The Food and Drug Administration (FDA or we) is issuing a final rule to establish requirements concerning “gluten-free” labeling for foods that are fermented or hydrolyzed or that contain fermented or hydrolyzed ingredients. These requirements are needed to help ensure that individuals with celiac disease are not misled and receive truthful and accurate information with respect to fermented or hydrolyzed foods labeled as “gluten-free.”

This rule requires that, for foods that are fermented or hydrolyzed or contain one or more fermented or hydrolyzed ingredients, and bear any of these claims: “gluten-free,” “no gluten,” “free of gluten,” or “without gluten,” the manufacturer must have records that demonstrate adequate assurance that the food, or fermented or hydrolyzed ingredient(s), is “gluten-free” in compliance with 21 CFR 101.91(a)(3). In addition, the rule requires documentation by the manufacturer that any potential for gluten cross-contact has been adequately assessed, and where such potential has been identified, that the manufacturer has implemented measures to prevent the introduction of gluten during the manufacturing process. The rule also provides that we will evaluate compliance of distilled foods, such as distilled vinegar, by verifying the absence of protein using scientifically valid analytical methods that can reliably detect the presence of protein or protein fragments in the food.

Full compliance with this final rule would have annualized costs of about $7 million to $11 million per year at both 3% and 7% discount rates. For the rule to break even with primary costs, the annualized benefits would need to be at least $8.8 million at a 3% discount rate and $9.1 million at a 7% discount rate. Based on our simulation analysis, the rule would break even with primary cost estimates discounted at 7% if at least 0.07% of estimated individuals with celiac disease following a gluten-free diet benefit from the rule each year.

Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods FRIA Document (PDF - 246KB)

Federal Register: 85 FR 49240,  August 13, 2020

Docket: FDA-2014-N-1021