On August 2, 2013, the FDA issued its final rule defining the term “gluten-free” (and its equivalents, such as “no gluten,” “free of gluten,” and “without gluten”) for voluntary use in food labeling. The key provisions of the rule remain the same as originally proposed (discussed here), defining “gluten-free” to mean that the food is either free of any gluten-containing grains or has been processed to remove the gluten, resulting in gluten levels below 20 ppm. The rule is intended to create uniformity in the labeling of “gluten-free” products to ensure that individuals with celiac disease and other gluten allergies are able to make safe and informed purchasing decisions. The rule provides that any food that bears a “gluten-free” label but fails to meet the requirements under the rule will be deemed “misbranded.” The rule goes into effect on September 1, 2013, but food manufacturers will have until August 5, 2014, to reach full compliance. Given the current popularity of food “misbranding” claims, we will likely see an increase in litigation challenging the use of “gluten-free” labels in the coming years.