FDA releases Final Rule for gluten-free fermented and hydrolyzed foods
The U.S. Food and Drug Administration (FDA) has issued a final rule to establish compliance requirements for fermented and hydrolyzed foods, or foods that contain fermented or hydrolyzed ingredients, and that bear the «gluten-free» claim. The rule pertains to foods such as soy sauce, yogurt, sauerkraut, pickles, cheese, and green olives. Distilled foods, such as distilled vinegars, are also included in the final rule.
The final rule adds compliance requirements for hydrolyzed or fermented foods that use the «gluten-free» labeling claim, since gluten breaks down during these processes and currently available analytical methods cannot be used to determine if these products meet the «gluten-free» definition. The rule requires manufacturers of these food products to make and keep records providing adequate assurance that:
- the food meets the definition of «gluten-free» before fermentation or hydrolysis;
- the manufacturer has adequately evaluated the potential for cross-contact with gluten during the manufacturing process;
- and if necessary, measures are in place to prevent the introduction of gluten into the food during the manufacturing process.
The rule also discusses how FDA will verify compliance for distilled products.
Final Rule: «Gluten-Free Labeling of Fermented or Hydrolyzed Foods» (85 FR 49240)