Addendum Guidelines for the 

Prevention of Peanut Allergy 

in the United States 

Report of the NIAID-Sponsored Expert Panel 

ADDENDUM GUIDELINES FOR THE PREVENTION OF PEANUT ALLERGY IN THE UNITED STATES 3 

ADDENDUM GUIDELINES FOR THE PREVENTION 

OF PEANUT ALLERGY IN THE UNITED 

STATES: REPORT OF THE NATIONAL 

INSTITUTE OF ALLERGY AND INFECTIOUS 

DISEASES–SPONSORED EXPERT PANEL 

Alkis Togias, MD,a Susan F. Cooper, MSc,a,* Maria L. Acebal, JD,b Amal Assa’ad, MD,c James R. Baker, Jr, MD,d Lisa A. Beck, MD,e Julie Block,f Carol 

Byrd-Bredbenner, PhD, RD, FAND,g Edmond S. Chan, MD, FRCPC,h Lawrence F. Eichenfield, MD,i David M. Fleischer, MD,j George J. Fuchs III, MD,k 

Glenn T. Furuta, MD,l Matthew J. Greenhawt, MD, MBA, MSc,j Ruchi S. Gupta, MD, MPH,m Michele Habich, DNP, APN/CNS, CPN,n Stacie M. Jones, 

MD,o Kari Keaton,p Antonella Muraro, MD, PhD,q Marshall Plaut, MD,a Lanny J. Rosenwasser, MD,r Daniel Rotrosen, MD,a Hugh A. Sampson, MD,s 

Lynda C. Schneider, MD,t Scott H. Sicherer, MD,u Robert Sidbury, MD, MPH,v Jonathan Spergel, MD, PhD,w David R. Stukus, MD,x Carina Venter, 

PhD, RD,y and Joshua A. Boyce, MDz 

Bethesda, Md; McLean, Va; Cincinnati and Columbus, Ohio; Ann Arbor, Mich; San Rafael and San Diego, Calif; New Brunswick, NJ; Vancouver, 

British Columbia, Canada; Aurora, Colo; Lexington, Ky; Chicago and Winfield, Ill; Little Rock, Ark; Rockville, Md; Padua, Italy; Kansas City, Mo; 

New York, NY; Boston, Mass; Seattle, Wash; and Philadelphia, Pa 

Background: Food allergy is an important public health problem because it affects children and adults, can be severe and even

life-threatening, and may be increasing in prevalence. Beginning in 2008, the National Institute of Allergy and Infectious Diseases,

working with other organizations and advocacy groups, led the development of the first clinical guidelines for the diagnosis and

management of food allergy. A recent landmark clinical trial and other emerging data suggest that peanut allergy can be prevented 

through introduction of peanut-containing foods beginning in infancy.

Objectives: Prompted by these findings, along with 25 professional organizations, federal agencies, and patient advocacy groups, the 

National Institute of Allergy and Infectious Diseases facilitated development of addendum guidelines to specifically address the 

prevention of peanut allergy.

Results: The addendum provides 3 separate guidelines for infants at various risk levels for the development of peanut allergy and is intended 

for use by a wide variety of health care providers. Topics addressed include the definition of risk categories, appropriate use of testing 

(specific IgE measurement, skin prick tests, and oral food challenges), and the timing and approaches for introduction of peanut-containing 

foods in the health care provider’s office or at home. The addendum guidelines provide the background, rationale, and strength of evidence 

for each recommendation.

Conclusions: Guidelines have been developed for early introduction of peanut-containing foods into the diets of infants at various risk levels 

for peanut allergy. 

Key words: Food, peanut, allergy, prevention, guidelines 
4 ADDENDUM GUIDELINES FOR THE PREVENTION OF PEANUT ALLERGY IN THE UNITED STATES

From the National Institute of Allergy and Infectious Diseases, 

Bethesda, Md;a

 the Board of Directors, Food Allergy Research 

& Education, McLean;b

 the Division of Allergy and Immunology, 

Cincinnati Children’s Hospital Medical Center, University of 

Cincinnati;c

 Food Allergy Research & Education, McLean, and the 

Division of Allergy and Clinical Immunology, University of Michigan 

Health System, Ann Arbor;d

 the Department of Dermatology, 

University of Rochester Medical Center;e

 the National Eczema 

Association, San Rafael;f

 the Department of Nutritional Sciences, 

Rutgers University, New Brunswick;g

 the Division of Allergy and 

Immunology, Department of Pediatrics, BC Children’s Hospital, 

University of British Columbia, Vancouver;h

 the Departments of 

Dermatology and Pediatrics, University of California, San Diego 

School of Medicine, Rady Children’s Hospital, San Diego;i

 the 

Section of Allergy and Immunology, Department of Pediatrics, 

Children’s Hospital Colorado, University of Colorado Denver School of 

Medicine, Aurora;j

 the Division of Gastroenterology, Hepatology, and 

Nutrition, Department of Pediatrics, University of Kentucky College 

of Medicine, Kentucky Children’s Hospital, Lexington;k

 the Digestive 

Health Institute, Children’s Hospital Colorado, Aurora, and the 

Section of Pediatric Gastroenterology, University of Colorado Denver 

School of Medicine, Aurora, Colo;l

 the Division of Academic General 

Pediatrics and Primary Care, Department of Pediatrics, and the Ann 

and Robert H. Lurie Children’s Hospital of Chicago, Northwestern 

University Feinberg School of Medicine, Chicago;m Northwestern 

Medicine, Central DuPage Hospital,Winfield;n

 the Division of Allergy 

and Immunology, Department of Pediatrics, University of Arkansas 

for Medical Sciences, Arkansas Children’s Hospital, Little Rock;o 

Metro DC Food Allergy Support Group, Rockville;p

 the Food Allergy 

Referral Centre, Department of Women and Child Health, Padua 

University Hospital;q

 University of Missouri-Kansas City School of 

Medicine, Kansas City;r

 the Division of Allergy and Immunology, 

Department of Pediatrics,s

 and the Division of Pediatric Allergy and 

Immunology, Icahn School of Medicine at Mount Sinai, New York;u 

the Division of Allergy and Immunology, Boston Children’s Hospital;t 

the Department of Pediatrics, Division of Dermatology, Seattle 

Children’s Hospital, University of Washington School of Medicine, 

Seattle;v

 the Division of Allergy and Immunology, Department of 

Abbreviations used:

CC: Coordinating Committee

EP: Expert Panel 

GRADE: Grading of Recommendations 

Assessment, Development and Evaluation

EAP: Learning Early about Peanut Allergy

NIAID: National Institute of Allergy and 

Infectious Diseases

OFC: Oral food challenge

sIgE: Specific IgE

SPT: Skin prick test

Pediatrics, Children’s Hospital of Philadelphia, Perelman School 

of Medicine at University of Pennsylvania, Philadelphia;w the 

Department of Pediatrics, Section of Allergy and Immunology, 

Nationwide Children’s Hospital, Ohio State University College of 

Medicine, Columbus;x

 the Division of Allergy and Immunology, 

Cincinnati Children’s Hospital Medical Center;y

 and the Departments 

of Medicine and Pediatrics, Harvard Medical School, Boston.z 

Published on behalf of the American Academy of Allergy, Asthma & 

Immunology; American College of Allergy, Asthma & Immunology; 

Canadian Society of Allergy and Clinical Immunology; Society for 

Pediatric Dermatology; World Allergy Organization; and Society of 

Pediatric Nurses. Copublished in the Journal of Allergy and Clinical 

Immunology; Annals of Allergy, Asthma & Clinical Immunology; 

Allergy, Asthma & Clinical Immunology; World Allergy Organization 

Journal; Pediatric Dermatology; and the Journal of Pediatric Nursing. 

Disclosure of potential conflict of interest: A. Assa’ad received travel 

support from the American College of Allergy, Asthma & Immunology 

(ACAAI); was an elected member of the Board of Directors for the 

American Academy of Allergy, Asthma, & Immunology (AAAAI) from 

March 2012 to March 2016; has consultant arrangements with 

Aimmune; is employed by Cincinnati Children’s Hospital Medical 

Center; has received grants from DBV Technologies, Aimmune, 

Stanford Foundation, TEVA Pharmaceuticals, GlaxoSmithKline, 

the National Institutes of Health (NIH), Astellas, and Food Allergy 

Research & Education (FARE); and has received payment for lectures 

from the ACAAI. C. Byrd-Bredbenner and G. J. Fuchs III have received 

travel support from the NIH/National Institute of Allergy and 

Infectious Disease (NIAID). E. S. Chan has received travel support 

from the NIAID, has received grants from DBV Technologies, and has 

received payment for lectures from Pfizer, Sanofi, Mead Johnson, and 

Nestle. D. M. Fleischer has received travel support from the NIAID; is 

a board member for the National Peanut Board, the FAACT Medical 

Advisory Board, and the FARE Medical Advisory Board; has consultant 

arrangements with Adamis Pharmaceuticals Corporation, INSYS 

Therapeutics, DBV Technologies, Aimmune Therapeutics, Intrommune 

Therapeutics, and Kaleo Pharma; is employed by University 

Physicians; has received grants from Monsanto Company, Nestle 

Nutrition Institute, DBV Technologies, and Aimmune Therapeutics; 

has received payment for lectures from Nestle Nutrition Institute; 

and has received royalties from UpToDate. M. J. Greenhawt has 

received a grant from the Agency for Healthcare Research and Quality 

(1K08HS024599-01, Career Development Award); has received travel 

support from the NIAID and the Joint Taskforce on Allergy Practice 

Parameters; has a board membership with the National Peanut 

Board; has consultant arrangements with Adamis Pharmaceuticals, 

the Canadian Transportation Agency, Nutricia, Nestle/Gerber, 

Aimmune, Kaleo Pharmaceutical, and Monsanto; is an Associate 

Editor for the Annals of Allergy, Asthma, and Immunology; has 

received payment for lectures from the ACAAI, Reach MD, Thermo 

Fisher Scientific, the California Society for Allergy and Immunology, 
ADDENDUM GUIDELINES FOR THE PREVENTION OF PEANUT ALLERGY IN THE UNITED STATES 5 

the Allergy and Asthma Network, the New England Society for 

Allergy, UCLA/Harbor Heiner Lectureship, Medscape, the Western 

Michigan School of Medicine, the Canadian Society of Allergy and 

Clinical Immunology, and the Pennsylvania Society for Allergy and 

Immunology. R. S. Gupta has consultant arrangements with BEFORE 

Brands and DBV Technologies; has received grants from the NIH, 

FARE, and Mylan LLC; has received payment for lectures from Grand 

Rounds; and has received royalties from Createspace Independent 

Publishing Platform. S. M. Jones is on the Research Advisory Board 

for FARE; is on the Scientific Advisory Board for Aimmune; has 

consultant arrangements with Stallergenes; has received grants from 

the NIH/NIAID (Consortium of Food Allergy Research and Immune 

Tolerance Network–IMPACT Trial), FARE, Aimmune Technologies, DBV 

Technologies, and the National Peanut Board; has received payment 

for lectures from the Kansas City Allergy Society, Mercy Children’s 

Hospital, Riley Children’s Hospital, Southwester Medical School– 

Children’s Medical Center, the European Academy of Allergy & Clinical 

Immunology, the New York Allergy & Asthma Society, the University 

of Iowa Paul M. Seebohm Lectureship in Allergy, and the Iowa Society 

of Allergy, Asthma, and Immunology. A. Muraro has consultant 

arrangements with Meda, Novartis, and Menarini; is employed by 

Padua University Hospital; and has received payment for lectures 

from Meda and Menarini. L. J. Rosenwasser is a board member 

for the World Allergy Organization. H. A. Sampson has consultant 

arrangements with Allertein Therapeutics, Genentech/Roche, Sanofi, 

Stallergenes, Danone, and Merck; is employed part time as Chief 

Scientific Officer for DBV Technologies; has received grants from the 

NIAID and the Immune Tolerance Network; has received royalties 

from UpToDate and Elsevier; has been offered stock options in DBV 

Technologies; and is chairman of PhARF Award Selection Committee 

for Thermo Fisher. L. C. Schneider is on the Medical Advisory Board 

for FARE, has received a grant from DBV Technologies, and has 

received stock/stock options in Antera Therapeutics. S. H. Sicherer 

has received grants from the NIAID, FARE, and HAL Allergy; has 

received royalties from UpToDate; and is serving as Associate Editor 

for the Journal of Allergy and Clinical Immunology: In Practice. R. 

