New Regulations for Gluten Free Foods

November 10, 2013

by Cathe Friedrich

One of the most frustrating things about food labeling in the United States is that words like “free” don’t mean to the FDA (Food and Drug Administration) what they mean to the average person. Consider, for instance, the term “fat-free.” In common parlance, that would mean the food is 100% devoid of fat. To the FDA, however, a product need only contain less than 0.5 mg of fat per serving to be considered fat free. As annoying as this practice is for those on a diet, ambiguous labeling can be downright dangerous for people with food allergies or sensitivities. The problem has been especially relevant to people who suffer from wheat allergy or celiac disease (sensitivity to gluten, a protein found in wheat) because there has been no regulation at all in regards to use of the term “gluten-free.” Fortunately, that has changed.

FDA Rules on the Use of “Gluten Free” in Labeling

Celiac sufferers can relax a bit because shopping has gotten simpler. Rather than having to guess what the phrase “gluten-free” on product packaging means, shoppers now have a formal definition enforced by the FDA. In fact, the new regulation is designed to ensure that those shopping for a gluten-free diet aren’t mislead by a number of terms. The FDA has decided to regulate the use of the following terms:

 gluten-free

 without gluten

 free of gluten

 no gluten

Any product carrying the above labels must contain less than 20 parts per million (ppm) of gluten.

Why 20 Parts Per Million?

20 ppm was selected as the cutoff for a few reasons. First, it is the lowest level that can be consistently and accurately detected by available scientific tools. In other words, anything lower than 20 ppm is just too low for the FDA too reliably quantify.

More important than detection limits, however, is the fact that a gluten content of 20 ppm is generally low enough that people with celiac disease will be able to tolerate the food. While some people must avoid gluten entirely, the vast majority of individuals will not experience symptoms or disease recurrence when consuming food with 20 ppm of gluten (provided they don’t consume massive quantities of it).

Finally, 20 ppm is consistent with regulations set by other international food safety bodies. Shoppers in most nations where gluten is regulated can now be assured that gluten-free labels all mean roughly the same thing.

What Falls Under the New Gluten Regulation?

For food to meet the new standard set forth by the FDA, it will either have to comply with the following three criteria or it will need to be “intrinsically gluten-free.” Foods that are intrinsically gluten-free include things like vegetables, fruits, eggs, and bottled water. For all other foods, the following three criteria apply:

 The food may not contain any type of wheat, rye, or barley and cannot contain any crossbreed of these grains.

 If food is derived from the grains above, it must be processed to remove gluten.

 Foods processed to remove gluten must contain less than 20 ppm gluten.

All foods regulated by the FDA, including dietary supplements, will be subject to the new rule. Foods that do not fall under this new rule include those regulated by the U.S. Department of Agriculture (USDA) and those regulated by the Alcohol and Tobacco Tax and Trade Bureau (TTB). Exceptions not covered by the FDA rule include meat, poultry, eggs, and most alcoholic beverages containing 7% or more alcohol by volume.

When Will Gluten Labeling Laws Take Effect?

The regulation was published on August 5, 2013, and became effective 30 days after that. Manufacturers have one year to comply before the FDA will begin to levy fines. That means that the label “gluten-free” will finally be trustworthy on September 4, 2014.

FDA Rules on the Use of “Gluten Free” in Labeling

Why 20 Parts Per Million?

What Falls Under the New Gluten Regulation?

When Will Gluten Labeling Laws Take Effect?

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