Risk characterisation of milk protein contamination in milk-alternative ice cream products sold as frozen desserts in the United States

ABSTRACT

Milk protein is recognised as one of the eight most common food allergens in the United States, and one of the most common causes of fatal or near-fatal food-induced anaphylactic reactions globally. Undeclared allergens in food products are the leading cause of the U.S. Food and Drug Administration (FDA) requests for food recalls, with undeclared milk protein as the most frequently cited allergen. The purpose of this study was to evaluate the prevalence of milk protein contamination in milk-alternative ice cream products sold as frozen dessert in the U.S. and labelled as ‘non-dairy’, ‘dairy-free’, and/or ‘vegan’, and to characterise the potential risk for allergic individuals consuming these products. Thirty-two unique milk-alternative frozen dessert products, including flavours with and without inclusions, from 16 different brands, were tested for the presence of milk proteins using enzyme-linked immunosorbent assay. Milk protein was detected in three of the tested products: two contained solid inclusions, and one did not have inclusions. One of the three products with detectable milk protein had an advisory statement indicating the product was made in a facility that processed milk. Although no consensus exists as to the minimal dose of milk protein necessary to elicit an adverse effect in a milk-sensitised individual, the milk protein quantities in one serving of each of the three products exceeded some of the published thresholds. These results suggest that one serving of certain milk-alternative frozen dessert products could potentially elicit an allergic response in highly sensitive individuals.

KEYWORDS:

• Milk protein
• allergen
• food allergy
• ice cream
• frozen dessert
• exposure assessment
• risk assessment

Acknowledgments

The authors thank Benjamin Roberts, Andrew Monnot, Kenneth Unice, Brent Finley, Carrie Kahn, and Pamela Armstrong for their review, comments, and assistance in preparing this manuscript.

Disclosure statement

The authors are currently (LGLY, RKB) or formerly (RNH, MTD) employed by Cardno ChemRisk, a consulting firm that provides scientific advice to the government, corporations, law firms, and various scientific/professional organizations. Cardno ChemRisk has been engaged by several companies to provide general consulting on scientific matters related to allergens in food products. However, the time invested by the authors to write this paper was provided by their employer, and no external funding was received for the study, the research supporting the analysis, nor the time needed to prepare the article. Furthermore, this work product, including the conclusions drawn, are exclusively those of the authors, and have not been influenced by anyone other than the authors. Aside from the authors, no one, including clients of Cardno ChemRisk, has reviewed, commented on, or revised this paper prior to its submission. No potential competing interest was reported by the authors.

Additional information

Funding

The author(s) reported there is no funding associated with the work featured in this article.