Information from FDA Regarding Gluten-Free Labeling of Hydrolyzed and Fermented Foods

The latest from the FDA on where the Agency stands in regard to the proposed rule on the gluten-free labeling of hydrolyzed and fermented food…

On August 1, I sent the following email to FDA:

“Is there any information that can be released publicly regarding whether a proposed rule or guidance document is going to be released soon to help manufacturers determine whether they can label as gluten-free a hydrolyzed or fermented food or a food containing hydrolyzed/fermented ingredients? As you know, we have an increasing number of manufacturers who believe that if they test their final food product for gluten using the sandwich R5 ELISA and it tests below 20 ppm gluten then they can label the product gluten-free, regardless of ingredients. As a result manufacturers are labeling food gluten-free that contain malt, malt extract, malt syrup, extracts of rye, extracts of barley, hydrolyzed wheat, soy sauce (with a sub-ingredient list that includes wheat), etc. This is a fairly big problem from my perspective. Any information that you can share will be very helpful.

The Agency responded to me today (August 7) stating:

“Our proposed rule regarding gluten-free labeling of hydrolyzed and fermented foods is still under review and therefore we cannot release any information as yet.  Meanwhile the Gluten-free final rule has information about the requirements for labeling of these products for manufacturers.  We will make sure to clarify any doubts in a set of Questions and Answers that we hope to publish along with the proposed rule.  Thank you for your patience.”