On May 22, the U.S. Food and Drug Administration announced new guidance adding temporary flexibility to food labeling requirements to help minimize the impact of COVID-19 disruptions to the supply chain.
We understand the necessity for the guidance and support it, but we are concerned that the guidance, as it is written, could confuse manufacturers and pose risks to consumers who are on a medically-prescribed gluten-free diet. The guidance temporarily allows manufacturers to make certain minor ingredient substitutions without relabeling their products. While it contains some safeguards to prevent gluten and common allergens from being used as unlabeled substitutes, the safeguards do not go far enough.
Group Letter Submitted to the FDA
Our foundation joined six other organizations in submitting a group letter to the FDA yesterday, requesting a minor modification to help address our concerns. The collaborative letter was organized by Tricia Thompson, MS, RD, of Gluten Free Watchdog and signed by our foundation, the National Celiac Association, the Gluten Intolerance Group, Beyond Celiac, the Society for the Study of Celiac Disease and Dietitians in Gluten and Gastrointestinal Disorders. Two attorneys working pro bono, Adam Rapp of Glynn & Finley in Walnut Creek, California, and Kaki Schmidt, based in Washington, D.C., assisted in drafting the letter.
Call to Action for the Community
Our foundation is also asking community members to consider submitting individual comments to the FDA to strengthen our national voice. You may wish to draw from the group letter, from the points below or from your own experience with gluten-free labeling and its importance to your health.
Please submit a comment to the FDA docket at https://www.regulations.gov/document?D=FDA-2020-D-1139-0009 If this link doesn’t work (on most days the link goes directly to the docket for commenting; on Tuesdays and Thursdays it goes to a beta site), use https://beta.regulations.gov/comment/FDA-2020-D-1139-0009).
The full name of the document is “Guidance for Industry Temporary Policy Regarding Certain Food Labeling Requirements During the COVID-19 Public Health Emergency Minor Formulation Changes and Vending Machines.
Why We’re Concerned
Gluten-Free Watchdog detailed the policy’s implications for people with celiac disease or other gluten-related disorders. An article in Allergic Living provides an in-depth look at an “outpouring of concern” by the food allergy community about the FDA’s new guidance and describes actions that have been taken by advocacy groups.
We’re also concerned because the new guidance is part of a larger pattern of rolling back food regulations during the COVID-19 pandemic. The Washington Post described the new guidance as the fifth rollback of food rules during the pandemic. While manufacturers do need flexibility under difficult new food supply conditions, advocates are concerned that the rollbacks will become permanent and set back years of successful advocacy.
Consumers who are wondering if their trusted brands will be making minor unlabeled ingredient substitutions can check SnackSafely’s ongoing list of companies that have pledged not to substitute ingredients without updated labeling.
Points That Can Be Used in Comments to the FDA
We understand the need for the temporary guidance and support it.
We appreciate the existing safeguards in the guidance and are only requesting minor modifications.
As it is written, the temporary guidance may cause confusion to manufacturers and put consumers at risk.
The minor modifications suggested by celiac disease and food allergy organizations will help address dangerous ambiguities and reduce risk to the health of millions of Americans.
We are also asking the FDA to modify the temporary guidance to require manufacturers to disclose all substitutions on their websites in order to create transparency for consumers.
The temporary guidance should not become permanent policy.
