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FDA issues gluten-free guides after 9 years

It took a little longer than the construction of the Lincoln Memorial, but the Food and Drug Administration on Friday finalized its definition of what it takes for food to qualify as “gluten-free.”

The official government designation came nine years after Congress asked the agency to establish a standard for companies wanting to label their products as gluten-free and five years after the deadline set by lawmakers.

In the interim, a growing number of manufacturers have leaped into the lucrative and exploding market for foods without gluten, a protein found in barley, wheat and rye. While several independent organizations certify products as gluten-free, until Friday there was no government standard, meaning that foods marketed as gluten-free actually contained varying amounts of the protein.

At the same time, an increasing number of Americans have been diagnosed with celiac disease, an autoimmune condition in which consuming gluten can damage the lining of the small intestine and contribute to a range of health issues, from gastrointestinal problems to increased risk for osteoporosis, infertility, miscarriages and certain types of cancer.

About 3 million Americans, or about 1 in 133, suffer from celiac disease, according to the National Foundation for Celiac Awareness. An estimated 18 million are “gluten-sensitive,” meaning exposure to the protein can cause symptoms such as headaches, fatigue and joint pain.

The rule published Friday by the FDA says that for a product to be marketed as “gluten-free,” it must contain less than 20 parts per million of gluten. It also requires that any foods labeled “free of gluten,” “without gluten” and “no gluten” meet the same standard.

The agency said that while many foods currently being marketed as gluten-free already meet the new federal guidelines, manufacturers will have a year to comply.

“Adherence to a gluten-free diet is the key to treating celiac disease, which can be very disruptive to everyday life,” FDA Commissioner Margaret Hamburg said. “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.”

Alessio Fasano, director of the Center for Celiac Research at Massachusetts General Hospital, said the FDA took an “excruciating” amount of time to finalize its gluten-free definition in part because it had to consider the polarized positions of activists who wanted more stringent standards and industry officials who wanted more lenient requirements. In the end, he said, the agency ended up striking the right balance.

“They made a decision that was based on scientific evidence,” he said, adding that it was a ruling that finally will give celiac sufferers peace of mind in restaurants and grocery store aisles.

“Now, they don’t have to stress out,” Fasano said. “Now, they know there are rules, that there are parameters. It’s a big deal.”

Congress directed the FDA to set guides for the use of the term “gluten-free” when it passed a food labeling law in 2004. The agency organized a public meeting on the topic the next year and solicited input from a range of groups, including medical professionals, food manufacturers and millers.

The FDA published a proposed rule in 2007 but continued to study the matter for years, saying it demanded careful consideration and technical analysis, such as determining how accurately manufacturers could test gluten levels in their products. The agency asked for another round of public comment in 2011 and finally sent its proposal to the White House earlier this year for final review.

While the U.S. government tried to settle on a definition of gluten-free, other countries, such as Australia and Canada, along with the Europe-based Codex Alimentarius Commission, have each set labeling standards of their own. Those standards generally are in line with the 20 parts per million set Friday.

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