On November 17, the FDA issued a proposed rule establishing that fermented, hydrolyzed and distilled foods must meet certain requirements to carry a gluten-free label. The gluten free labeling rule that went into effect in August 2014 indicated difficulty in scientifically detecting gluten in fermented and hydrolyzed foods and that the FDA would release a proposed ruling on that issue in the future. The future is now.
Hydrolyzed, fermented and distilled foods with the gluten free label have to meet the main requirements of the original gluten-free labeling rule. The new proposal evaluates additional compliance measures for manufacturers:
- Companies making fermented or hydrolyzed foods must keep records that “demonstrate adequate assurance that the food is ‘gluten-free’ in compliance with the [gluten-free rule] before fermentation or hydrolysis.”
- For foods with one or more fermented or hydrolyzed ingredients that will be labeled gluten free, the manufacturer will have to keep records showing that the ingredients are gluten free.
- Distilled foods manufacturers must be able to verify the absence of the protein using testing methods that can “reliably detect the presence of protein or protein fragments in the food.”
- If there is a risk of cross-contamination, a plan must be in place to prevent it.
The biggest area of contention for this ruling is in regards to what is currently termed: “gluten-reduced beers”—beers such as Omission and a new beer line of New Planet’s in which the beer starts with gluten containing grains, but with the introduction of a brewing enzyme, the gluten protein chains are broken apart and removed. This ruling could affect whether breweries that remove gluten from beers can qualify their beers as gluten-free if testing and adequate measures are taken.
Have an opinion on this? This FDA ruling is only proposed, including the final wording of the proposed ruling, which means that public comments may be influential. The FDA is accepting public comments through February 16. To electronically submit comments to the docket, click here. If this option is not working, go to www.regulations.gov and type FDA-2014-N-1021 in the search box to comment. To submit comments to the docket by mail, use the following address and be sure to include docket number FDA-2014-N-1021 on each page of your written comments:
Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852