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Summary: At the FDA Food Allergy Research Forum on November 17, 2025, HHS Secretary Robert F. Kennedy Jr. announced major investigations into what he called the “malpractice” of federal agencies for failing to study why food allergies have become epidemic since 1990, while FDA Commissioner Dr. Marty Makary blamed decades of flawed pediatric guidance for igniting the peanut allergy crisis and ARPA-H Director Dr. Alicia Jackson called for “fearless” scientists to join the agency’s high-risk, high-reward research programs. The forum brought together top federal health officials and biotech executives to address a disease that now affects 33 million Americans at an annual cost of $370 billion, with Kennedy controversially suggesting aluminum adjuvants in vaccines as a potential culprit that fits the timeline of the epidemic while committing to end “taboo” restrictions on research into chronic disease causes.
Forum Participants
Federal Health Officials:
- Robert F. Kennedy Jr. – Secretary of Health and Human Services
- Dr. Marty Makary – FDA Commissioner
- Dr. Alicia Jackson – Director, Advanced Research Projects Agency for Health (ARPA-H)
- Dr. Jay Bhattacharya – Director, National Institutes of Health (NIH)
- Dr. Jeffrey Taubenberger – Acting Director, National Institute of Allergy and Infectious Diseases (NIAID)
Industry Executives:
- Michael Nelson – CEO, Intrommune Therapeutics
- Tal Golan – Co-founder and CEO, Anjo
- Dr. Brian Wong – CEO, RAPT Therapeutics
Forum Hosts and Moderators:
- Alana – Food Allergy Fund
- Corrie Driebusch – Wall Street Journal (Panel Moderator)
FDA Commissioner Makary: How “Groupthink” Created the Peanut Allergy Epidemic
Dr. Marty Makary opened the forum with a striking mea culpa from the medical establishment, placing blame squarely on a flawed recommendation issued around 2000 by the American Academy of Pediatrics nutrition committee. That guidance advised parents to avoid giving peanut products to children in their first few years of life—advice Makary says was issued without consulting experts in transplant surgery or immunology who understood a well-established principle called oral tolerance.
“I went back and asked people, ‘Why did you say that? What science was it based on?’” Makary recounted. “They hadn’t talked to anybody in that field. They did not know that literature, and the ignorance of groupthink issued this decree.” The principle of oral tolerance—known for decades in transplant medicine—holds that early exposure to potential allergens helps the developing immune system learn to accept rather than attack those substances. The pediatric community’s advice ran directly counter to this science.
Makary described a “perpetual vicious cycle” that followed: as more children developed peanut allergies, families, classrooms, and school districts eliminated peanut products, further reducing early exposure and driving allergy rates higher. The flawed guidance became a self-fulfilling prophecy. “It wasn’t really until a doctor named Gideon Lack had done a famous study called the LEAP Study” in 2013-2015 that the medical establishment realized its error, Makary explained. Lack faced resistance securing funding for research that challenged accepted wisdom. “Well, we know this is true. Why would you want to study it?”—a pattern Makary said appears across many areas of medicine.
Prior to the LEAP Study’s publication, pediatricians and family doctors had recited what Makary called an “easy-to-remember chant” to new parents: “Remember, 1, 2, 3. Don’t start milk products until they’re one year of age. Don’t start eggs until they’re two, and don’t start any peanut butter or peanut products until they’re three.” This dogma persisted until 2015. “So we’re still reeling in from that mistake,” Makary acknowledged.
The Microbiome Connection
Beyond early allergen exposure, Makary emphasized the largely unstudied role of the gut microbiome—the complex ecosystem of over a billion different types of bacteria in the digestive system—in overall health, including food allergies. “Gut health is central to overall health,” he stated, describing the microbiome as “the frontier in health” despite receiving minimal research funding.
Makary explained that an altered microbiome increases intestinal inflammation, causing low-grade but constant stretching of the gut wall. In young children, this manifests not as obvious pain but simply as “being sad”—a subtle clinical presentation that gets overlooked. The microbiome produces substances essential to health: vitamins, clotting factors, and notably 90% of the body’s serotonin, the neurotransmitter involved in mood regulation.
