FDA Issues Final Rule for “Gluten-Free” Labeling

The U.S. Food and Drug Administration (FDA) has issued a final rule defining the term “gluten-free” for voluntary food labeling. Among other things, the rule defines “gluten-free” to mean that a food does not contain (i) an ingredient that is a gluten-containing grain (e.g., spelt wheat); (ii) an ingredient derived from a gluten-containing grain that has not been processed to remove gluten (e.g., wheat flour); or (iii) an ingredient derived from a gluten-containing grain that has been processed to remove gluten (e.g., wheat starch). In addition, a food must contain less than 20 parts per million of gluten to use the term “gluten-free” on its label. According to FDA, a food that bears the claim “no gluten,” “free of gluten” or “without gluten” on its label and fails to meet the requirements for a “gluten-free” claim will be deemed misbranded. The rule will take effect 30 days after its publication in the Federal Register. See FDA News Release, August 2, 2013.