Banned
Sugars, Sweeteners & Carbohydrates |
 |
Various
scientific commissions have determined that Stevia’s
potential for toxicity renders it an inappropriate sweetener
in humans: |
| •
|
In
2007, Stevia glycosides were been shown to exhibit genotoxicity
(Nunes AP, Ferreira-Machado SC, Nunes RM, Dantas
FJ, De Mattos JC, Caldeira-de-Araújo A (2007). "Analysis
of genotoxic potentiality of stevioside by comet assay".
Food Chem. Toxicol. 45 (4): 662–6). |
| •
|
The
National Academy of Sciences has determined
that “Metabolically Activated Steviol, the Aglycone
of Stevioside, is Mutagenic.” |
| •
|
The
European Commission, Directorate-General XXIV Consumer
Policy and Consumer Health Protection, Scientific Committee
on Food, Opinion on Stevioside as a Sweetener,
concluded that: |
| |
“The
review on the safety of stevioside was updated by the
Committee in 1989 (2) and 1999. In both these opinions,
several questions of concern were raised by the Committee
regarding the purity of the extracts that had been tested,
the metabolism of stevioside, mutagenicity of metabolites,
questionable chronic toxicity and carcinogenicity studies,
and finally fertility and teratogenicity studies not
performed according to Good Laboratory Practice. |
| |
In
conclusion, the Committee could not accept its use based
on the submitted documentation and stevioside extracts
from Stevia rebaudiana leaves were considered as toxicologically
not acceptable.” |
Beverages
that contain STEVIA AND/OR STEVIOL GLYCOSIDES do not
qualify for the “Certified Natural Beverage” mark. |
|
CENTER
FOR SCIENCE IN THE
PUBLIC INTEREST
WASHINGTON, D.C. |
|
SAFETY
SUMMARY
POSITION ON STEVIA: May pose a risk and needs to be better
tested. Try to avoid.
REBIANA: TRUVIA & PUREVIA
Natural, high-potency sweetener: used in diet beverages. Also
called rebaudioside A; sold under brand names Truvia and PureVia.
Purified from crude extracts of stevia, which itself is sold
as a table-top sweetener at some "health food" stores.
STEVIA, which is about 100 times sweeter than sugar, is obtained
from a shrub (yerba dulce) that is grown in Brazil, Paraguay,
southeast Asia, and elsewhere.
The actual sweet chemicals are the closely related stevioside
and rebaudioside A.
Stevia and its derivatives are said to be the holy grail of
high-potency sweeteners, because they are naturally derived
alternatives to the often-controversial synthetic sweeteners
(saccharin, aspartame, acesulfame-K, cyclamate).
Stevia has been used in Japan and several other countries.
Still, many people perceive stevia and its sweet derivatives
to have a foul taste in certain foods. Just because a substance
is natural, does not mean that it is safe.
In the 1990s, the U.S. FDA rejected stevia for use as a food
ingredient. Likewise, Canada did not approve stevia, and a
European Community scientific panel declared that stevia was
unacceptable for use in food.
High dosages fed to rats reduced sperm production and increased
cell proliferation in their testicles, which could cause infertility
or other problems. Pregnant hamsters that had been fed large
amounts of a derivative of stevioside called steviol had fewer
and smaller offspring.
In the laboratory, steviol can be converted into a mutagenic
compound, which may promote cancer by causing mutations in
the cells’ DNA.
In the 21st century, Cargill and Merisant (which marks aspartame-based
Equal) developed extracts of stevia that are 95 percent pure
rebaudioside A and 200 times as sweet as sugar. The companies
call their products Truvia and PureVia, respectively, with
the nickname of rebiana.
In 2008, Cargill and Merisant told the FDA that rebiana should
be considered “generally recognized as safe,” or GRAS. (GRAS
substances are given less scrutiny by the FDA than standard
food additives.)
A third company, Wisdom Natural Brands, declared that its
stevia-related product to be GRAS without even notifying the
FDA.
UCLA
toxicologists and the Center for Science in the Public
Interest, however, urged the FDA to reject the GRAS
claims for Rebiana |
They reported that FDA’s guidelines call for major new food
additives to be tested for two years on both rats and mice,
but rebiana had only been tested on rats.
