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The Glycemic Research Institute®
is an Internationally Accredited Testing & Certification
Organization approved by International Governments, including
the United States government.
The
Glycemic Research Institute® Certification Program
and Certification Programs are Registered, Authorized, and
Licensed by the United States, Canada, and United Kingdom
governments, and accepted Worldwide per World Health Organization
(WHO) Guidelines.
The
Glycemic Research Institute® government-issued Certification
Marks represent 27-years of Clinical Research in the fields
of the Glycemic Index, Diabetes, Cephalic Response, Obesity,
Adipose Tissue Fat-Storage, and Childhood Obesity.
The
Glycemic Research Institute® Certification Marks
are legally authorized to make a clinical statement, such
as “LOW GLYCEMIC” or ‘DIABETIC FRIENDLY” or “LOW CEPHALIC
INDEX” or “KID FRIENDLY” or “NATURAL BEVERAGE” on an FDA label
for a commercial food, Nutraceutical, beverage, or Pharmaceutical
product.
Any
Certification Mark statement representing a clinical claim
must be backed by Human In Vivo Clinical Trials per FDA CFR
21 guidelines and per the Clinical Trials Guidelines submitted
by the organization licensed to use said Certification Mark.
A Certification
Mark on a commercial product legally enables bounding
(being under legal obligation) under the following guidelines:
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The existence of a Legal Product Certification Agreement
between the manufacturer of a product and the
organization that possesses accreditation by a national
government for both testing and product certification. |
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Legal
evidence that the product was successfully tested in
accordance with a nationally accredited standards. |
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Legal
assurance the accredited certification organization
has ensured that the item that was successfully tested,
and is identical to that which is being offered for
sale. |
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Legal
assurance that the successful test has resulted in a
certification listing, which is considered public information,
which sets out the tolerances and conditions of use
for the certified product, to enable bounding, and thus
compliance with the law. |
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Legal
assurance that the manufacturer is being regularly audited
by the Certification Organization, at unannounced intervals,
to ensure the maintenance of the original process standard
that was employed in the manufacture of the test specimen
that passed the test, and that if the manufacturer should
fail an audit, all product certification, including
labels of stock on hand, on construction sites, with
end-user customers and on distributor store shelves,
shall be immediately removed, and all stakeholders will
be informed that the de-listed product certification
is no longer eligible for use in bounding. |
QUALITY
ASSURANCE
THE LEGAL RELATIONSHIP BETWEEN
CERTIFIER & CLIENT |
Product certification
and product qualification is the cornerstone of all bounding
for Certification Marks, and the process of certifying that
a specific product has passed performance and quality assurance
tests or qualification requirements stipulated in regulations
and Nationally Accredited Test Standards, and that a product
complies with a set of regulations governing quality and/or
minimum performance requirements.
On
the part of the certifier, in this case, the Glycemic
Research Institute® (GRI), is certifying that
a product has passed all Clinical Protocols established to
use the Glycemic Research Institute® Certification
Marks on a label and/or product marketing materials, including
websites.
For
products that pass the strict Clinical Protocol, the Glycemic
Research Institute® allows the use the GRI Mark on the
product label, thus indicating legal eligibility of the product
for use in bounding, and certifies the origin, material, mode
of manufacture of products, mode of performance of services,
quality, and accuracy of other characteristics of the product.
Products,
once certified, may be endorsed with the Authorized Certification
Mark and may be eligible to display said Certification Mark,
under the direction and guidelines of the Glycemic Research
Institute®.
TRADEMARKS
VS CERTIFICATION MARKS |
Trademarks are
vastly different from Certification Marks. Trademarks are
issued to individuals and companies and represent a word (s)
or logo used by that entity.
Certification
Marks are difficult to register, and are only issued
by the government to companies that are Nationally
Accredited Testing and Certification Organizations.
It
is difficult, lengthy, and expensive to obtain a Certification
Mark from the government, as the organization applying for
said Mark must prove worthiness on many different levels of
competence, expertise, and good standing in the community.
