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

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 as a starting material can be labeled gluten-free.
  • Wheat starch itself is not considered by FDA to be a fermented or hydrolyzed food.

Background information:

  • In 2015, FDA opened a comment period on the proposed rule for gluten-free labeling of fermented or hydrolyzed foods.
  • Gluten Free Watchdog posed the following question, “How does FDA recommend that manufacturers ensure that the wheat starch and wheat starch hydrolysates used in their products do not contain hydrolyzed gluten in amounts that may cause harm to individuals with celiac disease?” 

FDA’s response to the above question (as addressed in the comment portion of the 2020 final rule):

  • “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.”

PROBLEM (from Gluten Free Watchdog’s standpoint):

  • According to information on the website of the International Starch Institute, hydrolysis (the breakdown of a substance using water) is intrinsic to the starch-making process.
  • NEW (July 6. 2021): According to R-Biopharm, hydrolytic enzymes may be used during the production of water washed wheat starch.
  • A 2014 study presented at the Proceedings of the 27th Meeting of the Working Group on Prolamin Analysis and Toxicity found wheat starch to contain from less than 5 parts per million of gluten to over 10,000 parts per million of gluten.
  • According to this same study:
    • Gluten may be partially degraded during the manufacturing process of starch which could lead to a loss of the second epitope required for antibody recognition in the Sandwich assay.”
  • The assay manufacturer R-Biopharm recommends use of the competitive R5 ELISA (versus the sandwich R5 ELISA) when testing starch for residual gluten.
    • The sandwich ELISA is used to quantify intact gluten protein.
    • The competitive ELISA is used to detect gluten that has been broken apart by processing procedures, such as hydrolysis.
      • Unfortunately, there are issues with the competitive R5 ELISA (as outlined in the post on testing food for gluten).
    • NEW: “If hydrolytic enzymes were used in the production process of (water washed) starch the use of R7021 (competitive ELISA) is the better choice. If hydrolysis can be excluded R7001 works fine.”

OPINION: FDA considers properly manufactured wheat starch to be free of gluten protein and an ingredient processed to remove gluten. Regardless, because of the current limitations associated with testing wheat starch for gluten, it is the opinion of Gluten Free Watchdog that products containing wheat starch are best avoided by individuals with celiac disease.

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

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