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Understanding the global trade and public health regime complex: A case study on breastfeeding and commercial breastmilk substitutes PRELIMINARY AND INCOMPLETE, PLEASE DO NOT QUOTE
Katheryn Russ1*, Phillip Baker2, Michaela Byrd1, Manho Kang1, Rizki Nauli Siregar1, Hammad Zahid1, David McCoy3 1. University of California, Davis California, USA 2. Institute for Physical Activity and Nutrition, Deakin University, Geelong, Australia 3. Centre for Primary Care and Public Health, Queen Mary University, London, United Kingdom
*Address for corresponding author: Katheryn Russ, University of California, Davis, One Shields Avenue, Davis, California 95616 USA
Acknowledgements: Russ received research funding from Alive & Thrive FHI360. The authors thank Karin Lapping, Roger Mathisen, and Elizabeth Zehner for helpful comments.
Conflict of interest statement:
Contributor statement:
Keywords: infant formula, breastmilk substitutes, infant and young child feeding, trade policy, commercial determinants of health, political economy
Abstract
Not breastfeeding is believed to cause more than a half-million child deaths annually from diarrhoea and pneumonia, and nearly 100,000 excess deaths from breast and ovarian cancers, and type-2 diabetes in adult women. Inappropriate marketing by producers of breastmilk substitute is linked to lower rates of breastfeeding. This paper examines how the trade policy regime intersects with the global public health regime for infant and young child. We find that BMS and dry milk exporting countries intervene heavily at the World Trade Organization (WTO) and in standards-setting processes at the Codex Alimentarius Commission (CAC) to restrict the ability of developing countries to implement the WHO’s International Code on the Marketing of Breastmilk Substitutes. The exporters making the interventions are generally advanced economies with some of the lowest rates of breastfeeding in the world. We present data documenting how the BMS industry works—both itself and through national governments—to influence these proceedings, with the result being increasing conflict between the WHO, the CAC, and the WTO in what has become a regime complex of overlapping and conflicting fora.
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Introduction The World Health Organization (WHO) recommends that “infants should be exclusively
breastfed for the first six months of life to achieve optimal growth, development and health
[…and thereafter] receive nutritionally adequate and safe complementary foods while
breastfeeding continues for up to two years of age or beyond.” 1 Few interventions can surpass
breastfeeding as a positive health measure for children.2 Not breastfeeding is estimated to cause
595,379 child (6 to 59 months) deaths annually from diarrhoea and pneumonia, and 98,243
deaths from breast and ovarian cancers, and type-2 diabetes in adult women. Not breastfeeding
also generates US$341.3 billion in global economic losses annually, resulting from premature
mortality, higher health care costs and lost productivity.3 Although the rate of exclusive
breastfeeding in the first 6 months improved globally from 33% in 1995 to 42% in 2018,4 this is
an insufficient rate of progress to meet the World Health Assembly’s global target of 50% by
2025.
One contributing factor to low worldwide breastfeeding rates is the inappropriate marketing and
aggressive promotion of breastmilk substitutes (BMS), defined as foods marketed or otherwise
represented as partial or total replacements for breastmilk.5 These include not only standard
infant formulas (marketed for infants aged 0-6 months), but also “follow-up formula for older
infants” (6-12 months) and drinks for toddlers (13-36 months) and specialised milks for
therapeutic purposes. The purpose of this paper is to describe how the institutions, rules and
agreements of the global public health regime and the global trade regime overlap and interact to
influence breastfeeding rates.
To do so, we draw from regime complex theory developed by international relations,
environmental, and global health scholars.6,7 The term regime complex refers to “…a set of
overlapping and perhaps even contradictory regimes that share a common focus,” such that
“…decisions made in one forum can be influenced, revised, or undermined by decisions and
politics within a parallel or overlapping domestic or international forum (pp.330-331)7.” We
demonstrate the relevance of the theory by examining how the separate regimes for global public
health and trade policy interact with each other around the promotion of BMS trade, including
the evolution, application, and enforcement of BMS standards. We describe how this interaction
3
involves both state and non-state actors and cuts across multiple arenas within key multilateral
institutional fora—the World Health Assembly (WHA), World Health Organization (WHO),
Codex Alimentarius Commission, and the World Trade Organization (WTO). Then we study
how industry actors work at the national level to influence national governments’ participation in
arenas within these fora, as well as provide example of how the regime complex works within or
upon the national political arenas of a BMS importer and exporter.
With this approach, we address two neglected aspects of the literature on the trade-health policy
nexus. First, unlike much existing scholarship which tends to focus on single institutions (e.g.
WTO) or trade agreements (e.g. NAFTA), this paper examines the complex reality of a multi-
institutional and multi-agreement trade regime, shaped fundamentally by the power relations of
different actors and interests. Only one previous study has investigated how these evolving
public health and trade regimes interact in relation to breastfeeding and BMS marketing: a 2020
policy brief by the WHO and UNICEF.8 In this paper, we examine how relevant international
trade policies, processes, rules and standards are used by commercial actors (and the
governments that represent them) across multiple international and national institutional arenas
to influence public health policies in support of breastfeeding. Second, we go beyond the
tendency of trade policy scholars to focus on the influence of industry actors on national trade
policies by looking at how they influence multilateral institutions, including bodies involved in
international standard-setting and enforcement, both directly and through their representative
governments.
