Congress is considering making big changes and cuts to the Medicaid program. These changes could make it harder for people to access insurance coverage and health care services.

Nearly half of all children with asthma in the U.S. are covered by Medicaid or the related Children’s Health Insurance Program (CHIP). Medicaid is also essential for many low-income adults, and adults with disabilities including asthma. For low-income adults and children with allergies to food or other allergens, Medicaid helps them get the care and treatments they need.

Because of Medicaid’s crucial role for people living with asthma and allergies, the Asthma and Allergy Foundation of America (AAFA) strongly supports the Medicaid program and opposes changes such as:

• Block grants
• Spending caps
• Work reporting requirements
  
  

These and other measures would reduce or limit care and coverage for millions of people. In addition to harming the health of individuals, it would also strain the entire health care ecosystem.

What Is Medicaid and Why Is It Important?

Medicaid is a federal-state insurance program that provides health insurance coverage and long-term services. It supports about 80 million people in the United States.¹ Medicaid covers nearly 4 in 10 children and 1 in 5 people overall, including:

• 7.2 million seniors, among them 756,000 nursing home residents²
• 36.8 million children³
• 14 million rural Americans⁴
• 9.9 million adults with disabilities⁵
  
  

The federal government sets minimum eligibility standards. But states may expand coverage beyond these minimum requirements. For example, in many states, low-income adults qualify for Medicaid coverage whether or not they have children.

Medicaid is a very effective program. It has helped reduce the number of uninsured people in the U.S. from 45 million to 29 million.⁶ Medicaid is also effective in improving access to care, in supporting financial stability among low-income families, and in improving health outcomes.⁷

Each state runs its own Medicaid program. They have broad guidelines set at the federal level. Most states have Medicaid managed care programs. They contract with health insurance companies to provide care for enrollees. CHIP covers additional low-income children.

What Benefits Does Medicaid cover?

Medicaid covers a broad range of services. All states must cover certain required services, including:

• Doctor visits
• Hospital services
• Rural health clinic and federally qualified health center visits
• Early and periodic screening, diagnostic, and treatment services for children
  
  

All states have also opted to cover prescription drugs. Other key Medicaid services covered in many states include physical therapy, occupational therapy, and speech, hearing, and language disorder services.

Why Is Medicaid Important for People with Asthma and Allergies?

Almost 28 million Americans – nearly 1 in 12 – have asthma. Medicaid is a very important source of care for our community.

• Nearly half (47%) of U.S. children with asthma are enrolled in Medicaid or CHIP.
• Adults enrolled in Medicaid are 2 times as likely to have asthma as adults with private insurance.⁸
  
  

People with food or other allergies who live at low-income levels face barriers to appropriate care and medicine.⁹ Medicaid is a vital bridge across these gaps.

Why Does the Congressional Budget Resolution Threaten Medicaid Coverage?

The House of Representatives passed a budget resolution directing the Energy & Commerce (E&C) Committee to cut at least $880 billion from programs it oversees, which includes Medicaid. This means lawmakers are proposing major funding cuts that could force states to cut Medicaid benefits, limit who qualifies, or reduce payments to health care providers.

These cuts could seriously impact people with asthma and allergies who rely on Medicaid to pay for doctor visits, medicines, and emergency care. If Congress moves forward with these changes, millions of people may become uninsured. This puts people’s health at risk as well as the stability of health care services. The cost of providing care to uninsured people will pass on to all patients. Hospitals and clinics in rural areas may close, making it harder for all people to access care.

How Can I Help Protect Medicaid?

If you or someone you know relies on Medicaid for asthma or allergy care, we want to hear your story. Please share your experiences with us! We are working to meet with members of Congress and want to make sure they understand how important Medicaid is for our community.

You can help make a difference by sharing your story and speaking up for Medicaid.

Contact AAFA's advocacy team to get involved and protect Medicaid. Kids with Food Allergies (KFA) is a division of AAFA.

CONTACT AAFA

Where Can I Learn More About Medicaid?

Learn more about Medicaid by visiting these websites:

• Centers for Medicare and Medicaid Services: https://www.cms.gov/ or http://medicaid.gov
• Kaiser Family Foundation: https://www.kff.org/
• Families USA: https://familiesusa.org/

