Heather Christine RusipersName, Laurence Grummer-StrawnpersName, Maryanne Tigchelaar PerrinpersName, Tracie RislingpersName, Meredith Lee BrockwaypersName (2024date). “Conceptualizing the Commercialization of Human Milk: A Concept Analysis..” Journal of Human Lactationtitle·j.
Object of study — the commercializationterm·key of human milkterm·key by for-profit companies
Research question — how the commercializationterm·key of human milkterm·key should be conceptualized and defined, and what policy it calls for
Contribution — a conceptual definition of commercialized human milkterm·dom, with its antecedents and consequences
phenomenon · claim-type · cross-domain-transfer · mechanism · claim-relation · replication-status · limitation — grounded in the full text| phenomenon | a fast-growing for-profit human milk industry operating without consistent guidelines or regulation — “Historically, the commercial market for human milk has existed as food and medicine for adults and children ( Cohen, 2019 ), however, over the past 20 years, there has been a surge in the number of for-profit human milk companies developing, marketing, and selling human milk products.” | |
| claim-type | existence — “The identified literature revealed that, despite the growth in CHM products and companies, guidelines and regulations are lacking and inconsistent” | |
| method — evidence | — “To theorize and define the commercialization of human milk, we conducted a concept analysis using Rodgers’ (1989) framework.” | |
| object of study — evidence | — “Currently, the commercialization of human milk, as a concept, is ambiguous and inadequately defined for healthcare providers and decision makers.” | |
| research question — evidence | — “The aim of this study was to utilize this framework to conceptualize the issue of the commercialization of human milk, develop a conceptual definition, and discuss the need for policy guidelines and regulations.” | |
| contribution — evidence | — “Reviewing the literature, we developed a definition for commercialized human milk (CHM). CHM can be defined as the packaging and sale of human milk and human milk components for financial gain.” | |
| mechanism | increased demand for human milk Rising demand and evidence of milk's bioactive value likely drew for-profit companies into producing human milk products. — “As a result, increased demand for human milk and evidence of important bioactive components found in human milk ( Ballard & Morrow, 2013 ) have likely motivated for-profit human milk companies to invest in new technologies to produce CHM products.” | mechanisms[0] |
| mechanism | payment by volume Paying donors by volume could give an incentive to dilute milk. — “Further, if payment for milk is based on volume, there may be incentive for lactating individuals to dilute their milk with the intention to increase the volume, and therefore receive additional compensation.” | mechanisms[1] |
| builds-on | Rodgers (1989), evolutionary concept analysis — “Rodger’s framework of concept analysis ( Rodgers, 1989 ), which maintains that concepts are dynamic and continually evolving ( Tofthagen & Fagerstrøm, 2010 ), was used” | claim_relations[0] |
| sense | human milk (as commodity) - a tradable product sold at a profit since the early 2000s — “Since the early 2000s, human milk for infants has turned into a tradable commodity ( Newman & Nahman, 2022 ).” | senses[0] |
| sense | processed human milk (versus breastfeeding) - not equivalent to milk from the breast — “While human milk products may be beneficial in some settings and are likely superior to infant formula in some contexts, current evidence demonstrates that processed human milk is not equivalent to human milk from the breast ( Ames et al., 2023 ).” | senses[1] |
| sense | human milk (regulatory category) - classified variously as food, medicine, medical product of human origin, or tissue — “There is also debate regarding how human milk should be categorized, leading to inconsistencies in the regulation of human milk. Current categorizations of human milk include human milk as a food, medicine, medical product of human origin, or tissue ( Shenker et al., 2024 ).” | senses[2] |
| relation | CHM —same-as→ commercialized human milk — Reviewing the literature, we developed a definition for commercialized human milk (CHM). CHM can be defined as the packaging and sale of human milk and human milk components for financial gain. — “Reviewing the literature, we developed a definition for commercialized human milk (CHM). CHM can be defined as the packaging and sale of human milk and human milk components for financial gain.” | concept_edges[0] |
| weight | CHM —same-as→ commercialized human milk — 0.9 — “Reviewing the literature, we developed a definition for commercialized human milk (CHM). CHM can be defined as the packaging and sale of human milk and human milk components for financial gain.” | concept_edges[0] |
| relation | DHM —same-as→ donor human milk — When infants are unable to be fed MOM or require supplementation, donor human milk (DHM) is the recommended alternative, particularly for those who are vulnerable — “When infants are unable to be fed MOM or require supplementation, donor human milk (DHM) is the recommended alternative, particularly for those who are vulnerable” | concept_edges[1] |
| weight | DHM —same-as→ donor human milk — 0.9 — “When infants are unable to be fed MOM or require supplementation, donor human milk (DHM) is the recommended alternative, particularly for those who are vulnerable” | concept_edges[1] |
| relation | HMFs —same-as→ Human milk-based fortifiers — Human milk-based fortifiers (HMFs) were developed as an alternative to bovine-based milk fortifiers for fortifying donor human milk. — “Human milk-based fortifiers (HMFs) were developed as an alternative to bovine-based milk fortifiers for fortifying donor human milk.” | concept_edges[2] |
