Food manufacturers are now required to comply with the FDA’s regulations regarding gluten-free products, a shift required by the agency in a August 2013 ruling that defined the characteristics a food product must have to bear a “gluten-free,” “without gluten,” “free of gluten,” or “no gluten” label.

To be considered “gluten-free,” a food product must contain less than 20 parts per million (ppm) of gluten, which is the lowest level that can be consistently detected in foods that may carry the label. This is aligned with international standards on gluten-levels.

Prior to the ruling, the FDA estimated that 5% of foods formally labeled “gluten-free” contained 20 ppm or more of gluten. A food product may hold a gluten-free label, if the product does not contain any of the following:

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  • 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

Although all new products that hit shelves will be held to the new compliance standards, the FDA cautions consumers that foods like pasta, which may have been labeled before the ruling and have a longer shelf life, may continue to be for sale.

The agency suggests that patients who have any doubts about a product’s ingredients should first contact the manufacturer and check its website for additional nutrition information. Foods that bear a “gluten-free” label but are not compliant will be subject to regulatory action by the FDA.

Restaurants, however, are not being held to the agency’s ruling, as it only pertains to packaged foods. “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,” urged the FDA on its Consumer Updates page.

Patients with diagnosed gluten allergies that are dining out are encouraged to ask the restaurant management how the menu item was prepared, and what ingredients make up the item in order to assess if the item is gluten-free or not.

The agency’s ruling may come as relief to the 3 million patients diagnosed with celiac disease, a condition where the body’s natural defense system reacts to gluten by attacking the lining of the small intestine. Without this protective lining, the body cannot absorb necessary nutrients, sometimes resulting in delayed growth and nutrient deficiencies that lead to anemia, osteoporosis, diabetes, and intestinal cancers.