Sidbury has received travel support from the NIH and the Hawaii 

Dermatology Seminar, has consultant arrangements with Anacor, 

has provided expert witness testimony on behalf of Roche in 

Accutane–inflammatory bowel disease cases, has received a grant 

from Epidermolysis Bullosa Research Partnership, has received 

payment for lectures from the Taiwanese Dermatological Society, 

and has received royalties from UpToDate. J. Spergel has consultant 

arrangements with DBV Technologies and Danone; has received 

grants from DBV Technologies, Aimmune Therapeutics, and the NIH; 

has received payment for lectures for Dartmouth College, the ACAAI, 

and the Florida Allergy Society; and has received stock/stock options 

in DBV Technologies. D. R. Stukus has received payment for lectures 

from the ACAAI. C. Venter has consultant arrangements with Danone 

and Nestle, has received payment for lectures from Mead Johnson, 

and has received travel support from Thermo Fisher. The rest of the 

authors declare that they have no relevant conflicts of interest.

Received for publication September 16, 2016; accepted for 

publication October 18, 2016.

* Corresponding author: 

Susan F. Cooper, MSc, 

Division of Allergy, Immunology, and Transplantation, 

National Institute of Allergy and Infectious Diseases, 

National Institutes of Health, 

5601 Fishers Lane, Room 7C28, Rockville, Md 20892. 

E-mail: coopersu@niaid.nih.gov 
6 ADDENDUM GUIDELINES FOR THE PREVENTION OF PEANUT ALLERGY IN THE UNITED STATES
ADDENDUM GUIDELINES FOR THE PREVENTION OF PEANUT ALLERGY IN THE UNITED STATES 7 

INTRODUCTION 

Peanut allergy is a growing public health problem. In 1999, 

peanut allergy was estimated to affect 0.4% of children and 

0.7% of adults in the United States,1

 and by 2010, peanut allergy 

prevalence had increased to approximately 2% among children 

in a national survey,2

 with similar results reported in a regional 

cohort.3

 Peanut allergy is the leading cause of death related to 

food-induced anaphylaxis in the United States,4,5

 and although 

overall mortality is low, the fear of life-threatening anaphylactic 

reactions contributes significantly to the medical and psychosocial 

burden of disease. In the majority of patients, peanut allergy 

begins early in life and persists as a lifelong problem. Therefore, 

cost-effective measures to prevent peanut allergy would have 

a high effect in terms of improving public health, reducing 

personal suffering, and decreasing health care use and costs. 

The “Guidelines for the diagnosis and management of food allergy 

in the United States”6

 were published in December 2010 by an 

Expert Panel and a Coordinating Committee convened by the 

National Institute of Allergy and Infectious Diseases (NIAID). These 

guidelines did not offer strategies for the prevention of food allergy 

and particularly peanut allergy because of a lack of definitive 

studies at the time. The guidelines indicated that “insufficient 

evidence exists for delaying introduction of solid foods, including 

potentially allergenic foods, beyond 4 to 6 months of age, even 

in infants at risk of developing allergic disease.” This statement 

differed from previous clinical practice guidelines in the United 

Kingdom7

 and United States,8 which recommended the exclusion of 

allergenic foods from the diets of infants at high risk for allergy and 

is consistent with more recent recommendations regarding primary 

allergy prevention.9-12

In February 2015, the New England Journal of Medicine published 

the results of the Learning Early about Peanut Allergy (LEAP) trial.13 

This trial was based on a prior observation14 that the prevalence 

of peanut allergy was 10-fold higher among Jewish children in the 

United Kingdom compared with Israeli children of similar ancestry. 

In Israel, peanut-containing foods are usually introduced in the diet 

when infants are approximately 7 months of age and consumed in 

substantial amounts, whereas in the United Kingdom children do 

not typically consume any peanut-containing foods during their 

first year of life. The LEAP trial randomized 640 children between 

4 and 11 months of age with severe eczema, egg allergy, or both to 

consume or avoid peanut-containing foods until 60 months of age, 

at which time a peanut oral food challenge (OFC) was conducted to 

determine the prevalence of peanut allergy. LEAP trial participants 

were stratified at study entry into 2 separate study cohorts on 

the basis of pre-existing sensitization to peanut, as determined by 

means of skin prick testing: one cohort consisted of infants with no 

measureable skin test wheal to peanut (negative skin test response) 

and the other consisted of those with measurable wheal responses 

(1-4 mm in diameter). Infants with a 5 mm wheal diameter or greater 

were not randomized because the majority of infants at this level 

of sensitization were presumed to be allergic to peanut. Among the 

530 participants in the intention-to-treat population with negative 

baseline skin test response to peanut, the prevalence of peanut 

allergy at 60 months of age was 13.7% in the peanut avoidance 

group and 1.9% in the peanut consumption group (P < .001; an 

86.1% relative reduction in the prevalence of peanut allergy). Among 

the 98 participants with a measurable peanut skin test response at 

entry, the prevalence of peanut allergy was 35.3% in the avoidance 

group and 10.6% in the consumption group (P = .004; a 70% relative 

reduction in the prevalence of peanut allergy).

The LEAP trial was the first randomized trial to study early allergen 

introduction as a preventive strategy. Because of the size of the 

observed effect and the large number of study participants, its 

outcome received wide publicity in both the medical community and 

the press. This raised the need to operationalize the LEAP findings 

by developing clinical recommendations focusing on peanut allergy 

prevention. To achieve this goal and its wide implementation, the 

NIAID invited the members of the 2010 Guidelines Coordinating 

Committee and other stakeholder organizations to develop this 

addendum on peanut allergy prevention to the 2010 “Guidelines for 

the diagnosis and management of food allergy in the United States.” 

Twenty-six stakeholder organizations participated in this 2015–

2016 Coordinating Committee. Of note, unrelated to this effort, 

a consensus statement on behalf of 9 international professional 

societies regarding the implications and implementation of the LEAP 

trial findings was published as well.15

Additional evidence on early introduction of allergenic foods comes 

from the LEAP-On study,16 which demonstrated the durability of 

oral tolerance to peanut achieved in the LEAP trial and the Enquiring 

About Tolerance study,17 which assessed the potential benefits of 

early introduction of 6 allergenic foods in a non–high-risk cohort. 
8 ADDENDUM GUIDELINES FOR THE PREVENTION OF PEANUT ALLERGY IN THE UNITED STATES
ADDENDUM GUIDELINES FOR THE PREVENTION OF PEANUT ALLERGY IN THE UNITED STATES 9 

DEVELOPMENT OF THE 2017 ADDENDUM 

TO THE 2010 “GUIDELINES FOR THE DIAGNOSIS 

AND MANAGEMENT OF FOOD ALLERGY” 

The process to develop the 2017 Addendum closely followed that used in the 2010 Guidelines.6 

Coordinating Committee (CC) 

The NIAID established a Coordinating Committee (CC), the members 

of which are listed in Appendix A, to oversee the development of the 

addendum; review drafts of the addendum for accuracy, practicality, 

clarity, and broad utility of the recommendations in clinical 

practice; review and approve the final addendum; and disseminate 

the addendum. The CC members represented 26 professional 

organizations, advocacy groups, and federal agencies. 

Expert Panel (EP) 

The CC convened an Expert Panel (EP) in June 2015 that was 

chaired by Joshua Boyce, MD. The 26 panel members, listed in 

Appendix B, were specialists from a variety of relevant clinical, 

scientific, and public health areas. Panel members were nominated 

by the CC organizations, and the composition of the panel 

received unanimous approval by the CC member organizations.

The charge to the EP was to use the literature review prepared by the 

NIAID (see the next section) in conjunction with consensus expert 

opinion and EP-identified supplementary documents to (1) develop 

evidence-based recommendations for the early introduction of 

dietary peanut to prevent peanut allergy; (2) agree on principles for 

grading the evidence; (3) achieve consensus while allowing ample 

opportunity for consideration of divergent opinions; (4) determine 

whether the recommendations could extend beyond peanut to other 

food allergens; and (5) keep patient and societal interests at the 

forefront. The new recommendations are intended to supplement 

and modify guidelines 37 to 40 in Section 5.3.4 of the 2010 

guidelines: “Prevention of food allergy.”

Literature Review 

NIAID staff conducted a literature search of PubMed limited to 

the years 2010 (January) to 2016 (June). Using the following 

specific search terms ([food allergy or milk allergy or egg allergy or 

peanut allergy] OR [eczema or atopic dermatitis] AND prevention), 

PubMed returned more than 1500 articles. NIAID staff reviewed 

1506 abstracts and assessed each for relevance to the topic of 

food allergy prevention with an emphasis on peanut allergy. Sixtyfour publications (original research articles, editorials/letters, and 

systematic reviews) were deemed relevant and placed into 2 tiers: 

tier 1 contained 18 items considered highly relevant to the early 

introduction of peanut or other allergenic foods (see Appendix C), 

and tier 2 contained 46 items on related topics, such as food allergy 

or eczema prevention. 

Assessing the Quality of the Body 

of Evidence 

For each of the 18 tier 1 references, the EP assessed quality by using 

the Grading of Recommendations Assessment, Development and 

Evaluation (GRADE) approach.18 GRADE provides a comprehensive 

and transparent methodology to develop recommendations for the 

diagnosis, treatment, and management of patients. In assessing 

the body of evidence of a group of relevant articles or of a single 

article, GRADE considers study design and other factors, such as 

the precision, consistency, and directness of the data. By using this 

approach, GRADE then provides a categorical assessment of the 

contribution of individual publications and the overall quality and 

strength of the body of evidence. 