The Regime Complex for Infant and Young Child Feeding
Figure 1 illustrates the structure of the regime complex that influences breastfeeding and use of
BMS worldwide. There are two regimes, the global public health regime for infant and young
child feeding and the international trade policy regime. In the middle lies the Codex Alimentarius
(hereafter, Codex)—a compilation of international standards for food quality, safety and
labelling. The global public health regime contains four agencies from the United Nations
system: UNICEF, the WHO, the FAO, and the WHA, which is the governing body of the WHO,
whose mandate includes establishing and monitoring international standards for health policy.9
The WHO and the FAO are charged with jointly administering the Codex through the Codex
4
Alimentarius Commission (CAC). In this respect, the Codex is partly subsumed by the public
health regime, but it has a dual mandate, both to support public health and to facilitate fair trade
by setting standards through a consensus process yielding standards suitable as international
benchmarks. Using the Codex to define the international safety and quality standards of
products, including the way those products are labelled and packaged, is one way of reducing
barriers to trade, by harmonising standards. The CAC is independent in that 187 member
countries plus the EU populate the CAC and its committees and vote on the final standards.
Figure 1. The Regime Complex for Infant and Young Child Feeding
Within the international trade regime, WTO agreements and many regional trade agreements
integrating provisions of these WTO agreements either implicitly or explicitly reference the
Codex.10,11 In this sense, the international trade regime rests upon the Codex and the deliberative
processes of the CAC, whose committees have become arenas of conflict between industry and
public health proponents in setting standards for BMS. In principle, the global public health
regime and the international trade regime are separate—FAO and WHO administer the CAC,
with the CAC and its committees setting Codex standards independently from but used as
5
benchmarks in WTO arenas. However, the lines are blurring as governments supporting BMS
industry interests are starting to coordinate at the WTO in CAC governance and processes.
The global public health regime and the International Code of Marketing of BMS
An important plank of the current global public health regime is the WHO/UNICEF Global
Strategy for Infant and Young Child Feeding1 (GSIYCF), which calls on governments and other
actors to protect, promote and support breastfeeding. This includes enacting and enforcing
provisions of the 1981 International Code of Marketing of Breast-Milk Substitutes12 and
subsequent World Health Assembly (WHA) resolutions, hereafter called the International Code.
The International Code is further supported by state obligations under the Convention on the
Rights of the Child,13 including Article 24 on the right to health and nutritious food.
The International Code is a response to the growing body of evidence that the marketing and
promotion of BMS – including product labelling practices, engagement with health professionals
and direct-to-consumer advertising – undermines breastfeeding and harms infant, child and
maternal health in all country settings.12 Numerous studies document the prevalence of BMS
marketing in both advanced and developing countries,14,15 which can depress rates of
breastfeeding. Exposure to marketing messages—through free samples at hospitals and clinics,
or through advertisements in public media—is associated with reduced breastfeeding exclusivity
and duration, with women in many countries being more likely to recall BMS advertisements
than information about the benefits of breastfeeding.15–17
The WHA has the authority to strengthen or weaken the International Code. Every year,
delegates to the WHA gather in plenary to review reports and vote on resolutions that have been
drafted by various committees that collectively cover WHO’s mandate “to promote health and
ease the burden of disease worldwide.” These committees incorporate scientific evidence, as well
as expert opinion gathered and generated by WHO staff and others. Although the WHA has the
power to make international regulations on an opt-out basis, under pressure from industry and
the US, it instead adopted the International Code in 1981 as a set of non-binding
recommendations for WHO member countries to voluntarily adopt into national law. Many
countries have subsequently implemented aspects of the International Code in an attempt to
6
preserve or restore high rates of breastfeeding. The latest report on worldwide implementation of
the International Code found that 136 of 194 WHO member states (70%) have adopted at least
some provisions into national law. However, only 35 countries (18%) have adopted all
provisions. Moreover, an array of studies have documented systematic violations of the
provisions even when adopted into national laws, often with little consequence.18
BMS producers and the international trade regime
As actors within the global trade regime, BMS manufacturers and suppliers of dairy inputs and
other ingredients (together ‘the BMS industry’) have a competing goal of wanting to maximise
BMS consumption. Global BMS market expansion has been a phenomenal commercial success
in recent decades. Market reports describe a ‘white gold rush’ and a global BMS ‘sales boom’
since the early-2000s, especially in the rapidly industrializing countries of East and South East
Asia.19 Much of the recent growth has been driven by follow-up, toddler and specialised formula
consumption, with the majority of world sales accruing to a small number of transnational
corporations. According to Euromonitor data, five BMS manufacturers – Nestle, Danone, RB
Mead Johnson, Abbot and FreislandCampina – controlled 57% of global market sales in 2018.20
Market reports describe the industry as undergoing ‘terminal consolidation,’ with most national
markets dominated by a few transnational manufacturers, while regional and domestic players
present a competitive fringe in some countries. The major sources of dairy that supply BMS
