GOVERNMENT RULES AND
REGULATIONS REGARDING
“GLYCEMIC” CLAIMS



FDA & FTC

It is an FDA violation and Federal offense to print incorrect information on a label, such as stating a product is "Low Glycemic" if it is not.

It is an FTC violation to state a product is "Low Glycemic" on brochures, advertisements and product materials if it is not.

Additionally, the physical consequences of diabetics, hypoglycemics, and persons with insulin-related disorders consuming high glycemic products, believing them to be low glycemic, can be profound.

Products that claim to be low glycemic, and in reality, are not low glycemic, open themselves to lawsuits for fraud, FDA violations, FTC violations, class action suits, and medical damages.

With clinical evidence of the glycemic properties of a product, manufacturers can provide customers, as well as government agencies, finite proof that their product has been proven to be low glycemic.

The Glycemic Research Institute strictly adheres to FDA and FTC guidelines.

OTHER GOVERNMENT AGENCIES

Use of the GRI Seals of Approval on food, Nutraceutical, and Pharmaceutical labels may require legal approval from government agencies, other than the FDA and FTC. In said cases, such as USDA, GRI is not liable or responsible for approval of the Seals on specific food products, and approval is the sole responsibility of the client and their regulatory officers, on a case-by-case basis.

VALIDITY OF THE GRI CERTIFICATION MARKS

The GRI seals are Federally protected registered Certifications solely belonging to the Glycemic Research Institute for use in certifying edible goods such as foods, drinks, Nutraceuticals, and Pharmaceuticals.

GLOBAL USE OF THE SEALS

Aside from the United States, the GRI Certification Marks have been duly registered and accepted by government agencies in other countries, such as Canada and the UK.


U.S. FOOD and DRUG ADMINISTRATION:
GLYCEMIC INDEX


U.S. FOOD and DRUG ADMINISTRATION
CENTER FOR FOOD SAFETY AND APPLIED NUTRITION


Calories Count
Report of the Working Group on Obesity

http://www.cfsan.fda.gov/~dms/owg-toc.html


GLYCEMIC INDEX
Carbohydrates and Other Macronutrient Contributions to Caloric Value


Macronutrients are the components of food that provide energy (i.e., calories). There are three categories of macronutrients: carbohydrates, proteins and fats.

Carbohydrates represent over half, and fats about a third, of the energy intake of typical Western diets. Understanding the caloric contribution of macronutrients to the diet requires knowledge of their chemical composition.

Carbohydrates - Carbohydrates (sugars, e.g., glucose, sucrose; and starches) provide energy to cells in the body and glucose is a primary source of energy for the brain. Sugars and starches are broken down to glucose and the energy provided is 4 calories per gram.

Other types of carbohydrates such as sugar alcohols (e.g., sorbitol, maltitol) and dietary fiber are not well absorbed by the small intestine and are fermented by bacteria in the large intestine. Carbohydrates that are fermented in this manner provide a lower energy value per gram.

The rapidity and extent of carbohydrate absorption by the body directly influence the speed and extent of the rise in blood glucose (i.e., glycemic response), which, in turn, triggers an insulin response. The glycemic index of carbohydrate-containing foods has been proposed as a way to quantify the blood glucose response following their consumption (Jenkins et al., 1981). Many factors can affect the glycemic index of a single food, especially when the food is consumed in a meal.

Foods or meals that have a high glycemic index trigger the release of insulin into the blood. Elevated blood insulin levels stimulate the uptake of fat from the blood into fat cells, and inhibit the breakdown and release of stored fat from fat cells. Some scientists believe that consuming a high glycemic index food (e.g., a food that contains sugar or starch) can result in an increase in stored body fat.

Weight loss plans based on greatly restricting carbohydrate intakes have been promoted for more than a decade. "Low" carbohydrate products are being promoted as a way to reduce weight and to assist diabetics in their control of carbohydrate intake; however, not all carbohydrates raise blood glucose levels, nor deliver the same energy value per gram. In addition, when one macronutrient is restricted in a food product, it is often replaced with another macronutrient. For example, when "low" fat products were introduced several years ago, carbohydrates often were the replacement macronutrient. In many of the current "low" carbohydrate products marketed today, fat is often the replacement macronutrient. Also today many of the low carbohydrate products replace the high glycemic index carbohydrates (e.g., sugars and starches) with other carbohydrates such as sugar alcohols, which have no measurable glycemic index and may provide fewer calories per gram. Thus, it is important to look at the NFP to determine the calorie content of and the type of carbohydrate in a product.(1)

Fats (lipids) - A major source of energy for the body is derived from fats (lipids). Fats aid in the absorption of fat-soluble vitamins and carotenoids. There are two essential fatty acids, a-linolenic and linoleic. Fats contribute 9 calories per gram. There are three major components: saturated fatty acids, trans fatty acids and unsaturated fatty acids (monounsaturated fatty acids and polyunsaturated fatty acids). All yield the same caloric value, but may affect metabolism differently. Saturated fatty acids and trans fatty acids raise blood lipid levels, especially cholesterol and low density lipoprotein cholesterol, which have known adverse health effects. There is no known requirement for trans fatty acid for specific body functions.

Acceptable Macronutrient Distribution Range (AMDR) has been estimated for individuals. The AMDR is the range of intake for a particular energy source that is associated with reduced risk of chronic disease while providing adequate intakes of essential nutrients. The AMDR for carbohydrates and fats is estimated to be 45 to 65 and 20 to 35 percent of energy, respectively, for all adults. Consumption of carbohydrates and fats within these ranges reduces the risk for obesity, as well as certain chronic diseases such as coronary heart disease and diabetes.

Proteins - Proteins make up the major structural components of cells and are composed of amino acids. There are 20 essential amino acids. Proteins function as enzymes, hormones, and have other important functions in the body. Proteins provide 4 calories per gram. Animal protein sources (e.g., meat, milk, eggs) generally contain balanced amounts of the essential amino acids whereas vegetable protein sources frequently have a limited amount of one of the essential amino acids. Foods that are low in fat tend also to be low in protein; foods that are low in carbohydrate tend to be high in protein and fat.

(1) FDA has received petitions requesting that the agency provide for nutrient content claims related to the carbohydrate content of foods. As discussed in section V.A.3.b., the OWG recommends that FDA file these petitions and publish a proposed rule to provide for nutrient content claims related to the carbohydrate content of foods, including guidance for the use of the term "net" in relation to carbohydrate content of foods.


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