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“Gluten-Free” Now Has an Official FDA Definition

FDA has published a final rule defining the term “gluten-free” for voluntary use in food labeling.  Food labels will have to comply with the new regulatory definition starting August 5, 2014, roughly ten years after Congress directed FDA to define “gluten-free” in the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA).

The “gluten-free” definition is intended to assist consumers with celiac disease who must avoid gluten.  However, “gluten-free” foods have recently become popular with a larger audience, including individuals who are said to be gluten intolerant or gluten sensitive.

The final rule keeps the proposed rule’s requirement that “gluten-free” foods contain less than 20 parts per million (ppm) of gluten.  Here are the main features of the final rule:

  • The “gluten-containing grains” are wheat, barley, and rye, as well as crossbred hybrids of those three grains (e.g., triticale, a cross between wheat and rye).
  • Oats are not a gluten-containing grain.  However, because of the risk of commingling with wheat, barley, and rye, manufacturers of “gluten-free” foods should ensure that any oat-derived ingredients they use contain <20 ppm gluten.  In addition, since some individuals with celiac disease cannot tolerate oats, FDA encourages manufacturers to identify any oat-derived ingredients in “gluten-free” foods that do not use the word “oats” in their name (e.g., beta glucans derived from oats).
  • “Gluten-free” means that either: (1) the food and its ingredients are inherently free of gluten, and any gluten present in the finished food is <20 ppm; or (2) the food contains ingredients derived from gluten-containing grains that have been processed to remove gluten (e.g., wheat starch), and any gluten present in the finished food is <20 ppm.
  • A “gluten-free” claim may not be made if: (1) the food contains a gluten-containing grain (e.g., wheat); (2) the food contains an ingredient derived from a gluten-containing grain that has not been processed to remove gluten (e.g., wheat flour); or (b) the food contains more than 20 ppm gluten, regardless of how it got there.  Thus, FDA will not allow a “gluten-free” claim where the finished food, as opposed to an ingredient, has been processed to remove gluten.
  • FDA strongly prefers that “gluten-free” foods use the claim “gluten-free,” but will accept use of certain equivalent terms (“no gluten,” “free of gluten,” and “without gluten”).  Other truthful and non-misleading statements about gluten may also be made, including:
    • A  statement of the amount (or maximum amount) of gluten in the food;
    • A certifying organization’s seal or logo; and/or
    • A statement such as “not made with gluten-containing ingredients.”

The final rule, unlike the proposed rule, does not require foods that are inherently free of gluten to bear a qualifying statement (e.g., “milk is inherently gluten-free”).

  • Some ingredients derived from wheat (e.g., some modified food starches) that have been processed to remove gluten may still be subject to allergen labeling due to the presence of wheat protein.  If a food labeled “gluten-free” uses the term “wheat” in its ingredients list or allergen label statement (e.g., “Contains wheat”), the word “wheat” must be followed by an asterisk (or other symbol) that refers to the following statement in close proximity: “The wheat has been processed to allow this food to meet the Food and Drug Administration (FDA) requirements for gluten-free foods.”
  • FDA acknowledges there are currently no scientifically valid tests for gluten in fermented or hydrolyzed foods.  FDA intends to issue a separate proposed rule addressing how it will evaluate compliance when such foods bear “gluten-free” claims.
  • The final rule applies to all FDA-regulated human food, including dietary supplements and restaurant foods.  It does not apply to food for animals.  FDA is working with the U.S. Department of Agriculture and the Alcohol and Tobacco Tax and Trade Bureau to ensure consistency among the three agencies’ “gluten-free” definitions.
  • FDA states that there is federal preemption of State and local laws defining “gluten-free” differently than FDA’s final rule.  However, State and local governments are not preempted from establishing labeling requirements for gluten that do not obstruct the federal purpose, such as a requirement for a warning statement about the health effects of gluten for persons with celiac disease.

FDA also promises to issue a guidance document about the testing methods it will use for compliance purposes.

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