Plea to FDA: Turn your attention to the manufacturers who blatantly use fermented and hydrolyzed wheat or barley ingredients in labeled gluten-free foods
Text of email sent to FDA July 13, 2020:
Dear Dr. Mayne,
Gluten Free Watchdog has reported twelve products to CAERS for gluten-free facial misbranding in 2020. Six of these products have been recalled and posted on either FDA’s enforcement report page or recall listing. On behalf of the Gluten Free Watchdog community, thank you for the role you’ve played in these recalls. Please continue your efforts and recall the remaining six products.
Products that have not been recalled include (product photos available at https://www.glutenfreewatchdog.org/news/running-list-of-misbranded-gluten-free-products-reported-to-fda-by-gfwd-in-2020/):
- Gourmet Warehouse Ernest Hemingway Feast and Rum Runner marinades. Reported to FDA via CAERS on June 8, 2020. Report acknowledged by CAERS on June 8, 2020. Both products are labeled gluten-free yet list wheat as a sub-ingredient in the soy sauce. Feast marinade was first reported to FDA via CAERS on September 4, 2019.
- So Nourished Gold Alternative Sweetener. Reported to FDA via CAERS on May 26, 2020.Report acknowledged by CAERS on May 28, 2020. Product packaging includes a gluten-free claim. The ingredients list reads, “Erythritol, Tagatose, Malt extract, Monk fruit extract, Glycerol.”
- Dandy Blend Instant Herbal Beverage. Reported to FDA via CAERS on May 18, 2020. First reported to FDA in 2014 (6 1/2 years ago). Report acknowledged by CAERS on May 19, 2020. Product packaging includes a gluten-free claim. The ingredients list reads, “extracts of roasted barley, rye, chicory root, dandelion root and sugar beet.”
- Grow Girl Hair Growth Dietary Supplement. Reported to FDA via CAERS on January 28, 2020. Report acknowledged by CAERS on January 29, 2020. The product is labeled “no gluten” which FDA considers a synonym for “gluten free” yet it includes “malt syrup” in the ingredients list.
- Restructure Protein Powder. Reported to FDA via CAERS on January 5, 2020. Report acknowledged by CAERS on January 8, 2020. RECALL March 3, 2020 posted on FDA’s Recalls, Market Withdrawals, & Safety Alerts page BUT because of undeclared milk only. The gluten-free claim remains on new product packaging and the ingredient “germinated barley seed powder” has not been removed.
Products that have not been recalled have one thing in common—they all contain as ingredients either fermented or hydrolyzed wheat or barley. Some of the products in this list have been allowed to remain on store shelves for years. One product—Dandy Blend—has been tested numerous times by Gluten Free Watchdog through the ISO accredited lab Bia Diagnostics. Results using the competitive R5 ELISA vary but have been as high as 116 parts per million of gluten. We first reported this product to FDA in 2014. In 2020 the product continues to carry a gluten-free claim and it continues to list “extracts of roasted barley, rye” in the ingredients.
While we understand that the proposed rule for gluten-free labeling of fermented or hydrolyzed foods (or foods containing fermented or hydrolyzed ingredients) has not yet been finalized, the “original” gluten-free labeling rule doesn’t allow for the inclusion of ingredients such as hydrolyzed wheat protein and fermented barley. Further, FDA has clarified in writing on numerous occasions to Gluten Free Watchdog, USDA, and in various presentations (including a joint presentation with FDA and Gluten Free Watchdog at the Academy of Nutrition and Dietetics Food and Nutrition Conference and Expo) that ingredients such as wheat-based soy sauce, malt, malt extract, and malt syrup are not allowed in foods labeled gluten-free.
The complete lack of enforcement of the gluten-free labeling rule when foods labeled gluten-free contain fermented or hydrolyzed wheat or barley is putting the health of people with celiac disease at risk. It also is emboldening manufacturers to openly disregard the codified rule. We ask that FDA promptly turn its attention to the manufacturers who blatantly use fermented and hydrolyzed wheat or barley ingredients in labeled gluten-free foods.
Thank you for your continued attention to this important issue.
Tricia Thompson, MS, RD
Founder, Gluten Free Watchdog, LLC
Hon. Alex Azar, U.S. Health and Human Services Commissioner
Claudine Kavanaugh, Director, Office of Nutrition & Food Labeling, CFSAN
Robin McKinnon, Senior advisor for nutrition policy, CFSAN