Carst and Walker

US: FDA establishes definition of ‘gluten-free’ for food labels

After years of waiting, the US FDA has released new rules defining exactly what “gluten-free” on a food label means. The standardised definition will help the three 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. The rule also extends to foods labeled “free of gluten”, “without gluten” or “no gluten”.

Both the European Union and Canada have set the same level of fewer than 20ppm for their gluten-free labels.

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.

FDA’s final rule on gluten-free labelling, announced on August 2, comes six years after the agency published its proposed definition of gluten-free in 2007 and 9 years after Congress requested a universal definition of gluten-free from the agency in the Food Allergen Labeling and Consumer Protection Act (FALCPA).

The push for a standard definition for the term “gluten-free” has been spurred by an increase in the number of people diagnosed with celiac disease over the past few years. Celiac disease prevents a person from being able to absorb nutrients after eating gluten. An estimated one percent of Americans are thought to have the condition, although 83 percent of cases currently go undiagnosed.

“Adherence to a gluten-free diet is the key to treating celiac disease, which can be very disruptive to everyday life,” said Margaret Hamburg, commissioner of FDA, in a comment on the new rule. “The FDA’s new ‘gluten-free’ definition will help people with this condition make food choices with confidence and allow them to better manage their health.”

FDA said it chose 20ppm rather than 0ppm as the limit because current scientific methods can’t detect levels of gluten below 20ppm.

“In addition, some celiac disease researchers and some epidemiological evidence suggest that most individuals with celiac disease can tolerate variable trace amounts and concentrations of gluten in foods (including levels that are less than 20ppm gluten) without causing adverse health effects,” the agency stated in its Q&A on the new rule.

The amount of 20ppm of gluten in food can be visualised by picturing two grains of salt in a piece of bread.

Celiac awareness advocates praised the release of the rule.

“For years, gluten-free labels have gone unregulated, putting our gluten-free community in danger,” Alice Bast, president of the National Foundation for Celiac Awareness, said in a statement Friday. “We applaud the FDA for finally publishing a standard definition of gluten-free.”

The new rule applies to all FDA-regulated foods and drinks, including dietary supplements.

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.

The new labelling 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.”

Sources: Food Safety News, USAToday, FDA

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