The Food and Drug Administration has finalized regulations intended to define the term "gluten free" on food packaging in an effort to give celiac disease patients and others following the gluten-free diet confidence that the food they buy is safe for them to consume.
The new regulations, which were nearly a decade in the making, do not require food manufacturers to label products as gluten free. Instead, they lay out the rules to follow if those manufacturers want to voluntarily place "gluten-free" labels on products.
The rules state that manufacturers can label foods "gluten free" if they contain less than 20 parts per million (ppm) of gluten, a protein found in wheat, barley, and rye. According to the FDA, most celiac disease patients can tolerate a small amount of gluten in their food each day.
The regulations prohibit the use of the term "gluten free" on any product that contains wheat, barley, or rye ingredients unless those ingredients have been processed to remove the gluten. Products that are naturally gluten free, such as eggs, fruits, vegetables, and bottled water, also can carry the "gluten free" label.
Physicians who treat celiac disease patients praised the ruling. "Without proper food labeling regulation, celiac patients cannot know what the words ‘gluten free’ mean when they see them on a food label," Dr. Alessio Fasano, medical director of the Center for Celiac Research at MassGeneral Hospital for Children, Boston, said in a statement.
About 3 million people in the United States have celiac disease; many of them are undiagnosed. The regulatory action brings the United States into line with Canada and the European Union, both of which consider "gluten free" to mean less than 20 ppm of gluten.
Manufacturers have1 year to comply with the regulations or risk facing compliance action from the FDA. The agency said that the vast majority of "gluten free"–labeled products on the shelves today – 95% – already comply with the regulations.