As the leading celiac disease organization focused on accelerating discovery, development and access to new treatments and a cure, Beyond Celiac focuses our advocacy efforts on maximizing investment of public funds in research and public policy supporting these desired outcomes.
We also recognize that not everyone has access to the care and treatments they need. To indicate our dedication to ensuring this is resolved, we have signed on to the National Health Council’s Health Equity Consensus Statement: in short, we, as an organization representing and advocating for health care for all people regardless of race/ethnicity, gender identity, sexual orientation, disability status, or country of origin, etc., must commit to take action within our organizations and the communities we serve to reduce health inequities.
Our community has the power to drive change by encouraging our legislators to support initiatives that make it easier for people with celiac disease to safely consume gluten-free foods, beverages, medications and supplements AND to drive funding for celiac disease research.
Alcoholic beverages need better nutrition, ingredient, allergen, and alcohol content labeling! We joined 34 organizations and academics to call for more robust labels.
UPDATE: This bill was reintroduced into the Senate in spring of 2023. The new bill numbers are H.R.2901/S.1289. There have been slight changes to sections of the bill unrelated to gluten. The gluten-free labeling provision remains the same, and we continue to support it.
PRIOR STATEMENT: In August 2021, Representatives Frank Pallone, Jr. (D-NJ) and Rosa DeLauro (D-CT), along with Senators Richard Blumenthal (D-CT), Sheldon Whitehouse (D-RI) and Ed Markey (D-MA) reintroduced the Food Labeling Modernization Act of 2021 (FLMA) to the House and the Senate. This bill is extremely significant for those living with celiac disease and non-celiac gluten sensitivity as it requires all manufacturers to disclose any gluten-containing grains on their labels.
Beyond Celiac supports the Food Labeling Modernization Act (H.R 4917/S. 2594) and encourages everyone in our community to contact their representatives and senators to urge them to support it as well.
Those wishing to get involved can copy and paste the following sample letter and share with your representatives. Adding personal stories and experiences is also encouraged:
We need your support for a new bill that requires that products disclose gluten-containing grains on labels.
Congressman Pallone and Senator Blumenthal have reintroduced an important Bill into the House and the Senate: The Food Labeling Modernization Act of 2021 (FLMA). The FLMA is a comprehensive effort to address numerous food labeling issues and includes amending FALPCA (Food Allergen Labeling and Consumer Protection Act) to require that food product packaging must disclose gluten-containing grains.
This Bill amends FALPCA. If an FDA-regulated food product includes a gluten-containing grain, this must be disclosed in the ingredients list or separate Contains statement – just like for wheat and the other major allergens. This would be required regardless of whether the food was labeled gluten-free.
Thank you for your support of H.R 4917/S. 2594.
The FDA has created and developed patient-focused drug development (PFDD) over recent years. Now, FDA will accept patient experience or preference data as a part of a new drug application. However, there is little clarity regarding how that data is used. The The Better Empowerment Now to Enhance Framework and Improve Treatments (BENEFIT) Act, H.R. 1092, would require that the FDA indicate whether it used the submitted data in the review process and if it had any impact. Providing this information to the public, and patient communities making significant investments in developing PFDD, creates transparency and will accelerate PFDD strategies more broadly.
On August 24, 2021, the Congressional Celiac Disease Caucus was launched with the goal of advancing legislation that will support the needs of the celiac disease community and address the need for increased federal funding for celiac disease research. Importantly, it will work to raise awareness of celiac disease across congressional districts.
A congressional caucus is composed of a group of members of the United States Congress that meets to pursue common legislative objectives. Introduced by Congresswoman Betty McCollum (DFL-Minn.), this bi-partisan Congressional Celiac Disease Caucus will provide the impetus to address the needs of the celiac disease community directly.
Along with Congresswoman McCollum, the inaugural members of this caucus are Representatives Jake Auchincloss (D-MA), Earl Blumenauer (D-OR), Matt Cartwright (D-PA), Madeleine Dean (D-PA), Brian Fitzpatrick (R-PA), Josh Gottheimer (D-NJ), Chrissy Houlahan (D-PA), John Joyce (R-PA), Tim Ryan (D-OH), Mary Gay Scanlon (D-PA), Glenn Thompson (R-PA), David Trone (D-MD), and Susan Wild (D-PA).
