After years of waiting, the Food and Drug Administration released new rules Friday defining exactly what "gluten-free" on a food label means. The standardized definition will help the 3 million American who have celiac disease, along with millions more who follow a gluten-free diet for other reasons.
Under the federal definition, which FDA has been working on since 2007, food that carries a "gluten-free" label must contain fewer than 20 parts per million of gluten.
With the new rule, when consumers see "gluten-free" on a food label," they can be assured that those claims have meaning," said Michael Taylor, the FDA's deputy commissioner for foods and veterinary medicine.
Gluten is a protein that occurs naturally in wheat, rye and barley. Celiac disease is an inherited auto-immune condition that makes it impossible for those who have it to digest gluten. If they eat gluten, their bodies produce antibodies that attack and damage the lining of the small intestine. This can cause severe health problems including nutritional deficiencies, osteoporosis, growth retardation, infertility, miscarriages, short stature and intestinal cancers.
The new label rules will be "fantastic," said Andrea Levario, whose son has celiac disease. Right now when she shops, "if I pick up a product and it says 'gluten-free' I don't know what that means because there's no federal standard." Levario is the executive director of the American Celiac Disease Alliance in Alexandria, Va.
Food packages will be required to conform to the new rules within one year, Taylor said.
Labeling is crucial because for people with celiac disease, following a gluten-free diet is the only treatment available. "While a diabetic needs insulin to survive, a celiac must have gluten-free food," Levario said. "Without clear ingredient information and a definitive labeling standard, celiac consumers are playing Russian roulette when it comes to making safe food choices."
Congresswoman Nita Lowey, D-Westchester, who first began arguing for labeling standards in 1999, hailed the new rules.
"I am pleased that our federal government has finally set clear, uniform standards that will rein in a fast-growing, unregulated market," Lowey said.
The Food Allergen Labeling and Consumer Protection Act of 2004 required that the FDA issue standards for the term "gluten-free." It also required food packaging to clearly list whether they contained any of the top eight ingredients that cause allergic reactions. Those are milk, egg, peanuts, tree nuts, fish, crustacean shellfish, soy and wheat. That portion of the act went into effect in 2006.
Gluten-free foods have become very popular over the past five years. The market was estimated to be $4.2 billion in 2012, according to Packaged Facts. The market research firm estimates sales will reach $6.6 billion by 2017.
Companies that market gluten-free products were pleased with the new rules. "We are thrilled by the FDA's decision to regulate gluten-free labeling," said T.J. McIntyre, vice president of Boulder Brands, which makes Glutino gluten-free products. "This is bigger than products or brands, this is a consumer safety issue."
Both the European Union and Canada have set the same level of fewer than 20 parts per million for their gluten-free labels, Taylor said.
The new labeling will be useful for people with celiac disease, however "there is a common misconception that gluten-free diets are 'healthier' or for weight loss," said Dana Angelo White, a nutritionist at Quinnipiac University in Hamden, Conn.
People who are not afflicted with celiac disease "put themselves unnecessarily at risk for nutrient deficiencies by banishing all gluten from their diet," she said. It also isn't helpful for weight loss because "many gluten-free products, including a variety of baked goods, are higher in calories than their gluten-free counterparts."
Stefano Guandalini, director of the University of Chicago's Celiac Disease Center, concurred. "There is no evidence that a gluten-free diet is healthier or is a means to lose weight," he said. "When completely removing gluten (wheat, barley and rye) from the diet and not replacing with substitutes, you might indeed experience weight loss, but that is not from the lack of gluten, rather from the lack of other calorie sources, especially carbohydrates, that are removed along with gluten."