Updating the community on gluten-free facial misbranding and FDA & USDA enforcement of gluten-free claims: Celiac Disease Awareness Month 2020
During the first 4½ months of 2020, Gluten Free Watchdog reported 8 products appearing to be facially misbranded to FDA and 1 product to USDA. Products are considered facially misbranded (a term coined by the GFWD team) when they are labeled gluten-free but the ingredients list includes an ingredient not allowed in foods making a gluten-free claim.
As of May 12, 2020, 6 products reported to FDA have been recalled for gluten-free misbranding. This is actually extraordinary given that very little enforcement of the gluten-free labeling rule by FDA has occurred up until now. Enforcement action appears to coincide with a letter writing campaign by the Gluten Free Watchdog community to alert an expanded list of folks at HHS/FDA about the lack of enforcement action. Thank you to the community for this tremendous effort.
While it is a very big deal that 6/8 products reported to FDA by GFWD in 2020 have been recalled, it is important to note that recalled foods contain some form of intact wheat or barley (e.g., wheat grain, barley grain, wheat flour). The 2 products not yet recalled by FDA contain forms of gluten that have been broken down due to fermentation or hydrolysis (germinated barley seed powder, malt syrup). The product reported to USDA also includes an ingredient derived from fermented wheat and barley (porter ale/beer). The manufacturer of this product is voluntarily removing the gluten-free claim but a recall was not mandated. More information about these products is available at https://www.glutenfreewatchdog.org/news/running-list-of-misbranded-gluten-free-products-reported-to-fda-by-gfwd-in-2020/
While the increase in enforcement action is welcome, it remains the case that no FDA enforcement is taking place when fermented and hydrolyzed barley and wheat-based ingredients are used in labeled gluten-free foods. This means that products containing wheat based soy sauce and barley malt remain on store shelves. FDA has pretty much stated to Gluten Free Watchdog that they will not be enforcing the gluten-free rule when it comes to fermented and hydrolyzed wheat and barley until the proposed rule on the gluten-free labeling of fermented and hydrolyzed foods is finalized.
The potential good news is that the proposed rule appears to be in its final stages. An FDA contact stated to me in writing at the end of 2019 that the rule is undergoing administrative review prior to release in the near future. However, given the current pandemic, it is anyone’s guess when the rule will actually be released.
Regardless of the lack of enforcement, FDA has stated in writing that wheat-based soy sauce and barley malt ingredients aren’t allowed in foods labeled gluten-free. It remains important to continue reporting misbranded products to Gluten Free Watchdog, including those that are labeled gluten-free and contain hydrolyzed or fermented wheat or barley. Gluten Free Watchdog will continue to file complaints with CAERS. We also plan to file additional FOIA requests to determine what if anything is being done in response to these complaints.