Our immediate goal is to increase the strength of this caucus by encouraging representatives to join the Congressional Celiac Disease Caucus. Please contact your Congresspeople asking them to join the Congressional Celiac Disease Caucus in order to make progress in addressing the needs of the 3 million Americans with celiac disease.
Call or write to your Congresspeople and request that they join the Congressional Celiac Disease Caucus today!
Download a sample letter to send to your Representatives asking them to join the Congressional Celiac Disease Caucus in order to make progress in addressing the needs of the 3 million Americans with celiac disease.
Contact your representatives and encourage them to support these legislative initiatives.
Oct 2023
10-year-old Jax Bari submitted a Citizen Petition to the FDA to require the labeling of Gluten on all food packages in the US to eliminate the gluten guessing game.
Labeling gluten, found in wheat, barley, and rye, as a major food allergen on all packaged foods in the US, like it is in more than 85 other countries around the world, will better protect 3.3 million Americans with celiac disease.
Labeling gluten will reduce the treatment burden, food insecurity and diet-related disease for millions of Americans with celiac disease.
We encouraged folks to share their lived experience with the FDA! They could visit www.celiacjourney.com/comments to find a sample letter, talking points and step-by-step instructions of what to do to submit comments to the FDA.
June 2023
On June 21, 2023, the Allergen Disclosure In Non-food Articles Act (ADINA Act) was introduced to the United States House of Representatives. This bill would require drugs that contain any of the top 9 allergens or gluten to be labeled as such.
In the words of Nancy Ginter, our director of administration, “Ingredient transparency enables individuals to make informed choices when selecting medications. This information empowers them to manage their condition effectively and avoid unnecessary risks.”
We firmly endorse this guidance and encouraged folks to contact your representatives on this bill, H.R. 4263 / S. 2079.
Get a sample letter or script from Gluten-Free Watchdog
Read the full text of the bill
Learn more about our work on gluten in medications
May 2023
The bipartisan NIH Clinical Trial Diversity Act was developed with input from a variety of stakeholder groups including NIH, HHS, AdvaMed, PhRMA, BIO, ASCAN, and FasterCures. The bill is endorsed by No Health Without Mental Health, National Organization for Rare Diseases, Leukemia and Lymphoma Society, Faster Cures/Milken Institute, the Association of Black Cardiologists, the American Psychological Association, as well as Beyond Celiac. The bill is headed up by Congresswoman Robin Kelly.
April 2023
Step therapy is a tool used by health plans to control spending on patient’s medications. While step therapy can be an important tool to contain the costs of prescription drugs, in some circumstances, it has negative impacts on patients, including delayed access to the most effective treatment, severe side effects, and irreversible disease progression. Currently, when a physician prescribes a particular drug treatment for a patient, the patient’s insurance company may require them to try different medications and treatments before they can access the drug originally prescribed by their physician. This protocol is known as “step therapy” or “fail first.” Step therapy protocols may ignore a patient’s unique circumstances and medical history. That means patients may have to use medications that previously failed to address their medical issue, or – due to their unique medical conditions – could have dangerous side effects.
September 2022
Alongside more than 115 organizations, we signed onto Research!America’s organizational letter urging timely action on FY23 appropriations to meet the very real research funding needs before us. Our nation’s progress against health threats like celiac disease relies on the longstanding bipartisan commitment to medical research, and this year is no different. Read the letter.
Aug 2022
On Apr 19, 2022, the The Food and Drug Administration (FDA) announced the draft guidance “Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act.” The guidance proposes that the FDA should only consider adding a food to the top 9 allergens when it elicits certain IgE-mediated immunologic reactions (among other criteria). This would prevent any petitions to add barley or rye to the top 9 list from moving forward.
2021
The RISE Act would authorize approximately $25 billion in emergency relief for federal research agencies. This crucial funding will help prevent life-saving medical, public health, and scientific progress from becoming another of COVID-19’s victims.
