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Gluten-Free Labeling of Fermented or Hydrolyzed Foods is Focus of FDA Proposal

Wednesday, November 18, 2015
Sandler, Travis & Rosenberg Trade Report

New requirements for “gluten-free” labels on foods such as yogurt, pickles, cheese and certain beer would be established under regulations proposed by the Food and Drug Administration. This proposal would establish requirements for fermented and hydrolyzed foods, or foods that contain fermented or hydrolyzed ingredients, and bear the “gluten-free” claim. Comments on this proposal are due by Feb. 16, 2016.

The FDA states that this rule would provide alternative means for it to verify compliance for fermented or hydrolyzed foods labeled “gluten-free” based on records that are made and kept by the manufacturer. These records would have to demonstrate assurance that (a) the food meets the requirements of the gluten-free food labeling final rule prior to fermentation or hydrolysis, (b) the manufacturer has adequately evaluated its process for any potential gluten cross-contact, and (c) 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 have to keep these records for at least two years after the introduction or delivery for introduction of the food into interstate commerce.

Distilled foods such as distilled vinegars are also included. The FDA notes that distillation is a purification process that separates volatile components from non-volatile components such as proteins and that gluten should therefore not be present in properly distilled foods. Under the proposed rule the FDA would evaluate the compliance of distilled foods by verifying the absence of protein (including gluten) using scientifically valid analytical methods that can detect the presence of protein or protein fragments in the distilled food.

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