Modern medical practices, particularly antibiotic use, disrupt this delicate ecosystem. “Antibiotics can carpet-bomb parts of the microbiome, resulting in overgrowth of one type of bacteria,” Makary warned. He cited a recent Mayo Clinic study showing that children who received antibiotics in their first two years of life had higher rates of chronic diseases—from allergic rhinitis to obesity—compared to unexposed children. Yet the average American two-year-old has already received more than two courses of antibiotics, sometimes beginning on their first day of life “just as a precaution.”
Makary revealed that the NIH’s microbiome unit consists of just “a couple people” despite the gut’s centrality to health. However, he expressed excitement about research underway at Harvard Medical School suggesting that people with food allergies may be deficient in specific microbes. These researchers are working to identify which types of microbiome bacteria are missing in people with particular food allergies—research being funded by the Food Allergy Fund. “I think that’s some of the most exciting work that’s being done,” Makary said.
Regulatory Challenges for Microbiome Treatments
The FDA faces novel regulatory questions as microbiome-based treatments advance, Makary acknowledged. “What do you do with a pill that has a million microbes in it? Are we going to regulate each microbe separately? Are we going to regulate it for one condition? Or recognize that if people feel better, maybe that’s an outcome that we can recognize.” He noted that probiotics face minimal regulation while more targeted microbiome products face uncertain pathways. “These are the active discussions that we’re having,” he said, signaling the agency is actively working through these questions.
ARPA-H Director Jackson: A Call for “Fearless” Scientists to Tackle Food Allergies
Dr. Alicia Jackson, who became ARPA-H director in October 2025, issued an urgent recruitment call for exceptional scientists willing to lead high-risk, high-reward research programs targeting food allergies. She described the disease as “really growing into a crisis” with a “valley of death” between basic research and commercial treatments that ARPA-H is positioned to bridge.
Jackson, who previously served as Deputy Director of DARPA’s Biological Technologies Office and founded women’s health company Evernow, explained the unique ARPA model that allows her agency to take risks neither traditional government agencies nor private companies can accept. “In a place where food allergy sits right now, there’s a lot of hypotheses that are very risky to go after and to put big dollars after,” she said. “We tend to fund a lot of point solutions, or a lot of basic research, but clearly, there is something underlying all of this that we’re seeing in immunology overall.”
The scale of ambition at ARPA-H is deliberately audacious. “What if we could literally tomorrow flip a switch and reset everyone’s immune system, so that they don’t have a food allergy?” Jackson posed. “Those are the really big questions that we want to go after here.”
How ARPA-H Works: Program Managers Drive Everything
Unlike traditional research agencies with top-down priority-setting, ARPA-H depends on individual program managers who bring specific visions for breakthrough research. “The program ideas come from our program managers,” Jackson explained. These individuals must be “deeply technical” with “an incredible passion that they will break through a brick wall to achieve.” They typically serve three-year terms, creating intense urgency. “The day that somebody shows up, the clock starts ticking. What that means is that every day counts when you’re an ARPA program manager.”
Jackson described program managers as “a little bit crazy”—willing to challenge medical dogma and bring together unlikely collaborators. “Things that maybe don’t follow medical dogma, things that seem just beyond our reach, or require close collaboration between the microbiome community, between immunologists, between potentially other fields that we haven’t even been thinking about, and bring them all together.”
The agency’s contracting flexibility allows program managers to direct $10 to $200 million toward specific goals while maintaining hands-on management. “It basically enables us to not just give money and say goodbye and hope it went to a great place, but actually to give very focused, significantly sized dollars,” Jackson said. Programs can be scaled up, scaled down, or redirected as needed.
Jackson directly appealed to the audience: “If you have people in your networks, academics who are willing to come and spend a few years here, or people from industry, or a startup founder who wants to come and literally make the biggest impact of their entire lives—not just for a startup scale, or a paper, but really to drive forward an entire field—this is the place to come.” The goal: ensure that children currently suffering from food allergies at ages two or three can be free of them by ages 10 or 12.
