On On August 5, 2014, the U.S. Food and Drug Administration (“FDA”) regulations regarding “gluten free” labeling came into effect. Last year, on August 5, 2013, the FDA issued a final rule that effectively determined what characteristics a food must have in order to be considered gluten free and bear “gluten free” labeling. We reported about the final rule on gluten free labeling when it was issued exactly one year ago. Our previous report on the gluten free labeling rules may be accessed here.
FDA has authority to issue the rule defining gluten free and restricting gluten free labeling under Section 206 of the Food Allergen and Consumer Protection Act (FALCPA) of 2004. Under this provision, Congress directed the FDA to develop regulations pertaining to gluten free and “gluten free” labeling that will help protect consumers who suffer from celiac disease and related illnesses requiring a gluten free diet. The FDA Final Rule, which recently came into effect, defined “gluten free” as having less than 20 ppm (parts per million) of gluten. You can read the rule here. This definition includes foods that do not contain any of the following:
1. An ingredient that is any type of wheat, rye, barley, or crossbreeds of these grains;
2. An ingredient derived from these grains and that has not been processed to remove gluten, and
3. An ingredient derived from these grains and that has been processed to remove gluten, if it results in the food containing 20 or more ppm of gluten.
21 C.F.R. § 101.91 (2014).
The full text of the Final Rule on gluten free labeling may be accessed here. Foods labeled “gluten free” “free of gluten” “without gluten” and “no gluten” have to comply with this requirement as well. However, the use of the “gluten free” labeling is voluntary. Foods that are gluten free in-fact are not required to bear “gluten free” labeling.
Any food with a manufacture date after August 5, 2014 will have to comply with this labeling requirement. However, the coast is not completely clear for consumers. Some food items that hit the marketplace prior to August 5 may still not be in compliance with this final rule. If foods are misbranded, meaning that they bear “gluten free” labeling and they are not in fact gluten free, then the manufactures and/or distributors of these foods are subject to regulatory action by the FDA pursuant to the Food, Drug, and Cosmetic Act (FDCA). These actions may include warning letters, detention upon importation, and other types of enforcement measures. More information about gluten-free labeling of foods is provided on the FDA’s website, accessible here.
If you are concerned that your product labeling may not be in compliance with the new requirements, it is important to take steps to ensure your compliance in order to avoid regulatory action. Federal regulatory enforcement actions can be time consuming and costly for a business, as they can result in time-consuming delays and even product recalls. If you have any questions about the final rule on gluten free labeling or compliance with FDA regulations, please contact us at: [email protected].