production chains are New Zealand, the European Union, Australia and the US.21
By reducing frictions in the supply chain and increasing market access, trade liberalization is one
driver of this sales boom. The World Trade Organization (WTO) which emerged as a multilateral
institution in 1995 to help govern cross-border trade, further catalysed this sales boom by brokering
the Agreement on Technical Barriers to Trade (TBT) which weakened the capacity of governments
to implement domestic public health regulations in ways that the longstanding General Agreement
on Tariffs and Trade (GATT), which had been the guidepost since 1945, did not.22 The WTO TBT
Agreement includes references to international standards and the scientific justification of
measures for which Codex is accepted as the benchmark for evolving WTO jurisprudence around
food-related trade. The WTO Sanitary and Phytosanitary Agreement covering food, plant, and
animal safety, explicitly references the Codex as a benchmark for international standards. The
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WTO Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement protects
copyright and branding which overlaps the labelling of food products over which Codex has
responsibility.23 More recently, trade liberalization has been accelerated further through the
explosion in the number of ‘new generation’ regional free-trade agreements (FTAs). More than
half of FTAs explicitly reference the TBT Agreement, including all FTAs implemented since 2010,
and many also reference the SPS Agreement. Some FTAs also have even stronger provisions to
reduce non-tariff barriers (so-called ‘WTO-Plus’), including provisions for marketing and
labelling.11
Although the TBT Agreement, TRIPS and many FTAs recognise the protection of public health
as a legitimate objective of governments, they generally impose restrictions on regulatory action
by governments to pursue their public health objectives. TRIPS is being cited to prevent
restrictions on cross-promotion, where producers circumvent restrictions on marketing infant
formula by creating similar labelling and advertising for products meant for older infants and
toddlers. The TBT Agreement and FTAs adopting its provisions require regulatory action to be
not just “non-discriminatory” with respect to imports, as under GATT, but also “science-based”
and minimally “trade-restrictive.”22,24 These post-GATT agreements afford international
standards-setting bodies a greater role as legally binding benchmarks for what is “science-
based,” especially the CAC, which sets standards for BMS. As a result, the fraction of specific
trade concerns related to food raised in the WTO committees that oversee adherence to the TBT
and SPS Agreements citing deviation from the Codex more than quintupled between 2007 and
2016.10
National governments are also subject to ‘regulatory chill,’ where just the threat of trade sanctions
or costly arbitration is enough to prohibit regulatory action,24,25 especially in FTAs containing
investor protections in the form of investor-state dispute settlement (ISDS) provisions. The tobacco
industry has used ISDS provisions within preferential trade agreements to try to prevent many
countries from pursuing policies, like labelling requirements, designed to reduce demand for
cigarettes. These initiatives often have taken the form of lawsuits or threats of lawsuits, or other
language indicating that the new policies violate international trade agreements and therefore are
subject to punitive measures, which have been persuasive in some low-income countries lacking
8
the funds or infrastructure to engage in a prolonged lawsuit.26–31 Countries introduced a “carve-
out” from the ISDS provision mid-way through the negotiations of the Trans-Pacific Partnership
to ensure tobacco companies could not sue national governments in reference to domestic tobacco
control measures.32 The government of New Zealand summarizes the resulting protections,
broadened in the final Comprehensive and Progressive Agreement for Trans-Pacific Partnership,
as ensuring that ``…strong safeguards to protect the Government’s right to regulate in the public interest and prevent unwarranted claims have been retained… Overall safeguards mean the New Zealand Government cannot be successfully sued for measures related to public education, health and other social services, including the ability to rule out cases specifically relating to tobacco control measures.’’33
Observing country experience with the tobacco industry’s use of ISDS suggests that it has the
potential to become salient for BMS, also.
Methods Given the complex nature of the topic, and the diverse literature and data sources needed to
address the study aim, we adopted a theoretically guided illustrative case study design, involving
the synthesis of documentary and quantitative data sources.34,35 The analysis involved five steps.
Geography of BMS Trade and Breastfeeding Rates
In Step 1, we used quantitative data from UN Comtrade and Victora et. al (2016)2 to describe the
origins and destinations of BMS exports and examined their association with breastfeeding rates
across groups of countries, and the extent of implementation of the International Code as
reported annually by the WHO.36 For trade statistics we used HS code 190110 for dairy-derived
formula in accordance with the US Dairy Export Council and the US Department of Agriculture
Economic Research Service (LDPM-270-01 2016). We omitted non-dairy-based formulas,
pacifiers and infant feeding bottles because there is no HS code sufficiently specific to allow for
this.
Collecting Data on Positions of Actors within Multilateral Arenas
In Step 2, we examined the workings of institutions involved in shaping global and US trade
policy as it affects BMS. To do this, we searched grey literature and assembled a database of
documentary evidence from the online archives of relevant organizations including the Codex
9
Alimentarius, the WTO, the US Trade Representative, and the US Department of Agriculture.
Since the focus of our study is trade policy, we conducted an especially exhaustive search for
interventions at the WTO, described in Appendix A.
