Food Allergy Institute Lawsuit: Patient Petition and TIP Criticism

No lawsuit against the Food Allergy Institute appears in publicly available records. The Long Beach, California clinic founded by Dr. Inderpal Randhawa in 2015, and its proprietary Tolerance Induction Program (TIP), have instead drawn a different kind of scrutiny: an organized patient petition, sustained complaints about cost and transparency, and formal scientific criticism of the clinic’s published results. No enforcement actions, Medical Board sanctions, or government suits have surfaced in available reporting or regulatory databases.¹

What follows is what the public record does contain.

The TIP Truth Patient Petition

In July 2021, former and prospective patients organized under the name “TIP Truth” and launched a Change.org petition demanding greater transparency from the institute, then known as SCFAI. It gathered more than 300 signatures.²

The petitioners’ central complaint was that the clinic marketed a 99 percent success rate and an “unmatched safety record” without releasing independently reviewed safety or outcome data. They said the institute did not define how “success” was measured, did not disclose dropout rates, and did not share adverse-event data such as hospitalizations or epinephrine use. The petition asked FAI to publish this information annually and to seat an independent oversight body that included patient representatives.²

The petition also raised financial conflict-of-interest concerns, alleging that Dr. Randhawa held ownership or founding roles in several for-profit entities that patients were required to use as part of treatment, including Foundation Labs, Serologix LLC, GGG Immunotherapies, and Randhawa Ranch. Petitioners asked the institute to disclose those relationships. They also flagged a “philanthropy” arrangement under which people who donated $100,000 could bypass the clinic’s lengthy waitlist and receive priority appointments, and asked the Medical Board of California to review whether that arrangement violated state ethical norms.²

A separate grievance concerned the institute’s official Facebook group, “Southern California Food Allergy Institute’s Kitchen Table,” which had more than 4,000 members. Petitioners alleged that a SCFAI employee moderating the group fostered what they described as a “cultlike atmosphere,” deleting critical comments, banning members who questioned the program, and allowing loyal members to harass skeptics. They asked for a neutral facilitator and independent oversight.²

No public response from Dr. Randhawa or the institute to the petition has been documented.

Cost and Insurance Complaints

Money has been a persistent point of friction. FAI’s cash-pay subscription plan is $979 per month for patients aged 18 months to 25, and $1,079 per month for adults aged 26 to 50. The institute estimates first-year costs at roughly $11,748 under the subscription plan, or approximately $15,425 when using insurance-billed services. Those figures exclude food-dosing replacements, sublingual immunotherapy, and additional lab testing, which are billed separately.³

Insurance coverage is uneven. FAI accepts most PPO plans from carriers like Aetna, Anthem Blue Cross, Cigna, and Blue Shield of California, but Kaiser and HMO plans are generally considered out-of-network, and patients on those plans pay cash-pay rates or enroll in the subscription.⁴ Even for in-network patients, clinical and diagnostic costs are only “partially covered, depending on your benefits at the time of service,” with any uncovered billed services remaining the patient’s responsibility.³

Patient accounts published in the comments section of an Undark investigation described the strain in concrete terms. One parent, identified as Carrie Martin, expressed alarm over a $4,500 annual program fee, which had evolved from a “tax-deductible contribution” into a non-tax-deductible charge, on top of thousands of dollars in out-of-pocket lab costs not covered by insurance. Other parents described cross-country travel for required in-person visits and waitlists stretching beyond two years.¹

Scientific Criticism of TIP

The most pointed professional criticism concerns the gap between FAI’s marketing claims and its published evidence. For years, the program produced no peer-reviewed research. Allergist Dr. Philippe Bégin called the 99 percent success rate “just ridiculous.” Dr. Edwin Kim and Dr. Hugh Windom also questioned the reported outcomes, arguing that extraordinary claims required transparent, independently verifiable data.¹

Dr. Randhawa defended the lack of publications by saying his machine-learning algorithms were “groundbreaking and ahead of their time” and did not fit conventional publication frameworks. Critics responded that if the treatment worked as advertised, sharing the data would benefit millions of allergy patients, and that keeping it proprietary looked more like self-interest than science.¹

FAI has since published. A 2023 study in PLOS ONE described the machine-learning model underlying TIP’s diagnostic markers.⁵ A 2024 paper in the Journal of Allergy and Clinical Immunology: Global reported on long-term efficacy and safety of TIP for cow’s milk anaphylaxis.⁶

That 2024 paper drew a formal correspondence critique in the same journal. Researchers B.D. Modena, A. Ramsey, and S. Mustafa, joined by D. Jones and C. Caperton, argued that the study failed to provide standard measures of oral immunotherapy efficacy, including time to maintenance dose, dropout numbers, and specific pass rates for oral food challenges. They also said the description of the AI methodology lacked critical details such as specific algorithms, input features, model parameters, and performance metrics. Without those elements, they wrote, “it is impossible to draw meaningful conclusions” about TIP’s success rates and safety.⁶ Allergist Richard L. Wasserman raised similar concerns about data breadth and reproducibility.⁷

Randhawa and co-author Nathan Marsteller defended their methodology in a published reply, saying their database draws on longitudinal lab data including skin-prick tests, interleukin panels, complete blood counts, and immunoglobulin testing. They dismissed some of the criticism as reflecting “pedestrian experience in data science” and argued that replicating TIP requires a multidisciplinary effort built on nearly two decades of applied mathematics and immunobiology data.⁷

Regulatory Status

TIP is not FDA-approved. The institute’s own FAQ says “most food allergy treatments, like TIP and Oral Immunotherapy (OIT), do not fit within the categories of FDA approval,” which it describes as typically reserved for drugs, biologics, and medical devices. The program operates under Institutional Review Board oversight from Advarra.⁸ In 2023, FAI described its PLOS ONE study as a “precursor to our pending FDA submission for approval of TIP as a medical treatment model,” but no subsequent public update has confirmed whether that submission was made.⁵

No publicly available regulatory action against the institute or Dr. Randhawa has been reported. The disputes have unfolded through patient advocacy, journalism, and scientific correspondence, not through courts or agencies.

Where the Institute Stands Today

The Food Allergy Institute remains fully operational. It opened a new East Bay, California location in July 2025, and Dr. Randhawa continues as CEO and Chief Medical Officer. The clinic says it has treated more than 10,000 patients and employs over 200 staff, and it now offers accredited continuing medical education courses along with an epinephrine auto-injector training program for businesses and the public.⁹¹⁰

1
Undark. An Unusual Allergy Clinic Aims to Disrupt Medicine
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Change.org. Increase Transparency to Better Serve Patients — Tolerance Induction Program TIP at SCFAI
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Food Allergy Institute. TIP Treatment Cost
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Food Allergy Institute. TIP Cost
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BioSpace. Newly Published Study Demonstrates the Clinical Effectiveness of Machine Learning Used to Achieve Remission in Patients With Peanut Allergies
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JACI Global. Correspondence re: Randhawa et al, TIP’s Success in the Treatment of Cow’s Milk Anaphylaxis
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National Center for Biotechnology Information. Reply to Correspondences re: Long-Term Efficacy and Safety of Cow’s Milk Anaphylaxis Specific Immunotherapy
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Food Allergy Institute. TIP FDA Approval
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Food Allergy Institute. Upcoming Events
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Food Allergy Institute. News and Media