Each publication was assigned a grade according to the 

following criteria19,20:

• High—Further research is very unlikely to have an effect on the 

quality of the body of evidence, and therefore the confidence 

in the recommendation is high and unlikely to change. 

• Moderate—Further research is likely to have 

an effect on the quality of the body of evidence 

and may change the recommendation. 

• Low—Further research is very likely to have an 

important effect on the body of evidence and 

is likely to change the recommendation.

A GRADE designation of “low” for the quality of evidence does 

not imply that an article is not factually correct or lacks scientific 

merit. For example, a well-designed and executed single-site study 

of a treatment in a small cohort of highly selected subjects may 

still yield an overall GRADE rating of “low.” This is because such a 

study is characterized as providing “sparse” data, and the patient 

population may not be representative of the at-risk population. 

Each of these factors reduces the level of evidence from “high,” 

which is the initial designation for evidence from randomized 

controlled trials. It is worth emphasizing that these 2 limitations 

are not of the study per se but of the body of evidence. 
10 ADDENDUM GUIDELINES FOR THE PREVENTION OF PEANUT ALLERGY IN THE UNITED STATES

Preparation of the Draft Addendum 

The draft version of the addendum, prepared by the NIAID, contained 

3 new guidelines and was reviewed, modified, and endorsed by the 

EP members. The EP-approved document was forwarded to the CC 

members for review. 

Public Comment Period, Addendum 

Revision, and Final Approval 

Concurrent with CC member review, the draft addendum was posted 

to the NIAID Web site in March 2016 for a period of 45 days to allow 

for public review and comment. One hundred four comments were 

received. All comments were reviewed by the EP and the CC, and 

some contributed to the final revision of the addendum. The final 

addendum was reviewed and approved by the EP and the CC. 

Dissemination of the Addendum to 

the Guidelines 

The final addendum is published herein and available through 

the Internet. 

Defning the Strength of Each 

Clinical Guideline 

The EP has used the verb “recommends” or “suggests” for each 

clinical recommendation.

These words convey the strength of the recommendation, defined 

as follows:

• Recommend is used when the EP strongly recommended for or 

against a particular course of action.

• Suggest is used when the EP weakly recommended for or 

against a particular course of action. 
ADDENDUM GUIDELINES FOR THE PREVENTION OF PEANUT ALLERGY IN THE UNITED STATES 11 

ADDENDUM GUIDELINES 

Table I provides a summary of the 3 addendum guidelines to be used 

as a quick reference. 

The EP came to consensus on the following 3 definitions used 

throughout the addendum guidelines. 

• Severe eczema is defined as persistent or frequently recurring 

eczema with typical morphology and distribution assessed as 

severe by a health care provider and requiring frequent need 

for prescription-strength topical corticosteroids, calcineurin 

inhibitors, or other anti-inflammatory agents despite 

appropriate use of emollients. 

• Egg allergy is defined as a history of an allergic 

reaction to egg and a skin prick test (SPT) wheal 

diameter of 3 mm or greater with egg white extract, 

or a positive oral egg food challenge result.

• A specialist is defined as a health care provider with the 

training and experience to (1) perform and interpret SPTs and 

OFCs and (2) know and manage their risks. Such persons must 

have appropriate medications and equipment on site.

Addendum Guideline 1 

The EP recommends that infants with severe eczema, egg allergy, 

or both have introduction of age-appropriate peanut-containing 

food as early as 4 to 6 months of age to reduce the risk of peanut 

allergy. Other solid foods should be introduced before peanutcontaining foods to show that the infant is developmentally ready. 

The EP recommends that evaluation with peanut-specific IgE (peanut 

sIgE) measurement, SPTs, or both be strongly considered before 

introduction of peanut to determine if peanut should be introduced 

and, if so, the preferred method of introduction. To minimize a delay 

in peanut introduction for children who may test negative, testing for 

peanut sIgE may be the preferred initial approach in certain health 

care settings, such as family medicine, pediatrics, or dermatology 

practices, in which skin prick testing is not routine. Alternatively, 

referral for assessment by a specialist may be an option if desired by 

the health care provider and when available in a timely manner.

Fig 1 provides recommended approaches for evaluation 

of children with severe eczema, egg allergy, 

or both before peanut introduction.

A peanut sIgE level of less than 0.35 kUA/L has strong negative 

predictive value for the diagnosis of peanut allergy.21 Therefore, 

peanut sIgE testing may help in certain health care settings (eg, 

family medicine, pediatric, or dermatology practices, where skin prick 

testing is not routine) to reduce unnecessary referrals of children 

with severe eczema, egg allergy, or both and to minimize a delay in 

peanut introduction for children who may have negative test results. 

However, the EP emphasizes that a peanut sIgE level of 0.35 kUA/L 

or greater lacks adequate positive predictive value for the diagnosis 

of peanut allergy, and an infant with a value of 0.35 kUA/L or greater 

should be referred to a specialist. 

Thus, peanut sIgE testing can place an infant into one of 2 categories 

(Fig 1):

• sIgE Category A: If the peanut sIgE level is less than 0.35 

kUA/L (ImmunoCAP), the EP recommends that peanut 

should be introduced in the diet soon thereafter, with 

a cumulative first dose of approximately 2 g of peanut 

protein given in this feeding. This can be given as a feeding 

at home (Appendix D), considering the low likelihood 

of a severe allergic reaction. If the caregiver or health 

care provider has concerns, a supervised feeding can be 

offered at the health care provider’s office (Appendix E).

• sIgE Category B: If the peanut sIgE level is 0.35 

kUA/L or greater (ImmunoCAP), the EP recommends 

that the child be referred to a specialist for further 

consultation and possible skin prick testing.

The EP does not recommend food allergen panel testing or the 

addition of sIgE testing for foods other than peanut because of their 

poor positive predictive value, which could lead to misinterpretation, 

overdiagnosis of food allergy, and unnecessary dietary restrictions.6 

SPTs with peanut extract can place an infant in one of 3 categories 

(Fig 1):

• SPT Category A: If an SPT to peanut extract produces a 

wheal diameter of 2 mm or less above saline control, the 

EP recommends that peanut be introduced in the diet soon 

after testing, with a cumulative first dose of approximately 2 

g of peanut protein given in this feeding. This can be given at 

home (Appendix D), considering the low likelihood of a severe 

allergic reaction. If the caregiver or health care provider has 

concerns, a supervised feeding can be offered at the health 

care provider’s office (Appendix E).

• SPT Category B: If an SPT to peanut extract produces a wheal 

diameter of 3 to 7 mm greater than that elicited by the saline 

control, the EP suggests that a supervised peanut feeding 

or a graded OFC be undertaken at a specialist’s office or a 

specialized facility (see Appendices E and G, respectively). 

Infants in this category can be sensitized without being allergic 

to peanut and might benefit from early peanut consumption. 

If the supervised peanut feeding or graded OFC yields no 

reaction, the EP recommends that peanut should be added to 
ADDENDUM GUIDELINES FOR THE PREVENTION OF PEANUT ALLERGY IN THE UNITED STATES

Fig 1. Recommended approaches for evaluation of children with severe eczema and/or egg allergy before peanut introduction

* To minimize a delay in peanut introduction for children who may test negative, testing for peanut-specific IgE be the preferred initial approach in 

certain health care settings. Food allergen panel testing or the addition sIgE testing for foods otherthan peanut is not recommended due to poor 

positive predictive value.

Table I. Summary of addendum guidelines 1, 2, and 3 

Addendum guideline Infant criteria Recommendations Earliest age of peanut 

introduction

1 Severe eczema, egg allergy, or 

both 

Strongly consider evaluation 

by sIgE measurement and/or 

SPT and, if necessary, an OFC. 

Based on test results, introduce 

peanut-containing foods. 

4-6 months 

2 Mild-to-moderate eczema Introduce peanut-containing foods Around 6 months 

3 No eczema or any food allergy Introduce peanut-containing foods Age appropriate and in accordance 

with family preferences and 

cultural practices 

12 
ADDENDUM GUIDELINES FOR THE PREVENTION OF PEANUT ALLERGY IN THE UNITED STATES 13 

the child’s diet. If the supervised peanut feeding or the graded 

OFC results in an allergic reaction, the EP recommends that the 

child should strictly avoid dietary peanut and the family should 

be counseled regarding food allergy management. 

• SPT Category C: If an SPT produces a wheal diameter 8 mm or 

greater than that elicited by the saline control, the likelihood of 

peanut allergy is high. Children in this category should continue 

to be evaluated and managed by a specialist.21-23 

Important Considerations 

for Skin Prick Testing 

SPT reagents, testing devices, and methodology can differ 

significantly among health care providers in the United States 

or elsewhere.22 The EP recommends that specialists adjust 

their SPT categorization criteria according to their own training 

and experience. 

Health care providers conducting OFCs in infants with 3 mm 

or greater SPT responses should be aware that the probability 

of a positive challenge response increases with wheal size. 

These data come from the HealthNuts Study in children 12 to 

18 months of age; of note, the severity of these reactions was 

relatively mild.21,23 

How much dietary peanut protein to introduce. If the decision is 

made to introduce dietary peanut based on the recommendations 

of addendum guideline 1, the total amount of peanut protein 

to be regularly consumed per week should be approximately 

6 to 7 g over 3 or more feedings (see Appendix F). In the LEAP 

trial, at evaluations conducted at 12 and 30 months of age, 

75% of children in the peanut consumption group reported 

eating at least this amount of peanut, based on analysis of 

a 3-day food diary recorded just before the evaluation.

Rationale. Infants with severe eczema, egg allergy, or both are at high 

risk for the development of peanut allergy. Significant evidence on 

this group is available from the infants who participated in the LEAP 

trial or were screened for the LEAP trial but not enrolled because of a 

large SPT response (>4 mm). At 60 months of age, approximately 23% 

of peanut avoiders and those infants not enrolled had food allergy.24 

Balance of benefits and harms. In the LEAP trial, among the 530 

participants in the intention-to-treat population with negative 

baseline SPT responses to peanut, 13.7% of the avoidance group 

and 1.9% of the consumption group had peanut allergy at 60 

months of age (P < .001; a 12.6% absolute risk reduction and 

an 86.1% relative risk reduction in the prevalence of peanut 

allergy, resulting in a number needed to treat of 8.5 [number of 

infants needed to have early introduction of peanut to prevent 

peanut allergy in one child]). Among the 98 participants with 

positive peanut SPT responses at entry, 35.3% of the avoidance 

group and 10.6% of the consumption group had peanut allergy 

at 60 months of age (P = .004; a 24.7% absolute risk reduction 

and a 70% relative risk reduction in the prevalence of peanut 

allergy, resulting in a number needed to treat of 4).

The LEAP-On study24 demonstrated that the benefits achieved in the

LEAP trial persisted when LEAP trial peanut consumers subsequently 

avoided peanut for 1 year from 60 to 72 months of age. This indicates

that the oral tolerance achieved in the LEAP trial was durable. 