| weight | HMFs —same-as→ Human milk-based fortifiers — 0.9 — “Human milk-based fortifiers (HMFs) were developed as an alternative to bovine-based milk fortifiers for fortifying donor human milk.” | concept_edges[2] |
| replication | not-applicable | |
| limitation | Few studies exist on this new subject, and there is little evidence on how prevalent these products are. — “Due to the novelty of this subject, the literature review resulted in a limited number of studies, and there was a paucity of evidence on the prevalence of CHM products.” | limitations[0] |
| limitation | Only English-language manuscripts were used. — “The use of English-only manuscripts in this concept analysis can also be considered a limitation.” | limitations[1] |
| limitation | Study selection and data extraction were each done by one person. — “The study selection process was conducted independently by one project team member.” | limitations[2] |
finding · quantity · variable · definition · key-term — grounded in the full text| finding | Antecedents are increased demand, unmet need for human milk, and technology. — “These factors include increased demand for human milk, an unmet need for human milk, and technology.” | content_tags.findings[0] |
| finding | Consequences include undermining breastfeeding, safety risks, inequity, exploitation, displaced maternal feeds, and extraction from communities. — “These include undermining breastfeeding, quality and safety implications, inequitable distribution of products, exploitation and discrimination, potential displacement of maternal feeds, and extraction of human milk from communities.” | content_tags.findings[1] |
| finding | Human milk is not covered by the International Code of Marketing of Breast-milk Substitutes. — “However, human milk is not covered by the Code ( WHO, 2017 ).” | content_tags.findings[2] |
| quantity | 1,624; 49; 13 — — “A total of 1,624 articles were reviewed for title and abstract. The full text of 49 articles was reviewed and 36 articles were excluded as they did not address for-profit companies and the commercialization of human milk. A total of 13 articles met the inclusion criteria” | content_tags.quantities[0] |
| key-terms | commercialization, human milk, donor milk, breastfeeding, concept analysis, health policy, regulation, neonatology |
| concept | commercialized human milk — the packaging and sale of human milk and human milk components for financial gain — “Reviewing the literature, we developed a definition for commercialized human milk (CHM). CHM can be defined as the packaging and sale of human milk and human milk components for financial gain.” | concepts[0] |
| concept | CHM — commercialized human milk — “Reviewing the literature, we developed a definition for commercialized human milk (CHM). CHM can be defined as the packaging and sale of human milk and human milk components for financial gain.” | concepts[1] |
| concept | Breastfeeding — the child receiving human milk, either directly from the breast or expressed — “Breastfeeding can be defined as the child receiving human milk, either directly from the breast or expressed ( World Health Organization [WHO], 1991 ).” | concepts[2] |
| concept | donor human milk — not defined in this paper's own words; milk given by another lactating person, recommended when a mother's own milk is unavailable — “When infants are unable to be fed MOM or require supplementation, donor human milk (DHM) is the recommended alternative, particularly for those who are vulnerable” | concepts[3] |
| concept | DHM — donor human milk — “When infants are unable to be fed MOM or require supplementation, donor human milk (DHM) is the recommended alternative, particularly for those who are vulnerable” | concepts[4] |
| concept | mother’s own milk — not defined in this paper's own words; the infant's own mother's breast milk — “However, approximately 40% of infants in the neonatal intensive care (NICU) setting lack access to their mother’s own milk (MOM; Israel-Ballard, 2018 ).” | concepts[5] |
| concept | MOM — mother’s own milk — “However, approximately 40% of infants in the neonatal intensive care (NICU) setting lack access to their mother’s own milk (MOM; Israel-Ballard, 2018 ).” | concepts[6] |
| concept | Human milk-based fortifiers — developed as an alternative to bovine-based milk fortifiers for fortifying donor human milk — “Human milk-based fortifiers (HMFs) were developed as an alternative to bovine-based milk fortifiers for fortifying donor human milk.” | concepts[7] |
| concept | HMFs — Human milk-based fortifiers — “Human milk-based fortifiers (HMFs) were developed as an alternative to bovine-based milk fortifiers for fortifying donor human milk.” | concepts[8] |
| concept | Retort processing — a commercial food processing technology that sterilizes human milk using high heat of 121 °C — “Retort processing, a commercial food processing technology that sterilizes human milk using high heat of 121 °C ( Jimenez et al., 2024 ) is now being used to create shelf-stable human milk products ( Lima et al., 2017 ).” | concepts[9] |
| concept | concept analysis — a useful framework to provide clarification for novel or ambiguous concepts and develop conceptual definitions to aid in health practice and policy — “A concept analysis is a useful framework to provide clarification for novel or ambiguous concepts and develop conceptual definitions to aid in health practice and policy ( Rodgers, 1989 ).” | concepts[10] |
Full text — tagged
Conceptualizing the Commercializationterm·key of Human Milkterm·key: A Concept Analysisterm.
