The FDA was directed to issue the regulation by the Food Allergen Labeling and Consumer Protection Act (FALCPA), to set guidelines for the term “gluten-free” to help people with celiac disease maintain a gluten-free diet.
All food manufacturers will now need to conform to a uniform standard definition to help up to 3 million Americans who have the disease, which is an autoimmune digestive condition, managed by eating a gluten free diet.
Manufacturers have until August 5, 2014, to bring package labels into compliance. After that, gluten-free labeled foods containing 20ppm or more of gluten are deemed misbranded and subject to regulatory enforcement action.
“This long awaited regulation defining what a label saying gluten-free means, goes a long way to help build consistency in food labeling which will make it easier for people who need to be gluten-free to select food items,” said Joseph Murray, MD, Professor of Medicine, Mayo Clinic and CDF Medical Advisory Board Member.
“Manufacturers now know exactly what gluten-free means and will hopefully begin using this voluntary labeling standard immediately to provide safe food with clear information for consumers.”
The federal definition demands that to use the term "gluten-free" on its label, a food must meet all of the requirements of the definition, including it has to contain less than 20 parts per million of gluten. The rule also requires foods with the claims “no gluten,” “free of gluten,” and “without gluten” to meet the definition for “gluten-free.”
The term "gluten" refers to proteins that occur naturally in wheat, rye, barley and cross-bred hybrids of these grains. In people with celiac disease, foods that contain gluten trigger production of antibodies that attack and damage the lining of the small intestine.
Such damage limits the ability of celiac disease patients to absorb nutrients and puts them at risk of other very serious health problems, including nutritional deficiencies, osteoporosis, growth retardation, infertility, miscarriages, short stature, and intestinal cancers.