The toxicologists and CSPI said that testing of rebiana in
both rats and mice is particularly important, because several
tests found that rebiana-related substances caused mutations
and damaged chromosomes or DNA.
Despite the disagreement about rebiana’s safety, just before
Christmas 2008 the FDA agreed that the chemical could be considered
GRAS.
Shortly thereafter, beverage companies started marketing rebiana-sweetened
products.
|
|
UCLA & CENTER FOR SCIENCE
IN THE PUBLIC INTEREST RAISE SERIOUS HEALTH ISSUES RELATED
TO NEW STEVIA SWEETENER
Center
for Science in the Public Interest
NEWSROOM
Center
for Science in the Public Interest
Lab
Tests Point to Problems with
Trendy New Stevia Sweetener
Center for Science in the Public Interest Urges More
Testing Before Stevia Extract is Used in Food, Drinks
|
WASHINGTON
Coca-Cola and Pepsi are planning to introduce new drinks made
with rebiana, an extract of stevia leaves that is 200 times
sweeter than sugar.
But according to a new 26-page report by toxicologists at
the University of California, Los Angeles, several, though
not all, laboratory tests show that the sweetener causes mutations
and DNA damage, which raises the prospect that it causes cancer.
In a letter to the Food and Drug Administration, the Center
for Science in the Public Interest says the agency should
require additional tests, including a key animal study, before
accepting rebiana as Generally Regarded as Safe, or GRAS.
"A safe, natural, high-potency sweetener would be a welcome
addition to the food supply," said CSPI executive director
Michael F. Jacobson. "But the FDA needs to be as sure
as possible that rebiana is safe before allowing it into foods
that would be consumed by tens of millions of people. It would
be tragic if the sweetener turned out to cause cancer or other
problems."
One key animal study has not been conducted, according to
the UCLA experts and CSPI. The FDA's guidelines advise testing
prospective major new food additives on two rodent species,
usually rats and mice. The new sweetener has only been tested
on rats, but not mice.
The toxicologists' report said that because several studies
found mutations and DNA damage, a lifetime mouse study designed
to evaluate the risk of carcinogenicity and other health problems
was particularly important.
The new report was prepared for CSPI by Sarah Kobylewski,
a graduate student in the Department of Molecular Toxicology,
and Curtis D. Eckhert, Ph.D., a professor of Environmental
Health Sciences and Molecular Toxicology, at UCLA. They were
assisted by Professor Joseph R. Landolph, Jr., Ph.D., of the
Department of Molecular Microbiology and Immunology, and Pathology,
Keck School of Medicine, and the School of Pharmacy at the
University of Southern California.
The UCLA toxicologists emphasized the need for more genotoxicity
tests, because of the evidence that derivatives of stevia
that are closely related to rebiana damage DNA and chromosomes.
Their report noted that much of the recent research on rebiana
was sponsored by Cargill and urged the FDA to obtain independently
conducted tests to ensure that corporate biases don't influence
the design, conduct, or results of the tests.
Rebiana is shorthand for rebaudioside A, a component of stevia.
It is obtained from the leaves of a shrub native to Brazil
and Paraguay. Coke, Pepsi, and other companies are excited
about rebiana, because it supposedly tastes better than crude
stevia, which is sold as a dietary supplement in health-food
stores.
After all the controversies pertaining to saccharin, aspartame,
and other artificial sweeteners, the food industry expects
many calorie-conscious consumers to eagerly opt for this natural
sweetener.
Two companies—Cargill and Merisant—have told the FDA that
rebiana should be considered GRAS, a category given less scrutiny
by the FDA than ordinary food additives. A third company,
Wisdom Natural Brands, has declared that its stevia-based
sweetener is GRAS and will market it without giving evidence
to, or even notifying, the FDA. That company gave CSPI only
a heavily redacted report prepared by scientists it hired
to declare its stevia derivative, which is of unknown purity,
is safe.
Stevia is legal in foods in Japan and several other countries,
but the United States, Canada, and the European Union bar
stevia in foods because of older tests that suggested it might
interfere with reproduction. New tests sponsored by Cargill
did not find such problems.