Abstract Donor human milkterm·dom is recommended when infants are unable to be fed their mother’s own milkterm·dom or require supplementation. For-profit companies use technologies to create human milkterm·key products for infants in the neonatal intensive care setting without consistent guidelines and regulatory frameworks in place. This commercializationterm·key of human milkterm·key is inadequately conceptualized and ill-defined.
The aim of this study is to conceptualize and define the commercializationterm·key of human milkterm·key and discuss the need for policy guidelines and regulationsterm·key.
Using a concept analysisterm framework, we reviewed the literature on the commercializationterm·key of human milkterm·key, analyzed the antecedents and potential consequences of the industry, and developed a conceptual definition. The literature review resulted in 13 relevant articles.
There has been a surge in the development and availability of human milkterm·key products for vulnerable infants developed by for-profit companies. Commercialized human milkterm·dom can be defined as the packaging and sale of human milkterm·key and human milkterm·key components for financial gain. Factors contributing to the commercializationterm·key of human milkterm·key include an increased demand for human milkterm·key, and consequences include potential undermining of breastfeedingterm·dom. The lack of guidelines and regulationsterm·key raises concerns of equity, ethics, and safety.
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 milkterm·key banking, the future of breastfeedingterm·dom, and infant and maternal health.
Keywords: breastfeedingterm·dom, commercializationterm·key, concept analysisterm, donor milkterm·key, health policyterm·key, human milkterm·key, infant nutrition, lactation, neonatologyterm·key, pediatrics, regulationterm·key Key Messages There has been a surge in for-profit companies developing and selling human milkterm·key products targeted at vulnerable infants.
Guidelines and regulationsterm·key concerning human milkterm·key products for infants are inconsistent, leading to concerns of equity, ethics, and safety.
Commercialized human milkterm·dom products can be defined as the packaging and sale of human milkterm·key and human milkterm·key components for the purposes of financial gain.
There is a need for strong policies to ensure ethics, safety, and the protection of vulnerable infants.
Background The benefits of breastfeedingterm·dom and human milkterm·key are well-known globally. Breastfeedingterm·dom and human milkterm·key feeding are one of the most effective ways to promote healthy growth and optimal development in early childhood (United Nations Children’s Fund [UNICEF], 2018; Victora et al., 2016 ). Breastfeedingterm·dom can be defined as the child receiving human milkterm·key, either directly from the breast or expressed ( World Health Organization [WHO], 1991 ). While the WHO (2001) recommends that infants exclusively breastfeed for the first 6 months of life, the rate of exclusive breastfeedingterm·dom globally for infants under 6 months of age is only 48% ( WHO & UNICEF, 2022 ). However, approximately 40% of infants in the neonatal intensive care (NICU) setting lack access to their mother’s own milkterm·dom (MOMterm·dom; Israel-Ballard, 2018 ). When infants are unable to be fed MOMterm·dom or require supplementation, donor human milkterm·dom (DHMterm·dom) is the recommended alternative, particularly for those who are vulnerable ( WHO & UNICEF, 2018 ). Evidence shows that DHMterm·dom for preterm and sick infants in NICU settings is beneficial ( WHO, 2011 ). Preterm infants fed with DHMterm·dom compared to formula had lower rates of necrotizing enterocolitis (NEC; Quigley et al., 2019 ).
Historically, wet nursing was widely practiced to feed infants who were not breastfed by their own mothers ( Jones, 2003 ). Wet nursing declined in the 20th century as technological innovation introduced artificial infant formula and modern bottle feeding ( Stevens et al., 2009 ). Formula supplementation then became the substitute for breastfeedingterm·dom. Increased availability of infant formula and marketing strategies of formula companies may have contributed to high supplementation rates ( Rollins et al., 2023 ; Stevens et al., 2009 ).
Nonprofit milk banks were established in the early 1900s to provide DHMterm·dom to vulnerable infants ( Jones, 2003 ). Today, nonprofit milk banks receive DHMterm·dom, which is processed and provided to infants, usually in the NICU setting ( Human Milkterm·key Banking Association of North America [HMBANA], 2023 ). Many nonprofit milk banks are operated through milk banking associations which ensure processing and safety standards.
Since the early 2000s, human milkterm·key for infants has turned into a tradable commodity ( Newman & Nahman, 2022 ). An increasing number of private enterprises that can distribute profits to their owners (in contrast to nonprofit organizations that do not distribute earned profits to their owners or members, but rather use the earned funds for the organization’s objectives; Kenton, 2023 ) utilize technologies to develop human milkterm·key products from expressed human milkterm·key ( Hassan, 2010 ) or donated mammary cells ( Cohen & Cassidy, 2022 ) to be sold at a profit ( Newman & Nahman, 2022 ; Shenker et al., 2024 ; Smith, 2015 ). Human milkterm·key products were initially offered as multicomponent nutritional supplements, developed to increase nutrients for premature infants or infants with specific nutrient needs. Human milk-based fortifiersterm·dom (HMFsterm·dom) were developed as an alternative to bovine-based milk fortifiers for fortifying donor human milkterm·dom. A 2017 survey found that 44% of advanced neonatal care hospitals in the United States were using a human milk-based fortifierterm·dom developed by the world’s largest human milkterm·key company, Prolacta BioScience (Prolacta; Parker et al., 2020 ).