References
1. Kaiser Family Foundation. (2025, January 31). Medicaid Enrollment and Unwinding Tracker. Retrieved March 19, 2025, from https://www.kff.org
2. Centers for Medicare & Medicaid Services. (n.d.). Seniors & Medicare and Medicaid Enrollees. Medicaid.gov. Retrieved March 19, 2025, from https://www.medicaid.gov/medicaid/eligibility/seniors-medicare-and-medicaid-enrollees/index.html
3. Kaiser Family Foundation. (2025, January 31). Medicaid Enrollment and Unwinding Tracker. Retrieved March 19, 2025, from https://www.kff.org
4. Medicaid and CHIP Payment and Access Commission (MACPAC). (2021, April). Medicaid and Rural Health. Retrieved March 19, 2025, from https://www.macpac.gov
5. Centers for Medicare & Medicaid Services. (2020). Medicaid Enrollees Who Qualify for Benefits Based on Disability. Retrieved March 19, 2025, from https://www.medicaid.gov/medic...sbility-data-brf.pdf
6. Center on Budget and Policy Priorities. (n.d.). Policy Basics: Introduction to Medicaid. Retrieved March 19, 2025, from https://www.cbpp.org/research/policy-basics-introduction-to-medicaid
7. Center on Budget and Policy Priorities. (n.d.). Policy Basics: Introduction to Medicaid. Retrieved March 19, 2025, from https://www.cbpp.org/research/policy-basics-introduction-to-medicaid
8. Centers for Disease Control and Prevention, National Center for Health Statistics. (2015). National Health Interview Survey, 2015. Analysis performed by the American Lung Association Epidemiology and Statistics Unit using SPSS software. Atlanta, GA: Centers for Disease Control and Prevention. Retrieved March 19, 2025, from https://www.cdc.gov
9. Tepler, E., et al. (2022). Health Disparities in Pediatric Food Allergy. Annals of Allergy, Asthma & Immunology, 129(4), 417–423. Retrieved March 19, 2025, from https://www.annallergy.org

Arsell Recalls Benadryl Liquid Elixir 100 mL Bottle Due to Risk of Child Poisoning; Violation of Federal Regulation for Child Resistant Packaging;

For Immediate Release

March 20, 2025

Contact Information

recall@arsellsupport.com.

Company Announcement

Description:
This recall involves Benadryl Liquid Elixir sold in a round dark plastic bottle with a pink and white label on the front with the word “Benadryl” in blue text. The product contains 100 mL of Benadryl. The back label contains safety disclosures, storage instructions and manufacturer information. The product was packaged in a paper box decorated with pink and white with the word “Benadryl” written in blue text. The package has a white label on the bottom with the following code written in black text: “X003VRIGUL.”

Hazard:
The Benadryl contains diphenhydramine which must be in child-resistant packaging as required by the Poison Prevention Packaging Act. The packaging of the products is not child-resistant, posing a risk of poisoning if the contents are swallowed by young children.

Remedy:
Consumers should immediately secure the Benadryl out of the sight and reach of children and contact Arsell for a full refund. Consumers will be asked to submit their Amazon order number and a photo demonstrating disposal of the recalled Benadryl to recall@arsellsupport.com. Only the bottle is being recalled, not the medicine itself, but both should be disposed of. All known purchasers are being contacted directly.

Incidents/Injuries:
None reported

Sold At:
Sold online at Amazon.com from July 2023 through October 2024 for between $16 and $19.
Importer(s):
Arsell Inc., of Brooklyn, New York

Manufactured In:
Canada

Recall number:
25-194

Note: Individual Commissioners may have statements related to this topic. Please visit www.cpsc.gov/commissioners to search for statements related to this or other topics.

One of the most common allergic conditions is seasonal allergic rhinitis, sometimes called “hay fever” or “nasal allergies.” About 1 in 5 children in the U.S. have seasonal allergic rhinitis.¹ Seasonal allergies are usually caused by allergies to tree, grass, and weed pollen. Because of something called the allergic march, many children with seasonal pollen allergies also have food allergies.

If you or your child have a pollen allergy, it is important to start your allergy treatment before your pollen season begins.

To help people understand how location affects seasonal allergies and how they can manage their symptoms, the Asthma and Allergy Foundation of America (AAFA) has released the 2025 Allergy Capitals report. Kids with Food Allergies is a division of AAFA.

AAFA’s report ranks the 100 most populous cities in the United States by how challenging they are to live in with pollen allergies. Wichita, Kansas, is the #1 Allergy Capital for 2025 for the 3rd year in a row due to its:

• Worse-than-average tree and grass pollen
• Worse-than-average allergy medicine use
• Fewer board-certified allergists/immunologists

Our report also highlights:

• The impact of climate change on seasonal allergies
• Changes in rankings in the Western United States
• Managing your pollen allergy
  
  

The 2025 Allergy Capitals report is an independent research project of the Asthma and Allergy Foundation of America and made possible by support from Opella, the makers of Allegra®.;

References
1. Zablotsky, B., Black, L.I., & Akinbami, L.J.(2023). NCHS Data Brief, no 459: Diagnosed allergic conditions in children aged 0-17 years: United States, 2021. National Center for Health Statistics. https://dx.doi.org/10.15620/ cdc:123250

Har Maspeth Corp Issues Allergy Alert on Undeclared Eggs in “Jinga Glass Noodles w/ Vegetables (Japche)”

For Immediate Release

March 14, 2025

Contact Information

HAR Maspeth Corp
718-706-9300

Company Announcement

HAR Maspeth Corp, Maspeth NY, is recalling its 8 ounce and 12 ounce packages of "JINGA GLASS NOODLES W/ VEGETABLES (Japche)" because they contain undeclared eggs. Consumers who are allergic to eggs may run the risk of serious or life-threatening allergic reactions if they consume this product.

The recalled "JINGA GLASS NOODLE W VEGETABLES (Japche)" were distributed to H Mart stores in multiple states. The product comes in 8-ounce and 12-ounce clear plastic packaging with Best By dates of March 13, 2025, through March 18, 2025, stamped on top. The product UPC codes are:

• 265405006495
• 267405004495
• 266405008496
• 268405005499

No illnesses or allergic reactions involving this product have been reported to date.

