The Food and Drug Administration (FDA) has published its long awaited final rule defining “gluten-free” labeling requirements. Under the final rule, companies may choose to promote foods using “gluten free” labeling claims provided that the labeled foods qualify under the definition prescribed by FDA in the final rule. Under FDA’s final rule, “gluten-free” is defined to mean that the labeled food contains no ingredient that:

  • Is a gluten-containing grain OR
  • Is derived from a gluten-containing grain that has not been processed to remove the gluten OR
  • Is derived from a gluten-containing grain that has been processed to remove the gluten such that gluten levels do not exceed 20 parts per million.

In no case may foods containing levels of gluten that exceed 20 parts per million be labeled as “gluten free.”

Foods that are inherently free of gluten may be labeled to promote the gluten-free attribute, provided that the claim employs the “gluten-free” claim in a manner that refers to all foods of the same type (e.g. “milk, a gluten-free food”).

Producers of dietary supplements and food intended for human use producers will have until August 5, 2014 to comply with the rule.

In the final rule, the FDA also stated that it intends to exercise enforcement discretion regarding gluten-free beers that are made from either a non-gluten-containing grain or a gluten-containing grain that has been processed to ensure that gluten levels in the finished beer do not exceed 20 parts per million. In addition, the FDA intends to promulgate a separate rulemaking for fermented or hydrolyzed foods.