TIP is suitable for individuals between 6 months and 25 years of age. From a parent's perspective, the only requirement for TIP is to ensure that your child consistently consumes specific foods daily during the treatment. As long as your child maintains a healthy appetite, they are considered a suitable candidate for TIP. If there are any issues with flavors, taste, or texture, our TIP team is ready to assist you with recipes and techniques to make food proteins more appealing.

The Tolerance Induction Program™ (TIP) is not currently available through providers outside of California. The program requires specialized facilities, and allergist's offices are not equipped to offer TIP. TIP is considered cutting-edge, utilizing AI technology that demands significant data for development and operation. The biosimilar protein immunotherapy of TIP is also at the forefront of scientific research, necessitating years of study and development. As seen in the progression of AI in other fields, advanced technology requires time for comprehensive development. TIP, with a specific focus on children, has evolved gradually to maximize safety and outcomes.

While TIP is not throughout the entire United States, patients from across the country and around the world have sought treatment at our two California locations since 2008.

The duration of the Tolerance Induction Program™ (TIP) varies based on the individual's immune system, and the type and total number of allergens. TIP treats all allergens simultaneously, meaning if a child is allergic to five foods, they will undergo TIP while openly consuming all five foods. The advanced diagnostic testing, aided by AI, can identify allergies to specific food proteins, such as seeds or fish, that patients may not be aware of initially. These additional allergens will also be addressed during the treatment.

At the conclusion of TIP, individuals will no longer have to worry about food allergies. The average duration of treatment is approximately 2.5 - 4 years, but the specific time frame varies based on the results of the AI diagnostic testing for each individual.

Yes, the Tolerance Induction Program (TIP) is specifically designed to address the needs of children with conditions such as Crohn's disease, Celiac, FPIES, or EoE. Our program utilizes comprehensive data analysis to evaluate food anaphylaxis in patients who may have additional medical conditions. Once the intake process is completed and AI diagnostics are received, our experienced medical providers at FAI will provide personalized guidance to address these specific conditions in conjunction with the Tolerance Induction Program.

Regarding FPIES, while we do treat patients with IgE mediated diseases, we do not specifically treat FPIES. Allergic reactions and anaphylaxis are primarily mediated by immunoglobulin E (IgE) and are associated with the release of mast cells and basophil immune mediators. TIP focuses on treating IgE mediated systemic allergic diseases, while FPIES is a non-IgE mediated condition that affects the gastrointestinal tract.

As for EoE, although our program does not directly treat EoE, we have successfully treated patients with this condition. During the program, we will only introduce foods that your child is allergic to, which may not necessarily be the triggers for EoE. If the food being treated is also a trigger for EoE, your child will be prescribed medications to help control EoE symptoms. While EoE is something we can monitor and account for during the program, it may not necessarily improve as a result of the program. We have patients with EoE who require a slower and more cautious treatment plan. Here are some commonly asked questions about EoE that we discussed during our phone consultation:

- When should a patient undergo a scope, before onboarding or at launch?

If a patient has a history of EoE, we prefer to have the results prior to the launch appointment so that we can review them. If the results indicate uncontrolled EoE, it is important to get it under control before we start introducing and challenging foods.

- Is a scope necessary to start the program?

A scope may be highly recommended or required based on a patient's history, current medications, and symptoms. This will be discussed during your tele boarding appointment, which is a zoom appointment with your clinical provider scheduled three weeks before your in-person onboarding appointment.

- How long are the scope results valid for?

Ideally, we prefer scope results from within the last year, as long as there are no acute changes.

- How frequently should a scope be done during the treatment?

We defer to the family GI doctor for this decision. The frequency of scopes depends on the medications the child is on, the symptoms they are experiencing, and whether we are introducing potential triggers through our food treatment. Some patients already know their triggers, and if those triggers are not their anaphylactic foods, they can simply avoid them throughout the treatment without requiring frequent scopes.

