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:

1. The Alcohol and Tobacco Tax and Trade Bureau (TTB) regulates distilled spirits.
2. 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 the following statement is included on the label:
   1. “This product was distilled from grains containing gluten, which removed some or all of the gluten. The gluten content of this product cannot be verified, and this product may contain gluten.” For more info see: https://www.ttb.gov/images/pdfs/gluten-announcement.pdf
3. TTB’s interim rule remains in effect.
4. FDA’s 2020 rule does NOT change the TTB’s interim rule.
5. FDA’s 2020 rule does NOT change the 2013 definition of gluten-free.
6. FDA’s 2020 codified rule can be found on pages 26 and 27 of the Federal Register document. The rule addresses the stage in production when ingredients and foods must meet the definition of gluten-free (i.e., prior to fermentation/hydrolysis) and the records that must be maintained by manufacturers. It also addresses how FDA will assess compliance of distilled foods and ingredients.

Bottom line: Distillation is considered by the FDA to be a “process to remove gluten.” Distilled products regulated by the FDA may carry a gluten-free claim on product packaging. FDA considers such foods safe for people with celiac disease. Because there is no available method to detect and quantify gluten that may be present in a distilled product, FDA will assess compliance with the 2013 gluten-free labeling rule using scientifically valid methods that can reliably detect the presence or absence of protein or protein fragments. If there is no protein in the distilled component, there is also no gluten (remember gluten is a protein) in the distilled component.

Distilled foods and ingredients under the labeling jurisdiction of FDA include:

• Distilled vinegar
• Condiments containing distilled vinegar as an ingredient, such as some catsups
• Flavoring extracts containing distilled alcohol as an ingredient, such as vanilla extract
• Condiments containing distilled alcohol as an ingredient, such as some mustards
• Again, the FDA does NOT regulate distilled spirits
• FDA’s 2020 rule does NOT apply to distilled spirits

Keep in mind: Testing total protein does not work for products that are fermented or hydrolyzed because while the protein is broken down, it is not removed. 

The details: According to the FDA in clarifying information provided in the Q&A portion of the Federal Register document (with some additional explanation from GFWD):

• Assuming good manufacturing practices are followed, distillation removes all protein, including gluten
  • During distillation liquid is heated
  • Components of the liquid with lower boiling points vaporize
    • This vapor is captured and cooled and becomes the distillate
  • Components with higher boiling points do not vaporize
  • Assuming distillation is done properly, gluten is removed because protein, including gluten does not vaporize
    • There should not be any protein or gluten remaining in the distillate
  • Protein/gluten would be in the distillate only under poor manufacturing practices “in which the initial material is splashing into the distillate due to poor design of the still.”
• “Protein testing can be done to confirm that protein (and thus gluten) is absent in the distilled product.”

Ingredients/processing after distillation. According to FDA:

• “Any ingredients (such as flavors) added to the distilled product would need to comply with FDA regulations defining “gluten-free” for the finished product labeling to bear the gluten-free claim.
• FDA stipulates that, “only those vinegars made from distilled ethanol that are further processed in a manner to avoid the introduction of gluten can be considered “gluten-free.”

Getting into the weeds: Distilled vinegar, fermentation, and growth media

Warning: This is a tricky section. Please check back periodically for additional details.

Under the FDA Compliance Policy Guide for vinegar, “SPIRIT VINEGAR, DISTILLED VINEGAR, GRAIN VINEGAR. The product made by the acetous fermentation of dilute distilled alcohol.” For more information see https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cpg-sec-525825-vinegar-definitions-adulteration-vinegar-eels

FDA responded to a comment about vinegar and fermentation, stating:

•  “Creating distilled vinegar does involve fermentation… As for the possible introduction of gluten from those proteins and protein fragments that may originate from the ethanol fermentation process, as with any product, it is the manufacturer’s responsibility to implement measures preventing the introduction of gluten into the food elsewhere in the manufacturing process for an ingredient made “gluten-free” by distillation.”
  • “The manufacturer could request from their supplier that the raw materials, such as bacteria or yeast used in the fermentation of distilled vinegar, 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.”
      • GFWD note: If bacteria or yeast are grown on gluten-containing source material, the gluten may become hydrolyzed (see FDA statement below).
        • GFWD Question: What appropriate testing is the FDA suggesting if the gluten is hydrolyzed?
• FDA states elsewhere that, “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.”
  • “Wheat may be present in any carried-over nutrient media used to grow the microbes, and the gluten in the media may be subjected to proteolytic digestion (hydrolysis) making its quantity and biological activity hard to confirm using currently available technology.”
    • GFWD note: Barley also may be used in growth media

Manufacturers: On the off chance that you don’t believe growth media containing gluten is a concern, please see:

• Gluten Free Watchdog’s publication, Gluten-Free Labeling: Are Growth Media Containing Wheat, Barley, and Rye Falling through the Cracks? Tricia Thompson, Melinda Dennis, Luke Emerson J Acad Nutr Diet. 2018;118:2025-2028. Available at: https://www.glutenfreewatchdog.org/news/wp-content/uploads/2020/08/JANDProbioticsInPress.pdf
• Fermentation Growth Media for Yeast and Concerns about Residual Gluten https://www.glutenfreewatchdog.org/news/fermentation-growth-media-for-yeast-and-concerns-about-residual-gluten/

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