"I am not saying that rebiana is harmful, but it should
not be marketed until new studies establish that it is safe,"
Jacobson said.
Cargill's version of rebiana is called Truvia and would be
used by Coca-Cola. Pepsi’s version is called PureVia and is
produced by Merisant’s Whole Earth Sweetener division. Merisant
is best known for marketing the Equal brand of aspartame.
CSPI has not questioned the safety of two artificial sweeteners,
sucralose (Splenda) and neotame, but says that suggestive
evidence indicates that saccharin, aspartame (Equal, NutraSweet),
and acesulfame-K pose small risks of cancer.
"The whole issue of what gets GRAS status needs to be
reviewed by Congress," Jacobson said. "It’s crazy
that companies can just hire a few consultants to bless their
new ingredients and rush them to market without any opportunity
for the FDA and the public to review all the safety evidence."
Two of the most harmful ingredients in the food supply are
considered GRAS: salt, which raises blood pressure and causes
thousands of unnecessary heart attacks and strokes every year,
and partially hydrogenated oil, which is the source of artery-clogging
artificial trans fat. CSPI has long campaigned to get partially
hydrogenated oil out of the food supply and to reduce salt
to safe levels.
|
|
 |
 |
|
NOTICE
OF AGAVE
DELISTING
AGAVE
PRODUCTS & AGAVE CHOCOLATE
DE-LISTED & BANNED BY THE
GLYCEMIC RESEARCH INSTITUTE® |
The
Glycemic Research Institute® announced that they have
legally “De-Listed” and placed a ban
on Agave and Agave Nectar for use in Foods, Beverages, Chocolate,
and any other products, due to results of 5 years of Human
In Vivo Clinical Trials on Agave.
Manufacturers
who produce and use Agave and Agave Nectar in products are
now warned that they can be held legally liable for
negative health incidents related to ingestion of Agave. |
GLYCEMIC
RESEARCH INSTITUTE®
601 Pennsylvania Avenue
Suite 900
Washington, D.C
20004 |
U.S.
GOVERNMENT CERTIFICATION PROGRAM
UNITED KINGDOM GOVERNMENT CERTIFICATION PROGRAM
CANADIAN GOVERNMENT CERTIFICATION PROGRAM
|
AGAVE
DANGERS
RESULT IN DELISTING
& BANNING
Agave
Clinical Trials Halted Due to
Severe Side Effects in Diabetics
|
|
The
Glycemic Research Institute® announced that they have
halted and banned all future clinical trials of Agave
and are issuing warnings to manufacturers and the public about
the dangers related to Agave and Agave Nectar.
The
Medical Advisory Board of the Glycemic Research Institute®
(GRI) made the decision to halt all future clinical trials
involving Agave and Agave Nectar as a result of the latest
round of GRI Human In Vivo Clinical Trials, in which the diabetic
subjects experienced severe and dangerous side effects related
to the oral ingestion of the sweetener Agave/Agave Nectar.
This
announcement came as a surprise to the scientific community,
and has generated hundreds of inquiries involving the safety
of ingesting Agave.
Physicians
and diabetes health educators are now being advised to caution
their diabetic patients, both adults and children, about the
use of Agave.
This
also applies to persons with Metabolic Syndrome, Insulin Resistance,
and Pre-Diabetes. The medical community believes that up to
70% of the American public has some form of Insulin Resistance,
due to the rise in obesity and weight gain.
The
ban on Agave and agave Nectar includes “The use of Agave
as a sweetener and/or syrup, and/or Agave Nectar, as found
in foods, beverages, Nutraceuticals, chocolate, and any other
consumable product.”
CLINICAL
TRIALS RESULT IN
DELISTING & BAN
|
Results of the Human
In Vivo Clinical Trials involving Agave/Agave Nectar resulted
in alarming effects evidenced in the diabetic trial subjects.
According
to the researchers, the side effects seen in the diabetic
population are related to dosage. Very small amounts of orally
ingested Agave did not instigate immediate side effects in
diabetics, while larger doses caused severe side effects.