Historically, the commercial market for human milkterm·key has existed as food and medicine for adults and children ( Cohen, 2019 ), however, over the past 20 years, there has been a surge in the number of for-profit human milkterm·key companies developing, marketing, and selling human milkterm·key products. Prolacta began in 1999 ( Prolacta BioScience, 2022a ) and the human milkterm·key industry has since expanded to include other companies globally, including Medolac Laboratories, NeoLacta Lifesciences (NeoLacta), and Biomilq. The history of infant feeding and the commercializationterm·key of human milkterm·key can be found in the online Supplemental Materials .
Prolacta claims that it has served more than 90,000 premature infants globally ( Prolacta BioScience, 2022a ) while NeoLacta has provided their human milkterm·key products to over 30,000 preterm babies (NeoLacta, 2022). The number and range of human milkterm·key products offered on the market is increasing, primarily targeted towards infants in NICU settings (see Table 1 ; Shenker et al., 2024 ). Currently, in most countries, these products are limited to the NICU settings where their use is supervised by a clinician. However, there is now an emergence of these products in the community where caregivers of infants who are not hospitalized can purchase products online, therefore expanding to the well-baby and full-term populations.
A Snapshot of Commercialized Human Milkterm·dom Products on the Market and in Development.
While human milkterm·key products may be beneficial in some settings and are likely superior to infant formula in some contexts, current evidence demonstrates that processed human milkterm·key is not equivalent to human milkterm·key from the breast ( Ames et al., 2023 ). Processed human milkterm·key lacks the dynamic nature and personalized nutrition that human milkterm·key from breastfeedingterm·dom offers and is limited in many naturally occurring bioactive components and immune factors that contribute to infant growth, development, and immune function ( Ames et al., 2023 ).
Currently, the commercializationterm·key of human milkterm·key, as a concept, is ambiguous and inadequately defined for healthcare providers and decision makers. The rise in for-profit human milkterm·key companies and human milkterm·key products in the absence of consistent governance and regulationsterm·key raises concerns for vulnerable infants receiving these products. Thus, there is an urgent need to uncover and address the implications of the commercializationterm·key of human milkterm·key.
To theorize and define the commercializationterm·key of human milkterm·key, we conducted a concept analysisterm using Rodgers’ (1989) framework. The aim of this study was to utilize this framework to conceptualize the issue of the commercializationterm·key of human milkterm·key, develop a conceptual definition, and discuss the need for policy guidelines and regulationsterm·key.
Method Design We systematically reviewed the literature to identify current evidence on equity, ethics, and regulationsterm·key related to the commercializationterm·key, commodification, and marketing of, and profiting from, human milkterm·key products, human milkterm·key components, or laboratory-produced milk by for-profit companies. The rationale of the systematic review was to identify all current evidence related to the commercializationterm·key of human milkterm·key with the intention to make recommendations for child and maternal health policyterm·key development.
Rodger’s framework of concept analysisterm ( Rodgers, 1989 ), which maintains that concepts are dynamic and continually evolving ( Tofthagen & Fagerstrøm, 2010 ), was used to organize the systematic review. A systematic review protocol was not published. A concept analysisterm is a useful framework to provide clarification for novel or ambiguous concepts and develop conceptual definitions to aid in health practice and policy ( Rodgers, 1989 ). This method was relevant for this study as it aided us in analyzing the evolutionary and novel topic of human milkterm·key commercializationterm·key, developing a conceptual definition, and understanding the antecedents and consequences of the industry. Rodger’s framework is comprised of six steps including concept identification; data collection; determination of antecedents, consequences and related concepts; and identification of a model case ( Rodgers, 1989 ).
Sample: Defining the Articles Reviewed Inclusion criteria included (1) English language, due to English being the common language of the authors; (2) peer-reviewed articles; and (3) published between the years 2000 and 2023, since the commercializationterm·key of human milkterm·key for infants appeared on the market in the 21 st century. Exclusion criteria included articles written in languages other than English. The study selection process was conducted independently by one project team member. The PRISMA diagram summarizing the literature screening process is outlined in Figure 1 . The final sample size was 13 articles.
PRISMA Diagram.
