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

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 Federal Register https://www.federalregister.gov/documents/2020/08/13/2020-17088/food-labeling-gluten-free-labeling-of-fermented-or-hydrolyzed-foods

On August 13, 2020 FDA published a final rule in the Federal Register to establish requirements for “gluten-free” labeling for foods that are fermented or hydrolyzed or that contain fermented or hydrolyzed ingredients. The rule is effective October 13, 2020. The compliance date for this rule is August 13, 2021.

What the rule says in brief

  • Fermented and hydrolyzed foods carrying a gluten-free claim must be gluten-free as defined by the 2013 gluten-free labeling rule before fermentation and hydrolysis.
    • Manufacturers must have records that demonstrate all such foods are in compliance.
  • Fermented and hydrolyzed ingredients in foods carrying a gluten-free claim must be gluten-free as defined by the 2013 gluten-free labeling rule before fermentation and hydrolysis.
    • Manufacturers must have records that demonstrate all such fermented or hydrolyzed ingredients are in compliance.
  • Manufacturers must assess the potential for cross contact with gluten.
    • Manufacturers must have measures in place to prevent cross contact.

What this means from a practical standpoint

  • If a food or an ingredient in a food isn’t in compliance with the 2013 gluten-free labeling rule before fermentation or hydrolysis, it can’t be included in a labeled gluten-free food.
  • This means:
    • No ingredients that are wheat grain, barley grain, or rye grain.
    • No ingredients derived from these grains that have not been processed to remove gluten.
      • Wheat starch and barley starch are ingredients processed to remove gluten
      • Wheat flour and barley flour are Ingredients not processed to remove gluten.
    • Fermentation and hydrolysis are NOT considered a “process to remove gluten.”

The rule also covers distilled foods and ingredients

  • The process of distillation removes all protein, including gluten if good manufacturing practices are followed.
    • FDA will evaluate compliance with the 2013 gluten-free labeling rule by verifying the absence of protein (and thus gluten) in the distilled component using scientifically valid analytical methods that can reliably detect the presence or absence of protein or protein fragments in the food.
    • This topic will be covered in more detail in a future post.

What the FDA says about assays used to assess gluten levels of fermented & hydrolyzed foods

  • FDA states that they know of “no scientifically valid analytical method effective in detecting and quantifying with precision the gluten protein content in fermented or hydrolyzed foods in terms of equivalent amounts of intact gluten proteins.”
    • This includes the sandwich and competitive R5 ELISAs.
  • According to FDA, the R5 Competitive ELISA method is not suitable for the detection and quantification of gluten in any fermented or hydrolyzed food.
  • FDA stresses that the inability to detect any gluten using the R5 Competitive ELISA is not an indication of complete elimination or even a reduction of gluten.
  • There is research underway within FDA and elsewhere to develop methods to accurately detect and quantify the presence of gluten in fermented or hydrolyzed foods.
  • This topic will be covered in more detail in a future post.

The FDA also provides some general statements about the rule

  • The final rule does NOT change the definition of gluten-free as stated in the 2013 gluten-free labeling rule; the final rule simply adds compliance requirements for fermented, hydrolyzed, or distilled foods and ingredients.
  • The final rule is intended to cover all foods that are fermented or contain fermented ingredients and bear the term “gluten-free,” not just those from gluten-containing grains.
    • In other words, just because FDA includes sauerkraut and pickles in the list of examples of fermented foods does NOT mean that these products are at high risk of containing gluten.
  • The final rule requires manufacturers to adequately evaluate their manufacturing practices for the potential for gluten cross-contact.
  • The final rule does not require testing of foods or ingredients.
  • From FDA’s perspective, there is a difference between the physical removal of gluten and the modification (processing) of gluten to generate a product that does not cause an immune response in consumers with celiac disease.
    • According to FDA, when physically removing gluten, the question is whether all of the gluten has been removed so that there is no trace left that might cause an adverse health event.
      • An example of an ingredient subject to the physical removal of gluten is wheat starch (wheat starch is an allowed ingredient in foods labeled gluten-free BUT the use of this ingredient must not cause the final food product to contain a level of gluten at/above 20 parts per million.
    • According to FDA, modification of gluten is not definitive unless it is possible to demonstrate that all of the modified gluten or its protein components are no longer harmful for individuals with celiac disease.
      • Fermentation and hydrolysis are examples of processes that modify gluten.

