Ready, Set, Food! Makes Allergen Exposure Easy and Effective Daily supplement Mixes easily with formula or breast milk Prevents 80% of food allergies Product Benefits Easy: Mixes with breastmilk, formula, or food Natural: Organic, non-GMO, no added sugar Effective: Follows medical studies Safety: Starts with a gentle low dose 51
FAQs + Glossary 53
FAQs Early Allergen Introduction What is early allergen introduction, and what does it mean for my baby? Early allergen introduction is the process of gradually introducing common allergenic foods to your baby as early as four months of age. Recent groundbreaking clinical trials have offered scientific evidence that there is no benefit to delaying introduction of allergenic foods like peanuts, eggs, and cow’s milk to infants beyond 4 to 6 months of age. In fact, the data demonstrates that delaying the introduction of these foods may increase your baby’s risk of developing allergies. Therefore, early and sustained introduction of allergenic foods can help prevent food allergies. What are the current guidelines? Where did they come from? The current guidelines for early allergen introduction are to introduce and sustain small amounts of common allergenic foods between 4 and 6 months of age. These guidelines are supported by modern scientific studies performed in recent years. These new guidelines were noteworthy because for decades, many experts (particularly pediatricians and allergists) had been recommending that infants avoid potential allergens during their first year, particularly peanut. Specifically, in 2017, the AAP (American Academy of Pediatrics), NIH (National Institutes of A Parent’s Guide to Food Allergies readysetfood.com
Health), and FDA (Food and Drug Administration) all confirmed that feeding your baby peanut-containing foods early and often helps prevent peanut allergy. Ready, Set, Food! is a science-based product that was developed as a result of these guidelines and three recent clinical studies that were all independently funded and commissioned to determine the role of allergenic food introduction before six months of age in food allergy prevention. These pivotal studies are the LEAP (Learning Early About Peanut Allergy) study, the EAT (Enquiring About Tolerance) study, and the PETIT (Prevention of Egg Allergy in High-Risk Infants with Eczema) study. You can learn more in depth about these studies by viewing the full studies, or by viewing their summaries here. Why recommend early allergen introduction for all children and not exclusively those at risk? All babies are at risk for developing food allergies. While babies with a food allergy family history or eczema are at higher risk, studies conclusively show that over 50% of all food allergies occur in children with no direct family history of food allergy. As a baby’s immune system develops, parents only get one chance for creating a positive response to allergenic foods. How late is too late to start early allergen introduction? In the major clinical trials, some babies started as late as 11 months and still found a reduction in food allergies. So while it’s more effective to start as early as 4 months, we recommend starting as soon as possible, as long as your baby is under one year of age. 55
If your baby is over one year of age, please consult with your pediatrician on how to best begin with early allergen introduction. I consistently consumed peanut, egg, and milk during pregnancy and/or while breastfeeding. Do I still need to do early allergen introduction? Currently, doctors and scientists do not believe that specific maternal diets during pregnancy or breastfeeding are enough to reduce the risk of food allergies, but this area is still being studied. Although breastfeeding imparts countless benefits for mother and child, there is still inconclusive evidence proving that breastfeeding alone can reduce a baby’s risk of developing food allergies. Therefore, in addition to breastfeeding, early and sustained allergen introduction is recommended, regardless of the mother’s diet. What do I do if I’m exclusively breastfeeding and my baby isn’t ready for solid foods at 4 months? Current NIH and AAP guidelines clearly recommend introducing allergens as early as 4 months of age, but we understand that this may be earlier than when many parents want to introduce solids. That’s exactly why we designed Ready, Set, Food! to easily mix with breast milk. Given this, breastfeeding mothers can continue to exclusively nurse without having to introduce solids before their baby is ready to eat, while at the same time being able to help lower their child’s risk of developing food allergies. The landmark clinical trials on food allergy prevention also showed that early allergen introduction had no negative impact on breastfeeding. A Parent’s Guide to Food Allergies readysetfood.com