Data Collection: The Search Strategy and Process The dates of the inclusion period of the articles reviewed were from 2000 to 2023. The date last searched was June 2023 and included the following databases: Medline, Embase, CINAHL, Web of Science, Cochrane Database of Systematic Reviews, Alt Healthwatch, Law Journal Library, and ProQuest. Other sources include citations cited by the articles selected ( Figure 1 ). The search terms included “human milkterm·key,” “breast milk,” “breastmilk,” “donor milkterm·key,” “maternal milk,” “mother’s milk,” “mother’s own milkterm·dom,” and “commercializationterm·key,” “commodification,” “marketing,” “profit,” “ethics,” and “equity” (see the Appendix in the Online Supplemental Material ).
Measurement The process used to extract data from articles was conducted by one author. Data were organized and summarized according to common themes using a matrix ( Table 4 ). Themes included for-profit human milkterm·key, human milkterm·key companies, human milkterm·key products, lab-produced human milkterm·key, equity, ethics, regulationsterm·key, and safety. Themes were determined by one author through inductive analysis, which is a fundamental component of Rodgers’ framework, and allows for the identification of commonalities through thematic analysis ( Tofthagen & Fagerstrøm, 2010 ).
Themes Related to “Commercializationterm·key of Human Milkterm·key” Present in the Literature (N = 13).
Data Analysis The methods used to describe characteristics of the sample include demographic information of published articles ( Table 2 ), a summary of the articles reviewed, including study aim, sample, and design ( Table 3 ), and a matrix of common themes ( Table 4 ). Potential bias was evaluated by clearly defining the scope, objectives, and variables of the concept analysisterm. To limit bias, the literature review strategy was planned in collaboration with the senior author and an academic librarian. Reliability and validity were not considered because concept analyses aim to simply identify and examine commonalities amongst existing uses of a concept without employing rigorous standards ( Rodgers, 1989 ).
Demographic Information About Publishing Journals ( N = 13).
Study Aims, Sample, and Design ( N = 13).
Results A total of 1,624 articles were reviewed for title and abstract. The full text of 49 articles was reviewed and 36 articles were excluded as they did not address for-profit companies and the commercializationterm·key of human milkterm·key. A total of 13 articles met the inclusion criteria ( Figure 2 ). One non-peer-reviewed law review was included as it strongly addressed the commercializationterm·key of human milkterm·key and one PhD dissertation was included. The topics resulting from the systematic review are described; however, it is beyond the scope of this paper to discuss them fully.
Regulatory Frameworks for Donor Human Milkterm·dom (DHMterm·dom). Note. Regulatory frameworks for donor human milkterm·dom/human milkterm·key products globally. Striped indicates where two frameworks co-exist for different products (e.g., the United States and Australia), or where some regions of a country have regulationsterm·key and others do not (e.g., Germany). MPHO = medical product of human origin. Reprinted with permission from “ Comparison between the for-profit human milkterm·key industry and non profit human milkterm·key banking: Time for regulationsterm·key? ” by Shenker, N., Linden, J., Wang, B., Mackenzie, C., Hildebrandt, A. P., Spears, J., Davis, D., Nangia, S., and Weaver, G., 2024, Maternal & Child Nutrition , 20 (1), e13570 –e13570. Copyright 2023 by the Authors.
Definition and Attributes Concept analyses are useful to develop definitions to reduce ambiguity of a concept and provide clarity ( Rodgers, 1989 ). Reviewing the literature, we developed a definition for commercialized human milkterm·dom (CHMterm·dom). CHMterm·dom can be defined as the packaging and sale of human milkterm·key and human milkterm·key components for financial gain. Human milkterm·key and human milkterm·key components are obtained through the expression of milk from a lactating person or are developed using biotechnology. People either donate or receive remuneration for their human milkterm·key or mammary cells.
Antecedents: The Progression of Human Milkterm·key Commercializationterm·key The commercializationterm·key of human milkterm·key can be attributed to several factors. These factors include increased demand for human milkterm·key, an unmet need for human milkterm·key, and technology. Table 5 summarizes the antecedents that have contributed to CHMterm·dom.
Antecedents of Commercialized Human Milkterm·dom.
Increased Demand for Human Milkterm·key The demand for human milkterm·key has increased substantially. Throughout 2019, the amount of pasteurized DHMterm·dom dispensed to fragile babies throughout Canada and the United States increased from 6.4 million ounces to 7.4 million ounces ( HMBANA, 2020 ). Further, in 2022, HMBANA milk banks provided nearly 10 million ounces of DHMterm·dom, including to families during the formula shortage ( HMBANA, 2023 ). This increase can be attributed to the preference of caregivers to not formula feed, increased accessibility of obtaining DHMterm·dom from nonprofit milk banks ( Palmquist & Doehler, 2016 ), and temporary insufficient maternal milk supply for babies in NICU settings. Further, the demand for human milkterm·key in the NICU setting is being driven by the compelling evidence that human milkterm·key is superior to infant formula, including its ability to reduce rates of NEC in preterm infants ( Quigley et al., 2019 ). As a result, increased demand for human milkterm·key and evidence of important bioactive components found in human milkterm·key ( Ballard & Morrow, 2013 ) have likely motivated for-profit human milkterm·key companies to invest in new technologies to produce CHMterm·dom products.
