On August 5, 2013 the FDA issued its final rule on the voluntary labeling of food gluten-free. This is good news for both consumers and manufacturers.

The rule, promulgated under the Food Allergen Labeling and Consumer Protection Act of 2004 (“FALCPA”), provides that food can be labeled “gluten-free,“ “no gluten,” “free of gluten,” or “without gluten” where it does not contain an ingredient that is:

  • a gluten-containing grain
  • derived from a gluten-containing grain and has not been processed to remove the gluten; or
  • derived from a gluten-containing grain that has been processed to remove the gluten and where the finished food product constitutes 20 parts per million or more gluten.

Food that inherently does not contain gluten, like carrots, may also be labeled gluten-free so long as it does not contain 20 parts per million or more of gluten. Manufacturers must be in compliance by August 5, 2014.

By setting a consistent, threshold standard, health conscious consumers and those with celiac disease should have greater confidence in manufacturers’ labeling. The clear guidelines should also have a chilling effect on private false labeling claims by shifting the litmus test of liability from a ‘reasonable consumer’ standard to a discrete threshold. The rule will also provide the predicate for manufacturers to move to dismiss private civil suits based on federal preemption. Overall, the rule should have the effect of encouraging more manufacturers to label their compliant products gluten-free.