Industry Panel: The $370 Billion Market and Paths to Prevention and Treatment
Moderated by Corrie Driebusch of the Wall Street Journal, this panel featured executives from three companies representing different approaches to the food allergy crisis: prevention through early exposure, real-time monitoring during reactions, and next-generation biologic treatments.
The Scale of the Crisis: 33 Million Americans, $370 Billion Annual Cost
Michael Nelson, CEO of Intrommune Therapeutics, framed the market opportunity and human toll. Food allergies affect 1 in 10 adults and 1 in 13 children—33 million Americans total. “But it’s not just the people with the food allergies, it’s their entire families that are affected,” Nelson noted. A recent study by researcher Chris Warren found that direct and indirect costs total $370 billion annually.
For treatment-seeking patients, Nelson estimates about 10% of allergic individuals (3.3 million people) as the addressable market, though he believes more should receive treatment if cost barriers were removed. The prevention market is even larger: 3.6 million babies are born annually, with 40% at high risk due to atopic dermatitis or family history of allergies, asthma, or food allergies. Nelson estimated the early-introduction prevention market at $13 billion total, though “spending a couple hundred million dollars a year on early introduction, you could get a huge cost savings” through avoided lifetime medical expenses.
Intrommune’s Approach: Allergen-Containing Toothpaste
Intrommune is developing products that embed food allergens into daily routines—specifically, toothpaste containing peanut protein for adults and a gum-rubbing formulation for infants. “Early introduction sounds easy, but actually, giving a kid a food every day… you can’t just do it once because if you do it once, you’re actually sensitizing them,” Nelson explained. The toothpaste format contacts “more active parts of the mouth that have more of the Langerhans cells”—immune cells that play a role in tolerance development.
In their Phase 1 adult study, Intrommune saw safety advantages over traditional oral immunotherapy, which requires patients to eat increasing amounts of the food they’re allergic to. “We had no severe or moderate systemic adverse events,” Nelson reported. Traditional oral immunotherapy comes with significant lifestyle restrictions—patients cannot exercise for hours or take hot showers after doses—and in one study, 14% of patients needed emergency epinephrine. Intrommune’s sublingual approach appears to avoid these issues while still modifying the underlying disease rather than just suppressing symptoms.
Nelson highlighted an important distinction: “A lot of the biologics in development, they’re knocking down the immune system. But once you stop taking it, you’re right back where you started. Allergy immunotherapy actually modifies the disease and helps the body learn what to react to and not react to.”
Anjo: Wearable Technology for Early Anaphylaxis Detection
Tal Golan, co-founder and CEO of Anjo, described his company’s mission to transform allergic care “from being reactive to proactive” using advanced wearable devices and machine learning algorithms to detect anaphylaxis early—potentially before major symptoms appear.
The company’s origin story is tragically common among food allergy families: Golan’s co-founder’s daughter nearly died from anaphylaxis at daycare despite everyone knowing about her allergy. “What happened because of the delayed intervention is she spent four hours in the ICU where they literally fought for her life,” Golan recounted. “One of the most crucial factors to determine the outcome of an anaphylactic reaction is the timing of intervention. And the problem is most people have a difficult time differentiating between a mild reaction and a life-threatening one until major symptoms appear, but by then, the wolf is in the room.”
Anjo achieved clinical proof of concept in Israel in late 2024 and is now collaborating with leading research institutions to discover novel biomarkers for anaphylaxis. “We are the first company to monitor multiple biomarkers in real time throughout the whole lifecycle of an anaphylactic reaction,” Golan said. “We want to remove the ambiguity. We want to bring objective data and we want to bring early detection.”
The company sees applications beyond food allergies since anaphylaxis can be triggered by medications, insect stings, and other causes. “Why is it only diabetes that have connectivity and alerts and technology?” Golan asked. “We are on a mission to bring technology to the underserved allergic community.”
