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Internationally
Accredited Testing & Certification
Organization
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Certification
Programs
2010 |
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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 25-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®.
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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.
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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.
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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).
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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.
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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.
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Human
Clinical Trials
are Required for
"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®
Click
Here |
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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.
CLICK
HERE TO START DOWNLOAD
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.
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