FDA Makes Final Ruling on Gluten-Free Food Labeling

FDA has issued a Final Rule which defines " ... the term 'gluten-free' for voluntary use in the labeling of foods. The final rule defines the term 'gluten-free' to mean that the food bearing the claim does not contain an ingredient that is a gluten-containing grain (e.g., spelt wheat); an ingredient that is derived from a gluten-containing grain and that has not been processed to remove gluten (e.g., wheat flour); or an ingredient that is derived from a gluten-containing grain and that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food (i.e., 20 milligrams (mg) or more gluten per kilogram (kg) of food); or inherently does not contain gluten; and that any unavoidable presence of gluten in the food is below 20 ppm gluten (i.e., below 20 mg gluten per kg of food). A food that bears the claim 'no gluten,' 'free of gluten,' or 'without gluten' in its labeling and fails to meet the requirements for a 'gluten-free' claim will be deemed to be misbranded. In addition, a food whose labeling includes the term 'wheat' in the ingredient list or in a separate 'Contains wheat' statement as required by a section of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and also bears the claim 'gluten-free' will be deemed to be misbranded unless its labeling also bears additional language clarifying that the wheat has been processed to allow the food to meet FDA requirements for a 'gluten-free' claim ..."