Regulations that tell consumers just what it means when a product is labeled “gluten free” take effect on Tuesday — a “major milestone,” says one of the leading experts on gluten disorders.

“The gluten-free diet for someone with celiac disease is like insulin for diabetics,” says Dr. Alessio Fasano, director of the Center for Celiac Research at Massachusetts General Hospital and author of the recent book Gluten Freedom.

The Food and Drug Administration has determined that, as of August 5, packaged food labeled gluten free (or similar claims such as “free of gluten”) cannot contain more than 20 parts per million of gluten. (Another agency regulates meat and poultry.) One caveat is that use of the gluten-free label is voluntary; there is no requirement that a package containing gluten must declare that.

People who have the autoimmune disorder celiac disease can become very sick if they eat the tiniest amount of gluten, a protein found in wheat, barley and rye; there are, however, a range of other conditions set off by gluten, sensitivities that cause headaches, intestinal problems and respiratory issues.

Additionally, gluten-free diets have become “fashionable,” which has helped prompt hundreds of new gluten-free products but also has meant that real medical problems are sometimes treated lightly, Fasano says.

“For people like myself, this is a medical necessity. My diet is my medicine,” says Beth Hillson, the president of the American Celiac Disease Association.

“This labeling rule makes it very clear cut. That gives me a lot more comfort. My son, who is 27, is also celiac, and he’s out on his own and cooking. That gives me peace of mind for him as well,” says Hillson, author of the upcoming book “The Complete Guide to Living Well Gluten Free.”

People should not “just try out” a gluten-free diet if they suspect problems; a medical diagnosis is essential, Fasano says. For one thing, if the underlying problem could affect relatives, it’s important to know. And it’s impossible to find the effects of gluten in a person who eats none.

Fasano writes in his book that when he came here from Italy in 1993 and began talking about gluten issues in the United States, people told him celiac disease was almost nonexistent in this country. They were wrong, he says. About 1 in 133 people in the U.S. now is thought to have celiac disease.

These days, the market for gluten-free foods tops $6 billion, with a counterpart for cookies, cakes, pizzas and just about every food containing gluten, analysts say. Gluten, Fasano says, is “nutritionally useless,” so it’s generally fine for people to avoid it as long as they are careful to get the vitamins, fiber and minerals found in foods such as bread and pasta.

From his perspective, Fasano says, goals that remain are discovering a “safety net” treatment, a complement to a gluten-free diet for people who inadvertently are exposed, and to find a way to prevent the disorder.

The new FDA regulation doesn’t mean that people who must avoid gluten can completely relax. A product doesn’t have to carry any claim about gluten, unlike requirements for allergens such as nuts and wheat. Although wheat is one of the major foods containing gluten, it is not the only one. And some products that contain wheat have had the gluten removed. That means some consumers still must read ingredient lists carefully.

Consumers can file complaints about compliance with the regulation through the FDA’s Center for Food Safety and Applied Nutrition by calling (240) 402-2405 or by going to and typing into the search box “medwatch form.”


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