FDA’s Gluten-Free Rule: Issues in the Fine Print

in Celiac
Published: October 10, 2013

When the U.S. Food and Drug Administration’s released its long-awaited standard on gluten-free labeling of packaged foods in August 2013, it was welcomed by those with celiac disease and gluten sensitivity. The rule sets a strict maximum: food products which claim to be gluten-free must contain less than 20 parts per million of gluten.

But one celiac expert warned in late 2013 of a few issues that gluten-free consumers need to be aware of and that the new standard doesn’t resolve. Tricia Thompson, the registered dietitian who created GlutenFreeWatchDog.org, spoke via webinar to Beyond Celiac organization followers about the gluten-free rule. Here are some of the key issues she identifies:

– Watch the wording: Four terms on package labels – “gluten-free”, “no gluten”, “free of gluten” and “without gluten” – all count as a true gluten-free claim. Therefore they will require compliance with the FDA’s new standard.

However, there’s nothing to prevent food manufacturers from using other terminology – such as “made with no gluten-containing ingredients” and “not made with gluten-containing ingredients” – yet these don’t have to comply with the new less than 20 ppm rule.

– Testing: While many free-from manufacturers do rigorously test for gluten content, neither the FDA nor the manufacturers are “required” to test food products to comply with the standard. What is required is that the final product contains less than 20 ppm of gluten, but the manufacturers don’t have to “prove” it in order to display a gluten-free claim on their products.

The FDA does not have the means to test millions of products to confirm that they actually contain less than 20 ppm of gluten. Since the food manufacturers are not technically required to test the food either, it becomes a bit tricky. One way to avoid uncertainty is to stick to products that have undergone an established third-party certification program, such as the GFCP. This provides assurance that the product meets the FDA’s standard.

In the Beyond Celiac webinar, Thompson recommends that manufacturers producing gluten-free products “have a testing protocol in place developed in conjunction with a third party food testing laboratory or a certifying agency.”

– Standard’s scope: The rule applies to foods and dietary supplements regulated by the FDA, but consumers need to be aware that it does not extend to foods that are regulated by the USDA, including meat and poultry.

It also doesn’t apply to most alcoholic beverages, cosmetics, prescription and non-prescription drugs and pet food.

If a consumer believes that a food manufacturer has improperly labeled a food item as gluten-free, Allergic Living recommends speaking up and taking action. If you feel like you’ve been “glutened” by a purportedly GF product, contact the company and let them know. Confirm that the food item is meant to be gluten-free.

If you don’t receive a satisfactory response, you can contact your local FDA Consumer Complaint Coordinator (there’s one for each state, and you can find a list here).

The Good News: Despite these limitations, it’s important to note that many products that are currently labeled as gluten-free already meet the criteria. According to Thompson, Gluten Free Watchdog has tested hundreds of currently available gluten-free products, and the majority have tested well under 20 ppm.