The LEAP trial did not include infants with SPT wheals greater 

than 4 mm, and therefore no data are available on the potential 

effectiveness of peanut consumption in preventing peanut allergy in 

this group. However, EP members believe it is possible that some of 

these infants may benefit from early introduction of peanut provided 

that they tolerate oral peanut. 

As shown in Fig 1, the EP recommends that infants with severe 

eczema, egg allergy, or both, with peanut sIgE levels of less than 

0.35 kUA/L or with a peanut SPT wheal of 2 mm or less have dietary 

peanut introduced as early as 4 to 6 months of age without a need 

for further evaluation. This recommendation is supported by expert 

opinion and analysis of the LEAP population findings. In the LEAP trial, 

infants consuming peanut in this post hoc defined category had a 

relative risk reduction of 79% of having peanut allergy at 60 months 

of age compared with infants who avoided peanut. 

In the LEAP trial, at study entry, all infants randomly assigned 

to the consuming group had a baseline peanut OFC. Of the 272 

infants with no wheal induced by peanut SPT and who received a 

baseline oral peanut challenge, only 1 had a reaction presenting as 

an erythematous urticarial rash that was graded as a “moderate” 

adverse event and was treated successfully with chlorpheniramine. 

Among the 29 infants with a wheal diameter of 1 to 2 mm who 

received a baseline oral peanut challenge, 2 had reactions, which 

also presented with mild symptoms not requiring treatment with 

epinephrine. Therefore, for the SPT Category A children, the risk of a 

severe reaction to peanut at first introduction is low, and introduction 

of peanut at home is an option. However, it is understandable that 

some caregivers of infants with severe eczema, egg allergy, or both 

may be uncomfortable introducing dietary peanut at home. In such 

cases the health care provider should offer the option of a supervised 

feeding of a peanut-containing food in the office.

The rate of positive peanut OFC results at baseline for infants with 

a 3 to 4 mm wheal diameter (4/17 infants) was higher than in 

infants with 0 to 2 mm wheal diameters (3/301 infants), but the 

elicited symptoms were mild. Infants with larger wheal diameters 

(>4 mm) were not included in the LEAP trial, and therefore no 

safety data are available from this group. However, based on the 

Australian HealthNuts study, which conducted peanut OFCs in a 

large number of older (12-18 months old) children from the general 

Australian population, the rate of reactions to peanut is expected to 
14 ADDENDUM GUIDELINES FOR THE PREVENTION OF PEANUT ALLERGY IN THE UNITED STATES

be substantially higher with increasing SPT wheal diameter.21,23 In 

the HealthNuts study23 an SPT wheal diameter of 8 mm or greater 

had a 95% positive predictive value for peanut allergy (positive oral 

peanut challenge result). Therefore, the EP recommends that for SPT 

Category B infants (3 to 7 mm SPT wheal diameter), a supervised 

feeding or a graded peanut OFC should be conducted in a specialist’s 

office or a specialized facility (Appendix G). SPT Category C infants are 

considered high risk for established allergy to peanut and should not 

receive peanut-containing foods in their diet, unless such foods are 

recommended by a specialist after further evaluation.

Quality of evidence: Moderate. The designation of the quality of 

evidence as “moderate” (as opposed to “high”) is based on the 

fact that this recommendation derives primarily from a single 

randomized, open-label study: the LEAP trial. However, it should 

be noted that the assessment of the LEAP trial’s primary outcome 

was based on a double-blind, placebo-controlled OFC. Furthermore, 

confidence in this recommendation is bolstered by the large effect 

size demonstrated in the LEAP trial and prior epidemiologic data that 

peanut allergy is relatively infrequent in Israel, where early childhood 

consumption of peanut is common.

Contribution of expert opinion. Significant.

Additional comments:

1. Breast-feeding recommendations: The EP recognizes that 

early introduction of peanut may seem to depart from 

recommendations for exclusive breast-feeding through 6 

months of age.25,26 However, it should be noted that data 

from the nutrition analysis of the LEAP cohort27 indicate that 

introduction of peanut did not affect the duration or frequency 

of breast-feeding and did not influence growth or nutrition.

2. Age of peanut introduction: For children with severe eczema, 

egg allergy, or both, the EP recommends that introduction of 

solid foods begins at 4 to 6 months of age, starting with solid 

food other than peanut, so that the child can demonstrate the 

ability to consume solid food without evidence of nonspecific 

signs and symptoms that could be confused with IgE-mediated 

food allergy. However, it is important to note that infants in the 

LEAP trial were enrolled between 4 and 11 months of age and 

benefitted from peanut consumption regardless of age at entry. 

Therefore, if the 4- to 6-month time window is missed for any 

reason, including developmental delay, infants may still benefit 

from early peanut introduction. On the other hand, older age at 

screening is associated with larger wheal diameters induced by 

peanut SPT and hence a higher likelihood of established peanut 

allergy.28 A practical consideration for applying this guideline 

at 4 to 6 months of age is that infants visit their health care 

provider for well-child evaluations and infant immunizations 

at this time. This provides a fortuitous opportunity for eczema 

evaluation, caregiver reporting of egg allergy, and, if needed, 

referral to a specialist for peanut allergy evaluation before 

dietary introduction of peanut.

3. Considerations for family members with established peanut 

allergy: The EP recognizes that many infants eligible for early

peanut introduction under this guideline will have older

siblings or caregivers with established peanut allergy. The 

EP recommends that in this situation caregivers discuss with

their health care providers the overall benefit (reduced risk of

peanut allergy in the infant) versus risk (potential for further

sensitization and accidental exposure of the family member to

peanut) of adding peanut to the infant’s diet.

4. Children identified as allergic to peanut: For children who 

have been identified as allergic to peanut, the EP recommends 

strict peanut avoidance. This may include those children in SPT 

Category B who fail the supervised peanut feeding or the

 OFC, or those children in SPT Category C who, on further 

evaluation by a specialist, are confirmed as being allergic 

to peanut. These children should be under long-term 

management by a specialist. 

Addendum Guideline 2 

The EP suggests that infants with mild-to-moderate eczema should 

have introduction of age-appropriate peanut-containing food 

around 6 months of age, in accordance with family preferences and 

cultural practices, to reduce the risk of peanut allergy. Other solid 

foods should be introduced before peanut-containing foods to show 

that the infant is developmentally ready. The EP recommends that 

infants in this category may have dietary peanut introduced at home 

without an in-office evaluation. However, the EP recognizes that 

some caregivers and health care providers may desire an in-office 

supervised feeding, evaluation, or both.

Rationale. The LEAP trial did not target infants with mild or moderate 

eczema. The EP considered the potential risk/benefit ratio of early

dietary peanut introduction in infants with mild-to-moderate eczema

and concluded that the individual and societal benefits of introducing

peanut in this population would be significant. The EP has no reason

to believe that the mechanisms of protection of early dietary peanut

differ in infants with mild-to-moderate eczema from those that lead to

protection in infants at higher risk of peanut allergy.

Balance of benefits and harms. The LEAP trial included only infants 

with severe eczema or egg allergy based on careful medical history. 

Therefore, some infants who participated in the LEAP trial based 

on the presence of egg allergy had atopic dermatitis severity scores 

(SCORAD scores29) at screening that would have placed them in the 

moderate or mild eczema category. The EP considered the outcomes 

of these children and concluded that infants with mild-to-moderate 

eczema would likely benefit from early peanut introduction.

Quality of evidence. Low. 
ADDENDUM GUIDELINES FOR THE PREVENTION OF PEANUT ALLERGY IN THE UNITED STATES 15 

The quality of evidence is low because this recommendation is based 

on extrapolation of data from a single study.

Contribution of expert opinion. Significant.

Additional comment. Additional support for early introduction of 

peanut in infants who do not have severe eczema comes from the 

Enquiring About Tolerance study,17 which enrolled infants from the 

general population at 3 months of age and sequentially introduced 6 

allergenic foods beginning at the time of enrollment. These children 

were not intentionally selected based on increased risk of food allergy 

or atopy. Although the intention-to-treat group did not show benefit, 

most likely because of relatively poor compliance with feeding 

recommendations, the children in the per-protocol group who had 

peanut introduced early in infancy showed a significant reduction in 

peanut sensitization and peanut allergy at age 3 years. This study also 

provides support for guideline 3 below. 

Addendum Guideline 3 

The EP suggests that infants without eczema or any food allergy have 

age-appropriate peanut-containing foods freely introduced in the 

diet together with other solid foods and in accordance with family 

preferences and cultural practices.

Rationale. No evidence exists for restricting allergenic foods in 

infants without known risks for food allergy. The probability for 

development of peanut allergy in such children is very low. However, 

approximately 14% of all children with peanut allergy at age 12 to 18 

months in the HealthNuts Study lacked known risk factors for food 

allergy.16 Consequently, because such children constitute a significant 

majority of any birth cohort, they contribute substantially to the 

overall societal burden of peanut allergy. The EP finds no evidence to 

suggest that mechanisms of oral tolerance induction would differ in 

these infants from the immunologic mechanisms that are protective 

in infants at higher risk of peanut allergy. Thus, the early introduction 

of dietary peanut in children without risk factors for peanut allergy 

is generally anticipated to be safe and to contribute modestly to an 

overall reduction in the prevalence of peanut allergy. Furthermore, 

in countries such as Israel, where peanut products are a popular 

component of the diet and where they are introduced early in life, 

the prevalence of peanut allergy is low.14 

Balance of benefits and harms. The EP acknowledges that any 

analysis of benefit and harm in this population relies primarily 

on expert opinion and is subject to current differences in 

regional/societal rates of peanut consumption and peanut 

sensitization. In countries where peanut products are not 

widely consumed by adults, early dietary introduction of 

peanut could lead to an increase in sensitization and allergic 

manifestations. Hence the EP cautions that this guideline be 

implemented in the context of societal routines/norms.

Quality of evidence. Low. 

Contribution of expert opinion. Significant.

Clinical implications: These guidelines will help health care 

providers with early introduction of peanut-containing 

foods in infants at various risk levels for peanut allergy. Early 

introduction of peanut will result in the prevention of peanut 

allergy in a large number of infants. 
16 ADDENDUM GUIDELINES FOR THE PREVENTION OF PEANUT ALLERGY IN THE UNITED STATES

 

References 12. Muraro A, Halken S, Arshad SH, Beyer K, Dubois AE, Du Toit G, 

1. Sicherer SH, Muñoz-Furlong A, Burks AW, Sampson HA. 

Prevalence of peanut and tree nut allergy in the US determined 

by a random digit dial telephone survey. J Allergy Clin Immunol 

1999;103:559-62.

2. Gupta RS, Springston EE, Warrier MR, Smith B, Kumar R, 

Pongracic J, et al. The prevalence, severity, and distribution 

of childhood food allergy in the United States. Pediatrics 

2011;128:e9-17.

3. Bunyavanich S, Rifas-Shiman SL, Platts-Mills TA, Workman L, 

Sordillo JE, Gillman MW, et al. Peanut allergy prevalence among 

school-age children in a US cohort not selected for any disease. 

J Allergy Clin Immunol 2014;134:753-5.

