Call to Action: Submit Comments to FDA to Support Citizen Petition to Label Gluten as Major Allergen

Jon, Lexi, Jax and Leslie Bari

Make Your Voice Heard - Submit Your Comments to the FDA to Support Jax's Citizen Petition to Require the Labeling of Gluten on All Food Products

ICYMI: In honor of the first anniversary of the White House Conference on Hunger, Nutrition, and Health, 10-year-old Jax Bari submitted a Citizen Petition to the FDA to require the labeling of Gluten on all food packages in the U.S., just like Gluten is required to be declared on food labels in 87 other countries worldwide. You can click on the FDA-2023-P-3942 Docket to submit your comments to the FDA Web site.

This Citizen Petition is a response to President Biden's nationwide call-to-action with the "White House Challenge to End Hunger and Build Healthy Communities." Labeling Gluten will reduce the treatment burden, food insecurity and diet-related disease for millions of Americans with Celiac Disease, a potentially life-threatening and life-debilitating food allergy, auto-immune disease and digestive disease from adverse health effects that can arise following Gluten ingestion. Below you will find "Key Talking Points" and "Instructions to File Your Public Comments on the Citizen Petition to Label Gluten as a Major Food Allergen."

Share Your Lived Experience

Our family's story represents just one story from the millions of Americans who live with and/or care for someone with Celiac Disease and who must eat a strict Gluten Free diet. The FDA needs to hear from you! Read over the Key Talking Points and feel free to use these, but also share YOUR LIVED EXPERIENCE and tell the FDA why we need Gluten declared on the label of all food products in the United States. If you would like to read any of the Comments submitted, please click here.

We're Fed Up!

• Fed up with the voluntary labeling of Gluten & the Gluten guessing game in the absence of mandatory labeling

• Fed up with Gluten making Celiacs sick and damaging their small intestines

• Fed up with the FDA making decisions about us, without us

• Fed up with the FDA gaslighting Gluten as a second class allergen and Celiac as not a food allergy

• Fed up with the FDA's equivocation on the consumer protection needs of Celiacs

• Fed up with waiting for 2+ decades to have equal consumer protections with the required labeling of Gluten to the required labeling of the top 9 Major Food Allergens (Milk, Eggs, Fish, Crustacean Shellfish, Tree Nuts, Peanuts, Wheat, Soybeans, and Sesame)

• Fed up with food insecurity

• Fed up with the anxiety and worry from eating, every bite, every day

Requested Action

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. This Citizen Petition is requesting a long-overdue reckoning by the FDA to better protect more than 3.3 million Americans with Celiac by labeling Gluten (Wheat, Barley, Rye and Oats) as a Major Food Allergen on all packaged foods, just like labeling Gluten is required in more than 87 other countries. Under its existing authority in the Food Allergen Labeling and Consumer Protection Act in statute at 21 U.S.C. § 343(x), we have requested that the FDA issue a rule to: 1) require that all ingredients with Gluten be listed by name in the ingredient lists of all foods and; 2) add Gluten to the FDA's list of allergens in Sec. 555.250 of its Compliance Policy Guides Manual, "Statement of Policy for Labeling and Preventing Cross-contact of Common Food Allergens" to address both labeling and cross contact issues related to food manufacturing practices.

Key Talking Points

• Celiac Disease is a potentially life-threatening and life-debilitating food allergy, auto-immune disease and digestive disease that impacts at least 3.3 million Americans, greater than 1.0% of the general population.

• Gluten is found in Wheat, Barley, Rye and most Oats.

• In addition to vomiting and diarrhea, Gluten ingestion for people with Celiac can cause anemia, cancer, heart disease, immunological scarring, intestinal damage, malnutrition, etc.

• The only available treatment is strict adherence to a lifelong, Gluten Free diet. There is no pharmacological treatment available. Gluten Free food is our only medicine.

• 44% of people with Celiac Disease who follow a strict Gluten Free diet still get glutened once a month.

