By • Jennifer Iscol •

Comment now on the Citizen Petition to the FDA

“[W]ithout prompt and effective enforcement of the gluten-free labeling rule for the small but intractable fraction of companies that do not comply with it, the rule is considerably weakened and its purpose thwarted. A relatively small investment in enforcement would have a significant positive impact for those suffering from celiac disease and other gluten-related disorders.”

Excerpt from our foundation’s comment to the FDA (full comment at end of post)

Products labeled gluten-free must contain less than 20 parts per million (ppm) gluten, but the Food and Drug Administration does not require that they be tested. So celiac disease advocate Tricia Thompson, MS, RD, founded Gluten Free Watchdog, a consumer service that tests products for gluten content at an accredited third-party lab and provides the reports to subscribers.

Ms. Thompson found that most products are in compliance with the FDA’s gluten-free labeling rule, but that a persistent fraction of companies are intentionally or unintentionally flouting it. After years of reporting violations to the FDA, and frustrated by the agency’s inadequate response to the problem, Ms. Thompson submitted a Citizen Petition requesting that the agency develop a protocol for investigation and enforcement of the rule.

As required by law, the FDA published the Citizen Petition on its docket and opened it to comments. Comments are due by February 19, 2018. At the time of this writing, it has 1,252 comments. Virtually all of them appear to be in support of the petition, including comments from the Center for Science in the Public Interest, the National Celiac Association and Beyond Celiac.

The full comment submitted to the FDA on January 28, 2018, by our foundation is below:

The Celiac Community Foundation of Northern California, an all-volunteer nonprofit organization, offers its unqualified support to the Citizen Petition from Tricia Thompson, MS, RD.

The FDA’s gluten-free labeling rule provides immense benefit to consumers with celiac disease and other gluten-related disorders. Food manufacturers also benefit from the level playing field created by a uniform definition. In fact, the rule benefits every sector of society that relies on accurate food labeling to safely offer gluten-free meals, including restaurants, hospitals, nursing homes, event venues, transportation networks, schools and universities.

In light of the ongoing absence of full enforcement of the gluten-free labeling rule, Ms. Thompson has capably and methodically addressed compliance issues with individual companies and alerted the public to health and safety hazards, experience that informs her petition. Going forward, the burden of enforcing this regulation should be shouldered by the federal agency that promulgated it, not by concerned private citizens and other stakeholders.

With both the prevalence of celiac disease and its diagnostic rate rising in the population over time, according to peer-reviewed published studies, the need for enforcement of the gluten-free labeling rule increases commensurately to protect public health.

To a large extent, enforcement of the gluten-free labeling rule relies on an honor system, which is largely adequate for the mostly compliant industry of gluten-free food manufacturing. This approach also frees up FDA enforcement resources. However, without prompt and effective enforcement of the gluten-free labeling rule for the small but intractable fraction of companies that do not comply with it, the rule is considerably weakened and its purpose thwarted. A relatively small investment in enforcement would have a significant positive impact for those suffering from celiac disease and other gluten-related disorders.

We respectfully request that the FDA strongly consider the Citizen Petition and establish a specific protocol for increased surveillance, investigation and enforcement of potential violations of the gluten-free labeling rule.

We encourage all interested community members to submit a comment on the Citizen Petition by February 19, 2018.