Synthesis of Interventions within Multilateral Arenas
In Step 3, we categorized and quantified various types of recent interventions pertaining to BMS
sales and marketing in relevant committees at the Codex Alimentarius Commission and the
WTO, drawing on data from Codex and WTO archives gathered in Step 2. This allowed us to
show how WTO members have sought to shape Codex standards in a recent review of standards
for Follow-up Formula, and how they interpreted and used Codex standards to advance
negotiating positions in opposition to implementation of the International Code within the WTO
Collection of Data on Industry Actors within US National Arena
In Step 4, we assembled data on the actors involved directly or indirectly in US trade
interventions. The US provides a useful case study of industry efforts to exert influence on
national trade policy because various federal laws[1] require detailed public disclosure of
expenditures on lobbying activity and political contributions, including the source and
destination of the funds and often the issue being discussed. We also show how US-based
industry actors are similarly active in influencing the multilateral trade policy regime through,
for example, the major role played by the US in funding the United Nations System, wielding
disproportionate influence in WHO technical and global health policy-making processes37 and
the standards and processes governing BMS markets.
We retrieved bulk raw data on industry lobbying and political donations from the Centre for
Responsive Politics Open Secrets database (opensecrets.org) and organized the data in two
different ways: firm-focused and issue-focused (BMS-related). For the firm-focus, we collected
merger histories from company annual reports and online news articles, tracing the ownership of
BMS manufacturers to carefully match lobbying and political donations to individual firms.
Lobbying disclosed as BMS-related and lobbying by BMS producers are overlapping but not
identical sets. Due to the range of actors and the frequency of mergers, acquisitions, and spinoffs,
10
the firm-focused breakdown is less informative of the volume of resources devoted to lobbying
for the purpose of influencing BMS-related US regulatory and trade policy. Therefore, we
included a breakdown of the lobbying data by issue. To do this, we used word searches of the
lobbying disclosures to identify BMS-related lobbying. We also searched lobbying disclosure
notes for the names of countries receiving complaints by the US and others in the years where
we know from data gathered in Step 2 that interventions regarding BMS marketing took place at
the WTO, followed by manual inspection to identify lobbying likely related to WTO
interventions.[2]
Analysis of Data
In Step 5, we organised the data and findings from the above steps under a final set of themes
and descriptive statistics to illustrate the trade and public health regime complex on
breastfeeding and BMS consumption. We then organized the findings into four main sections.
First, we describe the conflicting objectives of players within the different multilateral and
national arenas by describing the global market for BMS, the marketing of BMS and worldwide
breastfeeding rates. Second, we provide an overview of the public health regime that has evolved
to protect breastfeeding against the inappropriate marketing of BMS, presenting an instance of
industry influence in shaping international standards. Third, we present the new data on trade-
related interventions involving BMS both inside and outside the WTO. Finally, we present an
analysis of the political activities used by the BMS industry to influence US State actions in trade
policy arenas.
Findings The Geography of BMS production, trade and Breastfeeding
The global BMS market has grown rapidly in recent decades and is projected to keeping
growing. The global market value was roughly US$4 billion in 1983,38 growing to US$23
billion by 2005. Industry estimates suggest it reached $47 billion in 2017 and will grow further
to $100 billion by 2026.21,39 Roughly one-fifth of these transactions involve international trade.
World BMS exports reached US$11 billion in 2018, more than double its level a decade before
and about ten times the level in 1998 (see Figure 2).
11
Figure 2. Global exports of BMS, 1988-2018, with share of top exporting countries
Notes: UN COMTRADE HS code 190110.
Figure 3. Global exports of milk powder 1988-2018, with share of top exporting countries
Notes: UN COMTRADE HS codes 040221, 040229, and 040210.
12
The geography of BMS trade suggests a contrast in the participation of advanced and developing
economies. Since 1995, the top-10 exporters have been almost exclusively advanced economies
of the OECD group of countries.[3] Figure 2 illustrates how Australia, New Zealand, the US, and
the top-5 exporters of BMS from the European Union accounted for about three-
quarters of world exports in 2018. Since then, China has entered the top ranks of BMS
exporters. Closely related is the export of milk powder (dried milk), a key input into production
of BMS and the reason why dairy interests are aligned with BMS producers in trade policy
spheres. Figure 3 shows New Zealand as a top producer, followed by the US and the
Netherlands.
Figure 4. Global imports of BMS 1988-2018, with share of top importing countries
Notes: UN COMTRADE HS code 190110. Exports and imports do not match precisely due to small discrepancies across reporting countries.
Figure 4 reveals that transitional and emerging markets populate the top-4 importers outside of
Europe: China, Malaysia, Russia, and Saudi Arabia. Between 2005 and 2018, the Philippines,
Thailand, and Vietnam dropped out of the top-10 importing countries, coinciding with the
adoption of policies to promote breastfeeding and legislation to impose or tighten marketing
restrictions.[4] Overall, BMS exports flow from advanced economies to developing economies,
13
with the main exception being China, which serves markets in Nigeria, Indonesia, Pakistan, and
Malaysia.