FAQs Ready, Set, Food! Is Ready, Set, Food! safe? I’m nervous about introducing allergenic foods to my baby. Ready, Set, Food! gradually introduces one food at a time, starting with very small amounts of each allergenic protein. In fact, our starting amounts are significantly less than what families typically first feed their infants. Our dosages by allergen are equivalent to less than 1 teaspoon of yogurt or cow’s milk, 1/8th teaspoon of peanut butter, and 1/250th of a cooked egg. Just three ingredients, all organic and sourced from the best quality farms. Given this, we are confident that our system provides the most gentle, yet methodical approach to exposing your baby to these common allergenic foods. Why do you recommend starting Ready, Set, Food! as early as 4 months old? Results of landmark clinical studies show that the ideal window of opportunity to expose your baby to food allergens is around 4 - 6 months of age in order to reduce their risk of developing a peanut, egg, or milk allergy by up to 80%. However, since many infants are not ready to eat solid food until after 6 months, our system allows parents to start as early as the guidelines suggest while the baby is still drinking breast milk or formula. 57
How long would I need to use Ready, Set, Food! to ensure the most effectiveness of early allergen introduction? The clinical trials and current guidelines recommend 3 to 6+ months of regular, sustained exposure to common allergenic foods. In fact, in the LEAP study, babies were exposed to allergens for 4 years! It all depends on when a parent begins early allergen introduction, but the right time to finish early allergen introduction is when a baby is regularly consuming peanut, egg, and dairy at least three times per week through solid food. For many families, this will be about 6 months from starting. My baby has eczema. Is Ready, Set, Food! right for my baby? Studies have determined that early allergen introduction is particularly important for this group, as infants with eczema actually have a significantly higher risk of developing food allergies. However, if your infant’s eczema is severe, current guidelines recommend having your baby tested for certain allergies prior to starting early allergen introduction. Can my baby use Ready, Set, Food! if they have a parent or sibling with a food allergy? Yes! Our product arrives in a box containing individually sealed, foil-lined packets of pre-measured powder. These packets are designed to be easily poured directly into your baby’s bottle or mixed into solid food without unintentional contact with the powder itself, significantly reducing the chance of exposing at- risk family members to the allergens. A Parent’s Guide to Food Allergies readysetfood.com
Why is Ready, Set, Food! the best option to introduce and sustain food allergen exposure? As physicians and parents, we developed Ready, Set, Food! for our children. With just three organic ingredients and a transparent, guided system, it’s our mission to make early and sustained allergen introduction safe and easy, even for the pickiest of little eaters. We provide the peace of mind parents need as their babies begin their introduction to food by easing the burden on parents deciding what amount of each of these foods to expose their child to, in what order, and when and how to increase the exposure. There are many ways to safely introduce potential food allergens to babies during the first year of life, but some ways are easier than others. Each family has a different set of health conditions, lifestyle circumstances, and concerns or fears, so knowing the options out there and finding the best method for your family is vitally important. 59
Glossary A Allergen A food protein that someone’s immune system treats as a foreign invader, and that causes an allergic reaction when the person eats that food. Allergic When the body’s immune system mistakenly responds to certain foods that it thinks are harmful. Anaphylaxis A severe, life-threatening allergic reaction. When the symptoms of a food allergy are severe, and involve more than one organ system, it is classified as anaphylaxis. Anaphylaxis can lead to constricted airways in the lungs, severe lowering of blood pressure and shock, and suffocation by swelling of the throat. B Bamba An Israeli snack food manufactured from peanut butter and puffed maize, which was used as a peanut protein source for testing in the LEAP (Learning Early About Peanut Allergy) study. LEAP study results showed an 80% reduction of peanut allergy in high-risk infants who consumed the recommended amount of peanut protein (i.e. Bamba) per week for the suggested time A Parent’s Guide to Food Allergies readysetfood.com
