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FDA Proposes Gluten-Free Labeling Rule for Fermented and Hydrolyzed Foods

On November 18, 2015, the U.S. Food and Drug Administration (FDA) published a proposed rule concerning the labeling of fermented and hydrolyzed food and beverages as “gluten-free”. Under FDA’s proposed rule, in order to label fermented and hydrolyzed foods as “gluten-free”, manufacturers would be required to maintain records demonstrating that:

  • the food met the requirements of the gluten-free food labeling final rule prior to fermentation or hydrolysis, and
  • 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.

Manufacturers would need to hold these records for at least two years after the food enters interstate commerce.

FDA published a final rule regarding gluten-free labeling of all food products in 2013, but the rule left the industry with “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.”  FDA intends for the new proposed rule to provide an additional method for the agency to verify that fermented and hydrolyzed foods comply with the agency’s gluten-free rules.

FDA also included distilled foods in its proposed rule.  FDA states that it would evaluate the compliance of distilled foods that bear the “gluten-free” claim by “verifying the absence of protein using scientifically valid analytical methods that can reliably detect the presence of protein or protein fragments in the distilled food.”

What are Fermented and Hydrolyzed Foods?

FDA defines fermented foods as foods that have “undergone fermentation—a process that typically involves the conversion of complex organic compounds, especially sugars and other carbohydrates, to simpler compounds such as lactic acid and ethyl alcohol.”  Common examples of fermented foods include yogurt, cheese, and pickles.

FDA defines hydrolyzed foods as foods in which the “chemical components—such as proteins—are broken into smaller organic compounds by reaction with water.”

FDA is accepting public comment on this proposed rule through February 16, 2016.  Submit a comment now.

Registrar Corp can help you determine whether your food product meets U.S. FDA requirements for being labeled as “gluten-free”.  For questions about FDA “gluten-free” labeling requirements or other FDA food labeling regulations, contact Registrar Corp at +1-757-224-0177. Live help is available 24-hours a day at www.registrarcorp.com/livehelp.

Update: FDA extended the comment period 60 days (April 16, 2016)