Call to Action: Submit Comments to FDA to Support Citizen Petition to Label Gluten as Major Allergen
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.
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
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:
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.
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.
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.
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
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.
Write a brief Comment cover note and reference your attached letter.
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.
Upload your letter in PDF format (or Word) under where it says "Attach Files."
Add your Email Address
Click "An Individual" or "An Organization" box under the "Tell us about yourself, I am..." section.
Fill out your your Name and Contact Information, or Fill our your Organization Type and Organization Name
Check the "reCAPTCHA" box next to "I'm not a robot"
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)
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
Christopher Rich, CEO / Executive Director, National Celiac Association, November 2, 2023, Comment ID: FDA-2023-P-3942-0050; Tracking Number: loh-o29z-1i6d
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