FDA Proposes Rule on ‘Gluten-Free’ Requirements for Fermented, Hydrolyzed and Distilled Foods

  • In August 2013, FDA issued a final rule on voluntary “gluten-free” food labeling.  The final rule defined “gluten-free” as meaning that the food either is inherently gluten free or does not contain an ingredient that is:
  1. a gluten-containing grain (e.g., spelt wheat);
  2. derived from a gluten-containing grain that has not been processed to remove gluten (e.g., wheat flour); or
  3. derived from a gluten-containing grain that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food.

Additionally, any unavoidable presence of gluten in the food must be less than 20 ppm.

  • The final rule noted the uncertainty in interpreting the results of current test methods for detecting gluten in fermented and hydrolyzed foods.  Yesterday, FDA issued a proposed rule to provide alternative means for the agency to verify compliance with the gluten-free labeling requirements for fermented and hydrolyzed foods and foods that contain fermented or hydrolyzed ingredients.  Under the proposed rule, manufacturers of such foods would be required to make and keep records demonstrating that:

    • the food meets the requirements of the gluten-free food labeling final rule prior to fermentation or hydrolysis;
    • the manufacturer has adequately evaluated its process for any potential gluten cross-contact; and
    • where a potential for gluten cross-contact has been identified, the manufacturer has implemented measures to prevent the introduction of gluten into the food during the manufacturing process.

With respect to distilled foods and ingredients, the proposed rule would also clarify that, for enforcement purposes, FDA will use a scientifically valid method to measure protein content and must find no detectable protein present in the distilled food or ingredient.

  • The proposed rule would affect the labeling of foods and food ingredients such as yogurt, hydrolyzed soy protein, distilled vinegar, and FDA-regulated beers (i.e., beers that are not made from malted barley and hops).  The rule may also have implications for beers regulated by the Alcohol and Tobacco Tax and Trade Bureau (TTB), as TTB has stated it “may revise [its gluten content statement] policy after FDA issues a final rule or other guidance with respect to fermented and hydrolyzed products.”  Comments on FDA’s proposed rule may be submitted via Regulations.gov (Docket Number FDA-2014-N-1021) through February 16, 2016.