The recall was initiated after being notified by New York State Department of Agriculture and Markets Food Inspectors during a retail inspection and the presence of eggs in the 8 and 12 ounce packages of "JINGA GLASS NOODLES W/ VEGETABLES (Japche)" which did not declare an egg ingredient on the label.

Consumers who have purchased 8 and 12 ounce packages of "JINGA GLASS NODDLES W/ VEGETABLES (Japche)" are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 718-706-9300, Monday through Friday, 9:00 AM – 6:00 PM (Eastern Time).

C.H. Guenther & Son LLC Issues Allergy Alert on Undeclared Egg in “365 Whole Foods Market Small Bites Macaroni & Cheese”

For Immediate Release

March 14, 2025

Contact Information

CH Guenther & Son LLC
210-227-1401

Company Announcement

C.H. Guenther & Son LLC of San Antonio, TX, is recalling its 365 Whole Foods Market Small Bites Macaroni & Cheese because it may contain undeclared eggs and meat ingredients. People who have allergies to eggs run the risk of serious or life-threatening allergic reaction if they consume this product. The recalled Small Bites were sold at Whole Foods Market Stores in the frozen food aisle nationwide (8.5 oz cartons).

The impacted Product UPC Code and Lot Code are as follows:

365 Whole Foods Market Small Bites Macaroni & Cheese

UPC Code: 99482499709

Best-By Date (BB): 11/29/25

Purchase Dates: 2/6/2025 - 3/11/2025

No illnesses have been reported to date.

The recall was initiated after receiving a consumer complaint that the product contained meat and was not a macaroni and cheese bite. This issue has been corrected and no other manufacturing dates or lots are impacted.

Customers who have purchased “365 Whole Foods Market Small Bites Macaroni & Cheese” with the Lot information listed above are urged to destroy any remaining product and can bring a valid receipt into the store for a full refund. Consumers with additional questions regarding this recall may contact CH Guenther & Son LLC at 1-210-227-1401.

CH Guenther & Son LLC takes allergies and food safety seriously and has implemented preventative measures to prevent any future occurrences.

Liaoning Cheng Da USA Inc. of San Gabriel, California is Recalling Hot Pot Sauce Because it May Contain Undeclared Peanut, Soy, Sesame, and Wheat

For Immediate Release

March 11, 2025

Contact Information

626-285-2887

Company Announcement

On March 11, 2025, Liaoning Cheng Da USA Inc. of San Gabriel, California is recalling Hot Pot Sauce Because it may contain undeclared peanut, soy, sesame, and wheat. People who have an allergy or severe sensitivity to peanut, soy, sesame, and wheat run the risk of serious or life-threatening allergic reaction if they consume this Hot Pot Sauce.

The recalled Hot Pot Sauce was distributed in California and it was sold through retail stores, 99 Ranch Market, Hawaii Supermarket, Great Wall Super market. The product is packaged in a plastic container, net weight is 160 grams or 5.64 ounces. The brand name is "Wangzhihe" with two flavors, regular and spicy flavors. The lot number on the back of the packages are as follows: 2023/12/20, 2024/1/31, 2024/4/15, 2024/10/18. UPC numbers are: 6907592001375 and 6907592001382, located on the front of the packages.

No illnesses have been reported to date.

The recall was initiated after the manufacturer discovered that the products containing peanut, soy, sesame, and wheat were distributed in packaging that did not reveal the presence of peanut, soy, sesame and wheat.

This recall is being made with the knowledge of the U.S. Food and Drug Administration.

Consumers who have purchased "Wangzhihe" Hot Pot Sauce are urged to return it to the place of purchase for a full refund. Consumers with questions may contact us at 626-285-2887 from 9:00 am to 5:00 pm, Monday through Friday Pacific time.

The Asthma and Allergy Foundation of America (AAFA) is deeply concerned about recent federal actions and congressional budget threats that could put millions of Americans with asthma and allergies at risk. These policy changes jeopardize access to essential health care, environmental protections, and disability accommodations—critical safeguards for the over 100 million people in the U.S. living with asthma and/or allergic diseases.

Ensuring access to quality health care, clean air, and safe learning environments is essential for managing these conditions. However, recent administrative and legislative developments put people with asthma and allergies at risk. These developments include the following:

• Congressional Budget Threats to Medicaid: The House Budget Committee has advanced a resolution that could cut up to $880 billion in Medicaid funding over the next 10 years. These cuts would drastically undermine Medicaid coverage for more than 80 million low-income individuals, including millions of children and adults with asthma and allergies who rely on Medicaid for access to life-saving medications, specialist care, and emergency treatments.
  
  Medicaid plays a critical role in managing asthma—the most common chronic disease in children. In fact, nearly half of all children with asthma are covered by Medicaid or CHIP, making the program essential for access to life-saving treatments. Medicaid cuts or policy changes that restrict eligibility, increase out-of-pocket costs, or limit access to specialists would disproportionately harm asthma patients, particularly in low-income and medically underserved communities.
  
  

• Reducing ACA Enrollment Opportunities: The Centers for Medicare and Medicaid Services (CMS) has proposed a rule that would shorten the Affordable Care Act (ACA) open enrollment period for the 2026 coverage year by a month. This change will give people less time to enroll in health insurance, increasing the risk that individuals with asthma and allergies will miss coverage deadlines and face gaps in medication access and preventive care.
  
