CELIACTODAY

Here’s a quiz: Does the term “gluten-free” mean that a product contains:

a) Zero gluten;

b) An amount of gluten so small that it cannot be measured, or

c) An amount that can be measured but that researchers believe is safe for people with celiac disease?

The “right” answer, it turns out, is a matter of opinion—and a strongly held opinion, at that.

The U.S. Food and Drug Administration is getting ready to render its opinion on the subject, and the agency’s decision will have big consequences.

That’s because the FDA’s definition will be the one that food makers will have to measure up to if they choose to label their products as gluten-free.

“Consumers now will have a better gauge of the products they are buying,” says Andrea Levario, executive director of the American Celiac Disease Alliance (ACDA). “They will have a standard for the first time.”

Effective Coalition

Based in Alexandria, Va., the ACDA is a coalition of people and organizations from the celiac community who convinced Congress a few years back to require food makers to note on the label the presence of any of eight major allergens (egg, fish, milk, peanuts, shellfish, soy, tree nuts and wheat).

The legislation also required the FDA to establish a legal definition for the term “gluten-free”—a phrase that so far has been unregulated in the U.S.

Congress gave the FDA a few years to study the issue, make a proposal, take public comments, and then issue its final definition. The deadline is next August, so the FDA’s decision could arrive any day now.

The agency published its proposed definition in early 2007. As it turns out, the FDA’s idea of “gluten free” is not “zero gluten.”

Microscopic Amount

Instead, the FDA proposed that a product can carry a gluten-free label if gluten accounts for less than 0.00002 percent of its total content. Stated another, slightly more technical way, the benchmark would set the gluten level at less than 20 parts per million (ppm).

The FDA said it chose that standard because “currently there are no available and appropriate test methods that can reliably and consistently detect gluten” at levels of below 20 ppm.

“The FDA has to go where the science is,” says Ms. Levario of the ACDA. “Twenty ppm is fine.”

However, the country’s biggest national support group disagrees. The Celiac Sprue Association (CSA), based in Omaha, Neb., suggests that the FDA should test to the lowest level of gluten that technology allows.

Currently, CSA says, that level is 3 ppm. That’s the level CSA tests for when evaluating whether products are eligible to display its CSA Recognition Seal Program.

“If a test comes out tomorrow and validates very well at two parts per million, that’s what we would like to see,” adds Mary A. Schluckebier, CSA’s executive director.

Goal: Zero Gluten

The goal for people with celiac, Ms. Schluckebier says, is to consume no gluten at all, adding: “There’s no research to show that there’s a safe level.”

The FDA standard, Ms. Schluckebier says, “is being set up, not as what’s safe for patients, but what’s workable for manufacturers.”

The country’s two other national support groups, though, support the proposed benchmark.

“Twenty parts per million is probably the most acceptable amount of gluten that we can ingest without harm, and that manufacturers can test down to,” says Elaine Monarch, executive director of the Celiac Disease Foundation in Studio City, Calif.

'Based in Science'

“It’s totally based in science,” adds Cynthia Kupper, executive director of the Gluten Intolerance Group of North America (GIG) in Auburn, Wash.

Ms. Kupper, a registered dietician, says that “trying to set the level to zero is unrealistic and impossible.”

GIG itself uses a standard of 10 ppm for its own product evaluation program, which it operates through an affiliate, the Gluten-Free Certification Organization.

It is, perhaps, not surprising that the support groups differ on what constitutes a safe level of gluten. The fact is, scientists themselves disagree.

Safe Threshold Debated

A few years ago, for example, a group of Finnish researchers concluded that “the threshold for gluten contamination can safely be set at 100 ppm.” More recently, though, an Italian-U.S. research team suggested that a threshold of 20 ppm was probably more appropriate.

Both teams agreed that additional research on the subject is still needed.

For now, though, the FDA appears likely to adopt the 20 ppm standard.

That standard will affect how food manufacturers advertise their products to people with celiac disease, and how people with celiac make purchasing decisions.

“The biggest impact might be to weed out some of the companies that say they’re gluten-free, but maybe they’re not,” says Steven J. Singer, president of Glutino Food Group in Laval, Quebec, Canada, just outside Montreal. “It might hurt some of the small companies that can’t control their environment.”

Labeling Is Voluntary

Importantly, however, the law doesn’t require companies to label their products as gluten-free. It’s completely voluntary. But, if they do choose to label a product as gluten-free, will have to measure up to the FDA’s standard.

Some celiacs are likely to rely on such labels, while others won’t, says Ms. Monarch of the Celiac Disease Foundation.

“I think some of the country wants to be told what to do,” she says. “And there are other people who handle the diet beautifully. They don’t need to see ‘gluten-free’ on the label.”

This story originally appeared in the (November, 2007 ) issue of CeliacToday.com. It was most recently updated in (October, 2009).