Marketing seems to play a role in the expansion of sales. Data on global BMS marketing
expenditures are unavailable, making it difficult to quantify the causal relationship. Yet growth
in BMS consumption has far outpaced growth in per capita income in a host of emerging
markets, while marketing is ubiquitous.19 Assuming that a sum between 3-10% of sales39,40 is
spent on marketing, we estimate that global BMS marketing expenditure was between US$1.68
and US$5.56 billion in 2013.21 These amounts far exceed state expenditures on breastfeeding
promotion, which are estimated to be between $10 million and $250 million annually, depending
on whether medical interventions to support breastfeeding are included, or only public
messaging campaigns.14
Trade patterns, breastfeeding rates and implementation of the International Code
Figure 5 shows the percentage of children breastfed at one year (12-15 months) by country.
Seven of the top eight exporters in Figure 2 are in the bottom quintile of breastfeeding rates. The
United Kingdom, Ireland, and France have some of the lowest rates of breastfeeding globally,
with less than 10 percent of infants breastfed at 12 months. There is a negative correlation
between the rate of breastfeeding at 12 months and exports, demonstrating that breastfeeding
rates are lower among exporters.[5] The top quintile of breastfeeding rates is dominated by
developing countries in Africa and Asia. Overall, Figure 3 shows production and export of BMS
being concentrated in advanced economies with low (and rising) breastfeeding rates, further
indicating that markets may be saturated in countries where production is concentrated, making
exports crucial to continued sales growth. Countries with higher rates of breastfeeding also tend
not to have a domestic BMS industry.
Figure 6 shows that legal measures restricting the marketing of BMS are strongest in countries
with relatively high breastfeeding rates – primarily in Africa and developing Asia. Among the key
exporters, no legal provisions are in place in the US, and few legal provisions exist in EU producer
countries. In countries where many or full provisions are in place, numerous studies
14
Figure 5. Percentage of children breastfed at 12 months, by country (latest available data)
Notes: UNICEF (2019), Victora et. al (2016); data for most recent year available
Figure 6. Country implementation status of the International Code, 2018
Notes: WHO (2018)
15
document widespread violations of the International Code41 and also find that claims in marketing
messages regarding the benefits of BMS are often inaccurate or misleading.42,43
Overall, we observe a general pattern of high-income countries with extremely low breastfeeding
rates and very weak or no restrictions on BMS marketing exporting to developing countries with
higher breastfeeding rates and stronger restrictions on BMS marketing.
Conflicts across fora of the regimes for public health and international trade
The World Health Assembly and World Health Organization
The design and adoption of the original International Code and its subsequent resolutions have
been highly politically contested events. Industry actors actively fought the adoption of the
International Code and sought to weaken its language prior to adoption.44,45 When the original
International Code was passed in 1981 by 118 member states, the US voted against it, after
having acted to weaken its language and ensure its introduction on an opt-in basis, rather than a
stronger opt-out basis. After the vote, the BMS industry circulated its own interpretation of the
International Code in an attempt to weaken the ways in which countries might implement it.46
The WHA meets each year and reviews nutrition policy guidelines that encompass the
International Code every two years, providing many opportunities to reshape priorities.
Subsequent efforts to strengthen provisions of the International Code through additional WHA
resolutions have been similarly subjected to international political dynamics. The most recent
contestation occurred in 2018 when Ecuador intended to introduce a resolution encouraging
governments to strengthen their efforts to implement the International Code, as well as language
urging the WHO to provide support for national monitoring and enforcement. Responding to
concerns from domestic industry stakeholders,47,48 the US sought to prevent Ecuador from
introducing the measure, threatening punitive trade sanctions as well as withdrawal of military
aid. More than 10 other countries, most in Africa and Latin America, declined to support the
resolution for fear of similar retaliation.
Eventually, Russia introduced the measure, which withstood resistance from the US in the form
of a contentious series of procedural manoeuvres—including proposing an unsuccessful
16
alternative measure that did not cite the International Code, advocated “complementary feeding”
for infants older than 6 months, and called for support to help countries build an “evidence base”
for infant and young child feeding strategies as though the benefits of breastfeeding have not
been scientifically demonstrated.49,50 A revision with guidance to support breastfeeding but
without language on enforcement eventually passed as WHA71.9.51–53
Industry influence at the WHA and WHO is likely to intensify through new avenues for direct
participation. In 2016, the WHA approved a Framework of Engagement with Non-State Actors
(FENSA), allowing greater non-state actor participation, including by businesses and business-
interest NGOs.[6] Stakeholders involved in advocating for breastfeeding under the International
Code oppose loosening restrictions on participation of the BMS industry in WHA processes54 in
light of the industry’s past history of working to weaken the Code, arguing that FENSA could not
eliminate conflicts of interest.46,55,56
The Codex Alimentarius
Beyond the International Code, the Codex Alimentarius may be considered the second major
plank of the global public health regime for infant and young child feeding. It consists of a set of
science-based minimum safety standards for food and food production, including BMS products,
and is therefore referenced in WHA resolutions related to the International Code. For example, the
2016 WHA resolution 69.9 calls on the Codex Alimentarius Commission to “give full
consideration to WHO guidelines and recommendations, including the International Code of
marketing of [BMS] and relevant WHA resolutions.”[7] Administered by the WHO and FAO, the
Codex is maintained by committees of the CAC. Observers.57
In addition to representatives from member country governments, the Codex Secretariat, and
WHO and FAO officials, other IGOs and NGOs are able to attend Codex committee meetings as
observers. Observers cannot vote, but can participate in working groups and meetings and post
written comments, so can be quite influential on behalf of industry positions. For the two
committees with primary jurisdiction over BMS, Figure 6 shows the prominence of industry
participation during annual meetings of the Codex Committee on Nutrition and Foods for Special
Dietary Uses (CCNFSDU) and the Codex Committee on Food Labelling (CCFL) in 2019. Industry
17
representatives within member delegations and industry-advocate observers made up more than
40 percent of total participants in the CCNFSDU meeting—nearly matching representation by
member governments and representatives from WHO, FAO, and Codex—and exactly one third of
participants in the CCFL meeting. The industry actors can appear not only as Observers, but also
as part of national delegations (with voting rights) or industry-friendly NGOs.
