Laboratories, Inc. of Salt Lake City completed
its Modified Antimicrobial Preservative Effect Test
(Lab Number 75705) for Aquagen®, the Stabilized
Oxygen Supplement (Batch SL6) at 50% concentration
on April 10, 1995 (Laboratory Number 75705), protocol
Number 950833-1) against the following organisms:
Bacteria:
Staphylococcus Aureas (ATCC 6538); Pseudomonas Aeruginosa
(ATCC 9027); Escherichia Coli (ATCC 8739)
Yeast: Candida Albicans (ATCC 10231)
Mold: Aspergillus Niger (ATCC 16404); Aspergillus
Flavus (ATCC 9643)
Organisms
were assayed for surviving organisms after 0 hours
(immediately after application of Aquagen®) and
at 24 hours. The table below is Nelson Lab's summary
which indicates that all four organisms were effectively
controlled at both 0 hour and at 24 hours 99.9%
|
|
|
Staphylococcus
Aureus
(ATCC 6538)
|
CFU/ml
count
Percent
Reduction
|
1,193,333
N/A
|
<
10
99.9%
|
<
10
99.9%
|
|
Pseudomonas
Aeruginosa
(ATCC 9027)
|
CFU/ml
count
Percent
Reduction
|
3,873,333
N/A
|
<
10
99.9%
|
<
10
99.9%
|
|
Esheriria
Coli
(ATCC 8739)
|
CFU/ml
count
Percent
Reduction
|
1,303,333
N/A
|
<
10
99.9%
|
<
10
99.9%
|
|
Candida
Albicans
(ATCC 10231)
|
CFU/ml
count
Percent
Reduction
|
1,180,000
N/A
|
<
10
99.9%
|
<
10
99.9%
|
|
Aspergillus
Niger
(ATCC 16404)
|
CFU/ml
count
Percent
Reduction
|
297,333
N/A
|
<
10
99.5%
|
<
10
99.9%
|
|
Aspergillus
Flavus
(ATCC 9643)
|
CFU/ml
count
Percent
Reduction
|
1,742,333
N/A
|
<
10
99.5%
|
<
10
99.9%
|
|
3.
Dr. Joseph Montelcalvo, Jr., PhD, of Central Coast
Consulting, completed a preliminary study of the Antimicrobial
effect of a 1% solution of Aquagen® on Cat's Claw
(herb) on July 25th, 1995. He wrote: "We find
that Aquagen® is very effective when used as a
sanitizing disinfectant on the Cat's Claw. The results
of this study show that on average the 1% SL-12-1
product showed a reduction of 85.7% of total molds
on the powder and 82.9% reduction on the chips...Based
on these findings, Aquagen® shows great promise
as a sanitizing agent for herbs, spices and other
agricultural products where a significant reduction
in mold colony units is required to enhance / maintain
quality, reduce spoilage and extend shelf life."
4. Dr. Joseph Montelcalvo, Jr., PhD, of Central Coast
Consulting, completed a second study of the Antimicrobial
effect of a 3.5% solution of Aquagen® on Cat's
Claw (herb) chips on October 12, 1995. He concluded:
"Aquagen® showed a percent mold reduction
of 85.56% and 94.23% after 5 and 15 minutes respectively.
Yeast reduction as a function of Aquagen® treatment
was 88.19% and 91.1% after 5 and 15 minutes of treatment.
These results clearly indicate that Aquagen® treatment
at 3.5% level can reduce over 94% of the level of
mold and over 91% of yeast cell contamination...On
the basis of the data obtained from this study, Aquagen®
is very effective and its effectiveness should be
relatively the same on agricultural products such
as apples, pears, grapes, carrots, etc. Therefore,
there is great need in the industry to find a sanitizing
compound that could take the place of chlorine (Chlorine
Dioxide). Aquagen® shows promise based on the
available data and information provided to me to date."
Chemical
Assay Tests:
1. Chemtech Analytical Laboratory in Salt Lake City,
UT completed a certificate of analysis (Lab #U011783)
on ten drops of Aquagen® (Batch SL18B) in 8 ounces
of distilled water on July 27th, 1994. The lab's analysis
determined that the TDS level in mg/L was 202 with
almost every parameter test near or below the lab's
minimum detection levels. Only Chloride (at 145 ppm
or mg/L). Nothing on the lab analysis approaches FDA's
or EPA's maximum contaminate levels or is an unapproved
constituent in a food supplement.
2. Pace Incorporated Environmental Laboratories in
Camarillo, CA completed a laboratory analysis (Lab
# CK-5540-1) on a 100% solution of Aquagen® on
November 15, 1994. The lab determined that Aquagen®
contains no sodium chlorite (NaClO2) no any chlorite
(ClO2).
3. Pace Incorporated Environmental Laboratories in
Camarillo, CA completed a laboratory analysis (Lab
# CK-6317-4) on a 100% solution of Aquagen® on
January 4th, 1994. It was determined that Aquagen®
contains trace nutritional minerals including Calcium
(52 mg/L) and magnesium (23 mg/L).
4. John H. MacDonald, Ph.D, Senior Scientist at USANA,
Inc. in Salt Lake City, UT, analyzed Chemtech Aquagen®
Assay Report #U011783-SL-18_B sampled 7/21/94 and
determined: "I can find no substance with levels
high enough to indicate toxicity to anyone consuming
Aquagen®. The sodium levels at only 9.24 ppm are
well below the recommended daily reference values
determined by the U.S. Government. Toxic metals (lead,
mercury & arsenic) are virtually undetectable
as are nitrate levels and other trace minerals. Aquagen®,
in its current formulation, is totally safe to the
human body.
FDA
Review:
M. Val Miller, Attorney at Law, specialist in FDA
regulations and former Associate Chief Counsel for
the FDA in Washington, D.C. wrote: "Clearly,
Aquagen International's product is subject to the
conditions of the D.S.H.E.A. (Dietary and Supplement
Health Education Act). By definition, a dietary supplement
means, 'a product intended to supplement the diet
by increasing the total dietary intake that bears
or contains one or more of the following dietary ingredients:
a vitamin, a mineral, an herb or other botanical...'
(See 21 USC p. 321 et. seq.) Aquagen® the stabilized
oxygen supplement is, as a matter of law, a dietary
supplement."
Thomas L. Sawyer, Director, Compliance Branch, Department
of Health and Human Services, Public Health Service
Food and Drug Administration, wrote on October 5,
1995: "We have reviewed your revised package
label, container label and promotional material submitted
and have the following comments. The product Aquagen®
is a dietary supplement as defined in Section 201(f)
of the Federal Food, Drug, and Cosmetic Act (the Act)."
The above information is provided for reference
purposes. Aquagen International does not represent
that this information infers or represents that its
product Aquagen® is designed or may be used for
any medical purpose nor is the provided information
intended to diagnose or treat any medical condition.
Aquagen® the oxygen supplement is designed and
sold as a dietary supplement under the strict regulations
and guidelines of the United States Federal Dietary
and Health Education Act of 1995. No portion of this
report may be reproduced in part or as a whole without
the expressed written permission of Aquagen International.
|