One year after the United States Food and Drug Administration told food manufacturers they had no more than 12 months to ensure all of their "gluten-free" claims are valid, regulators can take action against food makers whose products are suspect.

The now-to-be-enforced definition of "gluten-free" eliminates uncertainty about the labeling for such items, Felicia Billingslea, director of FDA's division of food labeling and standards, said in an announcement posted at the agency's Website. "People with celiac disease can rest assured that foods labeled 'gluten-free' meet a clear standard established and enforced by FDA."

According to the online medical site WebMD.com, celiac disease is "a digestive and autoimmune disorder that results in damage to the lining of the small intestine when foods with gluten are eaten ... the damage to the intestine makes it hard for the body to absorb nutrients, especially fat, calcium, iron, and folate."

For the the estimated 3 million Americans with celiac disease, avoiding gluten entirely is the only safe course of action, said the FDA.

Meanwhile, it's believed more people have some form of gluten intolerance, a less severe but still potentially painful and aggravating condition.

The FDA allows manufacturers to label a food "gluten-free" if the product does not contain any of the following:

  • An ingredient that is any type of wheat, rye, barley, or crossbreeds of these grains;
  • An ingredient derived from these grains and that has not been processed to remove gluten;
  • An ingredient derived from these grains and that has been processed to remove gluten, if it results in the food containing 20 or more parts per million (ppm) gluten;
  • Foods such as bottled spring water, fruits and vegetables and eggs - if they inherently don't have any gluten.

Under the final rule, a food label that bears the claim "gluten-free," as well as the claims "free of gluten," "without gluten," and "no gluten," but fails to meet the requirements of the rule is considered misbranded and subject to regulatory action by FDA.

Billingslea contends consumers should know that some foods in the marketplace labeled "gluten free" may have been labeled before the rule's Aug. 5 compliance date.

So, some food with a longer shelf life, such as pasta, may legally remain on the shelves a little longer, even if they are technically out of compliance with the rule.