FDA proposal on gluten in drugs is inadequate

Celiac disease advocates have been asking the Food and Drug Administration to address the issue of gluten in drugs for over 10 years. As anyone with celiac disease or gluten sensitivity can attest, it is often difficult or impossible to tell if a medication contains gluten. Gluten in drugs is rare, but without appropriate labeling there is often no way to tell if it is present in a given product.

In December 2017, the FDA finally published a proposal; it encourages, but does not require, drug companies to label for gluten. We believe this approach is inadequate. It will only postpone the development of a meaningful solution. As the FDA itself states in its proposal, individuals with celiac disease “may be harmed through uncertainty and lack of information” about gluten in specific drug products.

The FDA proposal is officially titled “Gluten in Drug Products and Associated Labeling Recommendations.” Public comments are due by February 12, 2018 [Update: the docket is still open for comments months after the deadline]. The Celiac Community Foundation of Northern California submitted the following comment on the proposal to the FDA on January 28, 2018:

The Celiac Community Foundation of Northern California, an all-volunteer nonprofit organization, does not support the proposed “Gluten in Drug Products and Associated Labeling Recommendations Guidance for Industry.” Rather than resolving the difficulty faced by individuals with celiac disease when they try to determine whether specific drug products contain gluten, or even serving as a significant step in that direction, the proposed guidance would give the false impression that the FDA is taking a useful and meaningful action to address this ongoing public health issue.

Issuing industry guidance on the voluntary labeling of gluten in drugs leaves the burden primarily on consumers to research and analyze whether a drug is safe for those with celiac disease and other gluten-related disorders. Voluntary labeling does not resolve uncertainty when most drugs remain unlabeled for gluten. The approach is inadequate and unlikely to have a significant impact on the problem.

We encourage the FDA to draft a more meaningful approach. If gluten in drugs is as rare as the FDA asserts, there is no defensible reason not to require labeling or ban it altogether.

For more background on the topic, please see our article “Gluten in Medication: Pressing the FDA to act now.”

TAKE ACTION: We encourage all interested community members to comment on the FDA’s proposal: https://www.regulations.gov/docket?D=FDA-2017-D-6352