FDA Responds to Requests to Finalize Rule for Gluten-Free Labeling

Aug 05, 2011   

On July 21, 2011, United States Senators Ron Wyden (D-OR) and Patrick Leahy (D-VT) urged U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg to take prompt action and finalize the proposed rule for gluten-free labeling. As we previously reported, the FDA has not defined “gluten-free” in over four years following the release of the proposed definition.

Pursuant to the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCP), the FDA was tasked with proposing rules for gluten labeling within two years of enactment and finalizing the rules within four. The FDA issued a proposed rule in January of 2007, but has yet to promulgate a final rule. Senators Wyden and Leahy are concerned that the lack of federal standards has caused confusion for consumers. Accurately labeling gluten-free products would help those who suffer from celiac disease, a chronic inflammatory disorder of the small intestine which is triggered by certain proteins known as gluten.

Today, the FDA responded and reopened the public comment period on the proposed rule for “gluten-free” labeling for 60 days beginning August 3, 2011. The FDAs goal is to eliminate uncertainty about food labeling and assure consumers that foods labeled “gluten-free” must meet a clear standard established and enforced by the Agency. The FDA stated that the final rule will also apply to dietary supplements, whereas the proposed rule only applied to conventional food products.
In the proposed rule, a food labeled “gluten-free” does not contain any of the following:

  • Any type of wheat, rye, barley, or crossbreeds of these grains
  • An ingredient derived from these grains and that has not been processed to remove gluten
  • An ingredient derived from these grains and that has been processed to remove gluten, if it results in the food containing 20 or more parts per million (ppm) gluten
  • 20 ppm or more gluten

Until the issuance of the final rule, Quality Assurance International (QAI) and the healthcare nonprofit National Foundation for Celiac Awareness (NFCA) created a “Certified Gluten-Free” label to assure customers about accurate gluten-free labeling. The label certifies that the food contains no more than 10 ppm of gluten.

This is not the first time that specific label terms have been left vague or undefined. For example, before the U.S. Department of Agriculture (USDA) finally took action to define the term “organic,” many consumers relied on third party certifications to ensure that food labels were accurate. USDA officials finally drafted a set definition for the term “organic” after seven years in 1997. See our previous report here for more information regarding this issue.
Fuerst Ittleman will continue to monitor the FDA for changes to gluten-free labeling requirements. For more information regarding the labeling of food products, contact us at contact@fidjlaw.com.