Celiac Support Association

FDA defines “gluten-free” for food labeling 

New regulation provides standardization in definition for the voluntary use on food labels.
Applies to FDA regulated products whether produced in or outside of the US

 August 2013

The U.S. Food and Drug Administration published a new regulation defining the term "gluten-free" for voluntary food labeling. This provides a uniform standard definition. The new definition is purported to help the up to 3 million Americans who have celiac disease replaces the Compliance Guideline that for truth in labeling when the term "free" is used it must mean none, unless there is a specific definition. Now there is a specific definition "gluten-free."  

This new federal definition standardizes the meaning of “gluten-free” claims across the food industry. It requires that, in order to use the term "gluten-free" on its label, a food must meet all of the requirements of the definition, including that the food must contain less than 20 parts per million of gluten. The rule also requires foods with the claims “no gluten,” “free of gluten,” and “without gluten” to meet the definition for “gluten-free.”  So why are companies using gluten free without the dash?

“Adherence to a gluten-free diet is the key to treating celiac disease, which can be very disruptive to everyday life,” said FDA Commissioner Margaret A. Hamburg, M.D. “The FDA’s new ‘gluten-free’ definition will help people with this condition make food choices with confidence and allow them to better manage their health.”

“We encourage the food industry to come into compliance with the new definition as soon as possible and help us make it as easy as possible for people with celiac disease to identify foods that meet the federal definition of ‘gluten-free’” said Michael R. Taylor, the FDA’s deputy commissioner for foods and veterinary medicine.  However, CSA supported product testing of about 500 foods, currently labeled as “gluten-free”, records that 95% of the products are not detectable  meet the new federal definition.  Food manufacturers have a year after the rule is published to bring their labels into compliance with the new requirements. The labeling regulation takes affect August of 2014.

The term "gluten" is an inclusive term refering to protein fractions naturally in wheat, rye, barley and cross-bred hybrids of these grains and to a less extent in oats.. In people with celiac disease, foods that contain gluten trigger production of antibodies that attack and damage the lining of the small intestine. Such damage limits the ability of celiac disease patients to absorb nutrients with the risk of other very serious health problems, including nutritional deficiencies, osteoporosis, growth retardation, infertility, miscarriages, short stature, and intestinal cancers.

The FDA was directed to issue the new regulation by the Food Allergen Labeling and Consumer Protection Act (FALCPA), which directed FDA to set guidelines for the use of the term “gluten-free” to help people with celiac disease maintain a gluten-free diet.

The full regulation was published in the Federal Register.

Though the regulation is intended to improve the health of Americans with celiac disease, will it be protective enough?  

Suggested reading:

  The FDA Health Hazard Assessment for Gluten Exposure in Individuals with Celiac Disease : Determination of Tolerable Daily Intake Levels and Levels of Concern for Gluten wad compiled by the Office of Food Safety, Center of Food Safety and Applied Nutrition Food and Drug Administration.  The report includes summary of all research related to gluten tolerance published as of 2011.    

Statement on gluten tolerance levels from pages 45 and 46 follows:  

"Last, after the evaluation of all low dose-response data available on the adverse celiac disease (CD) related health effects of gluten, the tolerable daily intake level for gluten in individuals with CD was determined in a safety assessment to be 0.4 mg gluten/day for adverse morphological effects and 0.015 mg gluten/day for adverse clinical effects. Some evidence suggests that the possibility that the TDI for morphological effects based on a derivation that incorporated a 10-fold UF for inter-individual differences may not include 45 a margin of error (or safety) that protects all individuals with CD. The LOC values for gluten in food that correspond with these TDI values at the 90th percentile level of intake are less than 1 ppm for both morphological (~0.5 ppm) and clinical (~0.02 ppm) adverse effects. In sum, these findings indicate that a less than 1 ppm level of gluten in foods is the level of exposure for individuals with CD on a gluten-free diet (GFD) that protects the most sensitive individuals with CD and thus, also protects the most number of individuals with CD from experiencing any detrimental health effects from extended to long-term exposure to gluten."

FDA: Gluten-Free Labeling
FDA: Gluten-Free Labeling Final Rule Q&A
FDA, click here.

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