FDA’s “Gluten-Free” Labeling Rule Takes Effect

By Robert A. Hahn

On August 5th, FDA’s regulation defining the claim “gluten-free” for voluntary use in food labeling became effective.  FDA cautions consumers that there may still be some products on store shelves labeled “gluten-free” that do not comply with the new definition, but all foods entering commerce on or after August 5, 2014 must comply.

Here are the key features of the FDA rule:

Definitions

  • “Gluten” refers to certain proteins (e.g., prolamins and glutelines) in gluten-containing grains that cause adverse health effects in persons with celiac disease.
  • “Gluten-containing grains” are wheat, rye, and barley, as well as hybrids of those grains (e.g., triticale).
  • “Gluten-free” means either: (1) the food and its ingredients are inherently free of gluten, and any gluten present in the food is <20 parts per million (ppm); or (2) the food contains an ingredient derived from a gluten-containing grain that was processed to remove gluten (e.g., wheat starch), and any gluten present in the food is <20 ppm. The bottom line is that the food must contain <20 ppm gluten.

Labeling

  • FDA prefers the term “gluten-free” and discourages use of other terms, but will accept use of certain equivalent terms (e.g., “no gluten,” “without gluten”). Other truthful and non-misleading statements about gluten content are also permitted including: a statement of the amount (or maximum amount) of gluten in the food; a statement such as “not made with gluten-containing ingredients”; and/or a gluten-free certifying organizations seal or logo.
  • If a food label includes both a “gluten-free” claim and the word “wheat” (e.g., it lists a wheat ingredient that has been processed to remove gluten in its ingredients list), the word “wheat” must be followed by an asterisk 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.”
  • If a food is labeled “gluten-free,” FDA encourages manufacturers to identify any oat-derived ingredients in the food that do not use the word “oats” in their name (e.g., “beta glucan (from oats)”).
  • FDA notes that oats and other (non-gluten-containing) grains, legumes, and seeds may come into contact with “gluten-containing grains” during harvesting, storage, transportation, and manufacturing. Therefore, manufacturers of “gluten-free” foods containing other grains, legumes, or seeds need to be careful such foods contain <20 ppm gluten.

Scope

  • Use of the claim “gluten-free” is strictly voluntary.
  • The regulation applies only to packaged foods, including packaged foods sold in restaurants and other foodservice establishments. FDA encourages restaurants to comply with the definition of “gluten-free” for non-packaged foods as well.
  • The regulation applies to FDA-regulated human foods, including dietary supplements. It does not apply to food for animals.  It also does not apply to meat and poultry products regulated by the U.S. Department of Agriculture (USDA) or alcoholic beverages regulated by the Alcohol and Tobacco Tax and Trade Bureau (TTB), but FDA is seeking to harmonize with those agencies.

Compliance and Enforcement

  • Manufacturers making “gluten-free” claims are not required to test their ingredients or finished products for gluten. However, manufacturers are responsible for ensuring that “gluten-free” foods comply with the FDA definition.  Therefore, FDA encourages use of effective measures, such as:
    • Testing ingredients or finished foods for gluten;
    • Requiring certificates of analysis from ingredient suppliers; or
    • Participating in a third-party gluten-free certification program
  • If manufacturers of “gluten-free” products do test for gluten, they are not required to use any particular analytical method. However, FDA recommends use of scientifically valid methods, and identifies two ELISA methods that the agency will use in tandem for compliance purposes; they are the R5-Mendez Method (test kit available from R-Biopharm) and the “Morinaga method” (test kit available from Morinaga Institute for Biological Science, Inc.).
  • FDA acknowledges there is currently no scientifically valid method to test for gluten in fermented or hydrolyzed foods. FDA intends to publish a proposed rule explaining how it will evaluate compliance in “gluten-free” fermented and hydrolyzed foods.

FDA has issued a Small Entity Compliance Guide and Q&As on the “gluten-free” rule.