FDA Issues Rule On 'Gluten-Free' Foods

About 5 percent of foods that market themselves as "gluten-free" will not meet the new guidelines.


The Food and Drug Administration is defining what a "gluten free" label on a food package means after more than six years of consideration, during which manufacturers used their own discretion on how much gluten to include.


In a new legally binding rule, the Food and Drug Administration issued guidelines to enforce what food companies can label as "gluten-free."

The rule allows foods to be labeled as "gluten-free," "without gluten" or "no gluten" if they do not contain any type of wheat, rye, barley or crossbreeds of those grains where gluten is often present. Food packages will be required to comply with the new standards within one year.

[READ: Making Sense of the Gluten-Free Food Frenzy]

Before this rule, there was no federal regulation or definition as to what foods were free of gluten, and food companies often used the term at their own discretion. Under the new rule, about 5 percent of foods that are currently packaged as "gluten-free" would not meet the new standards, which limit the amount of those grains to 20 parts per million – the amount of gluten a person with a condition known as celiac disease can consume without getting sick.

Celiac disease is a condition that affects nearly 3 million people in the United States and damages the lining of the small intestine, making it difficult for people to absorb nutrients.

The damage can be attributed to an intake of gluten according to the FDA. There is no cure for the disease and the only way to treat it is by not eating gluten, which can be found in products like pasta, flour or even beer. When a person who suffers from the disease eats food that contains too much gluten, they can have side effects such as abdominal pain, fatigue, weight loss and diarrhea.

Without proper food packaging and labeling, people who suffer from celiac disease could not previously determine if a certain food item would cause them harm. But Michael Taylor, the FDA's deputy commissioner for foods, said in a released statement that the new rules will fix that.

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"This standard 'gluten-free' definition will eliminate uncertainty about how food producers label their products and will assure people with celiac disease that foods labeled 'gluten-free' meet a clear standard established and enforced by FDA," Taylor said.

Taylor told ABC News that the rule was originally proposed while George W. Bush was president. But it was delayed because the FDA was conducting a "scientific assessment" of the data.

Andrea Levario, executive director of the American Celiac Disease Alliance, said in a released statement that the new rule is a "huge victory" for people with celiac disease.

"This is a tool that has been desperately needed," Levario said. "It keeps food safe for this population, gives them the tools they need to manage their health and obviously has long-term benefits for them."

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