Gluten Free Watchdog Call To Action: Contact FDA Today Asking For Enforcement Action Against Manufacturers Of Products Labeled Gluten-Free Yet Containing Fermented Or Hydrolyzed Wheat & Barley

We are making progress but there is still more work to do. To date, six of nine products reported to FDA by Gluten Free Watchdog in 2020 have been recalled. If you have the energy during these trying times, please send emails to the HHS and FDA personnel listed below. Emails are recommended at the moment because FDA personnel may be working remotely. However, if you prefer to mail letters or post cards, this is of course fine too. The email letter I’m sending on behalf of the Gluten Free Watchdog community is pasted below. I’ve also attached photos of the three products we are focusing on during this email campaign. Please attach product photos to your emails. Pictures speak volumes. Please feel free to use any or all of the information below in your own letter.

Suggested recipients of your letter:

Mr. Alex M. Azar II

Office of the Secretary

U.S. Department of Health and Human Services

Hubert H. Humphrey Building

200 Independence Avenue, S.W.

Washington, D.C. 20201

Secretary@HHS.gov

Stephen M. Hahn, MD

FDA Commissioner

Food and Drug Administration

White Oak Building One

10903 New Hampshire Avenue; Room 2217

Silver Spring, MD 20993

Stephen.Hahn@fda.hhs.gov

Susan Mayne, PhD

Director, CFSAN

5001 Campus Drive

College Park, MD 20740-3835

Susan.Mayne@fda.hhs.gov

Claudine Kavanaugh

Director, Office of Nutrition & Food Labeling

CFSAN

5001 Campus Drive

College Park, MD 20740-3835 

claudine.kavanaugh@fda.hhs.gov

Megan Velez

(Acting) Director, Office of Regulations & Policy

CFSAN

5001 Campus Drive

College Park, MD 20740-3835

Megan.Velez@fda.hhs.gov

William A. Correll, Jr.,

Director, Office of Compliance

CFSAN

5001 Campus Drive

College Park, MD 20740-3835

william.correll@cfsan.fda.gov

Robin Mckinnon

Senior advisor for nutrition policy

CFSAN

5001 Campus Drive

College Park, MD 20740-3835

Robin.McKinnon@fda.hhs.gov

Text of Letter

Dear,

Six of the nine products reported to FDA via CAERS by Gluten Free Watchdog in 2020 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 three products. Photos of these products are included as an attachment to this letter.

The products yet to be recalled have one thing in common—they all contain as ingredients either fermented or hydrolyzed barley. While we understand that the proposed rule for gluten-free labeling of fermented or hydrolyzed foods (or foods containing fermented or hydrolyzed ingredients) has yet to be 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 that ingredients such as wheat-based soy sauce and barley malt 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

Products reported to FDA by Gluten Free Watchdog (Not Yet Recalled)

Dandy Blend Instant Herbal Beverage. Last 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 includes “extracts of roasted barley, rye.”

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” 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. It appears the gluten-free claim will remain on new product packaging and the ingredient “germinated barley seed powder” will not be removed.