Figure 6. Attendance at Codex Committee Meetings Discussing BMS Standards in 2019
Note: Data gathered from participant lists in REP19/FL and REP20/NFSDU.
Conflicts and conflicts of interest in BMS standard-setting at the CAC
The process for establishing standards for BMS products through the Codex committees is partially
observable in meeting summaries and written comments posted by participants. Koletzko and
Shamir (2006) discuss the adoption and revision of standards for BMS under the purview of the
CCNFSDU.58 Reporting on a meeting to update BMS standards in 2005, the authors describe the
considerable influence of commercial enterprises in the deliberation of the committee, such that
“scientific and medical arguments may be unduly influenced by commercial considerations
(p.621).” Other observers also have noted heavy industry influence in Codex deliberations that
works against public health considerations,6 including interference in providing scientific advice
to inform standards. The International Life Sciences Institute (ILSI), a non-profit scientific
0
50
100
150
200
250
300
350
400
Food Labelling Nutrition and Foods for Special Dietary Uses
Governments, IGOs, and Codex Public health and consumer NGOs
Industry and industry NGOs Academia
Other
18
research institute with majority funding from industry, serves as one channel for influencing
scientific advice to Codex, as well as many national and international bodies addressing issues
from tobacco to junk food.59,60 An officer of Abbott Nutrition currently is President of ILSI.
Danone, Kraft Heinz, and the (US) National Dairy Council also are members.61,62
As an example of conflicts in deliberations over BMS standards, Table 1 presents some of the
issues under contention during an ongoing review of the 1987 Standard for Follow-up Formula
(Codex Stan 156-1987), begun in 2017. Two of three co-chairs were top BMS producer-
exporters (New Zealand and France), a common practice in Codex processes.59 Members were
divided on whether this uniform standard for products made for persons 6 to 36 months of age
should be divided into two standards or kept as one. As a compromise, the CCNFSDU decided to
have one standard with two sections, one for “formula for older infants” (6-12 months) and one
for products made for “young children” (12-36 months). This was helpful for health objectives in
that it opened the door to require higher nutritional standards for “formula for older infants.”
Before the change, formula for infants 6-12 months was held to the weaker general standards for
the 6-36 months range. In the revised standard, products for older infants have higher nutritional
requirements than products for toddlers. Participants also debated other aspects of composition,
such as whether ingredients with a sweet taste, certain types of sugars, or caps on sugar content
should be allowed or recommended.
Members currently have not agreed on what to call products meant for young children 12 to 36
months old. Industry actors and governments in countries where the BMS industry is influential
have advocated for “formula” or “formulated” to be included in the name. Public health
proponents have argued that this both confuses consumers, risking inappropriate use for babies
0-12 months old and falsely suggesting nutritional adequacy or special health benefits.[8] The
debate over the name of the product also is closely related to a debate over “cross-promotion.”
Cross-promotion concerns marketing of follow-on and toddler formula that inappropriately
promotes use of infant formula because companies label and brand the products in a similar way.
Research shows that even in advanced economics, cross-promotion can lead parents to feed
infants with follow-up and toddler formula instead of the infant formula, which has more strict
nutritional requirements, putting infant health at risk.63–65
19
Table 1. Debates during the review of the Codex Standard for Follow-up Formula (CXS 156-1987)
Issue Perspectives Position Proponents at meetings of Codex Committee on Nutrition and Foods
for Special Dietary Uses
Labelling of products of young children, aged 12-36 months
Public health Do not allow "formula" or "formulated" in proposed product name, "[formulated] drink for young children."
Brazil, Cambodia, Colombia, Cote d'Ivoire, EU, HKI, Jamaica, Nepal, Sri Lanka
Industry-lenient Include "formulated" or "formula" in the product name, "[formulated] drink for young children."
Australia, Indonesia, India, ISDI, Malaysia, New Zealand, USA
Definition of products for young children, aged 12-36mos (Section B, 2.1.1)
Public health Products for young children are used as BMS (defined in WHA 69.9).