Yes, TIP is designed to treat children with conditions such as Crohn's disease, Celiac, FPIES, or EoE. The program utilizes extensive data to evaluate food anaphylaxis in patients who may have additional medical conditions. Upon completion of the intake process and receipt of AI diagnostics, the medical providers at FAI will offer guidance tailored to address these specific conditions in conjunction with the Tolerance Induction Program.

Does TIP Treat FPIES
Although we DO treat patients who have FPIES for IgE mediated disease we do not treat FPIES.   

Allergic reactions and anaphylaxis are mediated by immunoglobulin E (IgE) and lead to the release of mast cells and basophil immune mediators.  TIP treats IgE mediated systemic allergic disease while FPIES is a non-IgE mediated condition localized to the gastrointestinal tract.  

Does TIP treat EOE?
Though our program does not treat EOE, we successfully treat patients with EOE. We will only dose through foods that your child has allergies to which may not be the triggers of EOE. If the food we are treating is also a trigger for EOE, then your child will be on medications that will help control EOE symptoms. EOE is something we are able to account for and monitor while in the program but not necessarily something that will improve due to the program. We have patients that have EOE and move slower and more cautious with their treatment plan. Below are some commonly asked questions regarding EOE that we started to speak about over the phone:

When does a patient need to have a scope done, before onboarding or launch?

If a patient has a history of EOE we like to have results back with time to review them prior to the launch appointment.  If a patient gets results and shows that he/she has EOE that is uncontrolled we really need that under control before we start introducing foods and challenging foods. 

Is a scope required to start the program?

There are certain patients it will be highly recommended for and others that it will be required for based on their history, the medications they are on, and any current symptoms they have.  That will be discussed during your tele boarding appointment which is your zoom appointment with your clinical provider which is scheduled three weeks prior to your onboarding appointment in person. 

How long are the results good for?

We like to have scope results within the last year as long as there are no acute changes. 

How often does a scope need to be done while in treatment?

We defer to a family GI doctor on this.  It is based on the medications a child is on, symptoms they are having, and if we are introducing any potential triggers through our food treatment.  Some patients already know their triggers, and their triggers are not their anaphylactic foods, so they just avoid those throughout treatment and they do not have to do frequent scopes.

 

Medication during TIP is generally not mandatory. The only medications that may be regularly used during the Tolerance Induction Program™ (TIP) are those to control pollen allergies, such as over-the-counter antihistamines and nasal sprays. The use of these medications is recommended when necessary to manage environmental factors. It is important to remember that during TIP, the goal is to have the immune system focus on food proteins rather than being diverted to environmental factors. Therefore, any medication used is primarily for the control of environmental allergies and not directly related to the TIP process itself.

In Biosimilar Protein Immunotherapy, a component of TIP, a key milestone occurs within the first year, where lower level anaphylaxis-inducing foods are often cleared, and patients can freely consume them. TIP also conditions the immune system towards other food allergens, evidenced by reduced blood lab values for allergens like peanuts, even if not yet reintroduced. Continuous monitoring via data, AI, and medical oversight ensures a safe and smooth journey. Successfully completing challenges, such as allergen reintroduction, signifies progress. Our focus on primary allergen data response indicates the effectiveness of TIP, leading to a secure path to Food Freedom.

TIP centers around a singular outcome – enabling individuals, whether children or adults, to openly and without restrictions consume all foods, including those they are allergic to. This capability distinguishes TIP from OIT or Palforzia, as they lack the ability to achieve this comprehensive outcome. TIP places a primary focus on safety and minimizing side effects, a feature that is not prioritized in OIT or Palforzia. Moreover, TIP stands out by utilizing machine learning and AI to simultaneously address all food allergies, a unique approach not found in OIT or Palforzia. Comparatively, there is limited overlap between TIP and other treatments. TIP emerges as the future of food anaphylaxis treatment.