• There is no rescue medication (i.e., epinephrine or antihistamine) in the event of accidental ingestion and one cannot outgrow Celiac.

• Many with Celiac Disease pay over 40% more in annual healthcare costs.

• 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."

• Researchers are finding that Celiac Disease prevalence is doubling approximately every 15 years, making it a public health epidemic.

• The FDA has the existing authority and past-due responsibility to protect the Celiac community. See Citizen Petition, Statement on Legal Grounds, page 28.

Labeling Gluten (Wheat, Barley, Rye and Oats) as a Major Food Allergen on all packaged foods in the U.S., like Gluten is labeled in 87 other countries around the world, will better protect 3.3 million American Celiacs.

Labeling Gluten is in alignment with the conclusions of international food safety authorities and expert committees comprised of scientists, regulators, physicians, clinicians, and risk managers from academia, government and the food industry, as well as consumers, including:

• 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, Chair, and the FDA's Dr. Stefano Luccioli ("2021 FAO/WHO Expert Consultation"). The 2021 FAO/WHO Expert Consultation found, "Based on systematic and thorough assessments which used all three criteria (prevalence, severity and potency), the Committee recommended that the following should be listed as priority allergens: Cereals containing gluten (i.e., wheat and other Triticum species, rye and other Secale species, barley and other Hordeum species and their hybridized strains), crustacea, eggs, fish, milk, peanuts, sesame, specific tree nuts (almond, cashew, hazelnut, pecan, pistachio and walnut)." (emphasis added)

• 1,576 Comments submitted to the FDA on Labeling Gluten in Summer 2022 including from: Dr. Virginia Stallings, a board-certified nutrition pediatrician, Professor of Pediatrics and Director of the Nutrition Center at the Children's Hospital of Philadelphia and former Editor and Chair of the National Academies of Sciences, Engineering, and Medicine, Committee on Food Allergies; Beyond Celiac; National Celiac Association; Gluten Free Watchdog; Celiac Community Foundation of Northern California; University of Chicago Center for Celiac Disease; etc. (Docket: FDA-2021-N-0553).

FDA's Biases Against Celiac Need to Be Called Out

The FDA has perpetuated flawed scientific, governmental, and societal biases including:

1. A Gluten Free diet is all that is needed to treat Celiac Disease, as opposed to all that has ever been historically available to treat Celiac Disease.

2. With respect to labeling food products in the United States, the voluntary Gluten Free labeling scheme sufficiently protects consumers who are on medically required and very restrictive Gluten Free diets, as opposed to all that has ever been historically utilized labeling-wise in the U.S.

3. Othering the consumer protection needs for Celiacs in the United States by not evaluating the public health importance of Gluten as a food allergen because the Non-IgE-Mediated food allergy with Celiac is not capable of triggering anaphylaxis and being immediately life-threatening, while seemingly ignoring that Celiacs face potentially life-threatening and severe adverse health effects that can arise through Gluten ingestion, including by way of example and not limitation: anemia, cancer, heart disease, immunological scarring, intestinal damage, malnutrition, etc.

Just like the 2021 FAO-WHO Expert Consultation including Dr. Lauren Jackson, Dr. Stefano Luccioli, Dr. Joseph Baumert, and Dr. Stephen Taylor did not adversely distinguish between IgE-Mediated and Non-IgE-Mediated food allergies in their systematic and thorough assessments which used all three criteria (prevalence, severity and potency) to determine the Risk Assessment of Food Allergens, the FDA must stop discriminating between IgE-Mediated and Non-IgE-Mediated food allergies with Celiac when it comes to equitably evaluating the labeling of Gluten as a Major Food Allergen to protect 3.3 million American Celiacs.

Instructions to File Your Public Comments on the Citizen Petition to Label Gluten as a Major Food Allergen

** Read this First ** -- You can either type your comments directly into a comment box (which is limited to 5,000 characters) or upload a letter in PDF format (or Word). Please have your Comment prepared before beginning the steps below. You can use the Key Talking Points above to draft your letter, or click here for a sample document with the Talking Points.

