What are the Regulations for Listing Allergens on Food Packaging?

September 15, 2009

Why are gluten, barley, rye and, oats—which are harmful to individuals with Celiac Disease—not required to be listed as allergens on food packages?




The Food Allergen Labeling and Consumer Protection Act (FALCPA), which took effect on January 1, 2006, requires food labels to clearly identify eight major allergens, including wheat. While more than 160 food allergens had been identified when the law was enacted, the eight major food allergens identify by FALCPA account for over 90% of all documented food allergies in the U.S.

However, as you pointed out, people with Celiac disease—a chronic digestive disease that damages the small intestine and interferes with absorption of nutrients from food—cannot tolerate gluten. FALCPA took into account the approximately 2 million people in the U.S. with Celiac disease by requiring the U.S. Food and Drug Administration (FDA) to develop and finalize rules for the use of the term "gluten free" on product labels. On Jan. 23, 2007, FDA proposed a definition for the term "gluten-free" for voluntary use in the labeling of foods (72 Fed. Reg. 2795 (Jan. 23, 2007)). (More on the proposed definition can be found here.) After reviewing the comments it received on the proposed "gluten-free" definition, FDA proposed conducting a survey on gluten-free labeling of food products (74 Fed. Reg. 9822-9823 (March 6, 2009)). According to FDA, the purpose of the study is to, "gauge perceptions of characteristics related to claims of "gluten-free'' and allowed variants (e.g., "free of gluten,'' "without gluten,'' "no gluten''), in addition to other types of statements (e.g., "made in a gluten-free facility'' or "not made in a facility that processes gluten-containing foods'') on the food label."