Unmet Need for Human Milkterm·key The unmet need for human milkterm·key may also contribute to its commercializationterm·key. Globally, about 800,000 infants receive DHMterm·dom annually. However, approximately 500,000 infants born at less than 32 weeks do not have access to DHMterm·dom ( Shenker et al., 2021 ) leading to an unmet need for human milkterm·key. This has likely contributed to the market for CHMterm·dom products.
Technology Improvements in laboratory technology and advancements in human milkterm·key science have resulted in an increased availability of human milkterm·key ( Miracle et al., 2011 ) and, most likely, CHMterm·dom. Technology, including the breast pump, has facilitated the storage and transport of human milkterm·key ( Lee, 2019 ) while pasteurization technology has allowed for an extended shelf life of human milkterm·key and the elimination of bacteria, viruses, and other pathogens ( Lima et al., 2017 ). The Holder method of pasteurizing human milkterm·key at 62.58 °C for 30 minutes has historically been used as it reduces potential pathogenic contamination while also maintaining several bioactive components ( Lima et al., 2017 ). Retort processingterm, a commercial food processing technology that sterilizes human milkterm·key using high heat of 121 °C ( Jimenez et al., 2024 ) is now being used to create shelf-stable human milkterm·key products ( Lima et al., 2017 ). Retort processingterm has been shown to destroy more bioactive components compared to Holder pasteurization, although only limited studies have been conducted ( Meredith-Dennis et al., 2018 ). More research is needed to understand the results of retort processingterm on human milkterm·key and the consequences for the preterm population.
Advancements in human milkterm·key science and scientific discovery have also enabled the transformation of human milkterm·key into various products, and may also contribute to the commercializationterm·key of human milkterm·key. Human milkterm·key is increasingly viewed as a rich source of biomolecules that could serve other purposes, and scientific discovery provides companies with access to this rich bio-fluid. Human milkterm·key companies like Prolacta are even patenting their processes used in developing CHMterm·dom products ( McClain, 2018 ). Further, biotechnology is now being used to develop laboratory cultured human milkterm·key for infants from donated human mammary tissue ( BIOMILQ, 2022 ; Wilk, n.d.-b ).
Consequences There are several potential consequences resulting from the commercializationterm·key of human milkterm·key. These include undermining breastfeedingterm·dom, quality and safety implications, inequitable distribution of products, exploitation and discrimination, potential displacement of maternal feeds, and extraction of human milkterm·key from communities. These consequences are outlined in Table 6 .
Consequences Resulting From the Commercialized Human Milkterm·dom Industry.
Undermining Breastfeedingterm·dom The existence of CHMterm·dom products on the market may infer that MOMterm·dom is insufficient or that it does not have enough nutrients ( Hassan, 2010 ). Human milkterm·key companies are free to promote and sell their products without adequate safeguards in place to protect those who are the most vulnerable. These practices are reminiscent of infant formula companies ( Rollins et al., 2023 ) and can be misleading. Human milkterm·key companies make claims, including that their products are “the best thing for babies” ( Ni-Q, 2023 ), “breastmilk is becoming rarer and more difficult to obtain” ( Wilk, n.d.-a , section 2: Our first steps towards a brighter future) and they are “transforming care for vulnerable babies by unlocking the power of human milkterm·key” ( Prolacta BioScience, 2022a , page heading). Asserting that CHMterm·dom products are equal to or superior to MOMterm·dom is inaccurate and can undermine breastfeedingterm·dom. Further, human milkterm·key companies may work closely with healthcare providers and influence their clinical practices, which can negatively affect breastfeedingterm·dom. For example, in India, lactation support providers reportedly refer women with excess milk to NeoLacta, to whom they can donate their milk ( Newman & Nahman, 2022 ).
Quality and Safety Implications Currently, the use of CHMterm·dom in NICUs is governed by clinical decision-making by healthcare providers and insurance coverage rather than scientific evidence ( Paynter & Hayward, 2018 ). Further, guidelines and regulationsterm·key for the CHMterm·dom industry are inconsistent ( Shenker et al., 2024 ), which could lead to compromised quality and safety of CHMterm·dom products ( Hartmann, 2019 ; Klotz et al., 2022 ). For example, Neokare had to recall CHMterm·dom products provided to preterm infants in 2023 for high lead levels ( Dennys, 2023 ). Safety and quality of CHMterm·dom products is paramount since these products are provided to the most vulnerable infants.
Inequitable Distribution Access to CHMterm·dom is often inequitable and can create ethical issues. The potential for inequitable distribution is higher if preterm infants at risk of NEC lack access to human milkterm·key ( Thibeau & Ginsberg, 2018 ). CHMterm·dom products can be costly, and they are often not covered by insurance, creating barriers to access ( Thibeau & Ginsberg, 2018 ). While insurance coverage can improve equitable access to human milkterm·key, not all individuals have insurance coverage, creating further inequities in distribution. Therefore, vulnerable infants most in need of human milkterm·key may be at risk of not receiving it ( Thibeau & Ginsberg, 2018 ).