  Additionally, the rule eliminates the special monthly enrollment period for low-income households earning less than 150% of the federal poverty level, making it harder for vulnerable populations to obtain and maintain continuous coverage. The rule also threatens access to care under the ACA for some young people. These changes, combined with significant funding cuts for nonprofit navigator programs that help individuals enroll, could lead to a sharp decline in ACA participation and a rise in asthma-related emergencies due to loss of access to essential care.
  
  

• Eliminating EPA Environmental Justice Offices and targeting Clean Air Protections: The Environmental Protection Agency (EPA) announced the closure of all environmental justice offices, which were responsible for addressing pollution and environmental health disparities in marginalized communities. This decision removes vital resources for communities disproportionately impacted by poor air quality—a major trigger for asthma attacks and other respiratory issues. Without these offices, efforts to reduce pollution exposure, enforce clean air protections, and improve environmental health outcomes will be severely weakened.
  
  EPA Administrator Lee Zeldin also announced plans to roll back key clean air protections, including weakening National Ambient Air Quality Standards (NAAQS) for fine particulate matter (PM2.5) and ozone, reversing methane and greenhouse gas limits for oil and gas operations, and loosening vehicle emissions standards. These rollbacks will lead to increased air pollution, worsening asthma rates, and greater health disparities—especially for children and low-income communities who already bear the brunt of poor air quality.
  
  

• HHS Reorganization and Uncertainty: The Department of Health and Human Services (HHS) Office of General Counsel (OGC) announced a major reorganization that will close 6 of its 10 regional offices. OGC attorneys in these offices play a vital role in enforcing nursing home and hospital standards, overseeing public health policies, and ensuring compliance with programs like Head Start. The closures could significantly reduce federal oversight and enforcement of healthcare regulations, creating gaps in accountability and potentially worsening health outcomes for vulnerable populations, including those with asthma and allergies.
  
  Additionally, HHS announced the creation of a Chief Counsel for Food, Research, and Drugs—a position that will oversee legal matters related to the FDA and NIH. While the full implications of this restructuring remain unclear, any disruption in legal oversight for medical research and public health regulations could delay critical advancements in asthma and allergy treatment.
  
  These changes also coincide with a federal effort to offload “non-core” government properties, including many key HHS buildings, raising concerns about the long-term stability of public health agencies.
  
  

• Undermining Science-Based Public Health Information and Research: The National Cancer Institute (NCI), part of the NIH, has issued a directive limiting its engagement on certain public health topics, including vaccines and peanut allergies, raising concerns that NCI and potentially other NIH institutes may be restricted from sharing or funding research on critical health issues. While this directive currently applies only to NCI, AAFA is concerned it could expand to other institutes like the National Institute of Allergy and Infectious Diseases (NIAID), delaying or canceling essential research on food allergies, asthma, and other allergic conditions.
  
  These conditions require continued research and scientific advancements to improve treatment and prevention strategies. Limiting funding or restricting communication about public health science undermines trust in proven medical interventions and threatens the health of millions.
  
  

• Threats to 504 Plan Enforcement: The Department of Education announced layoffs of over 1,300 of its about 4,000 employees. These layoffs will significantly impact the Office of Civil Rights weakening oversight and enforcement of Section 504 plans. Section 504 plans ensure students with asthma and allergies receive necessary accommodations in school such medication access and emergency response plans. Schools, especially those in under-resourced communities, may face greater challenges in compliance, leaving students vulnerable to preventable health risks.

AAFA remains committed to advocating for policies that protect people with asthma and allergies. We call on policymakers to uphold strong disability protections, environmental health regulations, access to affordable healthcare, and science-based public health initiatives.

“Millions of Americans rely on policies that ensure they can breathe clean air, access affordable care and innovative treatments, and receive critical accommodations in schools,” said Kenneth Mendez, AAFA President and CEO. “These rollbacks threaten not only the health and safety of our community but also our economy by driving up healthcare costs and leading to more missed work and school days. AAFA will continue to fight for these protections and ensure that our community’s needs are heard.”

AAFA stands as a trusted voice for the asthma and allergy community, providing resources and advocacy to improve health outcomes. We will continue to monitor these policy changes and engage with lawmakers to prevent harmful rollbacks.

If you or a loved one has been impacted by asthma, allergies, or the potential loss of critical health protections, we encourage you to share your story with us. Your personal experiences are a powerful tool in helping us advocate for better policies and raise awareness about the real-world impact of these changes. Together, we can make our voices heard for all those affected by asthma and allergies. Share your story with AAFA today contacting us directly.

Peanut allergy is 1 of the most common food allergies, affecting about 2% of people in the United States. There are currently 2 immunotherapy treatments approved by the Food and Drug Administration (FDA) for children and adults with peanut allergy:

• PALFORZIA – a form of oral immunotherapy where people with a peanut allergy eat small amounts of peanut powder mixed with food every day to help their immune system react less strongly to peanuts.
• Omalizumab (Xolair®) – a shot given once or twice a month that helps block a part of the immune system that causes allergic reactions. Xolair is approved for all food allergies, including but not limited to peanut.
  