Companies
that are legally issued a Certification Mark must follow strict
government guidelines in order to obtain, maintain and continue
to use said Marks.
EXAMPLE
OF VALID
CERTIFICATION MARKS |
The
main purpose of government Certification Mark regulations
is to protect consumers against misleading practices.
Some
of the more commonly seen Certification Marks are:
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Underwriters
Laboratories holds a service mark on the phrase "UL
Listed," and allows manufacturers of electrical
and other safety equipment to use the UL mark only if
they are under follow-up agreement by UL. This lets
consumers identify products that meet quality criteria
set by a company other than the manufacturer. |
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The
"Champagne" certification mark, used to indicate
goods which have an appellation of origin of the Champagne
region in France. |
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The
Bureau Veritas Certification Mark, used to indicate
the Sea-Worthiness of Ships. |
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(U
in a full circle), the hechsher of the Orthodox Union. |
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Underwriters'
Laboratories of Canada (ULC), is an affiliate of Underwriters
Laboratories. ULC is accredited in Canada to conduct
testing and to provide certification, and to author
National Standards. |
LEGAL
REQUIREMENTS FOR
CERTIFICATION MARKS |
Authorized Certification
Mark issuers are required and must observe the construction
of test specimens to avoid any possible cheating on the part
of the submitter or parties affiliated with the submitter.
This
is mandated to avoid having an unethical submitter attempt
to have certified, a product that is not identical to the
original product submitted.
As
a result of documented abuses in this field, certifiers typically
reserve the right to re-test as a cautionary measure to ward
off such behavior.
De-Listing
is the process of recalling a Certification for a specific
product. While De-Listing is rare, it has occurred, which
has resulted in having strict and mandatory Certification
regimes in place.
De-Listing
can occur as a result of inaccurate data provided by the client
deliberately or non-deliberately submitting a product (such
as incorrect Ingredient Listings or Label data), or from Incremental
Degradation of a product (changing the original product formula/ingredients
from the original), or using the Certification Mark in an
illegal and/or unauthorized manner.
The
Glycemic Research Institute® holds full authority
to De-List and Recall its government Certification Marks as
a result of any breach of protocol on behalf of a client and/or
product submitted.
Said
breaches include using the Certification Mark on a product
that has passed the Glycemic Research Institute® Clinical
Trial Protocol, wherein said product has been sub-licensed
to another company. In said case, the Mark cannot be utilized
by the sub-licensee without the product being re-submitted
to Glycemic Research Institute® for Clinical Trials.
Only
"active" Certification Mark listings matter at the
point of purchase or use, as products and companies can become
"De-Listed" as a result of improprieties.
The
active Certification Mark listing is the cornerstone of all
bounding in actual use. It is a legal document against which
the product is compared to approvals by an Authority Having
Jurisdiction (AHJ).
An
Active Certification listing indicates three
mandates: |
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The
product is being made under a Certification, or follow-up
agreement that exists between the manufacturer and the
certification organization. This means that the certifier
can conduct up to 4 unannounced factory audits per year,
for the purpose of ensuring that the product being made
and sold is still identical to that which was tested. |
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The
product's packaging, literature and the manufacturer's
promotional information is authorized to use the Certification
Mark. |
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The listing is held and is listed in the Certification
Listings Directory of the Certification Organization. |
Certification
Marks are very highly regarded by governments Worldwide, as
well as by stockholders and investors of high-quality products.
Accredited Testing Organizations, such as the Glycemic
Research Institute®, are relied on to provide accurate
and legal reports and data regarding specific products.
In
Germany, Accredited Testing Organizations routinely audits
manufacturing locations and submits quality control results
to the government and to investors and stockholders.
De-Listing
can occur in the case of non-compliance. Trends in quality
are identified very early and brought to the attention of
all stakeholders to enable the prevention of problems.