1. Click this link to the FDA Docket for FDA-2023-P-3942 If the page does not load, copy and paste this into your browser, https://www.regulations.gov/document/FDA-2023-P-3942-0001

2. Click the Blue "Comment" Box on the top of the screen on the Docket page for the Citizen Petition, and a new page will load that says "Write a Comment" at the top.

3. Write a brief Comment cover note and reference your attached letter.

4. Select a Comment Category. Many commenters will select either "Individual Consumer," "Health Professional" or "Academia." Please note that there are many different options to choose from in the list provided.

5. Upload your letter in PDF format (or Word) under where it says "Attach Files."

6. Add your Email Address

7. Click "An Individual" or "An Organization" box under the "Tell us about yourself, I am..." section.

8. Fill out your your Name and Contact Information, or Fill our your Organization Type and Organization Name

9. Check the "reCAPTCHA" box next to "I'm not a robot"

10. Click "Submit Comment" button. After submitting your information, you will receive a Tracking Number for your comment on the FDA Citizen Petition to label Gluten.

Major Comments Submitted to the FDA (partial list)

• Matt Bzdel, Chief Executive Eater, @glutenfreestreetgang, January 16, 2024, Comment ID: FDA-2023-P-3942-0107; Tracking Number: lrf-bt4u-iiz3

• Vahe Badalyan, MD, MBA, MPH, Shayna Coburn, PhD, Lori Stern, CPNP, Abriana Cain, RD, MSN, Lauren Pavone, RD, MSN, Paige Trojanowski, PhD,  Jack Vagadori, BA, and Kate Raber, MA; Celiac Disease Program at Children's National Hospital, August 30, 2024, Comment ID: FDA-2023-P-3942-0913; Tracking Number: m0h-2ket-xufu

• Alice Bast, Beyond Celiac, April 2, 2024, Comment ID: FDA-2023-P-3942-0718; Tracking Number: lui-jltf-zdun

• Debra L. Bogen, MD, FAAP, Acting Secretary of Health, Pennsylvania Department of Health, on behalf of Pennsylvania Governor Josh Shapiro's Administration, April 2, 2024, Comment ID: FDA-2023-P-3942-0734, Tracking Number: lul-j5or-r992

• Eric Feldman, J.D., Ph.D., Heimbold Chair in International Law, Professor of Law; Professor of Medical Ethics & Health Policy; and Deputy Dean for International Programs, University of Pennsylvania Carey Law School, December 17, 2023, Comment ID: FDA-2023-P-3942-0083; Tracking Number: lq9-y1ag-k9mv

• Thomas Gremillion, Director of Food Policy, Consumer Federation of America, May 8, 2024, Comment ID: FDA-2023-P-3942-0806; Tracking Number: lvy-72d9-slnr

• Kirsi Jarvinen-Seppo, MD, PhD, Chief, Founders' Distinguished Professorship in Pediatric Allergy and Immunology, Professor of Pediatrics, Medicine, Microbiology and Immunology, Director, Center for Food Allergy, Golisano Children's Hospital, University of Rochester Medical Center, September 12, 2024, Comment ID: FDA-2023-P-3942-0920; Tracking Number: m12-78cw-925j

• Ciaran P. Kelly, MD, Professor of Medicine, Harvard Medical School, J. Thomas LaMont Professor of Gastroenterology, Associate Director, Gastroenterology Training Fellowship and Director, Celiac Center, Beth Israel Deaconess Medical Center, Boston, Massachusetts, October 4, 2023, Comment ID: FDA-2023-P-3942-0011; Tracking Number: lne-nfk7-siki

• Francisco Leon, MD, PhD, Immunologist, Entrepreneur, Chief Scientific Officer Provention Bio, a Sanofi Company, November 20, 2023, Comment ID: FDA-2023-P-3942-0069; Tracking Number: lp4-skl1-rx3w