period. Biphasic Reaction A second anaphylactic reaction that occurs 4 to 24 hours after the initial anaphylactic reaction, after the first reaction is treated with epinephrine. It can be less severe, just as severe, or more severe than the first reaction. Due to the possibility of a biphasic reaction, people with severe food allergies must have access to two epinephrine auto-injectors at all times C Celiac Disease A serious, gluten-related autoimmune disease that affects the intestines. If someone with celiac disease consumes gluten, it damages their small intestine. D Desensitized An increase in reaction threshold to a food allergen while receiving months of continued, active therapy that may equal protection from accidental ingestion. E Early and Sustained Allergen Introduction The process of gradually introducing common allergenic foods to your baby early and often, starting between 4-11 months of 61
age and continuing 2-7 times a week for several months. Recent groundbreaking clinical trials have offered scientific evidence that early and sustained introduction of allergenic foods, such as peanut, egg, and cow’s milk, can help reduce babies’ food allergy risk by up to 80%. Meanwhile, delaying introduction of common allergenic foods until after a baby’s first year of life may increase your baby’s risk of developing food allergies. Eczema Eczema is a general term for a group of inflammatory skin conditions. Atopic dermatitis, the most common type of eczema, causes red, dry, and itchy skin. In infants, this form of eczema usually affects the face, scalp, and skin creases, but can also affect other areas of the body. Research shows that infants with eczema are at the highest risk for developing food allergies. Epinephrine A life-saving, injected medication for treating allergic reactions; the only medication that can stop anaphylaxis. Also known as adrenaline. Promptly administering epinephrine using an autoinjector (such as an EpiPen) during early symptoms of anaphylaxis may help prevent serious consequences. F Food Allergy Food allergies cause the immune system to over-defend the body. When someone has a food allergy, their immune system mistakenly treats proteins in certain foods as foreign invaders. As a result, their body develops an allergic reaction each time they consume a food that they are allergic to. Symptoms of A Parent’s Guide to Food Allergies readysetfood.com
a food allergic reaction include hives, swelling of lips/tongue, stomach upset, breathing problems and other symptoms. Food Intolerance Adverse health effects caused by foods, which do not involve the immune system. Unlike food allergies, food intolerances are rarely ever life-threatening, and there is no validated test to diagnose a food intolerance. Common food intolerances include lactose intolerance and gluten-related disorders. FPIES Food Protein-Induced Enterocolitis Syndrome; a non-IgE mediated disorder that usually occurs in young infants. Symptoms include chronic vomiting, diarrhea, and failure to gain weight or height. When the allergenic food is removed from the infant’s diet, symptoms disappear. Milk and soy protein are the most common causes. G Gluten-Related Disorder Any disorder that causes intolerance to gluten, a protein present in many grains such as wheat, rye, and barley. These disorders range from mild gluten intolerance to the more serious celiac disease. Symptoms include skin swelling, shortness of breath, and gastrointestinal problems. Gluten-related disorders are intolerances, not allergies; there is no such thing as an allergy to gluten. An allergy to wheat is different than a gluten-related disorder because it causes an allergic immune response to a protein specifically found in 63
wheat. Meanwhile, gluten-related disorders are in response to gluten, which can be found in grains other than wheat. It is unknown what mechanisms cause this response to gluten. I IgE Antibodies Proteins produced by the immune system to defend the body, which reside in the bloodstream. When IgE is working properly, it defends against parasites and other possibly harmful substances that enter the body. It causes the body to develop coughing, wheezing, and hives when these substances enter the bloodstream. However, when someone has an IgE-mediated allergy to a certain food, their immune system makes special IgE antibodies to these allergens to help fight them off. These antibodies can help the cells cause a reaction each time a person eats a food they are allergic to. IgE-Mediated Food Allergy A food allergy that causes someone’s immune system to develop IgE antibodies to certain allergenic foods, such as milk, egg, peanut, or tree nuts, to help fight them off. Allergic reactions from IgE-mediated food allergies occur within minutes to hours of the person consuming the food. N Non-IgE Mediated Food Allergy A food allergy that involves different parts of the immune system, other than IgE antibodies. Allergic reactions with this A Parent’s Guide to Food Allergies readysetfood.com
