Is beer made using malted barley and crafted to remove gluten safe for folks with celiac disease? FDA says it is not possible to know based on current testing methods

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

Background (Important):

• FDA regulates the following:
  • Beer made without malted barley but with hops
  • Beer made without hops but with malted barley
  • Beer made without either malted barley or hops
• TTB regulates malt beverages including traditional beers made with both malted barley and hops.

Bottom Line:

• Beer under the labeling jurisdiction of FDA that is made from gluten-containing grains (including malted barley) cannot bear a “gluten-free” claim.
  • If beer under the labeling jurisdiction of FDA is made using a gluten-containing grain that is processed to remove gluten (e.g., wheat starch) BEFORE the beer making process, this beer may be eligible for a gluten-free claim.
• Beer made using malted barley under the labeling jurisdiction of TTB can be labeled processed/treated/crafted to remove gluten.

Details:

• According to FDA, “It has been well established that barley glutens are not completely digested to amino acids during the malting and fermentation stage and that the gluten fragments are present in the final beer product.”
  • Gluten is at least partially broken down by fermentation and other processes.
  • The presence or absence of gluten that has been broken down can’t be reliably detected using the sandwich ELISA (see testing primer below)
• 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 haze control enzymes such as “Brewer’s Clarex”).

Into the weeds:

• Enzymes such as Brewer’s Clarex break down gluten protein at the proline residues.
  • The competitive R5 ELISA detects the five amino acid sequence QQPFP where P is proline.
  • After treatment with Brewer’s Clarex, the pentapeptide detected by the competitive R5 ELISA may no longer be present in beer.
  • BUT gluten peptides that are not detectable using the competitive R5 ELISA may be present.
  • According to FDA, breaking apart gluten at the proline residues may not render beer harmless for people with celiac disease because there may be protein fragments still present that are capable of causing an immune response.

Please also read the post on testing for gluten available at https://www.glutenfreewatchdog.org/news/what-the-fda-has-to-say-about-testing-for-gluten/ Pasted from this post:

Brief primer on testing

• An enzyme-linked immunosorbent assay (ELISA) is commonly used to assess food for gluten.
  • This assay involves an antigen-antibody reaction.
  • Antibodies in the assay will react with antigens (e.g., gluten) in the food sample.
• Two types of ELISAs are currently used.
  • Sandwich ELISAs require two epitopes or antibody binding sites on a continuous sequence of amino acids.
  • Competitive ELISAs require only one epitope or antibody binding site on a continuous sequence of amino acids.
• The sandwich R5 ELISA is used worldwide to test food for gluten.
  • Based on the R5 antibody
  • Recognizes the 5 amino acid sequence QQPFP* found repeatedly in gluten protein (*glutamine-glutamine-proline-phenylalanine-proline)
  • Used to detect and quantify intact gluten proteins from wheat, barley, and rye
  • Codex Alimentarius Type 1 Method
• The competitive R5 ELISA is a modification of the sandwich R5 ELISA.
  • Used to test food for the presence of hydrolyzed/fermented gluten
    • Gluten that has been broken down into smaller gluten peptide fragments
  • PROBLEM: The competitive R5 ELISA is not a universally approved method of analysis by all regulatory agencies, including FDA due to all of the reasons stated previously.

Question: Why can’t the sandwich R5 ELISA be used to accurately assess food for the presence of hydrolyzed gluten?

Answer: Hydrolysis may result in gluten peptide fragments that do not contain the two QQPFP epitopes necessary for the sandwich R5 ELISA to work.

• Example: A gluten protein containing the repeating epitope QQPFP with “a” representing other amino acids might appear as:
  • QQPFPaaaaaaaQQPFPaaaaaaaaaaaaQQPFPaaaaaaaQQPFPaaaaaaaQQPFPaaaaaaaQQPFP
  • If this protein is hydrolyzed it may break apart into protein fragments:
    • Fragment 1: QQPFPaaaaaaaQQPFPaa
      • Two epitopes are present so the sandwich R5 ELISA CAN detect
    • Fragment 2: aaaaaaaaaaQQPFPaa
      • One epitope is present so the sandwich R5 ELISA can NOT detect
    • Fragment 3: aaaaaQQPFPaaaa
      • One epitope is present so the sandwich R5 ELISA can NOT detect
    • Fragment 4: aaaQQPFPaaaaaaaQQPFP
      • Two epitopes are present so the sandwich R5 ELISA CAN detect

If you have any questions, please leave a comment. Your comments will help inform updates to this post. Thank you.