“Establishing a definition of the term ‘gluten-free’ and uniform conditions for its use in the labeling of foods is necessary to ensure that individuals with celiac disease are not misled and are provided with truthful and accurate information with respect to foods so labeled,” FDA said in a 2011 re-opening of the proposal.
{mosads}In the rule, the FDA defines a product as “gluten free” if it does not contain the following: wheat, rye, barley, or any hybrid of these grains; ingredients such as wheat flour that have not been processed to remove gluten; or any item made up of more than 20 parts per million of gluten.
Celiac disease is a genetic disorder, also known as gluten intolerance, affecting at least 1 in 133 Americans, according to Celiac.com.
There are currently 143 rules and proposals sitting at OIRA, 84 of which have been sitting for more than the 90-day review limit imposed on the White House.
This post was updated on Feb. 28. In the original post, the second paragraph incorrectly stated that the rule would have a cost of $100 million or more.