Omalizumab was recently approved by the US Food and Drug Administration for treatment of any single food allergy or multiple food allergies in children aged 1 year and older and adults. There is currently no formal guidance regarding recommended best practices for omalizumab use in food allergy, including patient selection, anticipated goals and outcomes of therapy, procedure for monitoring patients who elect to start omalizumab therapy, and ways in which omalizumab can be incorporated into the landscape of food allergy management and daily clinical practice. This work group report was developed by the food allergy therapies subcommittee of the Adverse Reactions to Foods Committee within the American Academy of Allergy, Asthma & Immunology. Consensus, evidence-based guidance regarding experts' recommendations for using omalizumab to treat children and adults with food allergy was developed by using modified Delphi methodology. In iterative fashion, a total of 8 statements regarding how to use omalizumab to treat patients with food allergy were developed by 16 clinical experts. This guidance provides the clinician with a suggested approach to patient selection, initiation of therapy, monitoring of efficacy, and long-term follow-up care. The role of preference-sensitive care is emphasized, with most statements offering care recommendations relevant to the culture and values of a particular practice setting., Competing Interests: Disclosure statement Disclosure of potential conflict of interest: A. Anagnostou reports institutional funding from Novartis; advisory board service for of Genentech, Novartis, Bryn, and Ready, Set, Food!; and consultation/speaker fees from ALK, Adelphi, Bryn, Novartis, Genentech, Medscape, Food Allergy Research and Education (FARE), MHJ, and EPG Health. J. A. Bird reports consultancy for Allergenis, DBV Technologies, FARE, Genentech, Hanimmune Therapeutics, HAL Allergy, Infinant Health, Novartis, Nutricia, and Parexel, as well as research for Aimmune, DBV Technologies, Genentech, the National Institute of Allergy and Infectious Diseases (NIAID), Novartis, Regeneron, and Siolta. S. Chinthrajah receives grant support from the Consortium for Food Allergy Research (CoFAR), NIAID, and FARE and is an advisory board member for Alladapt, Novartis, Allergenis, IgGenix, Intrommune Therapeutics, Phylaxis, and Genentech. T. E. Dribbin has received funding and is supported by NIH (K23 AI175525). D. M. Fleischer has received research support from ARS Pharmaceuticals and DBV Technologies; serves as an unpaid advisory board member for the Food Allergy and Anaphylaxis Connection Team and the National Peanut Board; receives royalties from UpToDate; and has received personal fees as a consultant to Aquestive, ARS Pharmaceuticals, Bryn Pharma, DBV Technologies, Genentech, and Nasus outside the submitted work. E. Kim reports grants to his institution from NIAID and FARE; personal fees from ALK, Ukko, Cellergy Pharma, DBV Technologies, Genentech, Hanimumme Therapeutics, Novartis, Phylaxis, Revolo Biotherapeutics; and safety review board service for Allergy Therapeutics. A. Nowak-Wegrzyn receives research support from NIAID, DBV Technologies, and Siolta Therapeutics; speaking fees from Nestle, Danone, Medscape, and Genentech; and royalties from UpToDate. In addition, A. Nowak-Wegrzyn serves as an associate editor for the Annals of Allergy, Asthma and Immunology; as director of the AAAAI board; and as chair of the medical advisory board of the International Food Protein Induced Enterocolitis Syndrome Association. M. S. Shaker is a member and cochair of the Joint Task Force on Practice Parameters, serves on the editorial board of The Journal of Allergy and Clinical Immunology: In Practice, is an associate editor of Annals of Allergy, Asthma & Immunology, and serves on the board of directors of the AAAAI (all views expressed are his own). W. Shreffler reports grants to his institution from NIAID, the Food Allergy Science Initiative, and FARE; contract research support to his institution from Genentech, DBV, Allergy Therapeutics, Aravax, Novartis; personal consulting fees from Aimmune, DBV, Novartis, ALK, Allergy Therapeutics, FARE; and royalty payments from UpToDate. S. Sicherer reports royalty payments from UpToDate and Johns Hopkins University Press; grants to his institution from tNIAID, FARE, and Pfizer; and personal fees from the AAAAI as deputy editor of the Journal of Allergy and Clinical Immunology: In Practice outside of the submitted work. B. P. Vickery reports grants from Alladapt, AstraZeneca, Genentech, NIAID, and Siolta; personal fees from Allergenis, Aravax, Reacta Biosciences, and Sanofi Regeneron; both grants and personal fees from Aimmune, DBV, FARE, Novartis, and Regeneron; and stock options from Moonlight Therapeutics outside the submitted work. J. Wang is a member of the Joint Task Force on Practice Parameters; receives research support from NIAID, Aimmune, DBV, and Siolta; and receives consultancy fees from ALK-Abelló, DBV, and Novartis. M. Greenhawt is a consultant for Aquestive; is a member of physician/medical advisory boards for DBV Technologies, Takeda, Griffols, Nutricia, Novartis, Aquestive, Allergy Therapeutics, AstraZeneca, ALK-Abelló, Bryn, Genentech, and Prota; is a speaker for Genentech; is an unpaid member of the scientific advisory council for the National Peanut Board and medical advisory board of the International Food Protein–Induced Enterocolitis Syndrome Association; is a member of the Brighton Collaboration Criteria Vaccine Anaphylaxis 2.0 working group; is the senior associate editor for the Annals of Allergy, Asthma, and Immunology; and is member of the Joint Taskforce on Allergy Practice Parameters. In addition, J. Wang has received honoraria for lectures from ImSci, Red Nucleus, Medscape, Paradigm Medical Communications, Kaplan, Food Allergy Research and Education, and multiple state and local allergy societies. The rest of the authors declare that they have no relevant conflicts of interest., (Copyright © 2024 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)