Exploitation and Discrimination The CHMterm·dom industry has resulted in concerns of exploitation. Lactating individuals are encouraged to donate their milk, receiving little to no renumeration, while their expressed milk is sold at a significant profit ( Newman & Nahman, 2022 ; Subramanian, 2022 ). Reports have shown that NeoLacta donors typically have low education and receive small amounts of money or food for their expressed milk ( Newman & Nahman, 2022 ). Concerns of discrimination have also arisen. Medolac Laboratories faced criticism for campaigning for donations of expressed milk from Black women in a low-income area in Detroit with lower breastfeedingterm·dom rates ( Lee, 2019 ).
In contrast, some companies rely on the presumption that exploitation is negated when monetary compensation is not involved ( Newman and Nahman, 2022 ). NeoLacta convinces lactating individuals that their “excess” milk is waste and is an issue that can be resolved by donating their over-supply ( Newman & Nahman, 2022 ). Prolacta has been criticized for not being transparent regarding the use of their human milkterm·key donations. While encouraging individuals to donate their expressed milk for infants in South Africa, Prolacta sells their CHMterm·dom products at a profit in the United States ( Lee, 2019 ).
Displacement of Maternal Feeds Maternal feeds may be displaced for the donor infant due to the donor expressing their milk to provide to human milkterm·key companies. If a donor is regularly expressing milk, their milk supply could increase. However, if irregular expression occurs, the milk supply for their own infant could be reduced ( Hartmann, 2019 ). As with breast milk substitutes, there is a risk of displacement of maternal feeds. Appropriate support and counseling need to be provided to ensure minimal disruption of lactation.
Extraction of Human Milkterm·key From Communities Human milkterm·key is extracted from communities, particularly in lower-income countries, and sold at a profit to higher income countries. Ambrosia Labs paid impoverished women in Cambodia to express their milk for export to the United States. The Government of Cambodia outlawed the practice in 2017 with concerns that exporting human milkterm·key would exploit Cambodian women and could affect the supply of human milkterm·key available for the country’s own children ( Newman & Nahman, 2022 ). NeoLacta sourced human milkterm·key from low-income women in India and exported their CHMterm·dom products to Australia ( Newman & Nahman, 2022 ). These practices can negatively influence human milkterm·key feeding in the communities from which the human milkterm·key is being extracted, potentially reducing the supply of human milkterm·key available for the children of that community.
Governance and Policy The identified literature revealed that, despite the growth in CHMterm·dom products and companies, guidelines and regulationsterm·key are lacking and inconsistent ( Klotz et al., 2022 ; Paynter & Hayward, 2018 , Shenker et al. 2024 ). This raises concerns for ethics, safety, and the equitable distribution of human milkterm·key products ( Cohen, 2019 ; Hartmann, 2019 ; Shenker et al., 2024 ). On a global scale, there are no international guidelines regulating the marketing and sale of human milkterm·key. The International Code of Marketing of Breast-milk Substitutes (the Code) provides recommendations on regulationterm·key of the promotion of infant formula, bottles, and teats ( WHO, 2017 ). However, human milkterm·key is not covered by the Code ( WHO, 2017 ).
There is also debate regarding how human milkterm·key should be categorized, leading to inconsistencies in the regulationterm·key of human milkterm·key. Current categorizations of human milkterm·key include human milkterm·key as a food, medicine, medical product of human origin, or tissue ( Shenker et al., 2024 ). Existing regulatory frameworks for DHMterm·dom globally are outlined in Figure 2 .
Concepts Related to the Commercializationterm·key of Human Milkterm·key Cell-cultured human milkterm·key is not the first type of food to be produced in a laboratory ( Cohen & Cassidy, 2022 ). Cell culturing has also been used to develop food products including milk ( Wilk, n.d.-b ), yogurt ( Wilk, 2022 ), and meat ( Good Food Institute, 2023 ). The cultivated meat industry is changing quickly, and several countries are establishing policies for the sale of laboratory grown meat ( Good Food Institute, 2023 ). Human milkterm·key components, including human milkterm·key oligosaccharides and lactoferrin, are an additional growing area of research and product development. Companies are utilizing various technologies to further develop infant formula by adding these important human milkterm·key components ( dsm-firmenich, 2023 ; Helaina, 2023 ; Turtle Tree, 2024). However, these growing industries all have a need for consistent governance and policy.
