FDA Plans New Rule For Gluten-Free Labeling

You could be forgiven for assuming that a food labeled “gluten-free” has no gluten in it. Forgiven, but not necessarily correct in your assumption. Since there is no legal definition of gluten-free, food companies can make unfounded gluten claims on their packaging. So the U.S. Food and Drug Administration (FDA), which has been contemplating this issue for more than seven years, has promised to come up with gluten-free standards.

The proposed FDA rule would classify a food as “gluten-free” if it contained no more gluten than 20 parts per million, a standard used in the 27 countries that compose the Commission of European Communities. This is also the standard set by the Codex Alimentarius Commission in 2008.

Many experts agree that the proposed standard is acceptable. Dr. Stefano Guandalini, who created the University of Chicago Celiac Disease Center in response to the low rate of celiac disease detection in the United States, feels that people with celiac (having an autoimmune reaction to the gluten in wheat, rye and barley) can safely consume up to 10 mg of gluten daily. Under the new rule, he says, only if a person with celiac consumed more than about a pound of foods that had the maximum of 20 ppm of gluten would they suffer symptoms.

According to Dr. Alessio Fasano of the University of Maryland’s Center for Celiac Research, who has performed extensive research on gluten and celiac: “This is a standard that has been in use in Europe for almost two decades, and the science supports the U.S. adopting it as well.”

Growing Market

Chances are the FDA, despite its delays in the past, is serious about coming up with an enforceable gluten-free standard in the near future. The market for gluten-free products has been growing rapidly. It is estimated that about $2.6 billion worth of gluten-free foods are now sold every year in the U.S. That’s up from only $560 million seven years ago.

Beth Hillson, president of the American Celiac Disease Alliance (ACDA), a national advocacy organization representing patients, researchers, food manufacturers and others serving the celiac community, says of the proposed labeling rule: “This is critically important since individuals with celiac disease and gluten sensitivity have been left to fend for themselves, while companies place ‘gluten-free’ on products like water that never contained any of the forbidden grains — wheat, rye or barley.”

Dr. Guandini agrees, telling the ACDA: “Celiac disease is a serious, life-threatening medical condition. In this country, the food products that patients need to treat the condition are virtually unregulated, leaving these individuals at risk of harm each and every day. It is inexcusable.”

To read more about the FDA’s proposed rule and to send a message to the FDA about how you feel about the rule, go to http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm265212.htm.


Carl Lowe

By Carl Lowe

has written about health, fitness and nutrition for a wide range of publications including Prevention Magazine, Self Magazine and Time-Life Books. The author of more than a dozen books, he has been gluten-free since 2007.