Does FDA ever intend to take public enforcement action against manufacturers misbranding products gluten-free that list malt ingredients?

As of May 23, 2022, FDA has not taken any public enforcement action on misbranded products labeled gluten-free yet listing malt, malt extract, malt syrup, or malt vinegar in the ingredients (all made from barley unless another source is declared, such as corn malt).

On February 23, 2022, Gluten Free Watchdog sent a letter to Susan Mayne, PhD, Director of FDA’s Center for Food Safety and Applied Nutrition. The letter stated in part:

“We are deeply concerned that the gluten-free labeling […]

Grainful Purity Protocol Gluten-Free Lentils

Disclaimer: Gluten Free Watchdog provided feedback and encouragement to Grainful on their journey to bring purity protocol lentils to market. We are excited to see their efforts finally come to fruition. Gluten Free Watchdog does not formally endorse products.

We recently purchased two, three-pound bags of Grainful Purity Protocol Whole Red Lentils from Amazon. We sorted one bag looking for errant grain and sent the other bag to Bia Diagnostics for testing. We did not find any foreign material and the lentils did […]

General Mills Proposed Gluten Friendly Line

UPDATE February 12, 2020: Thank you so much to everyone who emailed and posted comments. Comments were sent to General Mills today.

Their response: “Thank you for sharing this information. I will be forwarding it on to the team that is working on the concept. I think it is also important for you to know that based on all of the feedback we received from the gluten free community, we removed the images from our website as we reevaluate […]

Gluten Free Watchdog Now Testing Restaurant Menu Items for Gluten

After
years of good intentions, Gluten Free Watchdog has started testing menu items
represented as gluten-free.

What is being tested? Early testing is focusing on nationwide chain restaurants that state in writing and verbally that their menu items marked gluten-free are appropriate for folks with celiac disease.

What is the protocol for collecting samples and sending them to the lab? Subscribers to Gluten Free Watchdog are facilitating this testing. Volunteers are purchasing the same menu item from chain restaurant locations across […]

Call to Action: Help Us Determine the Current Status of Facial Misbranding of Gluten-Free Foods on Store Shelves

Please help us assess the current labeling status of gluten-free foods previously reported to FDA for facial misbranding (i.e., food is labeled gluten-free but lists an ingredient not allowed under the FDA’s gluten-free labeling rule).

The next time you are shopping for food, please check store shelves for the products listed below. In the relatively recent past these products have included a gluten-free claim on their packaging and named in the ingredients list an ingredient not allowed under FDA’s […]

Gluten Levels in Medication: FOIA Request

Update: Six years after filing this FOIA, FDA finally responded:

This is in response to your electronic Freedom of Information Act request dated in which you requested information regarding NFCA grant 4288. Specifically, your request seeks “GFW seeks all data reflecting testing for gluten content from the FDA-sponsored study Gluten in Medication… A search of the records of the Center for Drug Evaluation and Research did not locate responsive records. Specifically, Division of Information Disclosure Policy has confirmed that FDA […]

Allergen advisory statements for wheat do NOT appear to be useful predictors of the potential for quantifiable gluten in database reviews

For Immediate Release April 4, 2018
Allergen advisory statements for wheat do NOT appear to be useful predictors of the potential for quantifiable gluten in database reviews 1,2
A pdf of this release is available at FINAL EJCNAAS2018PressReleaseApril4

In the U.S., allergen advisory statements are voluntary and are not currently defined by any federal regulation. The FDA continues to state that allergen advisory statements must be truthful and not misleading. Precautionary labeling may include language such as, “May contain wheat,” “Processed in a […]