Concerns about the approach of measuring allergens in early introduction foods for prevention of food allergy

Abstract

We would like to highlight the method limitations and assumptions in the article titled “Doses of specific allergens in early introduction foods for prevention of food allergy”1Filep S. Chapman M.D. Doses of specific allergens in early introduction foods for prevention of food allergy [published online ahead of print March 8, 2021]..https://doi.org/10.1016/j.jaip.2021.02.051Google Scholar as it relates to trying to measure certain proteins in early allergen foods (EIF). Most notably, a methodology of extracting the proteins from various food matrices is best implemented with an approach that properly captures all proteins from those foods, not just some. Specifically, by not extracting on a per-serving basis, the quantifications do not accurately represent the proteins of each food product consumed. For example, methodology only allowed for analysis of fewer than 1 of 50 total puffs in a complete daily serving of SpoonfulONE. This evaluation is, therefore, hardly a representation of the food. Similarly, the authors did not standardize their measurements on a total-protein basis, further obfuscating the interproduct EIF comparisons. Moreover, the assumption of single-allergen measurement by antibodies to quantify the total protein does not account for all the proteins in a single ingredient, let alone multi-ingredient foods. Filep and Chapman's extrapolation of a food's protein content from unrepresentative, unequilibrated servings with select antibody coverage of proteins and their components is limited. Our methods and formula were developed at the Sean N. Parker Center for Allergy and Asthma Research at Stanford University, and then transformed into a scalable and safe consumer product over the past 5 years using both independent commercial laboratory data and patent data from Stanford. We implement protein testing using SDS-PAGE and total protein by nitrogen content assays; with standards accepted by the U.S. Food and Drug Administration. It is a standard practice to ensure major protein components are preserved throughout the manufacturing process and in final products. Lastly, we check each product over the course of its shelf life (12 months) to ensure consistent protein integrity over time. All SpoonfulONE products are tested up to 3 times during manufacturing to ensure protein integrity of 16 food allergens (Figure 1). In our 3 years of production, we have run over 1,000 gels to obtain consistent and repeatable results for our products. SpoonfulONE also tests all ingredients and products for microbiological (bacteria, fungi), chemical contaminants (heavy metals, toxins), and total protein. If an ingredient or product does not meet safety standards for infants, it is rejected. Our protein integrity and food safety analysis is performed by an independent, ISO 17025:2005 accredited laboratory—AEMTEK Laboratories. Representative samples from all lots of ingredients and SpoonfulONE products are tested, and cannot be released until all microbiological, chemical and SDS-PAGE analyses are complete and compliant. In conclusion, we agree that scalable, reproducible protein integrity and quantification testing is needed in EIF; however, there are limitations in the methodology and extrapolations performed in the Filep and Chapman study.1Filep S. Chapman M.D. Doses of specific allergens in early introduction foods for prevention of food allergy [published online ahead of print March 8, 2021]..https://doi.org/10.1016/j.jaip.2021.02.051Google Scholar Our products are tested with the highest standards for food safety and protein integrity, and we look forward to continuing to try to understand how early diet diversity in infants/toddlers may improve health. Doses of Specific Allergens in Early Introduction Foods for Prevention of Food AllergyThe Journal of Allergy and Clinical Immunology: In PracticeVol. 10Issue 1PreviewConsumption of common allergenic foods, such as peanut, in early life can reduce the risk of food allergy among high-risk children and is recommended in revised clinical guidelines. Commercial early allergen introduction foods (EIF) containing single or multiple allergenic foods for feeding infants are promoted to consumers and health care providers as aids to prevent food allergy. Full-Text PDF Reply to “Concerns about the approach of measuring allergens in early introduction foods for prevention of food allergy”The Journal of Allergy and Clinical Immunology: In PracticeVol. 9Issue 7PreviewWe thank Weihi et al1 for their critique of our study.2 To be clear, our study was not to measure early introduction food (EIF) ingredients (such as rice or oat) but to measure allergens of known clinical importance. The underlying assumption of the Learning Early About Peanut Allergy (LEAP) study is that prevention of peanut allergy is mediated by the development of immunological tolerance to peanut allergens in infancy.3 Our study included measurements of 4 major peanut allergens. Together, U.S. Full-Text PDF