  

A Potential New Treatment Option for Peanut Allergy

VIASKIN® is another treatment option that is being developed. VIASKIN is a patch placed on the skin. The patch releases a tiny amount of peanut protein — about 1/1,000th of a peanut — through the skin each day. This small dose is picked up by special immune cells that carry it to nearby lymph nodes. It helps the body become less sensitive to peanuts without the protein entering the bloodstream.

Previous research shows that the VIASKIN peanut patch is a well-tolerated and effective treatment for children with a peanut allergy. A recent study shows the treatment is safe and effective long term.

In the study, children aged 4-11 years old were treated with the patch for up to 60 months (5 years). The results showed that the longer the children used the patch, the better they responded to peanut exposure. The number of kids responding to the treatment went from 39% after 1 year to 73% after 5 years.

The treatment also helped the body produce more peanut-specific antibodies. This means the immune system is reacting better to peanuts. After 5 years, 2/3 of the kids were able to increase the amount so they could eat 3 to 4 peanuts before reacting.

The study also found that nearly all (93%) of the kids stayed with the treatment for the entire study, which shows that the patch is safe and well-tolerated. These results suggest that using the VIASKIN peanut patch may help kids build a tolerance to peanuts. This could make it a possible option for managing peanut allergies. Having another option available for peanut allergy is important to ensure people and families managing food allergy have options that meet their needs, lifestyles, and preferences.

We Want to Hear from You!

VIASKIN is not yet approved by the FDA. But the maker, DBV Technologies, is seeking approval. The treatment is facing obstacles that could delay its availability to people with peanut allergy. Without continued investment, this promising treatment may never become available to the people who need it. This could also slow progress in researching and developing treatments for other food allergies.

It is helpful for FDA to hear directly from families living with peanut allergies. Sharing your peanut allergy story can help families like yours have more treatment options available. We invite you to share your daily life, the challenges you face, and how having new treatment options would make a difference. Using the form below, you will be able to contact the FDA directly as the agency makes its decision to approve this new treatment option.

Please fill out the form below and use the “Click to customize” button to share your food allergy story with the FDA.

Medical Review: March 2025 by Matthew Greenhawt, MD. Dr. Greenhawt is a member of AAFA's Medical Scientific Council. He is also a member of the medical advisory board for DBV Technologies, a member of the Joint Taskforce on Allergy Practice Parameters, and the senior associate editor for the Annals of Allergy, Asthma, and Immunology.

For people and families living with food allergies, dining in a restaurant can be a stressful experience. Without clear information about the ingredients of restaurant meals, people managing food allergies face challenges in making safe dining choices.

That’s why the Asthma and Allergy Foundation of America (AAFA) supports a new law called SB 68, also known as the Allergen Disclosure for Dining Experiences (ADDE) Act. Kids with Food Allergies (KFA) is a division of AAFA.

What Is California’s ADDE Act?

The ADDE Act is a bill introduced by California State Senator Caroline Menjivar this year. Senator Menjivar has severe food allergies and has experienced anaphylaxis, a serious allergic reaction, after eating at restaurants.

Senator Menjivar introduced this bill after hearing from 9-year-old Addie Lao about the challenges of eating safely at restaurants. Addie wants restaurants to make their menus easier to navigate for people with allergies.

If this law passes, every restaurant in California will be required to list the top 9 food allergens on their menus. These allergens are milk, egg, fish, crustacean shellfish, tree nuts, peanuts, wheat, soy, and sesame.

Why This Bill Matters

As of 2023, an estimated 2.5 million California residents live with one or more food allergies. This bill will help people in California eat at restaurants with much greater transparency and safety. Transparency means clear and easy-to-understand information. Up to 1 out of 4 serious food allergy reactions occur while dining out. Nearly half of food allergy-related deaths are linked to food from a restaurant or other food service provider.

For example, 2 months ago, a 34-year-old woman named Dominique Brown passed away in Los Angeles, California, after eating something she was allergic to at a holiday food event. This was a tragedy for our community that could have been prevented. AAFA believes that similar tragedies can be prevented by passing the ADDE Act.

What Is AAFA Doing to Help?

AAFA is leading efforts to get other groups, community members, and experts to support the bill. AAFA is also organizing events where people can share stories with their California senators about why this law matters.  

We are writing joint letters of support from national and state-based organizations, working with consumer protection experts, and coordinating several grassroots days of action in Sacramento, California.

How Can I Help?

If you live in California, here are a few ways you can help make restaurants safer:

• Let us know if you would be willing to write a letter about your experiences with food allergies in restaurants.
• Join our online training on how to write letters to lawmakers on Sunday, March 23, 2025.
• Come to our event in Sacramento on April 9, 2025.
• Join a virtual meeting with the people who are making these laws in California.

If you don’t live in California, you can still help!

• Share this article with someone who lives in California.
• Consider introducing a bill like this in your state, and contact AAFA about your interest.

Experts develop a standard definition of anaphylaxis and tools for health care professionals to aid in diagnosis and treatment

Melanie Carver, Chief Mission Officer of the Asthma and Allergy Foundation of America (AAFA), said the new consensus definition of anaphylaxis improves understanding and will also improve treatment.

