Rule on Gluten-Free Labeling of Fermented or Hydrolyzed Foods

Product Alert: Schiff Digestive Advantage Lactose Defense Formula labeled no added gluten contains an enzyme cultivated on growth media containing wheat

A concerned consumer reached out to Gluten Free Watchdog about this product. GFWD contacted the manufacturer asking about the source of wheat. The manufacturer reply stated: “The product does not contain any wheat or gluten. The enzyme used in our product is grown on fermented wheat so we are required to add it to our label.” HOWEVER, under FDA's newly released rule on gluten-free labeling of fermented and hydrolyzed ingredients, FDA has declined to exempt enzymes. This means that enzymes in...

What the FDA has to say about wheat starch and hydrolyzed gluten

This post is part of a series covering the FDA’s Final Rule on Gluten-Free Labeling of Fermented or Hydrolyzed Foods.  The rule is available at https://www.federalregister.gov/documents/2020/08/13/2020-17088/food-labeling-gluten-free-labeling-of-fermented-or-hydrolyzed-foods Bottom Line: Under the FDA’s 2013 gluten-free labeling rule, wheat starch is considered “an ingredient processed to remove gluten.”It is an allowed ingredient in foods labeled gluten-free as long as its use does not result in the final food product containing 20 parts per million or more of gluten.Fermented foods and ingredients made using gluten-free wheat starch...

What the FDA has to say about testing for gluten

This post is part of a series covering the FDA’s Final Rule on Gluten-Free Labeling of Fermented or Hydrolyzed Foods.  The rule is available at https://www.federalregister.gov/documents/2020/08/13/2020-17088/food-labeling-gluten-free-labeling-of-fermented-or-hydrolyzed-foods Bottom line Currently (and according to FDA), it is next to impossible to accurately test food for gluten when it has been partially broken down into smaller protein fragments during certain processing procedures, such as fermentation and hydrolysis. Examples of foods & ingredients that may contain gluten that has been partially broken down Soy sauce (hydrolyzed wheat protein)Malt vinegar (barley...

What the FDA has to say about gluten-free labeling of foods containing bacteria, enzymes, & yeast grown on gluten-containing media

This post is part of a series covering the FDA’s Final Rule on Gluten-Free Labeling of Fermented or Hydrolyzed Foods. The information on growth media in the Federal Register document is located in multiple sections and is not 100% clear. This post may be updated as FDA provides additional clarification. The rule is available at https://www.federalregister.gov/documents/2020/08/13/2020-17088/food-labeling-gluten-free-labeling-of-fermented-or-hydrolyzed-foods Bottom line Manufacturers, if you are labeling a food gluten-free that contains microbes or enzymes, please make sure that the growth media used in their development did not...

What the FDA has to say about gluten-free labeling of distilled foods and ingredients

This post is part of a series covering the FDA’s Final Rule on Gluten-Free Labeling of Fermented or Hydrolyzed Foods The rule is available at https://www.federalregister.gov/documents/2020/08/13/2020-17088/food-labeling-gluten-free-labeling-of-fermented-or-hydrolyzed-foods IMPORTANT: Please keep in mind the following points when reading this post and others on FDA and distilled spirits: The Alcohol and Tobacco Tax and Trade Bureau (TTB) regulates distilled spirits.Under the TTB’s interim rule on gluten-free labeling, alcoholic beverages distilled from wheat, barley, or rye can be labeled “processed to remove gluten” as long as...

Updated statement from FDA on soy sauce

For years Gluten Free Watchdog (GFWD) has been asking FDA to clarify for manufacturers that soy sauce made from wheat can NOT be included in foods carry a gluten-free claim. We were advised that the agency would not be providing additional guidance until the publication of the final rule on gluten-free labeling of fermented and hydrolyzed foods and ingredients. FDA was true to its word and on August 13, the same day the rule was published in the Federal Register,...

Updated statement from FDA on malt, malt extract, malt syrup, & similar malt-derived ingredients

For years Gluten Free Watchdog (GFWD) has been asking FDA to clarify for manufacturers that malt and malt extract from barley can NOT be included in foods carry a gluten-free claim. We were advised that the agency would not be providing additional guidance until the publication of the final rule on gluten-free labeling of fermented and hydrolyzed foods and ingredients. FDA was true to its word and on August 13, the same day the rule was published in the Federal...

FDA Publishes Final Rule on Gluten-Free Labeling of Fermented or Hydrolyzed Foods: The Basics

This is the first of several posts. The document published in the Federal Register is long and detailed. The FDA has included a lot of clarifying information related to the rules on gluten-free labeling of fermented or hydrolyzed foods and the 2013 gluten-free labeling. Notes have been added to indicate the topics that will be covered in future posts. If you have questions, please leave a comment. Your questions will help inform future posts. The source for all information is the...