by Marion Nestle
Aug 6 2013

Good news: FDA issues rules for a gluten-free claim on food packages

In what will surely be good news to people with celiac disease and other problems related to gluten intolerance, the FDA has just issued a final rule for defining foods as “gluten-free.”

This, after nine years of work on this issue (see timeline below).

The rule states that companies can label their products gluten-free if they contain less than 20 ppm (parts per million) gluten.  This, says FDA,

is the lowest level that can be consistently detected in foods using valid scientific analytical tools. Also, most people with celiac disease can tolerate foods with very small amounts of gluten. This level is consistent with those set by other countries and international bodies that set food safety standards.

As for gluten intolerance: Roughly 1% of the U.S. population has diagnosable gluten intolerance.  For those who do, eating grains containing gluten (wheat and some others) triggers an abnormal immune response that damages the intestinal tract.  To prevent symptoms—of which there can be many, none of them pleasant—people with this condition must scrupulously avoid eating gluten-containing foods.

The new rule will help establish some uniformity in labeling.  Note: gluten-free does not mean sugar-free.

In reading through the FDA’s notice in the Federal Register, I am struck by the complexity of the agency’s processes for doing something like this.

Policy wonk that I am, I immediately made a timeline.  This indicates that the FDA spent nine years getting to this point. Impressive, no?

Timeline: FDA’s Gluten-Free Rule

YEAR Action toward completing the rule
2004 Congress passes Food Allergen Labeling and Consumer Protection Act; instructs FDA to issue rule defining “gluten-free.”  FDA establishes Threshold Working Group to review literature on safety cut point.
2005 Threshold Working Group suggests approaches to defining threshold.  FDA asks for comments on the report.  Asks Food Advisory Committee to consider approaches.
2006 FDA posts report and responds to comments.  Announces public hearing.   Gets 2400 comments related to the hearing.
2007 FDA proposes rule to define gluten-free.  Sets 20 ppm cut point.  Begins Health Hazard Assessment.
2011 FDA publishes Health Hazard Assessment.  Reopens comment period.
2012 FDA responds to about 2000 comments.
2013 FDA publishes final rule.

FDA’s documents on the gluten-free rule:

  • Mark Ohler

    The words “Good news” and “government issues new rules” should never be in the same sentence.

  • This is indeed great news! Now people don’t have to be deceived on those so-called “gluten-free” products. Even I used to read nutrition labels before adding items to my grocery cart but after discovering that some of those labels are just deceiving consumers, I stopped doing so and instead stuck to other safe food items like oats and protein shake. This post changes everything!

  • Cara

    In local market this summer. Young man picks up a canister of oats and asks his friend, “Are oats gluten free?” No response. Then picks up box of hot cereal and asks friend, “Is Cream of Wheat gluten free?” Friend shrugs. Clearly consumers need help here:)

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  • Eliezel

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