Are Foods Labeled “Gluten-Free” Really Gluten-Free?

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If you have a child who suffers from allergies or food intolerance, you no doubt are a diligent food label reader. You spend countless hours each month reading and re-reading labels to ensure allergens are not present in the food you serve your children. However, imagine purchasing a food product labeled “gluten-free,” preparing and serving it to your little one who suffers from celiac disease, only to later learn the product was not in fact gluten-free. And, imagine that despite your diligent label reading and re-reading, there was no way for you to know the product contained levels of gluten high enough to cause your child to react negatively, even severely.

How could it be possible for food companies to mislabel products? Is it fraud or negligence for a manufacture to label a product “gluten-free,” when it is not, in fact, gluten-free? Well, prior to August 5, 2013 there were no standards or definitions for what constituted “gluten free,” meaning some products’ claims were less than reliable and there was no real remedy since no standard had been violated.

Standardizing the Claim “Gluten Free”

On August 5, 2013, the Food and Drug Administration (FDA) issued a “final rule” on the definition of “gluten-free,” and requirements for labeling foods as such. The rule states foods may be labeled “gluten-ree” if they are:

  • Inherently gluten-free
  • Do not contain:
    • A gluten containing grain
    • An ingredient derived from a gluten containing grain that has not been processed to remove the gluten
    • An ingredient derived from a gluten containing grain that has been processed to remove gluten, if the use of that ingredient will increase the presence of gluten to more than 20 ppm in the final product


Essentially, in order to claim a product is gluten-free, the food must contain less than 20 parts per million (ppm) of gluten. While easy enough to understand, the rule also allows for more confusing practices. For instance, the following items are allowed in packaged foods labeled “gluten-free,” if less than 20ppm gluten is present in the final product:

  • Grains, including wheat, rye and barley if they have been processed to remove gluten to less than 20 ppm
  • Oats that contain less than 20ppm gluten
  • Any food naturally free of gluten such as eggs, bottled water, fresh fruit and vegetables


For people who must avoid gluten at all costs, this provision seems counter-intuitive; gluten-containing items present in “gluten-free” foods. However, it appears the FDA has established that food with less than 20ppm of gluten is “safe” for people who must avoid it.

No Standards on Testing for the Presence of Gluten

The FDA’s final rule requires food bearing a gluten-free claim to contain less than 20 ppm of gluten. However, it does not require manufacturers to test for the presence of gluten in any individual ingredients. Which means manufacturers are only required to ensure the presence of gluten to less than 20 ppm in the finished product. Therefore, gluten-containing ingredients may be included at the start of food processing. So, how is the required assurance accomplished? Per the final rule, manufacturers may choose from the following “quality control tools”:

  • In-house gluten testing of either the starting ingredients or the finished product
  • Third-party in-house gluten testing
  • Gluten analysis certificates from ingredient suppliers
  • Third-party gluten-free certification programs


The FDA allows manufacturers to choose whichever testing methods best suit their individual needs when testing for the presence of gluten; no one method is required over another. And the FDA only recommends manufacturers use a “scientifically valid method” to test for gluten. One might ask, what other methods are sufficient to ensure a food item is safe for consumption? While standardizing the definition of “gluten-free” makes some headway, leaving testing methods to the discretion of the manufacturer seems less than comforting.

Requirements for New Labels

The label “gluten-free” is voluntary, which means that manufacturers are not required to label foods devoid of gluten as “gluten-free.” The rule focuses instead on ensuring labels that claim foods are gluten-free are in fact gluten free.

But, since there are no guidelines regarding a labels’ format, the “gluten-free” claim may appear anywhere on the food label, and may carry the designation “Gluten-Free” “No Gluten,” “Free of Gluten” or “Without Gluten.” In addition, manufacturers may display third-party certification symbols that designate a packaged food “glutenfree.” However, the FDA does not endorse, accredit or recommend any particular third-party certification, and the symbol alone can’t substitute for the words allowed by the FDA to indicate a food item is gluten-free.

A Step in the Right Direction

Though it appears there are a number of concerns still left unaddressed, standardizing a baseline gluten level to determine which packaged items can be labeled “gluten-free” is a start. The FDA intends to continue improving outreach and education to restaurants and manufacturers to ensure the provisions of the final rule are fully understood and to provide a safer food product for consumers.

The final rule applies to all packaged foods, foods imported internationally and dietary supplements. It excludes alcohol, tobacco and foods regulated by the USDA, such as meat and poultry and certain egg products. As of the August 2014 deadline, food products bearing a gluten-free claim must comply with the FDA final rule.


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