“A clear, straightforward definition of anaphylaxis will help ensure people experiencing this potentially life-threatening allergic reaction get the care they need,” said Carver. “We commend the work of this panel to derive an evidence-based, patient-centered definition. The result of this work will mean both improved awareness and increase the likelihood of timely treatment.”

Carver joined a group of experts and patient advocacy groups to collaborate across the globe to develop this new definition.

See below from Cincinnati Children’s for more on how the work was done and what the new definition means for patients and providers.

New Consensus Report on Anaphylaxis: A Major Advancement in Allergy Care

New tool offers fresh guidelines for first responders, emergency care providers, allergists, and others, including how to manage infants

CINCINNATI – A groundbreaking consensus report on anaphylaxis – the severe reaction some people experience from bee stings, peanut butter exposures, medications, and the like – has been released by the Global Allergy and Asthma Excellence Network (GA2LEN) and recently published in The Journal of Allergy and Clinical Immunology.

The report, developed by an international panel of leading medical experts and patient advocacy organizations, aims to standardize the often-differing definitions of anaphylaxis and teach people how to recognize and manage the condition.

“Many people, including young children and adults, carry epinephrine-injectors (aka epi-pens) to self-treat if an emergency occurs. Many others do not. Likewise, our sprawling medical system, from first responders to hospital emergency staff, does not consistently follow guidelines for diagnosing and treating anaphylaxis. This is partly because no uniform guidelines are used internationally to define, recognize and treat anaphylaxis. That’s what this report seeks to address,” says Tim Dribin, MD, an emergency medicine expert at Cincinnati Children’s and the study’s co-chair who devoted a year to leading the group that produced the new standards.

“This tool includes updated clinical criteria to help diagnose anaphylaxis, criteria for using and dosing intramuscular epinephrine, and much more. Importantly, this is the first tool to include distinct infant findings to improve anaphylaxis management in young children,” Dribin says.

Burden of Anaphylaxis

Anaphylaxis is a constant burden to patients and caregivers around the world. At any moment, thousands of people encounter situations that could cause severe allergic reactions, with symptoms including hives, swollen lips and tongue, difficulty breathing, wheezing, vomiting, and passing out. While fatalities are rare, successful outcomes require rapid recognition and treatment.

Epinephrine is the only proven anaphylaxis treatment to reduce the risk of hospitalization and death. However, only 21% of children and 7% of adults experiencing anaphylaxis receive epinephrine in the community. Additionally, epinephrine underuse in emergency departments is well-documented.

Expert Collaboration

The new report reflects the efforts of a 46-member panel of experts from 14 countries and seven medical specialties. The findings have received endorsements from 34 medical and patient advocacy organizations. The National Institutes of Health, the U.S. Food and Drug Administration, and the European Medicines Agency all participated in the study.

"The clinical support tool is a game-changer in anaphylaxis management,” says Hugh Sampson, MD, an internationally renowned food allergy and anaphylaxis expert at Mount Sinai School of Medicine and the study’s chair. “By improving the rate of epinephrine use, we can significantly reduce the risk of severe reactions and fatalities, ultimately saving lives. The report will also be instrumental for advancing cutting edge research to improve the care and outcomes of patients with anaphylaxis."

"I believe the elements of this report will help ensure that patients around the world receive timely and appropriate treatment, potentially saving lives," says Antonella Muraro, MD, PhD, an internationally renowned pediatric allergist at the University of Padova in Italy and the study’s co-chair. “The report will be invaluable to first responders, emergency department providers, hospital providers, and allergists, as well as researchers trying to better understand and manage this serious and burdensome condition.”

Key Highlights of the Report

1. Unified definition: The report introduces a new, widely agreed upon definition of anaphylaxis, emphasizing its potential to cause death and detailing the involved organ systems. This definition is designed to be easily understood by health care professionals and the general public to promote improved awareness of anaphylaxis.
   
   
2. Educational overview: An innovative educational tool for health care professionals from different medical fields, training backgrounds, and experience levels. The overview provides essential information on recognizing and managing anaphylaxis, including common causes, symptoms, timely treatment with epinephrine, and key concepts for managing life-threatening reactions.
   
   
3. Clinical support tool: A new clinical support tool will help health care providers diagnose and treat anaphylaxis. This tool includes updated clinical criteria, indications, and dosing for intramuscular epinephrine and common findings from the different anaphylaxis organ systems. It is the first tool to include distinct infant findings to improve anaphylaxis management in young children, benefiting health care providers not accustomed to caring for children.

Media Contact for Dr. Dribin:

Tim Bonfield
Cincinnati Children’s
Timothy.bonfield@cchmc.org

Kids With Food Allergies is sharing this press release from ARS Pharmaceuticals to bring you the latest research news quickly.

[PRESS RELEASE]

ARS Pharmaceuticals Announces FDA Approval of neffy® 1 mg (epinephrine nasal spray) for Type I Allergic Reactions, Including Anaphylaxis, in Pediatric Patients Weighing 15 to < 30 Kilograms

March 5, 2025

neffy 1 mg is the first and only needle-free epinephrine treatment approved for younger children

SAN DIEGO, March 05, 2025 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from allergic reactions that could lead to anaphylaxis, announced today that the U.S. Food and Drug Administration (FDA) has approved neffy® 1 mg (epinephrine nasal spray) for the treatment of Type I Allergic Reactions, including anaphylaxis, in children who are aged 4 years and older and weigh 15 to < 30 kilograms (33 to < 66 lb.). This approval represents the first significant innovation in the delivery of epinephrine for this patient population in more than 35 years.