type of allergy are more delayed, and occur within hours to days of food consumption. They often cause symptoms in the GI tract, such as vomiting, diarrhea, and blood and mucus in the stool. Non-IgE mediated food allergies are also known as delayed-type food allergies. O Oral Food Challenge A test which exposes a person to their potential allergenic food in small doses, slowly increasing over time with careful observation in a medical facility, to watch for signs of an allergic reaction. It is the only way to definitively diagnose a food allergy, but it can be risky. S Sustained Unresponsiveness After several years of therapy, a lack of clinical reaction to a food allergen after active therapy has been discontinued for a period of time. It requires some level of continued allergen exposure, and has been seen in only subsets of treated subjects. Stepwise Introduction A method of allergen introduction that starts with a low dose of an allergen and gradually increases to a higher dose, for maximum safety. 65
T Tolerance A complete lack of clinical reactivity to an ingested food allergen, not depending on continued food allergen exposure. V Vitamin D A vitamin that the body produces when it is exposed to sunlight. It is essential to helping the body maintain strong bones and teeth. Multiple studies suggest that vitamin D deficiency in a baby may result in increased risk of food allergies. 123 504 Plan A plan that details how a person with a disability will receive full participation in the benefits of public school. Having a food allergy falls into the disability category because major life activities can be impaired, such as breathing and eating, that would ultimately prevent a child from accessing the curriculum. A 504 Plan is essentially the written blueprint for how a school needs to accommodate your child in school. A Parent’s Guide to Food Allergies readysetfood.com
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Endnotes 1. Guidelines for the Diagnosis and Management of Food Allergy in the United States Summary for Patients, Families, and Caregivers. U.S. Dept of HHS National Institutes of Health National Institute of Allergy and Infectious Diseases NIH Publication No. 11-7699 May 2011 www.niaid.nih.gov 2. Food Allergy. American College of Allergy, Asthma, and Immunology. https://acaai.org/allergies/types/food-allergy. Published 2014. Accessed July 24, 2019. 3. Samady W, Trainor J, Smith B, Gupta R. Food-induced anaphylaxis in infants and children. Ann Allergy Asthma Immunol. 2018 Sep;121(3):360- 365. 4. Sampson et al. Food allergy: A practice parameter update—2014. J Allergy Clin Immunol. 2014 Nov; 134(5): 1016-25.e43. 5. AAAAI support of the EAACI Position Paper on IgG4. Adverse Reactions to Foods Committee, May 2010 6. Elli L, et al. Diagnosis of gluten related disorders: Celiac disease, wheat allergy and non-celiac gluten sensitivity. World J Gastroenterol. 2015 Jun 21;21(23):7110-9. 7. Gupta R, et al. The Public Health Impact of Parent-Reported Childhood Food Allergies in the United States. Pediatrics. Volume 142, number 6, December 2018:e20181235. 8. Nowak-Wegrzyn A, et al. Food-Allergic reaction in Schools and Preschools. Arch Pediatr Adolesc Med. 2001;155(7):790-795. 9. Warren C, et al. Prevalence, severity and distribution of adult-onset food allergy. ACAAI 2018; Abstract A311. 10. Egg Allergy. American College of Allergy, Asthma, and Immunology. https:// acaai.org/allergies/types-allergies/food-allergy/types-food-allergy/egg-aller- gy. Published 2014. Accessed July 24, 2019. 11. Milk & Dairy Allergy. American College of Allergy, Asthma, and Immunolo- gy. https://acaai.org/allergies/types-allergies/food-allergy/types-food-allergy/ milk-dairy-allergy 12. Savage J and Johns CB. Food Allergy: Epidemiology and Natural History. Immunol Allergy Clin North Am. 2015 Feb; 35(1): 45–59. https://www.ncbi. nlm.nih.gov/pmc/articles/PMC4254585/. Accessed July 24, 2019. 13. Gupta RS, Springston EE, Warrier MR, et al. The Prevalence, Severity, and Distribution of Childhood Food Allergy in the United States. Pediatrics Jul A Parent’s Guide to Food Allergies readysetfood.com
2011, 128 (1) e9-e17. https://pediatrics.aappublications.org/content/128/1/ e9.long. Accessed 24 July 2019. 14. Sicherer SH, Muñoz-Furlong A, and Sampson HA. Prevalence of seafood allergy in the United States determined by a random telephone survey. J Allergy Clin Immunol. 2004 Jul;114(1):159-65. https://www.ncbi.nlm.nih. gov/pubmed/15241360. Accessed July 24, 2019. 15. Savage JH, Kaeding AJ, Matsui EC, and Wood RA. The natural history of soy allergy. J Allergy Clin Immunol. 2010 Mar;125(3):683-6. https://www.ncbi. nlm.nih.gov/pubmed/20226303. Accessed July 24, 2019. 16. Annunziato RA, Rubes M, Ambrose MA et al. J Allergy Clin Immunology: In Practice 2014 Sep-Oct; 2(5): 639-641. Longitudinal evaluation of food allergy–related bullying. https://www.sciencedirect.com/science/article/pii/ S2213219814001871?via=ihub Accessed July 24, 2019. 