4. Bock SA, Muñoz-Furlong A, Sampson HA. Fatalities due 

to anaphylactic reactions to foods. J Allergy Clin Immunol

2001;107:191-3.

5. Bock SA, Muñoz-Furlong A, Sampson HA. Further fatalities 

caused by anaphylactic reactions to food, 2001-2006. J Allergy 

Clin Immunol 2007;119:1016-8.

6. Boyce JA, Assa’ad A, Burks AW, Jones SM, Sampson HA, Wood 

RA, et al. Guidelines for the diagnosis and management of food 

allergy in the United States: report of the NIAID-sponsored 

expert panel. J Allergy Clin Immunol 2010;126(suppl):S1-58.

7. Committee on Toxicity of Chemicals in Food, Consumer 

Products and the Environment. Peanut allergy, 1998. 

Available at: https://cot.food.gov.uk/sites/default/files/cot/

cotstatement200807peanut.pdf. Accessed July 2015.

8. American Academy of Pediatrics. Committee on Nutrition. 

Hypoallergenic infant formulas. Pediatrics 2000;106:346-9.

9. Greer FR, Sicherer SH, Burks AW. American Academy of 

Pediatrics Committee on Nutrition; American Academy of 

Pediatrics Section on Allergy and Immunology. Effects of early 

nutritional interventions on the development of atopic disease 

in infants and children: the role of maternal dietary restriction, 

breastfeeding, timing of introduction of solid foods, and 

hydrolyzed formulas. Pediatrics 2008; 121:183-91.

10. Chan ES, Cummings C. Canadian Paediatric Society, Community 

Paediatrics Committee and Allergy Section. Dietary exposures 

and allergy prevention in high-risk infants: a joint statement 

with the Canadian Society of Allergy and Clinical Immunology. 

Paediatr Child Health 2013;18:545-54.

11. Fleischer DM, Spergel JM, Assa’ad AH, Pongracic JA. Primary 

prevention of allergic disease through nutritional interventions. 

J Allergy Clin Immunol Pract 2013;1:29-36.

et al. EAACI food allergy and anaphylaxis guidelines. Primary 

prevention of food allergy. Allergy 2014;69:590-601.

13. Du Toit G, Roberts G, Sayre PH, Bahnson HT, Radulovic S, Santos 

AF, et al. Randomized trial of peanut consumption in infants at 

risk for peanut allergy. N Engl J Med 2015;372:803-13.

14. Du Toit G, Katz Y, Sasieni P, Mesher D, Maleki SJ, Fisher HR, et 

al. Early consumption of peanuts in infancy is associated with 

a low prevalence of peanut allergy. J Allergy Clin Immunol 

2008;122:984-91.

15. Fleischer DM, Sicherer S, Greenhawt M, Campbell D, Chan E, 

Muraro A, et al. Consensus communication on early peanut 

introduction and prevention of peanut allergy in high-risk 

infants. J Allergy Clin Immunol 2015;136:258-61.

16. Du Toit G, Sayre PH, Roberts G, Sever ML, Lawson K, Bahnson 

HT, et al. Effect of avoidance on peanut allergy after early 

peanut consumption. N Engl J Med 2016;374:1435-43.

17. Perkin MR, Logan K, Tseng A, Raji B, Ayis S, Peacock J, et al. 

Randomized trial of introduction of allergenic foods in breast-fed

infants. N Engl J Med 2016;374: 1733-43.

18. GRADE working group [Internet 2000-present]. Available at: 

http://www. gradeworkinggroup.org. Accessed July 2015.

19. Schünemann HJ, Oxman AD, Brozek J, Glasziou P, Jaeschke 

R, Vist GE, et al. Grading quality of evidence and strength of 

recommendations for diagnostic tests and strategies. BMJ 

2008;336:1106-10.

20. Brozek JL, Akl EA, Alonso-Coello P, Lang D, Jaeschke R, 

Williams JW, et al. Grading quality of evidence and strength 

of recommendations in clinical practice guidelines. Part 1 of 

3. An overview of the GRADE approach and grading quality of 

evidence about interventions. Allergy 2009;64:669-77.

21. Koplin JJ, Peters RL, Dharmage SC, Gurrin L, Tang MLK, 

Ponsonby AL, et al. Understanding the feasibility and 

implications of implementing early peanut introduction for 

prevention of peanut allergy. J Allergy Clin Immunol 2016;138: 

1131-41.e2. 

22. Tversky JR, Chelladurai Y, McGready J, Hamilton 

RG. Performance and pain tolerability of current 

diagnostic allergy skin prick test devices. J Allergy 

Clin Immunol Pract 2015;3:888-93.

23. Peters RL, Allen KJ, Dharmage SC, Tang ML, Koplin JJ, Ponsonby 

AL, et al. Skin prick test responses and allergen-specific IgE 

levels as predictors of peanut, egg, and sesame allergy in 

infants. J Allergy Clin Immunol 2013;132:874-80.
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24. Du Toit G, Tsakok T, Lack S, Lack G. Prevention of food allergy. J 

Allergy Clin Immunol 2016;137:998-1010.

25. American Academy of Pediatrics. Breastfeeding and the use of 

human milk. Policy statement. Pediatrics 2012;129:e827-41.

26. The World Health Organization’s infant feeding 

recommendation. May 1, 2001. Available at: http://www.who.

int/nutrition/topics/infantfeeding_recommendation/ en/index.

html. Accessed May 2016. 

27. Feeney M, Du Toit G, Roberts R, Sayre PH, Lawson K, Bahnson 

HT, et al. Impact of peanut consumption in the LEAP study: 

feasibility, growth and nutrition. J Allergy Clin Immunol 

2016;138:1108-18.

28. Du Toit G, Roberts G, Sayre PH, Plaut M, Bahnson HT, et al. 

Identifying infants at high risk of peanut allergy: the Learning 

Early About Peanut Allergy (LEAP) screening study. J Allergy Clin 

Immunol 2013;131:135-43, e1-12.

29. Severity scoring of atopic dermatitis: the SCORAD index. 

Consensus Report of the European Task Force on Atopic 

Dermatitis. Dermatology 1993;186:23-31.

30. Bird JA, Groetch M, Allen KJ, Bock SA, Leonard A, NowakWegrzyn AH, et al. Conducting an oral food challenge to peanut 

in an infant: a work group report. J Allergy Clin Immunol Pract 

2016 [In press].
18 ADDENDUM GUIDELINES FOR THE PREVENTION OF PEANUT ALLERGY IN THE UNITED STATES
ADDENDUM GUIDELINES FOR THE PREVENTION OF PEANUT ALLERGY IN THE UNITED STATES 19 

APPENDIX A. COORDINATING 

COMMITTEE MEMBER ORGANIZATIONS 

AND REPRESENTATIVES 

Academy of Nutrition and Dietetics

http://www.eatright.org/

Alison Steiber, PhD, RD 

Allergy & Asthma Network Mothers of Asthmatics (AANMA)

http://www.allergyasthmanetwork.org/main/

Tonya A. Winders, MBA 

American Academy of Allergy, Asthma & Immunology (AAAAI)

https://www.aaaai.org/home.aspx

Hugh A. Sampson, MD 

David Fleischer, MD 

American Academy of Family Physicians (AAFP)

http://www.aafp.org/home.html

Jason Matuszak, MD 

American Academy of Dermatology (AAD)

https://www.aad.org/

Lawrence F. Eichenfield, MD, FAAD 

Jon Hanifin, MD 

American Academy of Emergency Medicine (AAEM)

http://www.aaem.org/

Joseph P. Wood, MD, JD 

American Academy of Pediatrics (AAP)

https://www.aap.org

Scott H. Sicherer, MD, FAAP 

American Academy of Physician Assistants (AAPA)

https://www.aapa.org/

Gabriel Ortiz, MPAS, PA-C, DFAAPA

American College of Allergy, Asthma and Immunology (ACAAI)

http://acaai.org/

Amal Assa’ad, MD 

American College of Gastroenterology (ACG)

http://gi.org/

Steven J. Czinn, MD, FACG 

American Partnership for Eosinophilic Disorders (APFED)

http://apfed.org/

Wendy Book, MD 

American Society for Nutrition (ASN)

http://www.nutrition.org/

George J. Fuchs III, MD 

Asthma and Allergy Foundation of America (AAFA)

http://www.aafa.org/

Meryl Bloomrosen, MBA, MBI 

David R. Stukus, MD 

Canadian Society of Allergy and Clinical Immunology (CSACI)

http://www.csaci.ca/

Edmond Chan, MD, FRCPC 

Eunice Kennedy Shriver National Institute of Child Health and 

Human Development (NICHD)

https://www.nichd.nih.gov

Gilman Grave, MD 

European Academy of Allergy and Clinical Immunology (EAACI)

http://www.eaaci.org/

Antonella Muraro, MD, PhD 

Food Allergy Research & Education (FARE)

https://www.foodallergy.org/

James R. Baker, MD 

Mary Jane Marchisotto 

National Eczema Association (NEA)

http://nationaleczema.org/

Julie Block 
20 ADDENDUM GUIDELINES FOR THE PREVENTION OF PEANUT ALLERGY IN THE UNITED STATES

National Heart, Lung, and Blood Institute (NHLBI)

http://www.nhlbi.nih.gov/

Janet M. de Jesus, MS, RD 

National Institute of Allergy and Infectious Diseases (NIAID)

http://www.niaid.nih.gov/

Daniel Rotrosen, MD 

Alkis Togias, MD 

Marshall Plaut, MD 

National Institute of Arthritis and Musculoskeletal 

and Skin Diseases (NIAMS)

http://www.niams.nih.gov/

Ricardo Cibotti, PhD 

National Institute of Diabetes and Digestive 

and Kidney Diseases (NIDDK)

www.niddk.nih.gov 

Frank Hamilton, MD, MPH 

Margaret A. McDowell, PhD, MPH, RD (retired)

