NOTICE OF DE-LISTED & BANNED
PRODUCTS & INGREDIENTS

The Glycemic Research Institute® (GRI) has full legal authority to De-list and/or Ban any Product and/or Ingredient that has been shown to be dangerous, potentially dangerous, deleterious, and/or harmful to humans.

The De-Listing Notices and Banned Ingredients below describe the product/ingredient that was de-listed and the reason for de-listing.

This includes products/ingredients that have received prior Certification from GRI, and that have been subject to GRI “De-Listing” for illegal claims, harmful potential in humans, illegal labeling, and any other serious breaches.

Examples include the advertising of compounded drugs, the content of labels on dietary supplements and the advertising of so-called off-label uses of approved drugs.

Dietary Supplements and Nutraceuticals that market products in non-approved areas, such as “L-Arginine can be used to prevent or treat cardiovascular disease and/or diabetes” - are illegal claims and subject to injunction and significant fines levied by the FDA/FTC.

Stating that a dietary supplement/Nutraceutical can be used to prevent or treat any disease state or medical condition (such as cardiovascular disease or diabetes) is a violation of FDA and FTC regulations, even if the product has gone through clinical trials. Making said claims renders the product an “Unapproved Drug.”

The FDA has restricted product sponsors, manufacturers, and/or marketers from advertising or utilizing off-label uses of products.

Further, the FTC has ruled that Thermogenic, Fat-Burning products cannot make “weight loss” claims or statements, and has taken strong action against companies making said claims.

The Glycemic Research Institute® mandates compliance with all regulations of the U.S. Food & Drug Administration as related to off-label uses of products, and any breach will result in De-Listing.

Using the term “Low Glycemic” and/or “Diabetic Friendly” on any food, beverage, functional food, Nutraceutical or Pharmaceutical label is considered a “Health Claim” by the Food & Drug Administration (FDA).

As such, any use of the term “Low Glycemic” and/or “Diabetic Friendly” or “Safe for Diabetics” are viewed as ILLEGAL & ABUSIVE without Board Approved Human In Vivo Clinical Trials to back up said claims.

The FDA will take action against illegal claims on any food, beverage, ingested-agent, or Nutrition Label.

Illegal diabetic claims that are unfounded can put a diabetic at risk of mild-to-severe reactions, and is considered “Health Claim Abuse” by the FDA and FTC (Federal Trade Commission).

The Glycemic Research Institute® is legally required to report any and all incidences of negative health issues evidenced during Clinical Trials, to the appropriate authorities, including the FDA, and to alert the public to said issues, as in the case of Agave.

In severe instances, GRI can place a “Ban” (See Banned Ingredients and Products) a product and/or Ingredient from being used in any GRI Clinical Trials.

The FDA announced that they will not tolerate unsubstantiated health claims and will pursue necessary legal action to make sure companies manufacture and distribute safe, truthfully labeled products to consumers.

On February 22, 2008, the FDA announced enforcement action against companies and company-executives that have a history of abusing nutrition labels health claim regulations.

Those companies and executives were mandated to sign a consent decree of permanent injunction whereby they agree to remove drug and unauthorized health claims from their labels, brochures, and Web sites, as well as references to other Web sites that contain abusive claims.

Said companies now must hire an independent expert (such as the Glycemic Research Institute® to review the claims they make for their products and to certify that they have omitted all violative claims.

Per the consent decree, FDA can order the companies to stop manufacturing and distributing any product if the companies fail to comply with any provision of the consent decree, the Food, Drug and Cosmetic Act or FDA regulations. The companies can also be fined $1000 per violation per day.

The FDA has made it clear that there is a zero-tolerance stance against companies making unproven claims on food, beverage, and nutrition products, especially on claims related to Diabetes and/or Diabetics.

The U.S. Food and Drug Administration announced that Brownwood Acres Foods Inc., Cherry Capital Services Inc. (doing business as Flavonoid Sciences) and two of their top executives have been PROHIBITED from manufacturing and distributing any products with claims in the label or labeling to cure, treat, mitigate or prevent diseases.

The consent decree of permanent injunction is a result of the companies and their executives making unapproved drug claims and unauthorized health claims about their products, such as

"Chemicals found in Cherries may help fight diabetes."

The companies are prevented from making these claims until the products are approved by the FDA as new drugs, exempt from approval as investigational new drugs, or until the claims on the products' label and labeling comply with the law.

The companies that violated FDA Rules & Regulations are forced to remove all “drug and unauthorized health claims” from their labels, brochures, and Web sites, as well as references to other Web sites that contain such claims.

"The FDA will not tolerate unsubstantiated health claims that may mislead consumers," said Margaret O’K. Glavin, FDA Associate Commissioner for Regulatory Affairs.

"The FDA will pursue necessary legal action to make sure companies and their executives manufacture and distribute safe, truthfully labeled products to consumers."

As an Internationally Accredited Testing & Certification Organization approved by International Governments, including the United States government, the Glycemic Research Institute® has full legal authority to DELIST products and/or ingredients that have failed to comply with the appropriate Rules & Regulations.

Further, the Glycemic Research Institute® is authorized to make and to validate a clinical statement, such as “LOW GLYCEMIC” or ‘DIABETIC FRIENDLY” or “LOW CEPHALIC INDEX” or “KID FRIENDLY” as related to any orally-ingested ingredient or product, including any food, Nutrition, Nutraceutical, beverage, or Pharmaceutical product.

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 (Brain-Glycemic-Indexing), Obesity, Adipose Tissue Fat-Storage, and Childhood Obesity.

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:

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 GRI Marks on a label and/or product marketing.

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®.

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.

The main purpose of government Certification Mark regulations is to protect consumers against misleading practices.

Some of the more commonly seen Certification Marks are:

	UL LISTING 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. UNDERWRITERS LABORATORIES Underwriters Laboratories is authorized to conduct testing and to provide certification, and to author National Standards.
	The "Champagne" certification mark, used to indicate goods which have an appellation of origin of the Champagne region in France.
	BUREAU VERITAS: The Bureau Veritas Certification Mark, used to indicate the Sea-Worthiness of Ships.
	KOSHER CERTIFICATION (U in a full circle), the hechsher of the Orthodox Union.
	UNDERWRITERS LABORATORIES CANADA 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.

The Glycemic Research Institute® Certification Program is authorized by the United States government, the Canadian government, and the United Kingdom government for GLYCEMIC CLAIMS, DIABETIC CLAIMS, CEPHALIC (BRAIN GLYCEMIC INDEXING), KID FRIENDLY CLAIMS, and other specialties, which can be seen at: Glycemic.com

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 or ingredient.

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, and/or evidence of negative health issues in humans.

The Glycemic Research Institute® holds full authority to De-List and to 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 GRI 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 GRI for Clinical Trials.

The 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).

Accredited Testing Organizations, such as the Glycemic Research Institute®, are relied on to provide accurate and legal reports and data regarding specific products.

Accredited Testing Organizations routinely audit 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 and regulatory agencies to enable the prevention of problems.