The
Glycemic Research Institute® is legally bound to alert
the appropriate government and health authorities, as well
as the public, of any clinical trial results that pose a health
problem to the public-at-large.
The
Wall Street Journal interviewed researchers at the
Glycemic Research Institute® in 2009 (article available
at Wall Street Journal online), when results of the Agave
trial were made public.
As
of 2009, manufacturers and marketers of products containing
Agave and/or Agave Nectar can now be held legally responsible
for any negative medical issues resulting from ingestion of
Agave. The legal community has contacted the Glycemic Research
Institute® for verification and documentation that Agave
does elicit negative results in person with blood-sugar and
other related metabolic issues, and are prepared to take these
issues to court.
METABOLIC
RESPONSE OF
AGAVE IN DIABETICS |
The Glycemic Research
Institute® Agave trials, as well as other independent
data and research, demonstrate that diabetics respond differently
to oral ingestion of Agave than non-diabetics and persons
with normal glycemic responses.
The
biochemical reason is that all cells in the body, including
liver, muscle, and brain cells, are dependent on glucose
as fuel. Glucose is not capable of diffusing from the bloodstream
into the cells, and requires specialized proteins (not dietary
protein) to transport it across cellular membranes.
Insulin
is the catalyst for the cell-transporters that deliver glucose
into heart, muscle, and fat cells. Excess insulin causes adipose
tissue fat storage via Lipoprotein Lipase (LPL), so foods
and beverages that stimulate insulin cause weight gain and
obesity. This explains why Type 1 diabetics (lack of insulin)
are thin and Type 2 diabetics (excess insulin) are almost
always overweight or obese.
The
brain, however, works on a different fuel-basis. Glucose can
get into the brain to act as fuel (glucose-transport), while
insulin cannot, and fat-storage in the brain is not an option.
The Blood-Brain-Barrier (BBB) is the watch-dog in the
brain that is responsible for regulating the amount of
sugar/glucose going to cells inside the brain. The BBB only
allows very specific agents to enter the brain by crossing
the Blood-Brain-Barrier (BBB).
In
diabetics, muscle cells cannot obtain sufficient energy to
function normally, because the diabetic’s ability to
properly produce and/or utilize insulin is impaired. Diabetic
serum levels of glucose are consistently over-elevated, yet
muscle cells are stressed and starving.
Diabetics
using insulin-treatments (medication) often experience excess
insulin stimulation and uptake, resulting in insufficient
levels of glucose in the bloodstream.
Imbalances
in blood glucose and insulin levels are the standard trademark
of a diabetic patient. In type 2 diabetes (by far the most
common form of diabetes), high blood glucose levels cause
weight gain and obesity, which exacerbates insulin resistance,
risk of cardiovascular disease, and shortened lifespan. High
insulin levels further trigger weight gain and obesity, as
well as a myriad of health problems.
These
imbalances are problematic in the diabetic, as every food,
meal, snack, beverage, or orally ingested agent, causes a
glycemic reaction, ranging from mild to severe.
High
glycemic foods, beverages, and sweeteners stimulate high levels
of serum glucose, which makes diabetics susceptible to neurological
and physical problems, including stroke and memory loss.
In
a hyper-insulin state, which is triggered by ingesting foods,
beverages, and sweeteners that over-stimulate insulin, muscle
cells take up all of the available glucose, thus depriving
the brain of sufficient fuel.
This
causes severe Metabolic Low Blood Sugar, resulting
in wooziness, poor motor and thinking function, extreme lethargy,
and in many cases, lack of consciousness (fainting/passing
out).
Even
foods and beverages that claim No-Calories, No-Carbs,
cause a reaction in the diabetic and pre-diabetic.
This
is because the human brain has to contend with high and low
levels of glucose in the blood stream. Severe imbalances,
including very low levels of glucose, and reactive hypoglycemia,
can place diabetics in a precarious physical condition, in
which there is literally a “brain shut-down.”
This
type of metabolic cascade causes severe diabetic reactions,
including passing out – even behind the wheel of a car
while driving, and explains why oral ingestion of Agave induces
potentially dangerous metabolic states in diabetics.
