FDA Gluten-Free Definition Applies to Dietary Supplements

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WASHINGTON—FDA has defined the term "gluten-free" for labeling of food in a move the regulatory agency said would aid the three million Americans who are victims of celiac disease.

The agency explains the rule applies to all foods it regulates, including dietary supplements.

Gluten-free claims must adhere to all aspects of FDA's definition, including the requirement that the food contains less than 20 parts per million of gluten. Foods containing the claims "no gluten", "free of gluten" and "without gluten" also must meet the gluten-free definition.

"Establishing in this final rule a regulatory definition of the food labeling term 'gluten-free' and uniform conditions for its use in the labeling of foods is necessary to ensure that individuals with celiac disease are not misled and are provided with truthful and accurate information with respect to foods so labeled," the final rule, which was published last week in the Federal Register, states.

Food manufacturers will have one year to adhere to the FDA's labeling requirements.

The term gluten relates to proteins that occur naturally in barley, rye, wheat and cross-bred hybrids of these grains. Gluten-containing foods trigger production of antibodies that attack and damage the small intestine's lining in individuals who suffer from celiac disease, FDA explains. These individuals must adhere to a gluten-free diet in order to avoid health problems, according to the agency.

"To do otherwise is to risk gradually damaging the intestines, preventing the absorption of vitamins and minerals and leading to a host of other health problems, including nutritional deficiencies, osteoporosis, miscarriages, and cancer," Virginia Cox, Associate Commissioner of FDA's Office of External Affairs, wrote in a blog.

FDA projects the new requirements will yield annual health benefits of roughly $110 million, compared to estimated annual costs (related to testing and relabeling) of $7 million.

Industry has been awaiting a final rule for a long time. The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) directed the U.S. Department of Health and Human Services to define and permit the use of the word gluten-free in the labeling of foods. FDA published a proposed rule more than six years ago but the agency reopened the comment period on its proposal in August 2011.

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