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Foods that have "gluten-free" on their label may actually contain significant amounts of gluten -- enough to cause gastrointestinal symptoms in those with celiac disease who have an intolerance to the wheat protein. That's because the US Food and Drug Administration never established a standard for the label, leaving it up to manufacturers to define what they mean by gluten-free.

Now, though, the agency is moving forward with a new standard that manufacturers will be required to meet before they can slap on the gluten-free label. Federal officials are proposing that cookies, bread, and other wheat products making this claim can contain no more that 20 parts per million of gluten, a level below which gluten can't be detected by standard lab tests.

It's the current standard in European Union countries and has been widely accepted by researchers as a safe level for those with celiac disease, which affects nearly 3 million Americans. Those with the condition suffer damage to their small intestine when their immune system attacks healthy tissue whenever it detects gluten -- found in rye and barley as well as wheat.

"While fruits and vegetables are clearly free of gluten, there's no way for those with celiac to know if that brand of crackers they're buying is really gluten-free," said Linda Antinoro, a registered dietitian at Brigham and Women's Hospital. "A company can define it as 100 parts per million," a high enough level to trigger cramping, diarrhea, and intestinal inflammation in some celiac sufferers. "We tell patients, if in doubt, leave it out."

Some manufacturers of gluten-free products also state on the label that the product contains no more than 20 parts per million of gluten, and Antionoro said that's a good guide for consumers to use until the FDA issues its final regulations. "Companies have to back up the amount in that claim if they have it on the label."

The FDA this week invited consumers, celiac experts, and the industry to make comments on a rule that it had initially proposed back in 2007. (To comment go to regulations.gov and enter docket number FDA-2005-N-0404.) After the comment period closes in two months, the FDA will issue a final rule later this year for the industry to follow that will probably go into effect in 2012.

"Before finalizing our gluten-free definition, we want up-to-date input from affected consumers, the food industry, and others to help assure that the label strikes the right balance," Michael Taylor, FDA deputy commissioner for foods, said in a statement. "We must take into account the need to protect individuals with celiac disease from adverse health consequences while ensuring that food manufacturers can meet the needs of consumers by producing a wide variety of gluten-free foods."

Plenty of people without celiac disease have embraced these products, believing that avoiding gluten will help them lose weight, improve their mood, or increase their energy. Last year, sales of gluten-free products hit $1.2 billion, more than double the sales from 2005.