Rachel Fisher, MS, MPH, RD 

North American Society for Pediatric Gastroenterology, 

Hepatology and Nutrition (NASPGHAN)

http://www.naspghan.org/

Glenn Furuta, MD 

Society of Pediatric Nurses (SPN)

http://www.pedsnurses.org/

Michele Habich, DNP, APN/CNS, CPN 

United States Department of 

Agriculture (USDA)

http://www.usda.gov/

Soheila J. Maleki, PhD 

World Allergy Organization (WAO)

http://www.worldallergy.org/

Lanny J. Rosenwasser, MD 
ADDENDUM GUIDELINES FOR THE PREVENTION OF PEANUT ALLERGY IN THE UNITED STATES 21 

APPENDIX B. EXPERT PANEL, JUNE 2015 

Chair 

Joshua A. Boyce, MD

Professor of Medicine and Pediatrics 

Harvard Medical School 

Director, Inflammation and Allergic Disease Research Section 

Director, Jeff and Penny Vinik Center for Allergic Disease Research 

Specialty: Allergy/pediatric pulmonology

Panelists 

Maria Acebal, JD

Board of Directors, Food Allergy Research & Education 

Member of NIAID Advisory Council 

Former CEO of Food Allergy and Anaphylaxis Network

Specialty: Advocacy

Amal Assa’ad, MD

Professor, University of Cincinnati Department of Pediatrics

Director, FARE Center of Excellence in Food Allergy 

Director of Clinical Services, Division of Allergy and Immunology 

Associate Director, Division of Allergy and Immunology 

Cincinnati Children’s Hospital Medical Center 

Specialty: Allergy/pediatrics

James R. Baker, Jr, MD

CEO and Chief Medical Officer

Food Allergy Research & Education, 

McLean VA 

Founding Director, Mary H. Weiser 

Food Allergy Center, University of Michigan

Professor of Internal Medicine, 

Division of Allergy and Clinical Immunology 

University of Michigan Health System

Specialty: Allergy/advocacy/education

Lisa A. Beck, MD

Professor, Department of Dermatology 

University of Rochester Medical Center

School of Medicine and Dentistry 

Specialty: Dermatology

Julie Block

President and CEO

National Eczema Association 

Specialty: Advocacy/education

Carol Byrd-Bredbenner, PhD, RD, FAND

Professor of Nutrition/Extension Specialist 

Rutgers University, School of Environmental and Biological Sciences

Specialty: Nutrition/health communication/behavioral science

Edmond S. Chan, MD, FRCPC

Clinical Associate Professor 

Head, Division of Allergy and Immunology 

Department of Pediatrics 

BC Children’s Hospital 

University of British Columbia

Specialty: Allergy/pediatrics

Lawrence F. Eichenfield, MD

Professor of Pediatrics and Dermatology 

Chief, Pediatric and Adolescent Dermatology 

Rady Children’s Hospital, San Diego 

University of California, San Diego 

School of Medicine 

Specialty: Dermatology/pediatrics

David M. Fleischer, MD

Associate Professor of Pediatrics 

University of Colorado School of Medicine

Children’s Hospital Colorado, Aurora, CO

Specialty: Allergy/pediatrics

George J. Fuchs III, MD

Professor of Pediatrics 

University of Kentucky College of Medicine

Chief, Gastroenterology, Nutrition & Hepatology 

Kentucky Children’s Hospital 

Specialty: Gastroenterology/pediatrics

Glenn T. Furuta, MD

Professor of Pediatrics 

Director, Gastrointestinal Eosinophilic 

Diseases Program 

University of Colorado School of Medicine

Children’s Hospital Colorado, Aurora, CO

Specialty: Gastroenterology/pediatrics

Matthew J. Greenhawt, MD, MBA, MSc

Assistant Professor of Pediatrics 

Allergy Section 

University of Colorado School of Medicine

Children’s Hospital Colorado, Aurora, CO

Specialty: Allergy/pediatrics

Ruchi Gupta, MD, MPH

Associate Professor of Pediatrics and Medicine 

Director, Food Allergy Outcomes Research Program

Ann and Robert H. Lurie Children’s Hospital of Chicago 

Northwestern Medicine, Northwestern University

Specialty: Pediatrics
22 ADDENDUM GUIDELINES FOR THE PREVENTION OF PEANUT ALLERGY IN THE UNITED STATES

Michele Habich, DNP, APN/CNS, CPN

Advanced Practice Nurse 

Northwestern Medicine, Central DuPage Hospital 

Specialty: Nursing/pediatrics/education

Stacie M. Jones, MD

Professor of Pediatrics 

University of Arkansas for Medical Sciences

Chief, Allergy and Immunology 

Arkansas Children’s Hospital 

Specialty: Allergy/pediatrics

Kari Keaton

Facilitator, Metro DC Food Allergy 

Support Group 

Specialty: Advocacy/education

Antonella Muraro, MD, PhD

President of European Academy of Allergy 

and Clinical Immunology (EAACI)

Professor of Allergy and Pediatric Allergy 

Head of the Veneto Region Food Allergy Centre 

of Excellence for Research and Treatment 

University Hospital of Padua, Italy

Specialty: Allergy/pediatrics

Lanny J. Rosenwasser, MD

Immediate Past President, 

World Allergy Organization

Professor of Medicine 

University of Missouri-Kansas City-School of Medicine

Specialty: Allergy/pediatrics

Hugh A. Sampson, MD

Professor of Pediatrics, 

Allergy and Immunology 

Icahn School of Medicine at Mount Sinai 

Director, Jaffe Food Allergy Institute 

Specialty: Allergy/pediatrics

Lynda C. Schneider, MD

Professor of Pediatrics 

Harvard Medical School 

Director, Allergy Program 

Boston Children’s Hospital 

Specialty: Allergy/pediatrics

Scott H. Sicherer, MD

Professor Pediatrics, Allergy and Immunology 

Icahn School of Medicine at Mount 

SinaiDivision Chief, Pediatric Allergy and Immunology 

Specialty: Allergy/pediatrics

Robert Sidbury, MD, MPH

Professor 

Department of Pediatrics 

Chief, Division of Dermatology 

Seattle Children’s Hospital 

University of Washington School of Medicine

Specialty: Dermatology/pediatrics

Jonathan Spergel, MD, PhD

Stuart Starr Professor of Pediatrics 

Chief, Allergy Section 

Director, Center for Pediatric Eosinophilic Disorders 

The Children’s Hospital of Philadelphia 

Perelman School of Medicine, University of Pennsylvania

Specialty: Allergy/pediatrics

David R. Stukus, MD

Assistant Professor of Pediatrics 

Section of Allergy/Immunology 

Nationwide Children’s Hospital 

Columbus 

Specialty: Allergy/pediatrics

Carina Venter, PhD, RD

Allergy Specialist, Dietitian 

Cincinnati Children’s Hospital Medical Center 

University of Cincinnati College of Medicine

Specialty: Allergy/dietitian/pediatrics
ADDENDUM GUIDELINES FOR THE PREVENTION OF PEANUT ALLERGY IN THE UNITED STATES 23 

APPENDIX C: TIER 1 REFERENCES 

• Feeney M, Du Toit G, Roberts R, Sayre PH, Lawson K, Bahnson 

HT, et al. Impact of peanut consumption in the LEAP study: 

feasibility, growth and nutrition. J Allergy Clin Immunol 

2016;138:1108-18.

• Koplin JJ, Peters RL, Dharmage SC, Gurrin L, Tang MLK, 

Ponsonby AL, et al. Understanding the feasibility and 

implications of implementing early peanut introduction 

for prevention of peanut allergy. J Allergy Clin Immunol 

2016;138:1131-41.e2.

• Perkin MR, Logan K, Tseng A, Raji B, Ayis S, Peacock J, et al. 

Randomized trial of introduction of allergenic foods in breastfed infants. N Engl J Med 2016;374:1733-43.

• Du Toit G, Sayre PH, Roberts G, Sever ML, Lawson K, Bahnson 

HT, et al. Effect of avoidance on peanut allergy after early 

peanut consumption. N Engl J Med 2016;374:1435-43.

• Chang YS, Trivedi MK, Jha A, Lin YF, Dimaano L, García-Romero 

MT. Synbiotics for prevention and treatment of atopic 

dermatitis: a meta-analysis of randomized clinical trials. JAMA 

Pediatr 2016;170:236-42.

• O’Connor C, Kelleher M, O’B Hourihane J. Calculating the 

effect of populationlevel implementation of the Learning 

Early About Peanut Allergy (LEAP) protocol to prevent peanut 

allergy. J Allergy Clin Immunol 2016;137:1263-4.e2.

• Grimshaw KE, Bryant T, Oliver EM, Martin J, Maskell J, Kemp T, 

et al. Incidence and risk factors for food hypersensitivity in UK 

infants: results from a birth cohort study. Clin Transl Allergy 

2016;6:1.

• Rabinovitch N, Shah D, Lanser BJ. Look before you LEAP: risk 

of anaphylaxis in high-risk infants with early introduction of 

peanut. J Allergy Clin Immunol 2015;136:822.

• Peters RL, Allen KJ, Dharmage SC, Lodge CJ, Koplin JJ, 

Ponsonby AL, et al. Differential factors associated with 

challenge-proven food allergy phenotypes in a population 

cohort of infants: a latent class analysis. Clin Exp Allergy 

2015;45:953-63.

• Peters RL, Allen KJ, Dharmage SC, Koplin JJ, Dang T, Tilbrook 

KP, et al. Natural history of peanut allergy and predictors 

of resolution in the first 4 years of life: a population-based 

assessment. J Allergy Clin Immunol 2015;135:1257-66.e2.

• Du Toit G, Roberts G, Sayre PH, Bahnson HT, 

Radulovic S, Santos AF, et al. Randomized trial of 

peanut consumption in infants at risk for peanut 

allergy. N Engl J Med 2015;372:803-13.

• Martin PE, Eckert JK, Koplin JJ, Lowe AJ, Gurrin LC, Dharmage 

SC, et al. Which infants with eczema are at risk of food allergy? 

Results from a population-based cohort. Clin Exp Allergy 

2015;45:255-64.

• Grimshaw KE, Maskell J, Oliver EM, Morris RC, Foote KD, 

Mills EN, et al. Introduction of complementary foods and the 

relationship to food allergy. Pediatrics 2013;132:e1529-38.

• Palmer DJ, Metcalfe J, Makrides M, Gold MS, Quinn P, 

West CE, et al. Early regular egg exposure in infants with 

eczema: a randomized controlled trial. J Allergy Clin Immunol 

2013;132:387-92.e1.

• Du Toit G, Roberts G, Sayre PH, Plaut M, Bahnson HT, Mitchell 

H, et al. Identifying infants at high risk of peanut allergy: the 

Learning Early About Peanut Allergy (LEAP) screening study. J 

Allergy Clin Immunol 2013;131:135-43, e1-12.

• Joseph CL, Ownby DR, Havstad SL, Woodcroft KJ, Wegienka 

G, MacKechnie H, et al. Early complementary feeding and risk 

of food sensitization in a birth cohort. J Allergy Clin Immunol 

2011;127:1203-10.e5.

• Koplin JJ, Osborne NJ, Wake M, Martin PE, Gurrin LC, Robinson 

MN, et al. Can early introduction of egg prevent egg allergy 

in infants? A population-based study. J Allergy Clin Immunol 

2010;126:807-13.

• Katz Y, Rajuan N, Goldberg MR, Eisenberg E, Heyman E, Cohen 

A, et al. Early exposure to cow’s milk protein is protective 

against IgE-mediated cow’s milk protein allergy. J Allergy Clin 

Immunol 2010;126:77-82.e1.
24 ADDENDUM GUIDELINES FOR THE PREVENTION OF PEANUT ALLERGY IN THE UNITED STATES

 

APPENDIX D. INSTRUCTIONS FOR 

HOME FEEDING OF PEANUT PROTEIN 

FOR INFANTS AT LOW RISK OF AN 

ALLERGIC REACTION TO PEANUT 

These instructions for home feeding of peanut protein are provided 

by your doctor. You should discuss any questions that you have with 

your doctor before starting. These instructions are meant for feeding 

infants who have severe eczema or egg allergy and were allergy 

tested (blood test, skin test, or both) with results that your doctor 

considers safe for you to introduce peanut protein at home (low risk 

of allergy).