RAPT Therapeutics: Next-Generation Anti-IgE Biologics
Dr. Brian Wong, CEO of publicly traded RAPT Therapeutics, described his company’s effort to improve on omalizumab (Xolair), the first-generation anti-IgE antibody approved in 2024 for all IgE-driven food allergies following the NIAID-sponsored OUtMATCH study. Omalizumab has rapidly become standard of care, with over 85,000 food allergy patients now using it.
However, omalizumab has limitations: 25-30% of patients cannot use it due to their IgE levels, and it requires 26 subcutaneous injections per year, often multiple shots per visit. RAPT’s next-generation anti-IgE antibody, Ozureprubart, aims to address all food allergy patients regardless of IgE levels and reduce dosing to perhaps four times per year with just one or two shots.
“I’m myself a food allergy patient,” Wong noted. “Just imagine being able to send your child to college knowing that they’re going to be protected for a three or four month period, or the child who needs to be protected from an anaphylactic reaction at school.”
Wong reported that investor interest has grown dramatically as omalizumab sales demonstrate the market’s size—on pace for $2-3 billion in the first 18 months. “We’re seeing first the specialized healthcare investors start. Now we’re seeing the Vanguards and Fidelities start to invest in this area. I think that’s what’ll lift all boats now.”
Complementary Technologies Working Together
The panelists see their different approaches as complementary rather than competitive. Wong described speaking with both Golan and Nelson about collaborations. For clinical trials, wearable monitoring could make oral food challenges safer and more objective. For treatment, combining biologics with oral immunotherapy could provide more sustainable benefits than either alone.
All three executives identified funding as their primary barrier. Golan emphasized the need for data: “Machine learning and AI is not of much use unless it has data.” Nelson noted that investors remain skeptical of allergy immunotherapy markets despite growing evidence. Wong called for FDA pathways similar to those that accelerated oncology drug development.
What the Executives Want from Government
Given the forum’s audience of federal health officials, the panelists made direct asks:
Dr. Brian Wong requested partnership with the FDA on accelerated approval pathways for Ozureprubart, including novel trial designs and endpoints. “We would love to partner with the FDA to find ways to accelerate the approval process of this drug.”
Michael Nelson requested regulatory clarity and funding support, noting that developing an alpha-gal (red meat allergy) product could cost $1 billion over 5-7 years on top of the 10 years Intrommune has already invested. He also suggested a priority review voucher would help.
Tal Golan asked for recognition of food allergy as a critical public health issue, noting that pediatric regulatory pathways are “extremely complex and difficult” for a population that often cannot articulate what they’re experiencing. He also urged officials to address anaphylaxis broadly, not just from food triggers.
HHS Secretary Kennedy: Investigating Vaccine Adjuvants and Ending Research “Taboos”
The forum’s most anticipated segment featured HHS Secretary Robert F. Kennedy Jr. in conversation with Food Allergy Fund’s Alana, who noted that both are food allergy parents “a generation apart” who have seen little progress despite the disease reaching epidemic levels.
The Research Funding Gap
Alana presented stark funding disparities: in 2024, food allergy research received $2.69 per capita in NIH funding compared to $38 for Crohn’s disease and $59 for IBD—yet food allergy affects nearly 10 times as many patients. “Why has food allergy remained a low public health priority even as it now impacts nearly 10% of the population?” she asked.
Kennedy attributed this to public health agencies’ historical focus on infectious rather than chronic disease. “A lot of the chronic disease, particularly those that have gone to epidemic since 1990 when we saw this huge explosion in chronic disease happen, [is] at least comparatively underfunded or disproportionately underfunded.”
“Why Aren’t We Trying to Figure Out What’s Causing It?”
Kennedy expressed frustration that no one is investigating why food allergies emerged as an epidemic. “When I was a kid, I never met anybody with a peanut allergy. I had 11 siblings and around 70 first cousins, and I didn’t know anybody in my school.” He cited researcher Heather Fraser’s work indicating the epidemic began in 1990, with scientific literature before that time barely mentioning peanut allergies “because it was not an issue.”
