FDA's Gluten-Free Labeling Regulation

Manila Bulletin, August 10, 2013 | Go to article overview

FDA's Gluten-Free Labeling Regulation


Nowadays, consumers are getting more concerned and more vigilant about healthy foods to improve their quality of life. No wonder consumers now really take time and effort to understand labels appearing in containers of foods especially on manufacturers' claims on the nutrient contents and other supplement facts about the food products.

The gluten-free labelling regulation recently promulgated by the U.S. Food and Drug Administration (FDA) was warmly welcomed by the US consumers especially those who are benefitted by the regulation, namely people who are afflicted with celiac disease. It is estimated that celiac disease affects up to 3 million Americans.

One may ask: What is gluten? What is celiac disease?

Gluten is the protein found in many grains such as wheat (including durum, semolina, kamut, spelt), rye, barley, and oats. 'Gluten' comes from the Greek word for glue and its adhesive properties hold bread and cake together. Although gluten is the main ingredient of bread that makes it light and fluffy, some people are allergic to it and their digestive system seem unable to tolerate it. A disease called celiac sprue, celiac disease or gluten-sensitive enteropathy is now affecting 1 out of every 133 people in the United States. Celiac disease is a condition whereby the lining of the small intestine is damaged by gluten. The damage to the small intestine causes malabsorption of many important nutrients, resulting in weight loss and vitamin and mineral deficiencies - which can lead to a variety of health problems in the gut, the bloodstream, the brain, the joints, cardiovascular and endocrine systems. Not many know that gluten-sensitivity is a permanent condition. A complete lifelong abstinence from gluten is the only known effective treatment.

And now- here is the FDA recent rule on gluten-free labeling of food products. The rule simply defines the term "gluten-free" for the voluntary use by food manufacturers of food products in the labeling of foods, as follows:

"Gluten-free" means that the food either is inherently gluten free; or does not contain an ingredient that is: 1) a gluten-containing grain (e.g., spelt wheat); 2) derived from a gluten-containing grain that has not been processed to remove gluten (e.g., wheat flour); or 3) derived from a gluten-containing grain that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food. Also, any unavoidable presence of gluten in the food must be less than 20 ppm.

FDA further cautioned that "a food that bears the claim "no gluten," "free of gluten," or "without gluten" in its labeling and fails to meet the requirements for a "gluten-free" claim will be deemed to be misbranded. …

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FDA's Gluten-Free Labeling Regulation
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