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 is because the U.S. 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 cannot be detected by standard lab tests.

This is the current standard in European Union countries and 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 the small intestine when their immune system attacks healthy tissue whenever it detects gluten -- found in rye and barley as well as wheat.

“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 Antinoro said that is a good guide for consumers to use until the FDA issues its final regulations.

The FDA last week invited consumers, celiac experts, and the industry to comment on a rule that it had initially proposed in 2007. (To comment go to and enter docket number FDA-2005-N-0404.) After the comment period closes in two months, the FDA later this year will issue a final rule 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 . . . while ensuring that food manufacturers can meet the needs of consumers.”


From the August 8, 2011, Prepared Foods' Daily News.