#37 - 🏷️ FDA wants your input on gluten labels

Hey readers! 👋

What a week for the celiac community! The FDA just dropped some major news that has advocates buzzing, we're getting a clearer picture of the therapy pipeline, and there's fresh data revealing just how many kids are slipping through the diagnostic cracks. Grab your favorite gluten-free snack and let's dig in!

FDA Signals New Action on Gluten Labeling and Cross-Contact - The FDA has issued a Request for Information seeking data on gluten labeling and cross-contact in packaged foods, marking a significant step toward better transparency for our community. – Celiac Disease Foundation

This is genuinely exciting news. The RFI specifically targets rye, barley, and oats, and asks about the severity of reactions and cross-contact concerns. For years, people with celiac disease have been forced to "tiptoe around food" and guess about safety. While this is an early, non-binding step, it signals the FDA's intent to develop science-based, celiac-specific labeling policies.

The Celiac Disease Foundation's sustained advocacy work, including collaboration that helped shape international guidance from FAO/WHO and Codex, has been instrumental in getting us to this point.

FDA issues a request for information regarding labeling and preventing cross-contact of gluten in packaged food - Gluten Free Watchdog breaks down the four key areas the RFI covers: cross-contact of oats with gluten-containing grains, undisclosed gluten ingredients like malt extract from barley, consumer perspectives on labeling needs, and adverse reactions to non-wheat gluten grains. – Gluten Free Watchdog

Tricia Thompson and her team have been reporting on and filing complaints about these issues for two decades. The FDA reached out directly to Gluten Free Watchdog encouraging them to submit comments. If you have experiences to share about labeling confusion or adverse reactions, now is the time to make your voice heard.

FDA Moves to Tighten Food Label Rules to Warn About Gluten - Bloomberg covered the FDA's announcement, bringing mainstream attention to the labeling initiative. – Bloomberg

Future Therapies - The Celiac Disease Foundation has updated their comprehensive overview of investigational drugs and biologics currently in development for celiac disease. – Celiac Disease Foundation

While a strict gluten-free diet remains the only proven treatment today, the pipeline is more robust than ever. Candidates range from pre-clinical options like Allero's SOMIT mouth patch to phase-II molecules such as Immunic's IMU-856. The strategies being pursued are diverse: inducing immune tolerance, degrading gluten before it causes harm, and blocking key inflammatory cytokines.

The early clinical data on IMU-856 is particularly encouraging. The compound was observed to be safe and well-tolerated, demonstrating positive results across four key dimensions: histology, disease symptoms, biomarkers, and nutrient absorption. This multi-faceted approach to measuring success reflects how researchers are thinking more holistically about what effective treatment looks like.

Only 1 in 10 children with high risk for celiac disease are being tested - A study by Beyond Celiac and Weill Cornell Medicine found that only about 10% of children who meet high-risk criteria for celiac disease are actually screened, far below guideline recommendations. – Beyond Celiac

This finding is sobering. The analysis of nearly 224,000 private-payer claims also revealed stark racial disparities: non-Hispanic Black children were the least likely to be tested at under 7%, while non-Hispanic White children were most likely at approximately 12%. Neither number is acceptable.

These gaps in guideline adherence contribute to delayed diagnoses and poorer health outcomes. The authors call for either universal screening or targeted strategies to improve testing rates across all populations. For parents and practitioners alike, this is a reminder to advocate for testing when risk factors are present.

Celiac Disease in Children - The Celiac Disease Foundation provides a helpful overview of how celiac disease presents differently across age groups, from vomiting and poor growth in infants to abdominal pain in school-age children and extra-intestinal signs in teens. – Celiac Disease Foundation

The good news? Most children feel significantly better after two weeks on a gluten-free diet and attain normal height, weight, and bone health. Early testing is critical, especially for children with a family history or associated conditions like type 1 diabetes or thyroid disease.

Celiac and Gluten Resources and Treatment (GREAT) Clinic - Children's Hospital Los Angeles offers comprehensive, multidisciplinary care for pediatric celiac disease, wheat allergy, and non-celiac gluten sensitivity under Dr. Michelle Pietzak's leadership. – Children's Hospital Los Angeles

For families in Southern California seeking specialized pediatric care, the GREAT Clinic combines clinical evaluation, in-house testing, endoscopic procedures, and personalized diet counseling. They also offer support groups and guidance on navigating gluten-free food labeling, which can be invaluable for newly diagnosed families.

The gluten challenge should be illegal - A Reddit user expresses frustration over the requirement to consume gluten daily for eight weeks before an endoscopy, calling the diagnostic method "barbaric." – Kind_vibes

This post resonated with many in the community. While the gluten challenge remains medically necessary for accurate diagnosis in many cases, the experience highlights why researchers are working on less invasive diagnostic methods. If you've been through this process, you're not alone in finding it difficult.

That's all for this week! The FDA's RFI is a real opportunity to make our voices heard, so consider submitting your experiences before the comment period closes.

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