New FDA Requirements for Gluten-Free Food Labels

Food and Agriculture Law  

August 12, 2014


A new FDA regulation addressing the definition of “gluten free” for food labels on packaged food took effect on August 5, 2014.  The regulation states that packaged food advertised as “gluten free,” or other comparable phrases, cannot contain more than 20 parts per million of gluten.

The FDA determined that 20 parts per million of gluten is a virtually undetectable amount that most people with Celiac disease, a digestive condition that can only be managed by eating a diet free of gluten, will be able to tolerate.

The new regulation applies to all packaged foods sold in retail and food service establishments, including carryout restaurants.  Currently, the regulation does not apply to “gluten free” labeling on restaurant menus.

The FDA expects immediate compliance with the new regulation because the regulation was established August 2013 and the August 2014 compliance date was put in place to allow the food industry sufficient time to make necessary changes to the formulation or labeling of their foods that voluntarily bear a “gluten free” claim in the United States.

It is important to note that affixing a “gluten free” label to packaged food is voluntary and there are no current regulations mandating that one must declare whether their packaged foods contain gluten.