Model Case Baby Gabriel was born prematurely at 29 weeks’ gestation, weighing 1600 grams. Due to being premature, specialized care was needed in the NICU to support Gabriel’s growth and development. Unfortunately, Gabriel’s mother, Clara, experienced postpartum hemorrhage and as a result her milk production was delayed. Clara was advised by the neonatologist that Gabriel needed supplementation, with human milkterm·key being the preferred option. Since Gabriel was not considered low-birth weight, they did not qualify for DHMterm·dom according to the hospital’s NICU policy. The hospital offered Clara the choice to provide commercialized donor human milkterm·dom to Gabriel; however, it was costly and was not covered by her health insurance. Clara’s other option was to provide formula to Gabriel which placed Gabriel at a significantly increased risk for developing NEC. Clara struggled with the decision to pay for a CHMterm·dom product that may potentially improve Gabriel’s outcomes.
Discussion The literature identified provides an understanding of the implications of inconsistent guidance and regulatory frameworks relative to the CHMterm·dom industry. The rapidly growing CHMterm·dom industry will likely continue to accelerate and present further challenges. The marketing tactics resembling those used by formula companies are of international relevance as CHMterm·dom could be incorporated into The Code to regulate marketing used by human milkterm·key companies.
The current compensation structure for lactating individuals who provide their milk to for-profit companies is not readily available. It has been reported that companies vary in their compensation methods, ranging from voluntary donations to remunerating with food and small amounts of money. There may be incentive for lactating individuals to express their milk for remuneration, which can potentially lead to oversupply for that individual. Exploring the impact of remuneration on maternal health outcomes would be beneficial. Further, if payment for milk is based on volume, there may be incentive for lactating individuals to dilute their milk with the intention to increase the volume, and therefore receive additional compensation. While some companies test for foreign milk proteins and DNA ( Prolacta BioScience, 2024 ), it is not a mandatory practice, therefore, the potential for diluted milk exists. More research is needed in this area to determine how compensation may affect human milkterm·key donation.
The literature reviewed did not strongly discuss the benefits of CHMterm·dom products; however, there is potential to increase the supply of human milkterm·key and specialized human milkterm·key products as well as to advance human milkterm·key research. While marketing of CHMterm·dom could be an issue if it were to dissuade mothers from breastfeedingterm·dom, it could be beneficial if it encourages NICUs to use human milkterm·key rather than infant formula. The positive aspects of CHMterm·dom products could benefit from further research.
This subject is clinically relevant for lactation support providers as well as other healthcare providers. Increased awareness of CHMterm·dom in the clinical practice setting will help lactation support providers to employ critical thinking in their practice around the use of these products. It will also help providers to educate families so that they are able to engage in better informed decision-making around infant feeding.
Limitations Due to the novelty of this subject, the literature review resulted in a limited number of studies, and there was a paucity of evidence on the prevalence of CHMterm·dom products. This limitation in methodology can create challenges for understanding the full extent of the issues surrounding CHMterm·dom. The use of English-only manuscripts in this concept analysisterm can also be considered a limitation. The limited literature presents a need for further research and may also constrain implementation of the research into practice and policy.
Conclusion Commercialized human milkterm·dom can be defined as the packaging and sale of human milkterm·key and human milkterm·key components for financial gain. The commercializationterm·key of human milkterm·key is a rapidly growing industry with an urgent need for stronger national and global policies and regulationsterm·key to ensure accessibility, ethics, and safety. If left unaddressed, there could be potential risks for donor milkterm·key banking, the future of breastfeedingterm·dom, and infant and maternal health.
Supplemental Material Supplemental material, sj-docx-1-jhl-10.1177_08903344241254345 for Conceptualizing the Commercializationterm·key of Human Milkterm·key: A Concept Analysisterm by Heather Christine RusipersName, Laurence Grummer-StrawnpersName, Maryanne Tigchelaar PerrinpersName, Tracie RislingpersName and Meredith Lee BrockwaypersName in Journal of Human Lactation Supplemental material, sj-jpg-2-jhl-10.1177_08903344241254345 for Conceptualizing the Commercializationterm·key of Human Milkterm·key: A Concept Analysisterm by Heather Christine RusipersName, Laurence Grummer-StrawnpersName, Maryanne Tigchelaar PerrinpersName, Tracie RislingpersName and Meredith Lee BrockwaypersName in Journal of Human Lactation Acknowledgments We would like to acknowledge Dr. Diane Lorenzetti for her assistance with developing our search strategy.
Footnotes References Associated Data Supplementary Materials Supplemental material, sj-docx-1-jhl-10.1177_08903344241254345 for Conceptualizing the Commercializationterm·key of Human Milkterm·key: A Concept Analysisterm by Heather Christine RusipersName, Laurence Grummer-StrawnpersName, Maryanne Tigchelaar PerrinpersName, Tracie RislingpersName and Meredith Lee BrockwaypersName in Journal of Human Lactation Supplemental material, sj-jpg-2-jhl-10.1177_08903344241254345 for Conceptualizing the Commercializationterm·key of Human Milkterm·key: A Concept Analysisterm by Heather Christine RusipersName, Laurence Grummer-StrawnpersName, Maryanne Tigchelaar PerrinpersName, Tracie RislingpersName and Meredith Lee BrockwaypersName in Journal of Human Lactation