A New Era of “Gluten-free” Labeling by Michael R. Taylor of the FDA Voice

For most of us, choosing a meal is not a make or break decision. Most people prepare a meal without fearing that it will endanger their health. That’s not the case with people who suffer from celiac disease. I’ve learned first-hand from talking with people with the disease how much it means to them to be able to select gluten-free foods with confidence.

Celiac disease is a serious health issue and there is no cure. The only choice for the more than 3 million Americans living with the disease is adherence to a diet free of gluten — proteins that occur naturally in wheat, rye, barley and cross-bred hybrids of these grains. To do otherwise is to risk gradually damaging the intestines, preventing the absorption of vitamins and minerals, and possibly leading to a host of other health problems.

Last year FDA issued a rule on food labeling to improve life for people with celiac disease. The rule ensures that “gluten-free” claims on food packages are reliable and consistent. It provides a clear definition of the term so that all packaged food products bearing the claim “gluten-free” contain less than 20 parts per million of the protein.

And today is the compliance date for this rule. This is important because it means that any packaged food product labeled with the “gluten-free” claim, as of today, must meet the standard set by the FDA.

FDA gave companies a year to make the necessary changes to their products if they used the “gluten-free” claim. This past year, we took steps to educate industry about the rule and what it means to be gluten-free. In June, we issued a guide to help small businesses comply with the rule.

The gluten-free final rule applies to packaged foods, which may be sold in some retail and food-service establishments such as some carry-out restaurants. However, given the public health significance of “gluten-free” labeling, FDA says that restaurants making a gluten-free claim on their menus should be consistent with FDA’s definition. I’m pleased to note that the National Restaurant Association also advised operators offering “gluten-free” items on their menus to make sure their claims are consistent with the definition.

Honest and accurate “gluten-free” labeling will strengthen consumers’ confidence in the products that carry it. One of the rule’s requirements is that it establishes a threshold of 20 parts per million — meaning that to be labeled as free of gluten, each kilogram of the product must contain less than 20 milligrams of the protein. This is consistent with the threshold established by other countries and international bodies that set food safety standards.

I commend companies that have already stepped up to the plate to meet the definition for “gluten-free” labeling. They make it possible for consumers to have labels they can trust as they make well-informed food choices.

Courtesy of Michael R. Taylor is FDA’s Deputy Commissioner for Foods and Veterinary Medicine