November 18, 2015
TO: JPA Members
FROM: Patricia Faison
JPA Regulatory Update: FDA Publishes Proposed Rule on Gluten-Free Labeling of Fermented, Hydrolyzed or Distilled Foods
In August 2013, JPA members were notified that the Food and Drug Administration (FDA) had issued a final rule to define the term “gluten-free” for voluntary use on food labels. Members were advised that the Agency noted it would issue a proposed rule to address the compliance approach to fermented or hydrolyzed products labeled as “gluten-free.” It was noted that the FDA acknowledged that for fermented or hydrolyzed foods a scientifically valid method was not available to detect gluten at levels to verify the claim. The following foods are listed as examples of foods that are fermented during manufacturing: cheese, yogurt, vinegar, sauerkraut, pickles, green olives, beers, and wine. While this proposed rule does not directly impact the juice industry, we thought you should be aware of the proposed requirements in case your company produces other foods or beverages.
The final rule, codified in 21 Code of Federal Regulations Part 101.91, established that the use of the term “gluten-free” may be used on foods as follows:
• Foods that inherently do not contain gluten (e.g., raw carrots or grapefruit juice) may use the ‘gluten-free’ claim.
• Foods with any whole, gluten-containing grains (e.g., spelt wheat) as ingredients may not use the claim;
• Foods with ingredients that are gluten-containing grains that are refined but still contain gluten (e.g., wheat flour) may not use the claim;
• Foods with ingredients that are gluten-containing grains that have been refined in such a way to remove the gluten may use the claim, so long as the food contains less than 20 ppm [parts per million] gluten/has less than 20 mg [milligrams] gluten per kg [kilogram] (e.g. wheat starch);
• Foods may not use the claim if they contain 20 parts per million (ppm) or more gluten as a result of cross-contact with gluten containing grains.
Today, the FDA published a proposed rule in the Federal Register (80 FR 71990), available here, “to establish requirements concerning “gluten-free” labeling for foods that are fermented or hydrolyzed or that contain fermented or hydrolyzed ingredients.” The FDA’s Constituent Update is available here. In addition, FDA’s Questions and Answers document related to the proposed rule can be accessed here.
The FDA notes that since there is no scientifically validated method in detecting and quantifying the gluten protein in fermented and hydrolyzed foods, other means to verify compliance for “gluten-free” labeling are needed. Thus, the Agency is proposing to establish certain recordkeeping requirements to verify compliance. The proposed rule also includes compliance requirements for foods that are distilled (e.g., distilled vinegar) and bear a “gluten-free” claim.
Fermented and Hydrolyzed Foods
The FDA notes if the food or the ingredients used in a food fermented or hydrolyzed by the manufacturer contained less than 20 ppm of intact gluten before fermentation or hydrolysis, then the resulting fermented or hydrolyzed food also would contain less than 20 ppm intact gluten as long as gluten was not introduced during the fermentation or hydrolysis process. The proposed rule would require that the manufacturer of fermented or hydrolyzed foods bearing the "gluten-free" claim make and keep records that demonstrate the food is "gluten-free" before fermentation or hydrolysis and that gluten has not been introduced during the manufacturing process. For foods containing one or more fermented or hydrolyzed ingredients and bearing the "gluten-free" claim, the manufacturer would be required to make and keep records that demonstrate the fermented or hydrolyzed ingredients are "gluten-free." This may be demonstrated with test results or a certificate of analysis for the food or ingredients before fermentation or hydrolysis. Manufacturers must also implement and document measures to prevent gluten cross-contact.
The proposed rule would: (1) require that records be retained for 2 years after introduction or delivery for introduction of the food into interstate commerce; (2) allow records to be kept as original records, true copies, or as electronic records; and (3) state that the records must be available to FDA for examination and copying during an inspection upon our request.
When the final rule was published in 2013, the Agency noted it received comments expressing concern that distilled vinegar (as a food or ingredient) could contain gluten, and it was requested that the Agency not allow distilled vinegar to bear a “gluten-free” claim. The Agency agreed to consider these comments as part of this proposed rule. The FDA proposes that for distilled foods made from gluten-containing grains and bearing a “gluten-free” claim, compliance will be verified by the absence of protein (and thus gluten) in the vinegar using a scientifically valid method that can detect the presence or absence of protein in the food.
The FDA is proposing to establish a compliance date that becomes effective one year following publication of the final rule in the Federal Register.
Deadline for Comment
The FDA has established February 16, 2016 as the deadline to comment on the proposed rule. December 18, 2015 is the deadline to comment on the information collection provisions located in Section V., The Paperwork Reduction Act of 1995 (Pages 72001).
As always, please contact me with questions or comments.
(404) 252 - 3663