Lack of FDA enforcement action against manufacturers labeling products gluten-free that list barley malt ingredients

Several groups recently came together to ask FDA if they intend to take enforcement action against manufacturers labeling products gluten-free that list malt, malt syrup, malt extract, or malt vinegar in the ingredients. Thank you to the National Celiac Association, Beyond Celiac, the Society for the Study of Celiac Disease, the Gluten Intolerance Group, and Celiac Community Foundation of Northern California for joining Gluten Free Watchdog in this effort. It takes a unified gluten-free village!

When you have a spare minute, please send an email or letter in support of our request to Susan Mayne, PhD, Director of CFSAN. Please feel free to use all or some of the information from the group letter in your personalized letter. Also, feel free to tweet the link to the letter or photo of the letter to Dr. Mayne.

Email: Susan.Mayne@fda.hhs.gov

Address:

Susan Mayne, PhD

Director, CFSAN

5001 Campus Drive

College Park, MD 20740-3835

Twitter: @DrMayneFDAFood

……………………………………………………………

Dear Dr. Mayne,

The undersigned organizations share the mission of ensuring the safety of foods made available under the FDA’s Gluten-Free Labeling Rule. The gluten-free community includes patients with celiac disease who must adhere to a strict gluten-free diet as the only treatment for celiac disease.

We are deeply concerned that the gluten-free labeling rule (21 CFR § 101.91) is not being enforced by FDA. Based on a review of FDA’s Enforcement Reports page[1] for the period from January 1, 2020 to February 16, 2022, there have been a total of three recalls for products labeled gluten-free containing undeclared barley—but these products were recalled for other misbranding problems, specifically undeclared wheat or peanuts. There has not been any public FDA enforcement action for misbranded products labeled gluten-free listing a barley ingredient, namely malt, malt syrup, malt extract, or malt vinegar. This includes at least 14 products reported to FDA by Gluten Free Watchdog during this period.

FDA states the following about malt syrup and malt extract in Questions and Answers on the Gluten-Free Food Labeling Final Rule:[2]

Can ingredients such as barley malt and barley malt extract be used in foods bearing a “gluten-free” claim?

No. Malt syrup and malt extract are interchangeable terms for a viscous concentrate of a water extract of germinated barley, with or without a preservative. The terms barley malt or barley malt extract are used also. Malt extract and malt syrup are ingredients derived from a gluten-containing grain, barley, that has not been processed to remove gluten. Food and ingredient manufacturers should be aware that malt extract and other similar malt-derived ingredients are ingredients derived from gluten-containing grains that have not been processed to remove gluten and, therefore, cannot be used in foods that bear a “gluten-free” labeling claim.

On February 4, 2022, Gluten Free Watchdog purchased four previously reported products for the express purpose of reviewing current labeling; three of those four continue to carry a gluten-free claim. Of those three, two continue to list malt syrup as the first ingredient and one product continues to list malt extract in the ingredients:

1. Walgreens Supplements

Multiple Walgreens gummy supplements are labeled gluten-free yet the first ingredient listed is malt syrup. Supplements were reported to FDA via CAERS on July 30, 2021. As of February 4, 2022, black elderberry gummies remain available for purchase with the same labeling.

• Grow Girl Hair Growth Dietary Supplement

The product is labeled “no gluten” yet the first ingredient is “malt syrup”.  This product was reported to FDA via CAERS on January 28, 2020.  As of February 4, 2022,this product remains available for purchase with the same labeling. 

• The Fine Cheese Co Olive Oil and Sea Salt Crackers

This product is labeled gluten-free yet includes “gluten-free malted barley” in the ingredients list. This product was reported to FDA via CAERS on November 19, 2020. As of February 4, 2022, this product remains available for purchase with the same labeling.

These products are misbranded in clear violation of the gluten-free labeling rule, and they are dangerous to consumers who must adhere to a strict gluten-free diet. The fact that products reported to FDA remain available for retail sale with no apparent change to the label—months after FDA received complaints—indicates that the agency is not enforcing the gluten-free labeling rule. It has been eight years since the gluten-free labeling rule became effective, and the consumers protected by that rule need FDA to recall misbranded products in response to consumer reports.

The stated objective of FDA’s regulatory programs is to assure compliance with the Federal Food, Drug, and Cosmetic Act. As a community, we would like to hear from FDA. We are not requesting comment about the specific products highlighted as examples, but about how FDA intends to assure compliance with the gluten-free labeling rule. Does the agency intend to take enforcement action against manufacturers labeling products gluten-free that list malt, malt syrup, malt extract, or malt vinegar in the ingredients?

Sincerely,

Gluten Free Watchdog, LLC

National Celiac Association

Beyond Celiac

Society for the Study of Celiac Disease

Gluten Intolerance Group

Celiac Community Foundation of Northern California

cc:

Hon. Xavier Becerra, U.S. Health and Human Services Commissioner

Robert Califf, MD, U.S. Food and Drug Administration Commissioner

Dayle Cristinzio, Director, FDA Stakeholder Engagement Office of External Affairs 

Glenda R. Lewis, Supervisory Consumer Safety Officer Director, CFSAN

Robin McKinnon, Senior Advisor Nutrition Policy, CFSAN

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[1] https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/enforcement-reports

[2] https://www.fda.gov/food/food-labeling-nutrition/questions-and-answers-gluten-free-food-labeling-final-rule