Questions posed to FDA by Gluten Free Watchdog during the draft rule stage that are addressed in the Federal Register document

Gluten Free Watchdog asked FDA to clarify several issues during the comment period for the draft rule. FDA responded to our questions about malt, wheat starch, and growth media.

Malt

  • FDA: “We note that malt syrup and malt extract are interchangeable terms for a viscous concentrate of a water extract of germinated barley, with or without a preservative. The terms barley malt or barley malt extract are used also. Malt syrup is usually a brown and viscous liquid containing varying amounts of amylolytic enzymes with plant constituents. Malt extract and malt syrup are ingredients derived from a gluten-containing grain, barley, that have not been processed to remove gluten. Food and ingredient manufacturers should be aware that malt extract and other similar malt-derived ingredients are ingredients derived from gluten-containing grains that have not been processed to remove gluten and, therefore, cannot be used in foods that bear “gluten-free” labeling.”

Wheat starch

  • FDA: “Wheat starch, when properly manufactured, does not involve hydrolysis of the gluten and can be protein-free. However, as we explain in the preamble to the 2007 proposed rule for gluten-free food labeling, we recognize that there may be different methods of deriving wheat starch, and that some methods may remove less gluten than others… If the processing does involve hydrolysis resulting in hydrolyzed gluten, then the product would be subject to the requirements of this rule.”
  • This topic will be covered in more detail in a future post.

Growth media

  • FDA: “The issue of purity and potential carry-over of growth media containing gluten is a valid concern for both the manufacturers and consumers with celiac disease.”
  • Concerning enzymes produced on media containing wheat: “Wheat may be present in any carried-over nutrient media used to grow the microbes…”
    • Enzymes are not exempted from the rule.
  • Concerning bacteria and yeast used in the fermentation process of foods and ingredients: “The manufacturer could request from their supplier that the raw materials, such as bacteria or yeast used in the fermentation … be “gluten-free.” One way this can be accomplished is by avoiding the use of bacteria grown on any gluten-containing source material or by using appropriate testing to confirm that the material (bacteria) are “gluten-free.”
  • This topic will be covered in more detail in a future post.

Other topics of interest

Beer

  • Beers under the jurisdiction of FDA that are made from gluten-containing grains cannot bear a “gluten-free” claim.
  • Beers regulated by the TTB and made using a gluten-containing grain can be labeled “processed to remove gluten.”
  • FDA is not aware of any scientifically valid way to evaluate a claim that beer made from gluten-containing grains can be processed to remove gluten.
  • There is inadequate evidence concerning the effectiveness of gluten removal processes (e.g., via enzymes such as “Brewer’s Clarex”).
  • This topic will be covered in more detail in a future post.

That’s all for now. Another post will be forthcoming soon. Please remember to post any questions you would like addressed.

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Comments (4)

  • Amy Keller
    Reply

    I wonder if the TTB will follow suit and reconsider the labeling of GF removed beers? I hope so.

    August 14, 2020 at 3:36 pm
    • Tricia Thompson Reply

      Possibly. The TTB’s rule is in the interim stage. They require testing with the competitive R5 ELISA. BUT the FDA feels very strongly that this ELISA is not ready for prime time. The TTB appears to follow the FDA’s lead so maybe they will finalize the rule and make some changes.

      August 14, 2020 at 3:44 pm
  • Jim Williams Reply

    Disappointed that “gluten removed” will still be acceptable even while the FDA agrees with what many of us have already known, that nothing with gluten containing ingredients can be considered gluten free. Also surprised that they fell short of debunking the “gluten removal” process.

    Nonetheless, some progress was made! Thanks for the update and for staying with this over the years!

    August 14, 2020 at 7:56 pm
  • Chessie Reply

    Good info. I’m a vegan who eats a lot of nutritional yeast, and I always wonder what the yeast was grown on. I buy various kinds that are labeled GF, but I feel I never really know.

    August 15, 2020 at 10:26 am

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