17. Lack, G. Update on Risk Factors for Food Allergy. J Allergy Clin Immunol. 2012 May; 129(5): 1187–1197. 18. Sicherer SH, Sampson HA. Food allergy: A review and update on epidemi- ology, pathogenesis, diagnosis, prevention, and management. J Allergy Clin Immunol. 2018 Jan;141(1):41-58. 19. Tran, MM, et al. Predicting the atopic march: Results from the Canadian Healthy Infant Longitudinal Development Study. J Allergy Clin Immunol. 2018 Feb; 141(2): 601-607.e8. 20. Gupta RS, Walkner MM, Greenhawt M, et al. Food Allergy Sensitiza- tion and Presentation in Siblings of Food Allergic Children. J Allergy Clin Immunol Pract. 2016 Sep-Oct;4(5):956-62. https://www.ncbi.nlm.nih.gov/ pubmed/27421900. Accessed 24 July 2019. 21. Burks, AW et al. Treatment for Food Allergy. J Allergy Clin Immunol. 2018 Jan;141(1):1-9. 22. Jones, SM and Burks, AW. Food Allergy. N Engl J Med 2017;377:1168-76. 23. Sicherer SH, Sampson HA. Food allergy: A review and update on epidemi- ology, pathogenesis, diagnosis, prevention, and management. J Allergy Clin Immunol. 2018 Jan;141(1):41-58. 24. Food Allergy & Anaphylaxis Emergency Care Plan. Food Allergy Research and Education. https://www.foodallergy.org/life-with-food-allergies/food-al- lergy-anaphylaxis-emergency-care-plan. Published 2019. Accessed July 24, 2019. 25. Du Toit G, Roberts G, Sayre PH, et al. Randomized Trial of Peanut Con- sumption in Infants at Risk for Peanut Allergy. N Engl J Med 2015; 372:803- 813. 69
26. LEAP: Learning Early About Peanut Allergy. Immune Tolerance Network. http://www.leapstudy.co.uk/.Published 2015. Accessed July 23, 2019. 27. LEAP-ON Study Results. Immune Tolerance Network. http://www. leapstudy.co.uk/leap-study-results-0#.XThWmehKjIV. Published 2016. Accessed July 23, 2019. 28. Perkin MR, Logan K, Marrs T, et al. Enquiring About Tolerance (EAT) study: Feasibility of an early allergenic food introduction regimen. J Allergy Clin Immunol. 2016 May;137(5):1477-1486. https://www.ncbi.nlm.nih.gov/ pubmed/26896232. Accessed July 23, 2019. 29. Natsume O, Kabashima S, Nakazato J, et al. Two-step egg introduction for prevention of egg allergy in high-risk infants with eczema (PETIT): a randomised, double-blind, placebo-controlled trial. Lancet. 2017 Jan 21;389(10066):276-286. https://www.ncbi.nlm.nih.gov/pubmed/27939035. Accessed July 23, 2019. 30. ASCIA Guidelines: Infant feeding and allergy prevention. Australasian Society of Clinical Immunology and Allergy. https://www.allergy.org.au/ images/pcc/ASCIA_Guidelines_infant_feeding_and_allergy_prevention.pdf. Published 2016. Accessed July 23, 2019. 31. NIH-sponsored expert panel issues clinical guidelines to prevent peanut allergy. National Institutes of Health. https://www.nih.gov/news-events/ news-releases/nih-sponsored-expert-panel-issues-clinical-guidelines-pre- vent-peanut-allergy. Published 2017. Accessed July 23, 2019. 32. Newly issued clinical guidelines from the NIAID recommend early peanut introduction, not avoidance. American Academy of Allergy, Asthma & Immunology. https://www.aaaai.org/about-aaaai/newsroom/news-releases/ early-peanut-introduction. Published 2017. Accessed July 23, 2019. 33. Addendum Guidelines for the Prevention of Peanut Allergy in the United States: Report of the NIAID-Sponsored Expert Panel. National Institute of Allergy and Infectious Diseases. https://www.niaid.nih.gov/sites/default/ files/addendum-peanut-allergy-prevention-guidelines.pdf Published 2017. Accessed July 23, 2019. 34. FDA Acknowledges Qualified Health Claim Linking Early Peanut Intro- duction and Reduced Risk of Developing Peanut Allergy. U.S. Food and Drug Administration. https://www.fda.gov/food/cfsan-constituent-updates/ fda-acknowledges-qualified-health-claim-linking-early-peanut-introduc- tion-and-reduced-risk. Published 2017. Accessed July 23, 2019. 35. Preventing food allergy in your baby: a summary for parents. The British Society for Allergy and Clinical Immunology. https://www.bsaci.org/pdf/ A Parent’s Guide to Food Allergies readysetfood.com
Infant-feeding-and-allergy-prevention-PARENTS-FINAL-booklet.pdf. Pub- lished 2018. Accessed July 23, 2019. 36. Greer FR, Sicherer SA, Burks AW. The Effects of Early Nutritional Interven- tions on the Development of Atopic Disease in Infants and Children: The Role of Maternal Dietary Restriction, Breastfeeding, Hydrolyzed Formulas, and Timing of Introduction of Allergenic Complementary Foods. Pediatrics 2019 Apr, 143 (4). https://pediatrics.aappublications.org/content/143/4/ e20190281#xref-ref-30-1. Accessed July 23, 2019. 37. Timing of introduction of allergenic solids for infants at high risk. Canadian Paediatric Society. https://www.cps.ca/en/documents/position/allergen- ic-solids. Published 2019. Accessed July 23, 2019. For more information, visit ReadySetFood.com 71
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