Human Clinical Trials
are Required for Legal

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.

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).

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.

Copyright © 2008-2011 Glycemic Research Institute®

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