PRESENTATION
OF ACTIVE
CERTIFICATION MARKS |
Certification
Marks are easy to see on product labels and enable users to
track down the Certification Listings, the tolerances that
guide field use, and whether or not the listing is still active.
In
certain cases, a Certification Mark can mean the difference
between life-and-death. As an example, fire extinguishers,
fire alarms, electrical equipment, hospital equipment, emergency
room equipment, Paramedic equipment, and surgery-room equipment,
must be clearly labeled with appropriate Certifications.
This
understates the reasoning for utilizing and maintaining appropriate
Certifications, and personifies the illegality of obscuring
a Certification label.
The
Glycemic Research Institute® requires the use of
its Certification Marks to be presented clearly on the front
of a food, beverage, Nutraceutical, or Pharmaceutical label.
HUMAN
CLINICAL TRIALS ARE REQUIRED FOR LEGAL “LOW GLYCEMIC”
SUBSTANTIATION |
2010: Government requirements
related to any “Glycemic” claim, such as “Low Glycemic” require
mandatory Human In Vivo Clinical Trials.
All
carbohydrates mediate different glycemic properties depending
on the food matrix, and no predictions can be made or legally
asserted without proof of Human In Vivo Clinical Trials.
Additionally,
all foods and beverages produced without carbohydrates
or calories or sugars, such as "Calorie-Free, No Sugars
or Carbs" elicit a Cephalic Response, also called
Brain Glycemic Indexing, which can be quantified
in an approved Cephalic Testing laboratory.
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The
Glycemic Research Institute® Official Trials Laboratory
(Glycemic Research Laboratories) is the only Certified
Cephalic Testing Laboratory in the world
(United States Government Certification Program).
www.GlycemicResearchLaboratories.com
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Glycemic
claims related to an analysis or mathematical
analysis or composition of the product ingredients
or any methodology other than Human In Vivo Clinical Trials
are not legal.
Dr. Jeya Henry, professor of human nutrition at Oxford Brookes
University, a leading authority on diet and glycaemic (glycemic)
response, states:
“It is right to be cautious as it is not possible to ascribe
a Glycemic Index rating to a food by analysis in a lab or
predictions based on its composition; testing
must be done on humans.
The United States government (FDA) (FTC) mandates that Human
Clinical Trials are required for any “Glycemic” claim or statement,
per 21 CFR Guidelines.
The Canadian government also mandates Human In Vivo Clinical
Trials for any “Glycemic” claims.
The governing
body in the United Kingdom (UK), the European Food Safety
Authority (EFSA), 2010 ‘article 13.1’ mandates strict
control over any food or beverage making “Glycemic” claims.
The EFSA accepts that there is merit in trying to control
blood glucose, but requires convincing evidence including
Human In Vivo Clinical Trials submitted for claims.
The Glycemic Research Institute® Clinical Trials
Program for Glycemic Claim Substantiation is Registered
by the United Kingdom government, the United States government,
and the Canadian government.
SUBMITTING
A PRODUCT TO THE
GLYCEMIC RESEARCH INSTITUTE® |
Beverage
Products that may be
submitted for Claims and
Clinical Trials include:
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Sodas
& Colas |
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Milk drinks |
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Fruit
juices & drinks |
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Energy
drinks |
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Sports
drinks |
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Thermogenic
drinks |
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Children’s
beverages |
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Soy drinks |
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Nut drinks
(such as Almond milk) |
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Protein
drinks |
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Meal Replacements |
See
Product Application Documents Below |
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Product
Application Documents
To
submit a product for clinical testing, please
download the following PDF File Format document
and follow the instructions.
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Click
Here to download
Product Application Documents
Adobe
Reader is required to download, view,
and print PDF files.
If you do not have Adobe Reader,
click
here to download a
free copy of Adobe Reader.
Glycemic
Research Laboratories
Glycemic Solutions Corporation
111 Second Avenue N.E.
Suite 512
St. Petersburg, FL 33701
(727)
894-6900
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