With the Tolerance Induction Program™ (TIP), patients establish tolerance to their allergens through the progressive introduction of biosimilar proteins, structurally similar to their allergens. This allows patients to safely desensitize their immune system before initiating allergen dosing. In contrast, the safety of OIT has raised concerns, as revealed in systematic reviews and meta-analyses over the last three years. Up to 91.5% of adverse reactions were observed during OIT in all treated patients, occurring in 16% of the administered doses, with a success rate ranging between 60% to 80%. In contrast, TIP boasts an adverse reaction rate of less than 1% and a success rate of 99%.

The 1% of patients who may not achieve remission are typically those facing challenges with non-compliance in their food dosing regimen. It's crucial to note that FAI enrolls the most severe food allergy patients, and our extensive experience allows us to address even the most complex cases. Therefore, for those in the 1%, we are dedicated to finding solutions. In such cases, we often continue treatment using advanced data methods and proteins to ensure they too can attain Food Freedom. As long as the patient and the family are committed to reaching remission, the Food Allergy Institute remains steadfast in achieving this goal.

The gummy doses we provide contain the following ingredients: Water, Granulated Sugar, Beef Gelatin, Citric Acid, Potassium Sorbate, Artificial Flavor, Artificial Color, and Cornstarch. Currently, we do not offer options that are vegan, kosher, halal, or free of dyes. Our gummies are essential to our program and are made with beef gelatin, which we consider a critical component. We source each allergen in its powdered or flour form exclusively from suppliers who have been rigorously vetted by our clinical team. To avoid cross-contamination, we use separate equipment for each allergen.

Gummy dosing is not a matter of choice but a vital aspect of maintaining quality control in the TIP program. We do not accommodate requests to exclude sugar or food dyes.

Please note that all our gummies are made with beef gelatin without any alternatives. Patients may seek an exemption for religious reasons through their religious leader.

In rare instances, patients with a severe allergy to beef may not start with gummy dosing until they have successfully overcome their beef allergy via microdosing the actual protein. This approach is determined individually for each case.

Our Food Laboratory and its scientists are in the process of developing new types of food proteins that are both colorless and vegan. We will keep you updated on these advancements.

Approval for such requests is considered on a case-by-case basis. It's important to note that TIP is specifically designed based on data science targeting immune system responses and food protein sequences. Introducing additional treatments or herbal supplements may have an impact on the TIP system. We encourage you to undergo the intake process and discuss this option with your TIP medical provider for personalized guidance.

Remission opens up a whole new world! When someone asks about any food "restrictions," the answer is a resounding no. No more scrutinizing labels, avoiding restaurants, or skipping social gatherings. Live your life and enjoy food without the limitations of allergies. There are no restrictions; you can eat whatever you desire whenever you choose. FAI only requests compliance with weekly 1 dosing (or less, depending on the year of remission) and participation in annual blood lab data testing and analysis. While the use of epinephrine auto-injectors is almost nonexistent in remission, FAI still recommends carrying one. Our ongoing scientific goal is to eliminate the need for carrying an epinephrine auto injector.

Over  8,000 + patients have reached remission.  In 2023 One patient every day will successfully reach Food Freedom.

Remission patients will have a minimum dose of the lead food in each of their allergen groups that will drop down in frequency over time. This minimum dose will be required indefinitely to ensure your child’s ongoing tolerance and ability to freely eat. The program is designed to move your child into deeper and deeper states of tolerance, though large and infrequent exposure to their once most allergic foods. Regularly scheduled remission visits will adjust dosing schedules over time.

On average:

Zone 1 (Pacific + Mountain Time Zone + Arizona) every 6- 8 weeks for 1 - 2 days of appointments.

Zone 2 (Central + East Time Zone + Alaska + Hawaii) every 10 - 12 weeks for 2-3 days of appointments

Zone 3 (International) every 12 - 14 weeks for 3-5 days of appointments

Yes, typically if your child is taking allergy shots for environmental allergies this will be converted to sublingual immunotherapy or SLIT used to treat environmental allergens that share proteins with food allergies.