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Celiac Journey’s Citizen Petition Informed by 2021 FAO-WHO Expert Consultation on Risk Assessment of Food Allergens and 1,576 Public Comments Submitted to the FDA in Evaluating the Public Health Importance of Requiring the Labeling of Gluten On All Packaged Foods

Celiac.com Sponsor (A13):
Jax Bari, age 10, has filed a Citizen Petition with the FDA to label Gluten as a Major Food Allergen.

Celiac Journey’s Citizen Petition is requesting a long-overdue reckoning by the FDA to better protect more than 3.3 million Americans with Celiac Disease by labeling Gluten (Wheat, Barley, Rye and Oats) as a Major Food Allergen on all packaged foods in the U.S., just like labeling Gluten is done in more than 85 other countries.

This Citizen Petition is a response to the "White House Challenge to End Hunger and Build Healthy Communities."(1) Labeling Gluten will reduce the treatment burden, food insecurity and diet-related disease for those with Celiac Disease, a potentially life-threatening and life-debilitating food allergy and auto-immune disease, from adverse health effects that can arise following Gluten ingestion.(2)

Today, Wheat is required to be labeled in the U.S., but Gluten is not. Gluten is found in Wheat, Barley, Rye and most Oats. The Citizen Petition is actionable now under the FDA’s existing authority in the Food Allergen Labeling and Consumer Protection Act (21 U.S.C. § 343(x)). Celiac Journey is requesting that the FDA issue a rule to require that all ingredients with Gluten be declared on food labels.

Labeling Gluten comports with the "White House Conference Pillar #2, Integrate nutrition and health: Prioritize the role of nutrition and food security in overall health, including disease prevention and management, and ensure that our health care system addresses the nutrition needs of all people."(3)

Labeling Gluten is in alignment with the conclusions of international food safety authorities and expert committees comprised of scientists, regulators, physicians, clinicians, individuals and risk managers from academia, government and the food industry including the 2021 Food and Agriculture Organization of the United Nations/World Health Organization Expert Consultation on Risk Assessment of Food Allergens, which included the FDA’s Dr. Lauren Jackson and the FDA’s Dr. Stefano Luccioli.

According to the 2021 FAO-WHO Expert Consultation

"Based on systematic and thorough assessments which used all three criteria (prevalence, severity and potency), the Committee recommended that" Gluten should be labeled as a priority/major food allergen on packaged foods.(4)

The Citizen Petition was informed by many of the 1,576 public comments submitted to the FDA during Summer 2022 on evaluating the public health importance of protecting Celiac consumers with labeling Gluten as a Major Food Allergen (Docket: FDA-2021-N-0553).(5)

In October 2022, Jax Bari met President Biden, asked the President to help protect him by labeling Gluten and shared his lived experience, "Eating without fear is our hope. Food insecurity happens every day for Celiacs because of the constant threat of cross contact with Gluten, 80% of foods have Gluten in them, the high price of Gluten Free food, the limited availability of Gluten Free food, and moreover Gluten is not required to be labeled on packaged foods in the U.S.."(6)

"It should not be this hard to know what is safe to eat, but for those with Celiac Disease and their caretakers, it’s a daily struggle," said the Honorable Dr. David J. Shulkin, Ninth Secretary of the U.S. Department of Veterans Affairs. "While many healthcare issues can be complex and costly, labeling gluten is not. Gluten is required to be labeled in 85 other countries worldwide. As such, many consumer-packaged food manufacturers already label Gluten on their products sold in those other countries, and doing so in the U.S. would be consistent with their existing operations."

"As a father of a son with Celiac Disease, I recognize the importance of consistent labeling on packaged food items and the positive impact that this will have on our community," said Chris Rich, CEO & Executive Director of the National Celiac Association. "With more than 85 countries considering Gluten a Major Food Allergen, I feel that the timing is right for this same designation to be considered in the U.S. for the protection and well-being of consumers affected by Celiac and Gluten sensitivities."

"In the spirit of food is medicine, the FDA should prioritize a public health problem long- overdue for robust action: requiring the labeling of Gluten," said Jon Bari, Founder, Celiac Journey. "It’s time for the FDA to address this critical consumer protection food safety issue with the urgency it requires."

"Food labels are confusing and incomplete, often resulting in food insecurity and accidental glutenings," said Leslie Bari from @GlutenFreeFinds_pa. Research has revealed that up to 50% of individuals following a Gluten Free diet are inadvertently exposed to gluten.(7)

Celiac Journey respectfully requests that the evaluation of this Citizen Petition be conducted now through the lens of President Biden’s Executive Orders 13985 and 14091 on "Further Advancing Racial Equity and Support for Underserved Communities Through the Federal Government." The Citizen Petition includes a detailed analysis showing how the Celiac community represents an underserved community which shares a particular characteristic including a chronic disability with a potentially life-threatening and life-debilitating food allergy to eating Gluten.

To read the Citizen Petition: https://www.celiacjourney.com/post/10-year-old-files-citizen-petition-with-the-fda-to-label-gluten-as-a-major-food-allergen-in-the-u-s

1. https://www.whitehouse.gov/briefing-room/statements-releases/2023/03/24/fact-sheet-biden-harris-administration-launches-the-white-house-challenge-to-end-hunger-and-build-healthy-communities-announces-new-public-private-sector-actions-to-continue-momentum-from-hist/
2. https://grants.nih.gov/grants/guide/notice-files/NOT-AI-22-004.html
3. https://www.whitehouse.gov/wp-content/uploads/2022/09/White-House-National-Strategy-on-Hunger-Nutrition-and-Health-FINAL.pdf
4. http://www.fao.org/3/cb4653en/cb4653en.pdf
5. https://www.regulations.gov/docket/FDA-2021-N-0553/comments?filter=celiac
6. https://www.celiacjourney.com/post/jax-bari-talked-food-policy-with-president-biden-and-asked-for-help-please-label-gluten
7. https://grants.nih.gov/grants/guide/notice-files/NOT-AI-22-004.html

Source: finance.yahoo.com