Photo source: FDA

Any food product bearing a gluten-free claim label now must meet the requirements of a Food and Drug Administration (FDA) rule that defined what characteristics a food has to have to bear that label.

The rule, adopted by the FDA a year ago, also holds foods labeled "without gluten," "free of gluten," and "no gluten" to the same standard.

Meeting the terms

As one of the criteria for using the claim "gluten-free," FDA set a gluten limit of less than 20 ppm (parts per million) in foods that carry this label. This is the lowest level that can be consistently detected in foods using valid scientific analytical tools.

Also, most people with celiac disease can tolerate foods with very small amounts of gluten. This level is consistent with those set by other countries and international bodies that set food safety standards.

"This standard ’gluten-free’ definition eliminates uncertainty about how food producers label their products,” said Felicia Billingslea, director of FDA's division of food labeling and standards. “People with celiac disease can rest assured that foods labeled 'gluten-free' meet a clear standard established and enforced by FDA."

Warmly received

The new rule was welcomed by advocates for people with celiac disease, who face potentially life-threatening illnesses if they eat the gluten found in breads, cakes, cereals, pastas and many other foods.

Andrea Levario, executive director of the American Celiac Disease Alliance, notes that there is no cure for celiac disease and the only way to manage the disease is dietary -- not eating gluten. Without a standardized definition of "gluten-free," these consumers could never really be sure if their body would tolerate a food with that label, she adds.

Defining gluten

Gluten is a mixture of proteins that occur naturally in wheat, rye, barley and crossbreeds of these grains.

As many as 3 million people in the U.S. have celiac disease, which occurs when the body's natural defense system reacts to gluten by attacking the lining of the small intestine. Without a healthy intestinal lining, the body cannot absorb the nutrients it needs.

Delayed growth and nutrient deficiencies can result and may lead to conditions such as anemia (a lower than normal number of red blood cells) and osteoporosis, a disease in which bones become fragile and more likely to break. Other serious health problems may include diabetes, autoimmune thyroid disease and intestinal cancers.

How the FDA sees it

In addition to limiting the unavoidable presence of gluten to less than 20 ppm, FDA now allows manufacturers to label a food "gluten-free" if the food 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 can also be labeled "gluten-free" if they inherently don't have any gluten.

Under the new 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.

Restaurant food

Some restaurants use the term “gluten-free” in their menus. The gluten-free final rule applies to packaged foods, which may be sold in some retail and food-service establishments such as some carry-out restaurants. However, given the public health significance of “gluten-free” labeling, restaurants making a gluten-free claim on their menus should be consistent with FDA’s definition.

Billingslea suggests that consumers who are concerned about gluten-free claims in restaurants ask the following questions when ordering foods described as gluten-free:

  • What does the restaurant mean by the term “gluten free?”
  • What ingredients are used in this item?
  • How is the item prepared?

“With the new FDA gluten-free regulations now being enforced, restaurants will be well-served to ensure they are meeting the FDA-defined claim,” said Joy Dubost, Ph.D., R.D., senior director of nutrition, National Restaurant Association. “We will continue to work with restaurant operators and chefs to assist and ensure a favorable dining experience for consumers.”

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