Treatment Guidelines

Guidelines for the Diagnosis and Management of Food Allergy in the United States: Report of the NIAID-sponsored Expert Panel

In 2010, the National Institute of Allergy and Infectious Diseases (NIAID) released a set of comprehensive guidelines with 43 recommendations for the diagnosis and management of food allergies and food-induced anaphylaxis. The 2010 guidelines are organized into 5 major topic areas:

• Definitions, prevalence and epidemiology of FA
• Natural history of FA and associated disorders
• Diagnosis of FA
• Management of nonacute food-induced allergic reactions and prevention of FA
• Diagnosis and management of food-induced anaphylaxis and other acute allergic reactions to foods.

The quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Each recommendation was assigned a grade (high, moderate, or low) according to its confidence level and the likelihood of further research to impact the quality of evidence. A high grade indicates that it is very unlikely for further research to impact the quality of evidence and that the recommendation is unlikely to change, while a low grade indicates the converse: further research is very likely to significantly impact the quality of evidence and the recommendation is likely to change. A moderate grade indicates that it is likely for further research to impact quality of evidence and that the recommendation may change. The strength of each of the 43 guidelines was emphasized through the use of the verb “recommends” when the recommendation is strong, or “suggests” when the recommendation is weak. The reader is encouraged to examine the guidelines in the guideline publication; the recommendations for the prevention of food allergy (guidelines 36-40) and treatment of food-induced anaphylaxis (guidelines 42 and 43) are reproduced here in a re-formatted form:

• NIAID Guideline 36: The Expert Panel does not recommend restricting maternal diet during pregnancy or lactation as a strategy for preventing the development or clinical course of food allergy.
• NIAID Guideline 37: The Expert Panel recommends that all infants be exclusively breast-fed until 4 to 6 months of age, unless breastfeeding is contraindicated for medical reasons.
• NIAID Guideline 38: The Expert Panel does not recommend using soy infant formula instead of cow’s milk infant formula as a strategy for preventing the development of FA or modifying its clinical course in at-risk infants.
• NIAID Guideline 39: The Expert Panel suggests that the use of hydrolyzed infant formulas, as opposed to cow’s milk formula, may be considered as a strategy for preventing the development of food allergy in at-risk infants who are not exclusively breast-fed. Cost and availability of extensively hydrolyzed infant formulas may be weighed as prohibitive factors.
• NIAID Guideline 40: The Expert Panel suggests that the introduction of solid foods should not be delayed beyond 4 to 6 months of age. Potentially allergenic foods may be introduced at this time as well.
• NIAID Guideline 42: The Expert Panel recommends that treatment for food-induced anaphylaxis should focus on the following:
  • Prompt and rapid treatment after onset of symptoms
  • Intramuscular (IM) epinephrine as first-line therapy
  • Other treatments, which are adjunctive to epinephrine dosing.
• NIAID Guideline 43: The Expert Panel recommends that the management of food-induced anaphylaxis should focus on the following:
  • Dosing with IM epinephrine followed by transfer to an emergency facility for observation and possible further treatment
  • Observation for 4 to 6 hours or longer based on severity of the reaction
  • Education for patient and family on:
    • Allergen avoidance
    • Early recognition of signs and symptoms of anaphylaxis
    • Anaphylaxis emergency action plan implementation
    • Appropriate IM epinephrine administration
    • Medical identification jewelry or an anaphylaxis wallet card
  • Epinephrine auto-injector prescription and training provided at the time of discharge
  • Continuation of adjunctive treatment after patient discharge:
    • H1 antihistamine: diphenhydramine every 6 hours for 2-3 days; alternative dosing with a non-sedating second generation antihistamine
    • H2 antihistamine: ranitidine twice daily for 2-3 days
    • Corticosteroid: prednisone daily for 2-3 days
  • Follow-up appointment with primary health care professional (after the food-induced anaphylactic reaction), with consideration for additional follow-up with a clinical specialist such as an allergist/immunologist

In 2017, an Addendum to the 2010 NIAID guidelines was published, incorporating 3 additional recommendations on the prevention of peanut allergy. These recommendations are shown in Table 4-1.

Enlarge 

JTF Practice Parameters and Guidelines

The Joint Task Force (JTF) on Practice Parameters was formed by the American College of Allergy, Asthma and Immunology (ACAAI), the American Academy of Allergy, Asthma, and Immunology (AAAAI), and the Joint Council of Allergy, Asthma and Immunology (JCAAI) to enhance patient care by updating existing and creating new parameters for the diagnosis and management of IgE-mediated food allergies. The practice parameters published in 2006 included 107 summary statements and an annotated algorithm outlining the main decision points for evaluating and managing patients suspected of having food allergies (Figure 4-1).