Download a sample letter to send to your congressperson.
On December 11, 2019, Senator Richard Blumenthal [D-CT] introduced S.3021, to the Senate floor. This bill is meant to amend the Federal Food, Drug, and Cosmetic Act to require the label of a drug that is intended for human use and contains an ingredient that is derived directly or indirectly from a gluten-containing grain to identify each such ingredient, and for other purposes. It will also be known as the Gluten in Medicine Disclosure Act of 2019.
On April 3, 2019, Representative Tim Ryan [D-OH] introduced H.R. 2074, the Gluten in Medicine Disclosure Act of 2019 to the to the House of Energy and Commerce Committee’s Subcommittee on Health. It uses the same language as the Senate version of the bill.
On April 8, 2021, Representatives Tim Ryan (D-OH) and Steve Stivers (R-OH) reintroduced the Gluten in Medications Disclosure Act to the House floor. This legislation would require drug manufacturers to label medications’ ingredients, their source, and whether gluten is present. (Learn how to help get this bill passed here.)
If passed, these bills would amend the Federal Food, Drug, and Cosmetic Act to require gluten be labeled in all medications.
Early in our history, Beyond Celiac stepped into the field of advocacy when we learned that there were not any celiac disease organizations actively involved in addressing the risk of potential gluten exposure through medications.
Beyond Celiac has expanded its advocacy initiatives and has focused on advocating for access to high quality healthcare, along with gluten-free food and drug safety standards by providing training and resources to the foodservice industry and regulatory agencies.
Our current advocacy focuses include getting the Gluten in Medications bills passed as well as maximizing investment of public funds in research and public policy supporting these desired outcomes.
Below are some of our advocacy highlights:
Addressing Challenges for U.S. Gluten-Free College Students
In 2012, Beyond Celiac continued its work in the college and university setting by surveying nearly 1,000 U.S. gluten-free college students to strengthen our ability to advocate for improved training for college foodservice operator. This survey revealed a continued and pervasive lack of awareness and accommodation for students with gluten-related disorders.
Involvement with the Digestive Disease National Coalition (DDNC)
Beyond Celiac is a member of the Digestive Disease National Coalition (DDNC), an advocacy organization focused on improving public policy related to digestive diseases and increasing public awareness of and government funding for digestive diseases.
Participation in the U.S. Food and Drug Administration (FDA) Patient Representative Program
In 2012, Alice Bast, Beyond Celiac President and CEO and Kristin Voorhees, MA, Beyond Celiac Director of Healthcare Initiatives were chosen to serve as FDA Patient Representatives for celiac disease as part of FDA’s program to ensure that patients have a voice in its regulatory decision-making.
Drug Information Association (DIA) Participation
Kristin Voorhees, MA, Beyond Celiac Director of Healthcare Initiatives was a 2013 Patient Advocate Fellow for the Drug Information Association (DIA).
Education of Pharmacists and the Labeling of Gluten in Medications
Beyond Celiac works with the FDA and private organizations and corporations to meet our shared goal: safe pharmaceutical care for those who must maintain a medically necessary gluten-free diet.
Gluten-Free Food Labeling
Beyond Celiac actively worked to secure regulations that define the requirements for food companies manufacturing packaged products that make a gluten-free label claim.
Working with Celiac Centers of Excellence: Providing Data to Advance a Better Understanding of Celiac Disease
Beyond Celiac collects information and data from patients and their families about their concerns, attitudes and health outcomes, partnering with experts to advance a better understanding of the disease and how to manage it.
Speaking Engagements and Industry Presentations
Beyond Celiac influences decision makers that impact all aspects of life to advance the interests of the celiac disease community.
Beyond Celiac in National Media
Beyond Celiac engages in press outreach and fields press inquiries from national media and industry reporters looking for expert input.
Expanding Access to Gluten-Free Food
Beyond Celiac signed on to a 2023 letter urging the expansion of access and accommodations for patients with celiac disease utilizing WIC. The final rule was published on April 18, 2024, and can be viewed on the government website.
Ongoing Advocacy for Safe Medications
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