In the general population, approximately one in 13 children have severe food allergies, and more than 40 percent have experienced severe reactions.¹ Despite the clear link between early epinephrine use and better outcomes, research shows that approximately 40 percent of patients delay treatment², and 56 percent of caregivers fear using needle-based auto-injectors on their child³. neffy eliminates needles, delivering a precise epinephrine dose via a simple nasal spray, almost instantly, with no nasal hold time required.

“Today’s FDA approval of neffy 1 mg marks a major milestone towards our efforts to transform the management of severe allergic reactions,” says Richard Lowenthal, Co-Founder, President, and CEO of ARS Pharma. “Many children and caregivers fear needle-based auto-injectors, which can delay lifesaving treatment. neffy’s needle-free, easy-to-use design addresses this unmet need, offering families a long-awaited alternative. With nearly four out of 10 U.S. epinephrine prescriptions written for children under the age of 18—and nearly a third of those for children weighing 15 to 30 kilograms⁴ —we believe neffy 1 mg will improve access to a needle-free option for the treatment of severe allergies and reduce hesitation in treating this vulnerable group. It will also eliminate risks like accidental needle injuries to children or caregivers.”

The approval of neffy 1 mg is based on data from extensive clinical trials, including pharmacokinetic (PK) and pharmacodynamic (PD) responses in pediatric and adult subjects that were consistent with those of epinephrine injection products. Adverse events in pediatric trials were generally mild and transient. Human factor studies also show children as young as 10 can use neffy effectively by following instructions, and that even untrained individuals, such as babysitters or teachers, can effectively administer neffy. The device has a shelf-life of 24 months at room temperature and tolerance to temperature exposures up to 122°F (50°C) based on testing for up to 3 months. If accidentally frozen, neffy can be thawed without impact on the product quality and reliability.

“The availability of a needle-free epinephrine option for children is a breakthrough in the treatment of severe allergic reactions,” says Dr. David Fleischer, Section Head of Allergy & Immunology, and Professor of Pediatrics, at Children’s Hospital Colorado. “Many people wait to administer epinephrine until symptoms progress or take antihistamines as a first line of defense because they are afraid of injection. neffy’s small, user-friendly design addresses these challenges, empowering people to actually carry epinephrine and act quickly and confidently during an allergic emergency. This innovation will likely significantly improve health outcomes and enhance quality of life.”

ARS Pharma is committed to access and affordability, and neffy 1 mg is expected to be available in the U.S. by the end of May 2025. The neffyConnect program provides patients, caregivers, and healthcare professionals with information to guide their treatment journey, details about medication fulfillment services, financial support and navigating insurance requirements. Most commercially insured patients will pay no more than $25 for two single-use neffy devices through a co-pay savings program. The co-pay savings card can be accessed at neffy.com and downloaded to an Apple Wallet and provided to the pharmacy. If the product isn’t covered by insurance, the cash price of $199 for two doses is available through BlinkRx and coupon can be downloaded from GoodRx for use at local retail pharmacies. For certain uninsured or underinsured U.S. residents meeting eligibility criteria and exhausted all other options, the ARS Pharma Patient Assistance Program (PAP) will provide neffy at no cost.

Eligible schools participating in the neffyinSchools program can receive neffy 1 mg upon availability. For more information, and to register for neffyConnect, visit www.neffy.com.

The approval of neffy 1 mg follows FDA approval for neffy 2 mg on August 9, 2024 for children and adults weighing 30kg ( 66 lb.), and approval for EURneffy in the EU by the European Commission on August 22, 2024.

About neffy®

neffy is a nasal spray used for emergency treatment of allergic reactions including anaphylaxis, in adults and children aged 4 years and older who weigh 33 lbs. or greater.

INDICATION AND IMPORTANT SAFETY INFORMATION FOR neffy (epinephrine nasal spray)

INDICATION

neffy is indicated for emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients aged 4 years and older who weigh 33 lbs. or greater.

IMPORTANT SAFETY INFORMATION

neffy contains epinephrine, a medicine used to treat allergic emergencies (anaphylaxis). Anaphylaxis can be life-threatening, can happen in minutes, and can be caused by stinging and biting insects, allergy injections, foods, medicines, exercise, or other unknown causes.

Always carry two neffy nasal sprays with you because you may not know when anaphylaxis may happen and because you may need a second dose of neffy if symptoms continue or come back. Each neffy contains a single dose of epinephrine. neffy is for use in the nose only.

Use neffy right away, as soon as you notice symptoms of an allergic reaction. If symptoms continue or get worse after the first dose of neffy, a second dose is needed. If needed, administer a second dose using a new neffy in the same nostril starting 5 minutes after the first dose. Get emergency medical help for further treatment of the allergic emergency (anaphylaxis), if needed after using neffy.