Enlarge 

Each summary statement was assigned a Category of Evidence and a Strength of Recommendation grade. This practice parameter was updated in 2014 with 64 summary statements addressing the progress in food allergy diagnosis and management at the time. Since then, another update was released in 2020, covering advancements in peanut allergy diagnosis. The summary statements are too numerous to include in this module; the reader is directed to the 2006 practice parameter and the 2014 and 2020 updates.

In addition to the practice parameters, in 2013 the AAAAI published a set of guidelines on primary allergy prevention, which addressed maternal dietary restrictions, breast-feeding, the use of different infant formulas and the timing of introduction of complementary foods on the development of allergic disease in children. The 2013 AAAAI recommendations are summarized in Table 4-2.

Enlarge 

The AAAAI joined forces with the ACAAI and the Canadian Society of Allergy and Clinical Immunology (CSACI) to update the primary prevention guidelines in 2020, forming 5 key questions that yielded 7 recommendations (Table 4-3). Topics covered included: the definition of the at-risk child; recommendations for the timing of specific, potentially allergenic, complementary food introduction; recommendations regarding the role of dietary diversity; recommendations regarding the use of hydrolyzed formula; recommendations regarding the role of prenatal/postnatal exposures and breast-feeding; and a cost-effectiveness analysis of the recommendations.

Enlarge 

FDA Regulatory Information

The Food and Drug Administration (FDA) plays an important role in guiding the food industry and consumers in effectively assessing and managing allergens in food. This includes comprehensive measures to ensure proper labeling of major food allergens as defined by the Food Allergen Labeling and Consumer Protection Act (FALCPA). Starting January 1, 2006, under FALCPA, food manufacturers were mandated by law to disclose the presence of the eight (at the time) primary allergens – milk, egg, peanut, tree nuts, fish, crustacean shellfish, wheat and soy – on food labels, even in trace amounts. The Food Allergy Safety, Treatment, Education, and Research (FASTER) Act, signed into law in 2021, and effective since January 1, 2023, declared sesame the 9th major food allergen, making all FDA requirements for labelling and manufacturing applicable to sesame. Furthermore, the FDA conducts thorough inspections and recalls products in violation of FALCPA, maintaining food safety standards. For example, products labeled as "gluten-free" must meet strict criteria, meeting a defined standard for gluten content. This regulation provides assurance to individuals with gluten-related disorders and helps them make informed dietary choices.

Adherence to Guidelines and Multidisciplinary Management

Integrating food allergy recommendations into medical practice requires a multi-faceted approach encompassing education, resource optimization and skill development among healthcare professionals. First, comprehensive training programs should be established to educate medical students and trainees across various specialties about food allergy diagnosis, management and treatment. Specialist training in allergy should be emphasized to ensure a proficient cadre of practitioners equipped to address the complexities of allergic conditions. Furthermore, ongoing education initiatives should focus on enhancing the competency of healthcare professionals in performing skin prick tests and oral food challenges. Targeted training programs should emphasize effective management of allergic reactions, especially anaphylaxis, that could emerge during diagnostic testing. Centralizing diagnostic tests in specialized laboratories can streamline testing processes while ensuring the consistency and accuracy of results. Restricting tests to those with proven diagnostic utility can optimize resource allocation and minimize unnecessary testing. Healthcare professionals should receive training on result interpretation and the evidential basis of basophil activation testing.

Fostering multidisciplinary collaboration among allergists, immunologists, primary care physicians, dietitians and other relevant healthcare professionals is crucial for implementing comprehensive and coordinated care for patients with food allergies. Each member of the multidisciplinary team contributes unique expertise and insights, facilitating tailored care plans that consider not only the medical aspects but also the nutritional, psychological and social implications of food allergies. Collaborative efforts enable timely diagnosis, personalized treatment strategies, and ongoing support for patients and their families. With the prevalence of pediatric food allergies on the rise, a significant burden is put on general practitioners; multidisciplinary collaboration is an approach that can alleviate some of the workload while upholding or enhancing patient care.

The food allergy field is rapidly evolving, which makes it important to monitor updates in the literature, and to keep in mind that guidelines may quickly become outdated.