Kennedy noted that 1989-1990 is also when EPA scientists identified the beginning of the autism epidemic, which rose from less than 1 in 10,000 in the 1970s to 1 in 31 today. “Epidemic… Genes don’t cause epidemics. They may provide a vulnerability, but you need an environmental toxin.”
“Why aren’t the public health agencies asking this question, what’s causing it?” Kennedy demanded. “It’s a very easy study to do, you just make a list of all the potential culprits that fit those criteria, and then you begin eliminating them. But those studies have never been done. We are going to do them now and we will figure it out.”
Kennedy questioned why NIAID—the National Institute for Allergic and Infectious Diseases—has not prioritized this question despite “allergic diseases” being in its name. Allergies were so rare that the CDC did not even begin counting them until 1997.
Kennedy’s Personal Experience
Kennedy described his own family’s experience with food allergies: five of his seven children have allergies. His son was “severely anaphylactic to not only peanuts, but all tree nuts and a lot of other stuff” and made approximately 22 emergency visits by age two, coming “close to dying so many times.” Kennedy described the constant vigilance food allergy families must maintain: “You send your child to a birthday party and maybe the cake had peanut oil or somebody cooked in the same pan, something with peanuts in it, two days before. And so everything is a trap, everything is a potential killer of your child.”
Skepticism of the Early Exposure Hypothesis
Kennedy expressed doubt about the theory—advanced by Dr. Makary earlier in the forum—that lack of early peanut exposure caused the epidemic. He offered several counterarguments:
First, his personal experience: “My house was so filled with peanut butter and I was eating peanut butter two meals a day, and my wife, when she was pregnant, was eating peanut butter. And the kids were given peanut butter from as soon as they could chew food. And yet, we still had peanut allergies in our house.”
Second, historical patterns: “Peanuts really were not eaten by anybody until George Washington Carver came along… There was no mass consumption of peanuts until after peanut butter was invented” in the 1920s, with widespread consumption during World War I and II due to protein restrictions. “And so suddenly, you had a whole population that was eating peanuts, and yet there were no peanut allergies.” He added that many countries only began eating peanuts recently without experiencing waves of allergies.
Aluminum Adjuvants as a Potential Culprit
Kennedy identified aluminum adjuvants in vaccines as a hypothesis that “fits the timeline perfectly,” noting that increased aluminum exposure “is in lockstep” with the expansion of food allergies beginning in 1989. “We don’t have the science to say this is an effect or not,” he acknowledged, while calling for investigation alongside other potential factors like pesticides.
He explained the mechanism: “Aluminum adjuvants are designed to increase the immune response and to hyper-activate your immune system. And they do that along… they cause Th 2 inflammation, which creates IG-2” (referring to the IgE-mediated allergic pathway). Kennedy cited “many, many studies” showing that animals given aluminum adjuvants develop allergies to proteins in vaccines or in their environment.
He referenced research by Anthony Mawson of the University of Mississippi and a scientist named Gallings from Europe comparing allergies in vaccinated versus unvaccinated children, claiming Mawson’s study “found that vaccinated children had 30 times the rate of allergic rhinitis as unvaccinated children.” Kennedy hypothesized that aluminum exposure during a seasonal allergen outbreak might cause lifetime sensitization to that allergen.
“But again, we don’t know,” Kennedy emphasized. “The problem is there haven’t been any human cohort studies. There’s lots and lots and lots and lots of animal studies. Why didn’t CDC or NIH, NIAID do those human studies? Because it’s pretty easy to figure this out, and we will figure it out.”
The Japan Gelatin Example
Kennedy cited Japan’s experience in the 1990s as evidence that vaccine ingredients can cause population-wide allergic reactions. “In the 1990s, there were a lot of anaphylaxis cases suddenly exploding in Japan, and they traced it to gelatin in the live virus vaccines and the MMR vaccines and some of the other vaccines they had over there. And by 2000, they had removed it all and the anaphylaxis dropped dramatically.” He described this as a “human model” showing “broad allergic reactions that take place across an entire society that are linked to the vaccine schedule.”
