FDA Releases Proposed Rule on Gluten-Free Fermented, Distilled & Hydrolyzed Foods

fermented-foodsThe United States Food and Drug Administration (FDA) released a proposed rule on fermented, distilled and hydrolyzed gluten-free foods today. The proposed ruling would also affect foods with fermented, distilled or hydrolyzed ingredients.

The FDA announcement contains details of what the proposed ruling would entail:

The proposed rule, when finalized, would require these manufacturers to make and keep records demonstrating assurance that:

  • the food meets the requirements of the gluten-free food labeling final rule prior to fermentation or hydrolysis, and
  • the manufacturer has adequately evaluated its process for any potential gluten cross-contact, and
  • where a potential for gluten cross-contact has been identified, the manufacturer has implemented measures to prevent the introduction of gluten into the food during the manufacturing process.


The ruling would affect foods such as saurkraut, kimchi, vinegar, pickles and olives.

The FDA also confirms that all hydrolyzed, distilled or fermented products would be required to follow the same standards as other products if they want to label their product “gluten free”:

Hydrolyzed, fermented, or distilled foods voluntarily bearing the “gluten-free” claim will also still have to meet the requirements of the gluten-free food labeling final rule, including the definition of “gluten-free,” which means that they are either inherently gluten-free or they do not include any of the following:

  • Ingredients that are gluten-containing grains
  • Ingredients derived from a gluten-containing grain that have not been processed to remove gluten
  • Ingredients derived from a gluten-containing grain that have been processed to remove gluten if use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food

In either case, any unavoidable presence of gluten must be less than 20 ppm. 

The original gluten-free labeling law, released in 2013, acknowledged that it was difficult to scientifically detect gluten in fermented and hydrolyzed foods. The original rule stated the FDA would release a proposed ruling on this issue in the future.

Since this ruling is still “proposed,” changes to the language can still be made, and it will be some time before this ruling is finalized and put into effect.

The public can comment on the proposed ruling for 90 days. To comment on the ruling, go to www.regulations.gov/ and type in FDA-2014-N-1021 in the search box.


To learn more about the proposed ruling, see the FDA’s FAQ here.