• Debra Topham

Gluten Free – Three Years after the new standards


The FDA just posted an interview “Taking a Look at the Real-World Impact of the Gluten-Free Labeling Standard

Background: Manufacturers had until August 5, 2014 to properly use and label “gluten free.”  Which means, the product should meet one of the following (see 21 CFR 101.91 Gluten Free Labeling of Food.)

  • inherently gluten free or does not contain an ingredient that is: a gluten-containing grain;

  • derived from a gluten-containing grain that has not been processed to remove gluten;

  • or derived from a gluten-containing grain that has been processed to remove gluten if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food.

  • Also, any unavoidable presence of gluten in the food must be less than 20 ppm.

The interview looks at the impact of the gluten-free labeling requirements.  For the full interview see: “Taking a Look at the Real-World Impact of the Gluten-Free Labeling Standard


Here are two of the more interesting questions:


Q: After the rule went into effect, did the FDA do anything to ensure that products with gluten-free labels were in fact gluten-free?

D’Lima: Yes. Earlier this year we released the results of a sampling assignment (FDA Finds 99.5% of foods sampled comply with “gluten free”) in which 702 samples from more than 250 products labeled “gluten-free” were analyzed. Only one of those products did not comply with our labeling requirements. That product was recalled and subsequent sampling did not find any products that violated the regulation. We were very encouraged by these findings.


Q: How much of a difference does it make to have a standard definition of what is called “gluten-free?”

Fasano: It’s been a game changer. At the beginning, many of us were worried about whether the promise of this new standard would truly be realized. But the food industry took this seriously and did an exceptional job with the new labels, aided by the fact that the FDA spelled out exactly what was required.

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