Cambodia, Cote d'Ivoire, Ecuador, HKI, IBFAN, India, Jamaica, Lao PDR, Mali, Mexico, Nepal, Philippines, Senegal, UNICEF, WPHNA
Industry-lenient Products for young children are not manufactured for use as BMS.
Argentina, Australia, Brazil, Canada, Colombia, Costa Rica, EU, Ghana, Indonesia, ISDI, Malaysia, New Zealand, Switzerland, Thailand, USA
How to structure the standard for Follow-On Formula, which originally covered products labelled for ages 6-36 months
Public health Products for older infants (6-12 months) and products for young children (12-36 months) are governed by one standard with two parts.
Cambodia, Ecuador, EU, HKI, IBFAN, Nepal, Sri Lanka, UNICEF
Industry-lenient Products for older infants (6-12 months) and products for young children (12-36 months) are governed by two separate standards.
Argentina, Australia, Brazil, Canada, Colombia, ISDI, Malaysia, New Zealand, Switzerland, USA
Preamble for standard Public health Reference the International Code and subsequent resolutions (like WHA 69.9) in the Preamble
Cambodia, Ecuador, Egypt, Jamaica, Nepal, Philippines, HKI, IBFAN, UNICEF
Industry-lenient Do not reference sources "external to Codex" in the Preamble
USA
Sweeteners Public health Additives with sweet taste should not be used
EU, HKI, India, Lao PDR, Kenya, S Korea, Mali, Mexico, Morocco, Nigeria, Panama, WPHNA
Industry-lenient Additives with sweet taste should not explicitly be restricted in the standard
Chile, Costa Rica, ISDI, Russia
Cross-promotion (Section B, 9.6.4)
Public health Cross-promotion must be prohibited Burkina Faso, Cambodia, Chile, Ecuador, HKI, IBFAN, India, Kenya, Kuwait, Lao PDR, Mali, Mexico, Nepal, Nigeria, Senegal, Sri Lanka, Switzerland, Uruguay, UNICEF, WPHNA
Industry-lenient Cross-promotion is not clearly defined hence should not be regulated by the standard.
Argentina, Australia, Brazil, Costa Rica, Dominican Republic, EU, Guatemala, IDF/FIL, Indonesia, ISDI, Korea, New Zealand, Panama, Peru, USA, Vietnam
Mixed Amend the provision on cross-promotion
Australia, Canada, Colombia, Costa Rica, Indonesia, Malaysia, New Zealand
Sources: CS/NFSDU 18/40/4, CS/NFSDU 18/40/5, CS/NFSDU 19/41/5, NFSDU/41, and REP20/NFSDU (including all appendices and posted related comments).
20
The relevance of the International Code to the Codex is a point of contention. Proponents of
breastfeeding seek to reference the International Code in the Preamble to the revised Codex
standard and frequently cite the International Code and related supporting research to justify their
positions. As seen in Table 1, BMS industry proponents seek to prevent citation of the
International Code in the standard. They reject a number of its recommendations during
deliberation of the standard, including that cross-promotion of infant formula and products for
young children should be prohibited and that products for young children (13-36 months) should
be categorized and regulated as BMS, following WHA 69.9. Public health advocates succeeded in
inserting a footnote noting that (and thus forcing the international trade regime to permit) some
countries regulate these products as BMS.
The CCNFSDU is not the only committee that may be consequential for implementation of the
International Code. Contentious debates are occurring in the CCFL over how foods can be labelled
to warn consumers of the potential hazards from the inappropriate use of BMS. The CCNFSDU
consulted heavily with the CCFL to ensure that proposed revisions for follow-up formula are
consistent with standards on labelling. These consultations resulted in replacing some text with
references to standards set by the CCFL that also can be reviewed and revised over time, subject
to the same tensions seen in the review of the standard for follow-up formula.