IN
SUMMARY: Diabetics and persons with any insulin-related
disorder, including Pre-Diabetes and Insulin Resistance, are
urged to use extreme caution as related to oral ingestion
of Agave and Agave sweeteners and syrups.
MEDIA
& MEDICAL INQUIRIES |
Medical
and/or media-related questions may be addressed to the Glycemic
Research Institute, Human in Vivo Clinical Trials Facility
at (727) 894-6900 or via e mail from the Official Glycemic
Research Institute® website at www.Glycemic.com
|
 |
UPDATE
Agave Clinical Trials
Halted Due to Severe Side Effects in Diabetics
|
The
Glycemic Research Institute® announced today that
they are halting all future clinical trials of Agave
until researchers have discovered why an Agave product
caused severe side effects in diabetics. |
|
|
The
Medical Advisory Board of the Glycemic Research Institute®
(GRI) made the decision to halt all future clinical trials
involving Agave as a result of the latest round of GRI Human
In Vivo Clinical Trials, in which the diabetic subjects experienced
severe and dangerous side effects related to the oral ingestion
of an Agave product.
This
announcement came as a surprise to the scientific community,
and has generated hundreds of inquiries involving the safety
of ingesting Agave products.
Results
of the Human In Vivo Clinical Trials involving a Volcanic
Nectar Blue Agave product resulted in alarming effects as
evidenced in the diabetic trial subjects.
Researchers
at the Glycemic Research Institute (GRI) are currently examining
the data to determine why this abnormal reaction was seen
in the diabetic test subjects. In the interim, they will not
be conducting clinical trials for Agave products.
According
to the researchers, causes of the side effects evidenced by
the diabetic subjects have been narrowed to the following:
| 1) |
Dosage of the
Agave test food (high levels of Agave) |
| 2) |
The label of the product, data, and/or documents supplied
to GRI by the company that submitted the product (Volcanic
Nectar Blue Agave Maple Syrup) were not accurate |
| 3)
|
The
Agave product submitted by the client contained ingredients
not disclosed |
| 4) |
Inulin content of the product tested varies from original
trials |
DOSAGE: As of October
2009, prior clinical trials conducted globally on Agave and
Agave products appear to have been limited to lower doses,
administered to non-diabetic subjects. As of October
2009, we can find no evidence of Human in Vivo Clinical trials
conducted on diabetics at higher doses, other than the trials
conduced by the Glycemic Research Institute.
According to the data published at the University of Sydney
(October 29, 2009), three glycemic trials have been conducted
by the Human Nutrition Unit/Sydney University/Australia, on
Agave, and none of those trials list diabetics as
the test subjects (all are listed as normal test
subjects), and none of the trials listed high serving sizes
of Agave.
Two of the trials utilized Western Commerce Corporation
Organic Agave Cactus Nectar.
According to published information on the Internet:
“In 2000, with warrants in hand, federal agents
from the Office of Criminal Investigations of the Food and
Drug Administration (FDA) came banging on the door of North
America's largest agave nectar distributor, Western Commerce
Corporation in California. In an extremely rare case of the
FDA protecting consumer interests (rather than supporting
big business, while shutting down legitimate and health consciousness
competition), they discovered that Western Commerce Corporation
was adulterating their agave syrup with high fructose corn
syrup (to lower the cost even more and increase profit margins).
While the federal agents confiscated the material in the warehouse,
the owners of Western Commerce Corporation were nowhere to
be found. Those who ran the company fled the country with
millions of dollars in assets to avoid criminal prosecution.”
The third Agave trial published at the Human Nutrition Unit/Sydney
University/Australia, was limited to normal and not
diabetic subjects, and the dose fed to the test subjects
was listed as 8 grams of carbohydrate per serving from the
Agave product.
These prior trials cannot be directly compared to Human In
Vivo Clinical Trials utilizing diabetic subjects at higher
doses of ingested Agave.
GRI urges that researchers who have conducted Board Approved
Agave Human In Vivo Clinical Trials utilizing diabetics and
serving sizes over 10 grams Agave/8 g carbs, come forth with
their trial information.
