ShareThis Page

FDA finally defines 'gluten-free'

| Friday, Aug. 2, 2013, 8:09 p.m.

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

The official government designation occurred 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 for what it takes to earn that label, meaning that foods marketed as gluten-free 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 in order 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 A. Hamburg said in a statement. “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 guidelines for the use of the term “gluten-free” when it passed the Food Allergen Labeling and Consumer Protection Act of 2004. The agency organized a public meeting on the topic the next year and solicited input from a wide range of interested parties, 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 by the FDA.

In recent years, more and more consumers have begun buying gluten-free versions of breads, pastas, cereals and other staples, as well as gluten-free beer and wine.

The research firm Packaged Facts reported last year that the market for gluten-free products has grown more than expected, reaching $4.2 billion. “The conviction that gluten-free products are generally healthier is the top motivation for consumers of these products,” the firm said in its report, which projected that U.S. sales of gluten-free foods and beverages would cross $6.6 billion by 2017.

TribLIVE commenting policy

You are solely responsible for your comments and by using you agree to our Terms of Service.

We moderate comments. Our goal is to provide substantive commentary for a general readership. By screening submissions, we provide a space where readers can share intelligent and informed commentary that enhances the quality of our news and information.

While most comments will be posted if they are on-topic and not abusive, moderating decisions are subjective. We will make them as carefully and consistently as we can. Because of the volume of reader comments, we cannot review individual moderation decisions with readers.

We value thoughtful comments representing a range of views that make their point quickly and politely. We make an effort to protect discussions from repeated comments either by the same reader or different readers

We follow the same standards for taste as the daily newspaper. A few things we won't tolerate: personal attacks, obscenity, vulgarity, profanity (including expletives and letters followed by dashes), commercial promotion, impersonations, incoherence, proselytizing and SHOUTING. Don't include URLs to Web sites.

We do not edit comments. They are either approved or deleted. We reserve the right to edit a comment that is quoted or excerpted in an article. In this case, we may fix spelling and punctuation.

We welcome strong opinions and criticism of our work, but we don't want comments to become bogged down with discussions of our policies and we will moderate accordingly.

We appreciate it when readers and people quoted in articles or blog posts point out errors of fact or emphasis and will investigate all assertions. But these suggestions should be sent via e-mail. To avoid distracting other readers, we won't publish comments that suggest a correction. Instead, corrections will be made in a blog post or in an article.