General Instructions 

1. Feed your infant only when he or she is healthy; 

do not do the feeding if he or she has a cold, 

vomiting, diarrhea, or other illness.

2. Give the first peanut feeding at home and 

not at a day care facility or restaurant. 

3. Make sure at least 1 adult will be able to focus all of his or 

her attention on the infant, without distractions from other 

children or household activities.

4. Make sure that you will be able to spend at least 2 hours 

with your infant after the feeding to watch for any signs of an 

allergic reaction.

Feeding Your Infant 

1. Prepare a full portion of one of the peanut-containing foods 

from the recipe options below.

2. Offer your infant a small part of the peanut serving on the tip 

of a spoon. 

3. Wait 10 minutes. 

4. If there is no allergic reaction after this small taste, then slowly 

give the remainder of the peanut-containing food at the 

infant’s usual eating speed.

What are symptoms of an allergic reaction? What should I look for?

• Mild symptoms can include:

○ a new rash 

or 

○ a few hives around the mouth or face 

• More severe symptoms can include any of the following alone 

or in combination:

○ lip swelling 

○ vomiting

○ widespread hives (welts) over the body

○ face or tongue swelling 

○ any difficulty breathing

○ wheeze 

○ repetitive coughing

○ change in skin color (pale, blue)

○ sudden tiredness/lethargy/seeming limp

If you have any concerns about your infant's response to peanut, seek 

immediate medical attention/call 911.
ADDENDUM GUIDELINES FOR THE PREVENTION OF PEANUT ALLERGY IN THE UNITED STATES 25 

Four Recipe Options, Each Containing Approximately 2g of Peanut Protein 

Note: Teaspoons and tablespoons are US measures (5 and 15 mL for a level teaspoon or tablespoon, respectively).

Option 1: Bamba (Osem, Israel), 21 pieces (approximately 2 g of 

peanut protein)

Note: Bamba is named because it was the product used in the 

LEAP trial and therefore has proven efficacy and safety. 

Other peanut puff products with similar peanut protein 

content can be substituted.

a. For infants less than 7 months of age, soften the Bamba 

with 4 to 6 teaspoons of water. 

b. For older infants who can manage dissolvable textures, 

unmodified Bamba can be fed. If dissolvable textures are 

not yet part of the infant's diet, softened Bamba should

be provided. 

Option 2: Thinned smooth peanut butter, 2 teaspoons (9-10 g of 

peanut butter; approximately 2 g of peanut protein)

a. Measure 2 teaspoons of peanut butter and slowly add 

2 to 3 teaspoons of hot water. 

b. Stir until peanut butter is dissolved, thinned, and 

well blended. 

c. Let cool. 

d. Increase water amount if necessary (or add previously 

tolerated infant cereal) to achieve consistency comfortable 

for the infant. 
26 ADDENDUM GUIDELINES FOR THE PREVENTION OF PEANUT ALLERGY IN THE UNITED STATES

Option 3: Smooth peanut butter puree, 2 teaspoons (9-10 g of 

peanut butter; approximately 2 g of peanut protein)

a. Measure 2 teaspoons of peanut butter.

b. Add 2 to 3 tablespoons of pureed tolerated fruit or 

vegetables to peanut butter. You can increase or reduce 

volume of puree to achieve desired consistency. 

Option 4: Peanut flour and peanut butter powder, 2 teaspoons 

(4 g of peanut flour or 4 g of peanut butter powder; 

approximately 2 g of peanut protein)

Note: Peanut flour and peanut butter powder are 2 distinct 

products that can be interchanged because they have a 

very similar peanut protein content. 

a. Measure 2 teaspoons of peanut flour or peanut

butter powder.

b. Add approximately 2 tablespoons (6-7 teaspoons) of 

pureed tolerated fruit or vegetables to flour or powder. 

You can increase or reduce volume of puree to achieve 

desired consistency. 
ADDENDUM GUIDELINES FOR THE PREVENTION OF PEANUT ALLERGY IN THE UNITED STATES 27 

APPENDIX E. FOR HEALTH CARE PROVIDERS: 

IN-OFFICE SUPERVISED FEEDING PROTOCOL 

USING 2G OF PEANUT PROTEIN 

General Instructions 

1. These recommendations are reserved for an infant defined in 

guideline 1 as one with severe eczema, egg allergy, or both and 

with negative or minimally reactive (1 to 2 mm) SPT responses 

and/or peanut sIgE levels of less than 0.35 kUA/L. They also 

may apply to the infant with a 3 to 7 mm SPT response if the 

specialist health care provider decides to conduct a supervised 

feeding in the office (as opposed to a graded OFC in a 

specialized facility [see Fig 1]).

These recommendations can also be followed for infants with 

mild-to-moderate eczema, as defined in guideline 2, when 

caregivers and health care providers may desire an in-office 

supervised feeding. 

2. Proceed only if the infant shows no evidence of any 

concomitant illness, such as an upper respiratory 

tract infection.

a. Start with a small portion of the initial peanut serving, 

such as the tip of a teaspoon of peanut butter puree/

softened Bamba.

b. Wait 10 minutes; if there is no sign of reaction after this 

small portion is given, continue gradually feeding the 

remaining serving of peanut-containing food (see options 

below) at the infant's typical feeding pace.

c. Observe the infant for 30 minutes after 2 g of peanut 

protein ingestion for signs/symptoms of an allergic reaction.
28 ADDENDUM GUIDELINES FOR THE PREVENTION OF PEANUT ALLERGY IN THE UNITED STATES

Four Recipe Options, Each Containing 

Approximately 2g of Peanut Protein 

Note: Teaspoons and tablespoons are US measures (5 and 15 mL for a 

level teaspoon or tablespoon, respectively).

Option 1: Bamba (Osem, Israel), 21 pieces (approximately 2 g of 

peanut protein)

Note: Bamba is named because it was the product used in 

the LEAP trial and therefore has known peanut protein 

content and proven efficacy and safety. Other peanut 

puffs products with similar peanut protein content can 

be substituted for Bamba.

a. For infants less than 7 months of age, soften the Bamba 

with 4 to 6 teaspoons of water. 

b. For older infants who can manage dissolvable textures, 

unmodified Bamba can be fed. If dissolvable textures are 

not yet part of the infant's diet, softened Bamba should 

be provided. 

Option 2: Thinned smooth peanut butter, 2 teaspoons (9-10 g of 

peanut butter; approximately 2 g of peanut protein)

a. Measure 2 teaspoons of peanut butter and slowly add 2 

to 3 teaspoons hot water. 

b. Stir until peanut butter is dissolved and thinned and 

well blended. 

c. Let cool. 

d. Increase water amount if necessary (or add previously 

tolerated infant cereal) to achieve consistency 

comfortable for the infant. 

Option 3: Smooth peanut butter puree, 

2 teaspoons (9-10 g of peanut butter; approximately 2 g 

of peanut protein)

a. Measure 2 teaspoons of peanut butter.

b. Add 2 to 3 tablespoons of previously tolerated pureed 

fruit or vegetables to peanut butter. You can increase or 

reduce volume of puree to achieve desired consistency. 

Option 4: Peanut flour and peanut butter powder, 2 teaspoons 

(4 g of peanut flour or 4 g of peanut butter powder; 

approximately 2 g of peanut protein)

Note: Peanut flour and peanut butter powder are 2 distinct 

products that can be interchanged because they have, 

on average, a similar peanut protein content. 

a. Measure 2 teaspoons of peanut flour or peanut 

butter powder.

b. Add approximately 2 tablespoons (6-7 teaspoons) of 

pureed tolerated fruit or vegetables to flour or powder. 

You can increase or reduce the volume of puree to 

achieve desired consistency. 
ADDENDUM GUIDELINES FOR THE PREVENTION OF PEANUT ALLERGY IN THE UNITED STATES

Bamba Peanut butter Peanuts Peanut flour or peanut 

butter powder

Amount containing 

approximately 2 g of 

peanut protein 

17 g or 2⁄3 of a 28-g (1-oz) 

bag or 21 sticks 

9-10 g or 2 teaspoons 8 g or ~10 whole peanuts 

(21⁄2 teaspoons of grounded 

peanuts)

4 g or 2 teaspoons 

Typical serving size 1 bag (28 g) Spread on a slice of bread 

or toast (16 g)

21⁄2 teaspoons of ground 

peanuts (8 g)

No typical serving size 

Peanut protein per typical 3.2 g 

serving 

3.4 g 2.1 g No typical 

serving size 

Feeding tips For a smooth texture, mix 

with warm water (then 

let cool) or breast milk

or infant formula and 

mash well. 

Pureed or mashed fruit or 

vegetables can be added. 

Older children can be 

offered sticks of Bamba. 

For a smooth texture, mix 

with warm water (then let 

cool) or breast milk or 

infant formula. 

For older children, mix 

with pureed or mashed 

fruit or vegetables or any 

suitable family foods, 

such as yogurt or mashed 

potatoes. 

Use blender to create a 

powder or paste. 

2-21⁄2 teaspoons of ground 

peanuts can be added to a 

portion of yogurt or pureed 

fruit or savory meal. 

Mix with yogurt or apple 

sauce. 

APPENDIX F. PEANUT PROTEIN IN 

PEANUT-CONTAINING FOODS 

If the decision is made to introduce dietary peanut to the infant's diet, the total amount of peanut protein to be regularly consumed per week 

should be approximately 6 to 7 g over 3 or more feedings. In the LEAP trial, at evaluations conducted at 12 and 24 months of age, 75% of children in 

the peanut consumption group reported eating at least this amount of peanut.

Be Aware of Choking Risks 

• Whole nuts should not be given to children less than 5 years of age.

• Peanut butter directly from a spoon or in lumps/dollops should not be given to children less than 4 years of age.

If, after a week or more eating peanut, your infant or child displays mild allergic symptoms within 2 hours of eating peanut, you should contact your 

health care provider. 

Typical peanut-containing foods, their peanut protein content, and feeding tips for infants are provided in Table S-I, and their nutritional content is 

found in Table S-II. 

Table S-I. Typical peanut-containing foods, their peanut protein content, and feeding tips for infants

29 
ADDENDUM GUIDELINES FOR THE PREVENTION OF PEANUT ALLERGY IN THE UNITED STATES

Notes: Bamba (Osem, Israel) is named because it was the product used in the LEAP trial and therefore has known peanut protein content and 

proven efficacy and safety. Other peanut puff products with similar peanut protein content can be substituted for Bamba.

Teaspoons and tablespoons are US measures (5 and 15 mL for a level teaspoon or tablespoon, respectively).

Table S-II. Nutritional content of peanut-containing foods

Per approximately 2 g 

of peanut protein Bamba* (17 g) Peanut butter (10 g) Peanuts (8 g)

Peanut butter 

powder (4 g) Peanut flour (4 g)

kcal 93 59 45 15 13 

Sugar (g) 0.4 0.65 0.38 0.4 0.33 

Salt (mg) 68 48 1 31 7

Fat (g) 6.1 4.95 3.94 0.49 0.02 

* The nutritional content of peanut puff products (other than Bamba) can be obtained from their manufacturers.

