Friday, August 16, 2013

What is Gluten Free - FDA sets a standard

FDA established a standard that defines “Gluten Free”. Gluten free is a food that does not contain an a gluten containing grain such as wheat, does not contain an ingredient that is derived from a gluten containing grain, and does not contain an ingredient derived from a gluten containing grain that has been processed to remove the protein (such as wheat starch) where that ingredient has more than 20 ppm of gluten. And is produced so that the food will not be contaminated with the unavoidable presence of gluten to a level of no more than 20 ppm.

Foods that are free of gluten by their nature can be labeled as gluten free, however they do not have to be labeled as such if they are gluten free. It is voluntary. Manufacturers are not required to test for the presence of gluten, but are required to meet the requirements of the law, so manufacturers can use a number of tools to meet the standard.

Establishing this set standard allows uniform labeling thus making it easier for those with the celiac disease to make informed decisions regarding food items.

Gluten is protein that is found in wheat, rye, barley. In people with celiac disease, gluten triggers an immune reaction that results in antibodies attacking the intestinal lining. It can be painful for those individuals who inadvertently ingest gluten. It can also impact absorption of nutrients from the intestines. This condition is especially problematic in children where it can lead to growth problems, and weight loss. For adults, in addition to the stomach issues, it can lead to long term effects such as malnutrition, liver disease, and cancer of the intestines. It is estimated that roughly 1 in 100 people have the disease (whether they know it or not).

It is important to remember that gluten is an important part of the diet and a gluten free diet is not recommended for the general public

For Immediate Release: August 2, 2013

Media Inquiries: Shelly Burgess 301-796-4651,
Consumer Inquiries: 888-INFO-FDA
En EspaƱol1

FDA defines “gluten-free” for food labeling
New rule provides standard definition to protect the health of Americans with celiac disease

The U.S. Food and Drug Administration today published a new regulation defining the term "gluten-free" for voluntary food labeling. This will provide a uniform standard definition to help the up to 3 million Americans who have celiac disease, an autoimmune digestive condition that can be effectively managed only by eating a gluten free diet.

“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.”

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.” 

The FDA recognizes that many foods currently labeled as “gluten-free” may be able to meet the new federal definition already. Food manufacturers will have a year after the rule is published to bring their labels into compliance with the new requirements.

“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.

The term "gluten" refers to proteins that occur naturally in wheat, rye, barley and cross-bred hybrids of these grains. 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 and puts them at 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 regulation was published today in the Federal Register2.

For more information:
FDA: Gluten-Free Labeling3
FDA: Gluten-Free Labeling Final Rule Q&A4
Consumer Update

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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