A Food and Beverage Law Blog
Friday, August 2, 2013

FDA issued a final rule today on the voluntary use of “gluten-free” on food labels, as directed by the Food Allergen Labeling and Consumer Protection Act.  In summary, FDA set a threshold for gluten of less than 20 parts per million in foods that are labeled “gluten-free,” “no gluten,” “free of gluten,” and “without gluten.”  Food manufacturers will have one year to bring their labeling into compliance with the new regulation.  After that one year implementation period, any food labeling “gluten-free” or a similar claim with gluten more than 20 parts per million will be considered misbranded.  A threshold of 20 parts per million was selected because that is the lowest level of gluten that can currently be detected with validated methodology, and, as stated by FDA, “some celiac disease researchers and some epidemiological evidence suggest that most individuals with celiac disease can tolerate variable trace amounts and concentrations of gluten in foods (including levels that are less than 20 ppm gluten) without causing adverse health effects.”  In guidance accompanying the rule, FDA has also made clear that ingredients known to contain gluten should not be added to gluten-free products even if the gluten content will not exceed 20 parts per million.