Update Nov Dec 2013 - (Page 24)

FDA Issues Final Rule Defining the Term "Gluten Free": What Food Manufacturers Need to Know for Product Labeling By Rebecca Rodriguez, M.S., J.D. O n August 5, 2013, with the gluten free marketplace growing at a rate of twenty-eight percent a year, the U.S. Food and Drug Administration (FDA) published a final rule on defining and regulating the term "gluten free" on food product labeling in the United States.1 Why was a Gluten-Free Regulation Necessary? Rebecca Rodriguez is an attorney in the Food Law Practice Group at GrayRobinson, P.A. in Miami, Florida. She can be reached at (305) 913-0536 or rebecca.rodriguez@gray-robinson. com 24 Update November/December 2013 One in 133 Americans has Celiac Disease (CD)2 and currently there are no pharmaceutical cures for CD.3 A strict gluten-free diet is the only treatment for those with CD.4 Millions with CD rely on gluten-free labeling to make diet choices, in addition to those that seek the medical benefits associated with a gluten-free diet.5 The demand for gluten-free products has resulted in a growing 2.6 billion dollar market.6 Before the rule, there were no federal standards or definitions for the food industry to use in labeling products "gluten free."7 An estimated five percent of foods currently labeled "gluten free" contain 20 parts per million (ppm) or more of gluten.8 TFDA's new rule addressees this issue. FDA Commissioner Margaret A. Hamburg, stated that "[a]dherence to a gluten-free diet is the key to treating celiac disease, which can be very disruptive to everyday life . . . FDA's new 'gluten-free' definition will help people with this www.fdli.org http://www.fdli.org

Table of Contents for the Digital Edition of Update Nov Dec 2013

Update Nov Dec 2013