RESUMO
BACKGROUND: Donor human milk is recommended when infants are unable to be fed their mother's own milk or require supplementation. For-profit companies use technologies to create human milk products for infants in the neonatal intensive care setting without consistent guidelines and regulatory frameworks in place. This commercialization of human milk is inadequately conceptualized and ill-defined. RESEARCH AIMS: The aim of this study is to conceptualize and define the commercialization of human milk and discuss the need for policy guidelines and regulations. METHOD: Using a concept analysis framework, we reviewed the literature on the commercialization of human milk, analyzed the antecedents and potential consequences of the industry, and developed a conceptual definition. The literature review resulted in 13 relevant articles. RESULTS: There has been a surge in the development and availability of human milk products for vulnerable infants developed by for-profit companies. Commercialized human milk can be defined as the packaging and sale of human milk and human milk components for financial gain. Factors contributing to the commercialization of human milk include an increased demand for human milk, and consequences include potential undermining of breastfeeding. The lack of guidelines and regulations raises concerns of equity, ethics, and safety. CONCLUSION: The industry is rapidly growing, resulting in an urgent need for consistent guidelines and regulatory frameworks. If left unaddressed, there could be potential risks for donor milk banking, the future of breastfeeding, and infant and maternal health.