Can products containing fermented or hydrolyzed gluten be labelled as gluten-free?
We need to take a step back first: on August 5th, 2013 the United States food and Drug Administration (US-FDA) issued a definition for gluten-free used as voluntary label on food products:
The final rule defines the term ‘‘gluten-free’’ to mean that the food bearing the claim does not contain an ingredient that is a gluten-containing grain; an ingredient that is derived from a gluten-containing grain and that has not been processed to remove gluten; or an ingredient that is derived from a gluten-containing grain and that has been processed to remove gluten, if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food (i.e., 20 milligrams (mg) or more gluten per kilogram (kg) of food); or inherently does not contain gluten; and that any unavoidable presence of gluten in the food is below 20 ppm gluten (i.e., below 20 mg gluten per kg of food).
But occasionally, gluten-intolerant people may like to drink a beer [1]. And some brewers have beer that is claimed to contain less than 20 ppm of gluten. One example is the rather tasty Omission beer, which, according the brewery, is “specially crafted to remove gluten” and tested by gluten-ELISA. This and several similar products fell through the legal cracks of the gluten-free rule.
As of August 12, 2020, after numerous deliberations, US-FDA has provided the answer if products containing fermented or hydrolyzed gluten could be labelled as gluten-free. And the answer is “maybe”.
According to the rule which will come into effect October 13, 2020, the agency will assess the accuracy of the claim on a case-by-case basis, and based on the outcome of the inspection, allow the manufacturer to use the gluten-free label or not.
What is the challenge? The challenge here is the testing methodology used to determine gluten in fermented products. For most foods, ELISA, an immunological technique for the detection of gluten, is an appropriate tool. However, when products are hydrolyzed or fermented, gluten is partially broken down, and ELISA may no longer be able to detect it with sufficient sensitivity. To remedy this, FDA has also developed alternative, mass-spectrometry-based techniques which capture the sub-units of the proteins, the peptides. And yet, even these techniques may not successfully detect all gluten present.
Therefore, FDA issued the following Statement:
“Currently, FDA knows 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.”
“Thus, we plan to evaluate compliance of such fermented or hydrolyzed foods that bear a “gluten-free” claim based on records that are made and kept by the manufacturer of the food bearing the “gluten-free” claim and made available to us for inspection and copying. The records need to provide adequate assurance that the food or ingredients used in the food are “gluten-free” before fermentation or hydrolysis.”
The good news is that in principle, brewers can label their beers gluten-free but need to provide appropriate reassurance to FDA through their records and gluten test certificates.
Cheers to that!
[1] The Alcohol and Tobacco Tax and Trade Bureau (TTB) regulates alcoholic beverages. However, products which need to follow FDA regulations are wines containing less than 7% alcohol by volume and beers that are made from substitutes for malted barley (e.g., sorghum, rice, or wheat) and beers made without hops. There is a memorandum of understanding between both agencies.