He also noted that “the science suggests that aluminum alone will not cause allergies” but rather aluminum combined with proteins—whether latex, dairy, peanut, or others—creates the heightened immune response.
Breaking the Research “Taboos”
Kennedy characterized past restrictions on studying potential chronic disease causes as a “taboo” and “omerta” (code of silence) that he intends to break. “Why wasn’t this a question that was being asked, that was being demanded as soon as this allergy started to appear? Why weren’t we putting out requests for proposals, saying, ‘Tell us why this is starting?’ Instead, it became a verboten subject, you weren’t allowed to study it and science warned each other against studying it. And so we’re going to study it now, we’re going to break that omerta.”
He praised NIH Director Dr. Jay Bhattacharya for working to “recalibrate the compass at NIH where people feel safe, researching formerly taboo subjects.”
Administration Accomplishments on Food Safety
Kennedy outlined several food-related policy changes his agency has implemented or initiated:
GRAS Standards Reform: The “Generally Recognized as Safe” category, originally meant to exempt traditional ingredients like flour and yeast from testing requirements, was “hijacked by the food industry” so that every new ingredient automatically received GRAS status. “Now we have 10,000 ingredients in our food that are illegal in Europe,” Kennedy stated. The administration is closing this loophole through regulations (expected to take about six months) and will force companies to prove the safety of existing high-priority ingredients.
SNAP Waivers: Twelve states have received waivers allowing them to restrict food stamp purchases of soda (10% of SNAP expenditures) and candy (8%), with six more states in line. “We’re giving the poorest Americans diabetes from when they’re little and we are paying for the diabetes through Medicaid, so it makes no sense.”
Food Dyes: The administration is quickly eliminating all nine petroleum-based food dyes.
Operation Stork Speed: An initiative to improve baby formula quality.
Dietary Guidelines: New guidelines emphasizing protein and saturated fats, reversing the “war on saturated fats,” are expected next month and will be implemented in the military and federal institutions, with aggressive school nutrition improvements planned for next year.
Identifying Environmental Culprits
When asked about the “single most decisive step” to end the childhood chronic disease epidemic, Kennedy pointed to ultra-processed food as his primary suspect while acknowledging that “it’s criminal that we do not have a clear answer to that right now.” He described children “swimming around in a toxic stew with micro plastics, EMF radiation, and then pesticides and all of these toxic exposures.”
Beyond specific toxins, Kennedy emphasized the need for “gold standard science” free from “prejudice or bias, or to official orthodoxies” where “people are allowed to ask questions and they’re allowed to question everything.”
Realigning Perverse Incentives
Kennedy argued that the current healthcare system incentivizes keeping people sick: “The hospitals make more money, the doctors make more money, the insurance companies make more money. Everybody’s making more money for keeping us sick. No matter how good-hearted you are as an individual, those incentives will affect societal behavior.” He said CMS (Centers for Medicare & Medicaid Services) is working to realign incentives “so that you can do well by doing good, and people are going to be rewarded for making their patients better.”
Food Allergy’s Broader Implications
Alana framed food allergies as “the canary in the coal mine for chronic disease,” often presenting in the first two years of life before conditions like autism, juvenile diabetes, or asthma. The economic impact is substantial: emergency room visits every three minutes, 30% of food allergy mothers leaving the workforce, and $30 billion in direct medical costs.
Kennedy agreed, noting that answering the food allergy question will likely solve a “whole list of atopic diseases that exploded simultaneously in lockstep with food allergies”—eczema, anaphylaxis, and allergic rhinitis—conditions he says were virtually unknown in his childhood.
Looking Ahead: NIH and NIAID Leadership
The forum was scheduled to conclude with remarks from NIH Director Dr. Jay Bhattacharya and NIAID Acting Director Dr. Jeffrey Taubenberger, though the transcript ends before their presentations. Their participation signals the administration’s intention to redirect these agencies toward the chronic disease questions Kennedy outlined.
Reference
Rev.com. “RFK JR. FDA Food Allergy Research Forum.” Rev, 17 Nov. 2025, www.rev.com/transcripts/food-allergy-forum.