Tell your healthcare provider if you have underlying structural or anatomical nasal conditions, about all the medicines you take, and about all your medical conditions, especially if you have heart problems, kidney problems, low potassium in your blood, Parkinson's disease, thyroid problems, high blood pressure, diabetes, are pregnant or plan to become pregnant, or plan to breastfeed.

Tell your healthcare provider if you take or use other nasal sprays or water pills (diuretics) or if you take medicines to treat depression, abnormal heart beats, Parkinson's disease, heart disease, thyroid disease, medicines used in labor, and medicines to treat allergies. neffy and other medications may affect each other, causing side effects. neffy may affect the way other medicines work, and other medicines may affect how neffy works.

neffy may cause serious side effects. If you have certain medical conditions or take certain medicines, your condition may get worse, or you may have more or longer lasting side effects when you use neffy.

Common side effects of neffy include: nasal discomfort, headache, throat irritation, chest and nasal congestion, feeling overly excited, nervous or anxious, nose bleed, nose pain, sneezing, runny nose, dry nose or throat, tingling sensation, including in the nose, feeling tired, dizziness, nausea, and vomiting.

Tell your healthcare provider if you have any side effects that bother you or that do not go away after using neffy.

These are not all of the possible side effects of neffy. Call your healthcare provider for medical advice about side effects. To report side effects, contact ARS Pharmaceuticals Operations, Inc. at 1-877-MY-NEFFY (877-696-3339) or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see the full Prescribing Information and Patient Information for neffy.

About Type I Allergic Reactions Including Anaphylaxis

Type I allergic reactions are serious and potentially life-threatening events that can occur within minutes of exposure to an allergen and require immediate treatment with epinephrine, the only FDA-approved medication for these reactions. While epinephrine auto-injectors have been shown to be highly effective, there are well published limitations that result in many patients and caregivers delaying or not administering treatment in an emergency situation. These limitations include fear of the needle, lack of portability, needle-related safety concerns, lack of reliability, and complexity of the devices. There are approximately 40 million people in the United States who experience Type I Allergic reactions. Of this group, over the last three years, approximately 20 million people have been diagnosed and treated for severe Type I allergic reactions that may lead to anaphylaxis, but (in 2023, for example) only 3.2 million filled their active epinephrine auto-injector prescription, and of those, only half consistently carry their prescribed auto-injector. Even if patients or caregivers carry an auto-injector, more than half either delay or do not administer the device when needed in an emergency.

About ARS Pharmaceuticals, Inc.

ARS Pharmaceuticals is a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect patients from allergic reactions that could lead to anaphylaxis. The Company is commercializing neffy® (trade name EURneffy® in the EU) (previously referred to as ARS-1), an epinephrine nasal spray indicated in the U.S. for emergency treatment of Type I allergic reactions, including anaphylaxis, adult and pediatric patients 4 years of age and older who weigh 15 kg or greater, and in the EU for emergency treatment of allergic reactions (anaphylaxis) due to insect stings or bites, foods, medicinal products, and other allergens as well as idiopathic or exercise induced anaphylaxis in adults and children who weigh 30 kg or greater. For more information, visit www.ars-pharma.com.

Forward Looking Statements

Statements in this press release that are not purely historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to: the expectation that neffy will save lives; the effectiveness of neffy; neffyConnect’s ability to help patients and HCPs access financial support and medication fulfillment services; ARS Pharmaceuticals’ commercial coverage goals and the timing thereof; the expected timing for product availability of neffy 1 mg; neffy’s ability to improved health outcomes and quality of life; neffy’s shelf life and its effectiveness after being subject to extreme temperatures; and other statements that are not historical fact. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “anticipate,” “expects,” “if,” “may,” “potential,” “on track to,” “plans,” “will,” “would,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon ARS Pharmaceuticals’ current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation: potential safety and other complications from neffy; the ability to maintain regulatory approval for neffy in its currently approved indications the scope, progress and expansion of developing and commercializing neffy; the potential for governments and payors to delay, limit or deny coverage for neffy; the size and growth of the market therefor and the rate and degree of market acceptance thereof vis-à-vis intramuscular injectable products; ARS Pharmaceuticals’ ability to protect its intellectual property position; and the impact of government laws and regulations. Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption “Risk Factors” in ARS Pharmaceuticals’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, filed with the Securities and Exchange Commission (“SEC”) on November 13, 2024. These documents can also be accessed on ARS Pharmaceuticals’ website at www.ars-pharma.com by clicking on the link “Financials & Filings” under the “Investors & Media” tab.

The forward-looking statements included in this press release are made only as of the date hereof. ARS Pharmaceuticals assumes no obligation and does not intend to update these forward-looking statements, except as required by law. For more information, visit www.ars-pharma.com, and follow us on LinkedIn and X.

References:

1. Food Allergy Research & Education. Facts and Statistics. Available at Facts and Statistics - FoodAllergy.org. Accessed January 24, 2025.
2. Rooney E, et al. Poster Presentation at ACAAI 2022 (Louisville, KY).
3. Chad L, Ben-Shoshan M, Asai Y, et al. A majority of parents of children with peanut allergy fear using the epinephrine auto-injector. Allergy. 2013;68(12):1605-1609. https://doi.org/10.1111/all.12262.
4. ARS Data on File, 2025