• Sung Poblete, PhD, RN, CEO, FARE (Food Allergy Research and Education), February 27, 2024, Comment ID: FDA-2023-P-3942-0615; Tracking Number: lt5-7a12-hqf5

• Blair Raber, Founder of the Celiac Disease Program at Children’s National Hospital, Comment ID: FDA-2023-P-3942-0082; Tracking Number: lq0-a1jb-ejfzDecember 11, 2023

• Red Sneakers for Oakley, January 23, 2024, Comment ID: FDA-2023-P-3942-0126; Tracking Number: lrq-v2vu-ip7k

• Christopher Rich, CEO / Executive Director, National Celiac Association, November 2, 2023, Comment ID: FDA-2023-P-3942-0050; Tracking Number: loh-o29z-1i6d

• Brian Ronholm, Director, Food Policy Consumer Reports and Michael Hansen, PhD, Senior Scientist, Consumer Reports, January 5, 2024, Comment ID: FDA-2023-P-3942-0098; Tracking Number: lr0-v6ex-ha38

• Thomas Silvera, MSHS-PH, Co-Founder/Vice President, Elijah-Alavi Foundation, January 16, 2024, Comment ID: FDA-2023-P-3942-0108; Tracking Number: lrg-i4h9-c5dp

• Arunjot Singh, MD, Assistant Professor of Clinical Pediatrics, Co-Director, Children's Hospital of Philadelphia's Center for Celiac Disease, Division of Gastroenterology, Hepatology & Nutrition, Perelman School of Medicine, University of Pennsylvania, October 29, 2023, Comment ID: FDA-2023-P-3942-0028; Tracking Number: loc-acte-6f7c

• Jonathan Spergel, MD, PhD, Professor of Pediatrics, Chief, Allergy Section, Stuart E. Starr Chair of Pediatrics, Director of Center for Pediatric Eosinophilic Disease, Director, FARE Center of Excellence at The Children's Hospital of Philadelphia, November 14, 2023, Comment ID: FDA-2023-P-3942-0064; Tracking Number: loy-s86u-qo7p

• Virginia Stallings, MD, Board Certified Nutrition Pediatrician, Jean A. Cortner Endowed Chair in the Division of Gastroenterology, Hepatology and Nutrition at Children's Hospital of Philadelphia ("CHOP") and Director of CHOP's Nutrition Center; Emeritus Professor CE of Pediatrics (Gastroenterology, Hepatology and Nutrition), Perelman School of Medicine, University of Pennsylvania; and Report Editor and Chair of the National Academies of Sciences, Engineering, and Medicine, Committee on Food Allergies: "Finding a Path to Safety in Food Allergy: Assessment of the Global Burden, Causes, Prevention, Management and Public Policy." November 29, 2023, Comment ID: FDA-2023-P-3942-0078; Tracking Number: lpl-adrl-zbxc

• Seth Togal, Jennifer Togal and Adina Togal, the family who inspired The ADINA Act to require the labeling of Gluten in medicine, January 24, 2024, Comment ID: FDA-2023-P-3942-0128; Tracking Number: lrs-dz94-bo0i

Thank You!

QR Code, FDA Citizen Petition: Require the labeling of Gluten on packaged foods in the US, just like Gluten must be declared on all food labels in 87 other countries, FDA-2023-P-3942

Update

On March 5, 2024, the FDA's Claudine J. Kavanaugh, Director, Office of Nutrition and Food Labeling, Center for Food Safety and Applied Nutrition, sent a "180 day letter" which stated,

"We are advising you, in accordance with Title 21 Code of Federal Regulations, section 10.30(e)(2), that we have not been able to reach a decision on your petition within the first 180 days of its receipt, nor as of the date of this letter, because of other agency priorities and the limited availability of resources." (emphasis added)

This is why we need action from the White House and Congressional oversight!