VARIATIONS IN AGAVE PRODUCTS: According to many sources, the
refined fructose in Agave Nectar is much more concentrated
than the fructose found in High Fructose Corn Syrup, which
could account for the diabetic side effects at higher doses.
INULIN: On average, 25 percent of Agave’s weight is
inulin. Inulin/Polyfructoses are typically considered a dietary
fiber (Report of the Committee on Definition of Dietary
Fiber of the American Association of Cereal Chemists and Dietary
Reference Intakes Report of the Institute of Medicine of the
National Academies). The amount of dietary fiber in a
product affects the glycemic response. However, there are
questions about labeling them as such since only about 15%
of them are quantitated by the early Official Methods of Analysis
(AOAC 985.29 or AOAC 991.43) for the determination of dietary
fiber.
INDEPENDENT
OPINIONS ON AGAVE IN DIABETICS
According
to Dr. Susan Mitchell, PhD., RD, FADA, a licensed nutritionist
and registered dietician, Fellow of the American Dietetic
Association, and instructor in Nutrition and Health at the
University of Central Florida for over eight years:
“If you are diabetic, your blood glucose may or
may not be spiked…all depending on how much fructose
is in the particular agave product consumed
and your particular case of diabetes. Plus fructose sweeteners
may increase blood triglycerides if you have diabetes so be
sure and discuss this with your health care provider.”
“Is agave better for you than any other sweetener
such as sugar, maple syrup or honey?
Agave is promoted as a low glycemic alterative for diabetics.
Is it?
If you’re diabetic or have friends or family members
who are, you don’t want to miss this.
Here’s why. Agave and sugar have approximately the same
number of calories….about 16 per teaspoon. Agave is
sweeter than sugar so you could save a few calories by the
amount you use. Sugar is technically called sucrose which
is composed of 50% fructose and 50% glucose when it is broken
down in the body.
Agave varies in its fructose content with a range from 55%
up to 90%. It all depends on the processing method used which
can affect the fructose content. Agave nectar with 55% fructose
is about the same as high fructose corn syrup so there would
be no benefit in agave at 55% fructose over sugar, high fructose
corn syrup or honey from the standpoint of composition, only
taste and personal preference.
The reason you hear …theoretically… agave nectar
touted as safer for diabetics is that a higher fructose composition
typically doesn’t cause dangerous spikes in blood glucose.
Currently, we don’t have clinical studies as to agave’s
safety in diabetes.
Unless there is a label stating the exact percentage of fructose
in the agave nectar, it can range as we just talked about
from 55% up”
April 8, 2009
Sweetener Update: Agave and Stevia
IN
CONCLUSION
GRI
is dedicating significant time and resources to determine
if the reaction in diabetics occurs in generic Agave products
as a result of ingesting high levels of Agave, or is related
to other causes factors, such as stated in items 1-4.
Prior
GRI clinical trials in diabetics using smaller doses of Agave
did not instigate side effects, but the dosage levels used
in the recent clinical trials were much higher than the previous
trials.
The
company that submitted the Volcanic Nectar brand Agave product,
Global Goods Inc. of Highland, Utah, has been in direct contact
with the Glycemic Research Institute (GRI) regarding this
issue. Brian Oaks, President of Global Goods expressed his
sincere determination to continue to provide safe and efficacious
Agave products to the public, and is willing to take any necessary
actions to prevent any negative reactions to their products.
Brian
Oaks stated that the specific product submitted to GRI (Volcanic
Nectar Agave Maple Syrup) was never sold to the public, and
his intent was to have GRI conduct Human In Vivo Clinical
Trials on the product prior to releasing it to the public.
In
the interim, GRI has stated that they have instructed Brian
Oaks to remove all Diabetic-Friendly statements and Certification
Marks from their websites and marketing material until the
issue has been resolved.
MEDIA
& MEDICAL INQUIRIES
Medical and/or media-related questions may be addressed to
the Glycemic Research Institute, Human in Vivo Clinical Trials
Facility at (727) 894-6900 or via e mail from the Official
Glycemic Research Institute® website at www.Glycemic.com
|
|
|
|
