FDA Scrutinizes ‘Gluten-Free’ Claims

WASHINGTON (CN) - The Food and Drug Administration has issued a regulation that defines the term "gluten-free" for voluntary use on U.S. food labels for the first time.

The FDA's rule defines the term to mean "that the food bearing the claim does not contain an ingredient that is a gluten-containing grain (e.g., spelt wheat), an ingredient that is derived from a gluten-containing grain and that has not been processed to remove gluten (e.g., wheat flour)."

Under the new definition, food labeled "gluten-free" may contain grain that has been processed to reduce the amount of gluten to 20 parts per million, or 20 milligrams per kilogram, according to the FDA's action.

"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," the FDA said in its action.

In addition, food labels that include the term "wheat" or "contains wheat," but also claim to be "gluten-free" will be deemed misbranded.

The FDA said the term needed to be defined to protect consumers who suffer from celiac disease.

"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 agency said in its action.

The action also fulfills a directive under the Food Allergen Labeling and Consumer Protection Act of 2004, the FDA said.

Celiac disease is a hereditary and chronic inflammatory disorder of the small intestine triggered by gluten.

The inflammation can prevent tiny, fingerlike protrusions in the intestine, called "villi," from absorbing nutrients, leading to severe and even life-threatening health problems such as malnutrition, iron-deficiency, anemia, weight loss, infertility, miscarriage and osteoporosis.

The FDA estimates that about 0.4 percent, or about 1.5 to 3 million Americans (1 in 16) have celiac disease, but the 2009/2010 National Health and Nutrition Examination Survey claims a 0.14 percent prevalence, which accounts for those with "silent" celiac disease, which can go undetected for years. Silent celiac disease does not produce any symptoms that might clue a person in to a problem, causing it to be undetectable, sometimes for years. The National Health survey is based on known cases and those that are estimated not yet to be detectable.

The final rule takes effect on Sept. 4, with a compliance date of Aug. 5, 2014.

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