The Food and Drug Administration is proposing to establish requirements concerning "gluten-free" labeling for foods that are fermented or hydrolyzed or that contain fermented or hydrolyzed ingredients. These additional requirements for the "gluten-free" labeling rule 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." There is uncertainty in interpreting the results of current gluten test methods for fermented and hydrolyzed foods on a quantitative basis that equates the test results in terms of intact gluten. Thus, we propose to evaluate compliance of such fermented and hydrolyzed foods that bear a "gluten-free" claim with the gluten-free labeling rule based on records that are made and kept by the manufacturer of the food bearing the "gluten-free" claim and made available to us for inspection and copying.

Regulatory Impact Analysis

• Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods (Proposed Rule) (PDF - 387KB)
• Data and Simulation Inputs (Excel - 44KB)
  This file requires the @Risk software to run the simulation model. If opened in Excel, the statistical distributions used for the simulation will appear in the formula window but will not calculate.
  

Federal Register: 80 FR 71990, November 18, 2015

Docket: FDA-2014-N-1021