30 
ADDENDUM GUIDELINES FOR THE PREVENTION OF PEANUT ALLERGY IN THE UNITED STATES

Dose

Peanut butter 

volume*

Equivalent weight of peanut

butter (g [peanut protein content

in grams])†

Pureed fruit or vegetable 

volume

Total volume

1 1⁄8 teaspoon 0.67 (0.15) 1⁄2 teaspoon 5⁄8 teaspoon

2 1⁄4 teaspoon 1.33 (0.29) 3⁄4 teaspoon 1 teaspoons 

3 1⁄2 teaspoon 2.67 (0.59) 1 teaspoons 11⁄2 teaspoons 

4 1 teaspoon 5.33 (1.17) 2 teaspoons 3 teaspoons ‡ 

5 11⁄2 teaspoons 8 (1.6) 4 teaspoons 51⁄2 teaspoons

Total protein: 3.96 g

APPENDIX G. GRADED OFC PROTOCOL 

From “Conducting an oral food challenge to peanut in an infant: a 

work group report.”30 

General Instructions 

1. A graded OFC should be performed only by a specialist with the

training and experience to (1) perform and interpret skin prick

testing and OFCs and (2) know and manage their risks. Such

persons must have appropriate medications and equipment

on site. 

2. Four peanut preparations are provided:

a. Option 1: Smooth peanut butter mixed with either a

previously tolerated pureed fruit or vegetable. 

b. Option 2: Smooth peanut butter dissolved carefully with

hot water and cooled. 

c. Option 3: Peanut flour mixed with either a previously

tolerated pureed fruit or vegetable. Peanut butter powder

can be used instead of the peanut flour.

d. Option 4: Bamba peanut snack dissolved in hot water and

cooled or even as a solid (ie, as a stick).

Option 1: Measures for smooth peanut butter puree

Note: Bamba (Osem, Israel) is named because it was the product used 

in the LEAP trial and therefore has known peanut protein content and 

proven efficacy and safety. Other peanut puff products with similar 

peanut protein content can be substituted for Bamba.

3. The peanut protein content of the graded OFC protocol is

identical for all peanut preparations provided below, except

that the volume of food ingested per dose is different. The

protocol consists of 5 incremental doses, given 15 to 20

minutes apart, with a cumulative peanut protein total of

approximately 4 g per the 3.9 g total in the LEAP trial.

4. Refer to Table S-III and direct parents to discontinue specific

medications for the prescribed amount of time before the

graded OFC. Note that certain medications are allowed.

Be Prepared in Case of a Severe 

Reaction (see Table S-IV) 

Note: Teaspoons and tablespoons are US measures (5 and 15 mL for a 

level teaspoon or tablespoon, respectively).

* Amounts (volume) of peanut butter measured as teaspoons are approximate measures to keep the dosing as practical as possible.

† Peanut protein content is calculated on the average amount of protein for a range of butters using “Report: 16167, USDA Commodity, Peanut 

Butter, smooth,” from the USDA Nutrition Database (http://ndb.nal.usda.gov/ndb/foods).

‡ Three teaspoons = 1 tablespoon. 

31 
ADDENDUM GUIDELINES FOR THE PREVENTION OF PEANUT ALLERGY IN THE UNITED STATES

Dose

Peanut butter 

volume*

Equivalent weight of peanut

butter (g [peanut protein content

in grams])†

Pureed fruit or vegetable 

volume

Total volume

1 1⁄8 teaspoon 0.67 (0.15) 1⁄8 teaspoon 1⁄4 teaspoon 

2 1⁄4 teaspoon 1.33 (0.29) 1⁄4 teaspoon 1⁄2 teaspoon 

3 1⁄2 teaspoon 2.67 (0.59) 1⁄2 teaspoon 1 teaspoon 

4 1 teaspoon 5.33 (1.17) 1 teaspoon 2 teaspoons 

5 11⁄2 teaspoons 8 (1.76) 11⁄2 teaspoons 3 teaspoons ‡ 

Total protein: 3.96 g

Dose Peanut flour or peanut 

butter powder volume*

Equivalent weight peanut flour or peanut butter

powder† (g [peanut protein content in grams])

Pureed fruit or 

vegetable volume

Total volume

1 1⁄8 teaspoon 0.25 (0.13) 1⁄2 teaspoon 3⁄4 teaspoon 

2 1⁄4 teaspoon 0.5 (0.25) 1 teaspoon 11⁄4 teaspoons 

3 1⁄2 teaspoon 1.0 (0.5) 2 teaspoons 21⁄2 teaspoons 

4 1 teaspoon 2.0 (1.0) 3 teaspoons ‡ 4 teaspoons 

5 2 teaspoons 4.0 (2.0) 6 teaspoons § 8 teaspoons 

Total protein: 3.88 g

Option 2: Measures for smooth thinned peanut butter

 (http://ndb.nal.usda.gov/ndb/foods).

* Amounts (volume) of peanut butter measured as teaspoons are approximate measures to keep the dosing as practical as possible.

† Peanut protein content is calculated on the average amount of protein for a range of butters using “Report: 16167, USDA Commodity, Peanut 

Butter, smooth,” from the USDA Nutrition Database

‡ Three teaspoons = 1 tablespoon. 

Option 3: Measures for peanut flour or peanut butter powder

* Amounts (volume) of peanut flour or peanut butter powder measured as teaspoons are approximate measures to keep the dosing as practical

as possible. 

† Information regarding peanut powder and flour reflects averages obtained from the producers. Most brands of peanut flour/peanut butter 

powder are approximately 50% peanut protein by weight. However, weight can vary based on the fat content and also the brand chosen. 

Therefore a weight measurement can be more accurate than household measurements. 

‡ Three teaspoons = 1 tablespoon. 

§ Six teaspoons = 2 tablespoons. 

32 
ADDENDUM GUIDELINES FOR THE PREVENTION OF PEANUT ALLERGY IN THE UNITED STATES

Dose Bamba, no. of 

sticks

Equivalent weight (peanut protein

content [g])*

Volume of hot water (approximate, will need to be Approximate final 

adjusted for each child) volume

1 1 stick 0.81 (0.1) 1⁄2 teaspoon 3⁄4 teaspoon 

2 3 sticks 2.43 (0.3) 1 teaspoon 11⁄2 teaspoons 

3 5 sticks 4.05 (0.5) 11⁄2 teaspoons 21⁄4 teaspoons 

4 10 sticks 8.1 (1.0) 3 teaspoons ‡ 4 teaspoons 

5 21 sticks 17.01 (2.0) 6 teaspoons § 81⁄2 teaspoons 

Total protein: 3.9 g

Protocol Instructions for 

Options 1, 2, and 3 

1. Measure peanut butter, peanut flour, or peanut butter powder

for dose 1. 

2. Prepare the first dose:

a. If using option 1, add previously tolerated pureed fruit or

vegetable to measured dose 1 peanut butter and stir until

well blended. You can increase or reduce volume of puree 

to achieve desired consistency. Note: Increasing the volume

may increase the difficulty of getting through the entire

protocol with a young baby. 

b. If using option 2, slowly add hot water to measured dose

1 peanut butter and stir until peanut butter is dissolved,

thinned, and well blended. Let the mixture cool. You can 

increase water volume (or add previously tolerated infant 

cereal) to achieve desired consistency.

Option 4: Bamba peanut snack (Osem, Israel)

c. If using option 3, add previously tolerated pureed fruit

or vegetable to measured dose 1 peanut flour or peanut

butter powder and stir until well blended. You can increase

or reduce volume of puree to achieve desired consistency. 

Note: Increasing the volume may increase the difficulty of

getting through entire protocol with a young baby.

3. Label dose 1. 

4. Repeat steps 1 to 3 for the remaining doses 2 through 5,

labeling each dose appropriately and before proceeding to the 

preparation of the next dose.

5. Feed dose 1 to infant and observe for symptoms of reactivity

for 15 to 20 minutes.

6. If no symptoms appear, repeat with dose 2 and observe for 15

to 20 minutes. 

7. Continue in this manner with doses 3, 4, and 5.

Note: Other peanut puffs products with equivalent peanut protein content can be substituted for Bamba.

* The amount of Bamba sticks is an approximate measure looking at a range of Bamba products. Bamba snacks from different parts of the world

have a varied peanut protein content.30 The peanut protein content of Bamba was calculated according to the publication by Du Toit et al.13 

Protocol Instructions for Option 4 

1. Count Bamba sticks for dose 1.

2. Prepare the first dose by slowly adding hot water to measured

Bamba and stirring until Bamba is dissolved, thinned, well

blended, and cooled. You can increase water volume to achieve 

desired consistency. Note: Increasing the volume may increase

the difficulty of getting through the entire protocol with a

young baby. 

3. Label dose 1. 

4. Repeat steps 1 to 3 for the remaining doses 2 through 5,

labeling each dose appropriately and before proceeding to the 

preparation of the next dose.

5. Feed dose 1 to the infant and observe for symptoms of 

reactivity for 15 to 20 minutes.

6. If no symptoms appear, repeat with dose 2 and observe for 15

to 20 minutes. 

7. Continue in this manner with doses 3, 4, and 5.

33 
ADDENDUM GUIDELINES FOR THE PREVENTION OF PEANUT ALLERGY IN THE UNITED STATES

Medication Dose

First-line 

treatment 

Epinephrine (1:1000 

concentration)

0.01 mg/kg IM in the mid-outer thigh in health care settings 

or 

0.15 mg of autoinjector IM in the mid-outer thigh in community settings

Adjunctive 

treatment 

Albuterol nebulization 

Albuterol MDI inhalation 

Epinephrine doses may need to be repeated every 5-15 minutes

0.15 mg/kg every 20 min × 3 doses (minimum of 2.5 mg per dose) over 5-15 min

2 puffs, 90 μg per puff, with face mask

Oxygen 8-10 L/min through a face mask 

Diphenhydramine 1.25 mg/kg administered orally

Cetirizine 2.5 mg administered orally

Normal saline (0.9% isotonic 

solution) or lactated ringers

Steroids 

20 ml/kg per dose administered over 5 min intravenously

Prednisolone 1 mg/kg administered orally 

or 

Solu-Medrol 1 mg/kg administered intravenously 

Table S-III. Medication discontinuation considerations before OFC

Medications to be discontinued Last dose before OFC

Cetirizine 5 days

Cyproheptadine 10 days 

Diphenhydramine 3 days 

Fexofenadine 3 days 

Loratadine 7 days

Short-acting bronchodilator (eg, albuterol) 8 hours 

Medications that can be continued

Antihistamine eye drops 

Inhaled/intranasal corticosteroids 

Topical (cutaneous) steroids

Topical (cutaneous) pimecrolimus, tacrolimus

Table S-IV. Emergency medications for a severe reaction during an office-based infant OFC

34 
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