Monday, August 5, 2013

The FDA Creates Standard Regulation for Gluten-Free Foods

On August 2, 2013, the Food and Drug Administration made history for those with celiac and gluten sensitivities by finalizing (at last!) a standard definition of what constitutes “gluten-free.” This means that food labeled as gluten-free must now adhere to a uniform standard in the U.S. The standard also applies to foods labeled "without gluten," "free of gluten," and "no gluten."

The new regulations state that a food must contain less than 20 parts per million (ppm) of gluten in order to bear a “gluten-free” label. This is the lowest level most people with celiac disease can tolerate in foods, and researchers support this threshold as safe for those with celiac and other gluten-related disorders to consume. 20 ppm is also the lowest level that can be consistently detected in foods using valid scientific analytical tools.

This threshold is in line with what is accepted overseas; Europe has been ahead of us on this issue for a long time.

Why is this so historic?
First of all, it’s a long time in the making. The FDA first proposed the standard in 2007 in response to a 2004 law on food-allergen labeling that required a definition of gluten-free.

Second, until now, the term “gluten-free” had no clear definition in the food production field. Consumers have had to trust that companies where being truthful, honorable, and adhering to production practices that did not cause cross-contamination.

Having a published federal regulation and guideline will help people with celiac disease, wheat allergy, or those who choose gluten-free diets for other reasons.

More about the FDA Standard
The FDA’s web page about this regulation states that:

In addition to limiting the unavoidable presence of gluten to less than 20 ppm, FDA will allow manufacturers to label a food "gluten-free" if the food does not contain any of the following:
  1. an ingredient that is any type of wheat, rye, barley, or crossbreeds of these grains
  2. an ingredient derived from these grains and that has not been processed to remove gluten
  3. an ingredient derived from these grains and that has been processed to remove gluten, if it results in the food containing 20 or more parts per million (ppm) gluten

With a clear and enforceable standard in place, consumers now have more certainty about how food producers label their products and people will celiac disease are assured that gluten-free brands meet the FDA requirements.

The regulation will be published on August 5 and manufacturers have one year to comply and ensure that all relevant food packaging (and the actual food in those boxes and cans) meets the published criteria set by the FDA.

There are more details about this important ruling on the website of the National Foundation for Celiac Awareness and the organization will be posting a fact sheet that outlines the new regulations at The organization is also planning a free webinar about the FDA’s rule; see NFCA’s Webinar Schedule.