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Gluten-Free Go-Round re: Food Labeling

FDA extends comment period on proposed rule for gluten-free labeling of fermented or hydrolyzed foods.

  • FDA issued a proposed rule to address the application of “gluten-free” labeling requirements to fermented and hydrolyzed foods and foods that contain fermented and hydrolyzed ingredients.  The underlying issue is that uncertainty prevails in interpreting the results of current test methods for detecting gluten in such foods.

  • On February 12, FDA announced its intent to extend the comment period for this proposed rule.  Although the comment period technically closes on February 16, FDA will be reopening it to extend the timeframe for an additional 60 days (to be counted from the date that a notice reopening the comment period appears in the Federal Register).

  • The proposed rule would affect the labeling of foods and 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 also could affect beers regulated by the Alcohol and Tobacco Tax and Trade Bureau (TTB), as TTB has indicated that it may revise its own gluten claim policy once FDA has issued a final rule or other guidance.  Interested stakeholders are invited to submit comments via Regulations.gov (Docket Number FDA-2014-N-1021).

© 2020 Keller and Heckman LLPNational Law Review, Volume VI, Number 47


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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...