In a parallel but separate process, the CCFL has been drafting proposed guidelines for ‘Front of
Package Labelling’ since 2018.6,40,66,67 According to the WHO, front-of-package labelling systems
are designed to provide simple information on nutritional quality of products, like “high/low in…,”
etc. An energetic debate is evident over how much leeway countries are permitted to have in
requiring front-of-package labels to indicate high levels of particular substances such as fat, sugar
and salt.6,68 The most recent draft contained language that any system should be optional, even
though a number of countries already have adopted mandatory systems.62 The WHO had already
drafted its own guidelines in 2017, with an update in 2019 and a number of members have
expressed concern that the evolving new Codex standard already is in conflict with the WHO
guidelines.69 For instance, WHO guidelines expressly urge that BMS contain no front-of-pack
nutritional claims,70 but a provision exempting BMS from the new front-of-package labelling
standard is still under contention within CCFL’s deliberations.69 Thow et. al (2019) explore in
21
depth how conflicts of interest are influencing the deliberations, making it likely that standards
will conflict with WHO guidelines in a way that limits the ability of national governments to
implement them without risk of inciting a trade dispute.6
Conflicts over standards and governance between WHO, Codex, and WTO
Indeed, discrepancies already exist between Codex standards and the public health guidelines of
its parent bodies that are generating growing institutional frictions within both the public health
and trade regimes. At the 2016 annual meeting of the Codex Executive Committee (CCEXEC),
representatives of the FAO and WHO protested strongly that CAC members are not weighing FAO
and WHO policies in their work.71 FAO and WHO officials submitted a background document
citing eight examples of Codex guidance or processes—including on drinking-water quality,
nutrition labelling, and BMS—that were in conflict with FAO/WHO policies or UN public health
initiatives.72 The meeting ended without discussion of the issue, but the topic was raised at the next
meeting in 2017. The WHO representative pointed out that the effects of this inconsistency were
that WTO member states who are trying to implement measures adopted by the WHA are being
accused in the WTO TBT Committee of creating trade barriers by failing to comply with the
Codex.73 A WHO representative argued that international food standard setting was a function
delegated to WHO in its Constitution. Thus, the representative argued that even though Codex
standards are cited in the WTO SPS agreement, WHO standards could be considered as
international standards referred to in the WTO TBT Agreement.73,74
Rather than pursue the issue within the CCEXEC, member countries disagreeing with the WHO
and FAO took up the discussion in a WTO SPS Committee meeting in November 2017. The US
argued fervently in support of CAC independence from WHO and FAO as key to ensuring fair
trade in food products.75 Argentina and the US argued again at a WTO SPS Committee meeting in
March 2018 that because Codex is explicitly cited in the WTO SPS Agreement, it takes precedence
over FAO and WHO standards for food safety, using this as an argument for Codex independence
from its parent bodies, with member-driven processes and decisions.76
At the same time WTO members have been advocating for the independence of the Codex as a
standards-setting organization, they have been organizing to influence its governance, funding,
22
and standards-setting procedures. The FAO and WHO provide USD$12 million in technical
support for Codex processes largely through their Scientific Advice Program, but within the CAC
members have expressed concern that these funds are not from sustainable sources and are too
little, often turning to member states and even industry for donations.73 WHO representatives have
expressed reservations on the part of the WHA to increase support while Codex processes fail to
take adequate account of WHA/WHO policies and guidelines.77 Recently, Canada, the EU, and
the US have been put out calls within the SPS Committee for members to urge the WHO and FAO
to set aside sustainable funding for scientific advice, possibly by setting aside funds from the WHO
core budget, as well as to encourage members to contribute financially to support Codex risk-
assessment bodies.76
A communication from Mexico to the WTO TRIPS Council in November 2019 highlights another
example of other components of the trade regime influencing processes or standards-setting by
Codex. Several weeks before the annual 2019 CCNFSDU meeting, Mexico alerted the WTO
membership to proposals being considered in the Codex Committees aimed at prohibiting cross-
promotion of infant and follow-up formula under the same brand.78 Mexico argued that the
proposals, based on scientific evidence of likely harm to infants and consistent with WHA
resolutions, should be screened for consistency with the protection of the value of trademarks
under TRIPs and that TRIPS should take precedence in the design of the Codex standard:78
“Although Article 17 of the TRIPS Agreement provides for exceptions to the rights
conferred by a trademark, a prohibition on "cross promotion" must be examined to
determine whether it could be justified under this Article, as it provides that such
exceptions must take account of the legitimate interests of the owner of the
trademark and of third parties.”
Mexico’s communication is one example of how, in practice, the politics of trade influences the
Codex standards, rather than only scientific expertise. Table 1 documents how countries eventually
lined up on this issue at the CCNFSDU. In the end, while the Codex committee agreed that
labelling of follow-up formula would not be allowed to “refer” to infant formula, it did not
explicitly prohibit the labelling of infant and follow-on formula from resembling each other. The
committee also decided to remove all reference to the term “cross-promotion” altogether.79
23
Industry is still striving to have the word “formula” or “formulated” included in the name for drinks
for young children, which public health advocates argue supports cross-promotion.
The WTO and the regulation of BMS marketing
The treatment of restrictions on marketing of BMS by the WTO has not been systematically
documented in the literature. Concerns related to the marketing, labelling and safety of BMS have
been expressed in a variety of ways by WTO members. In this section, we use newly collected
data from the WTO archives to document the tensions between WHO guidance and Codex
standards and how this influences domestic regulations through trade policy.
The provisions of the SPS and TBT Agreements set parameters for regulations of the composition
and marketing of BMS. Concerns over implementation of the International Code have arisen in
various units of the WTO, including the SPS Committee and TBT Committee. They can also arise
with countries that are not yet members of the WTO during their Accession process or during
periodic surveillance known as Trade Policy Reviews (TPRs). Ultimately, any concerns that
members do not resolve in committee may end up being filed as disputes adjudicated by the
Appellate Body.
Table 2 shows where BMS-related interventions have been made within the WTO between 1995
and 2019. Most occur through the TBT Committee between members of the WTO, but many occur
during the Accession process.
Table 2. Interventions regarding BMS made by WTO members, 1995-2019
Committee or Council Interventions Agriculture 15 Council on Trade in Goods 1 Sanitary and Phytosanitary 2 Technical Barriers to Trade 58 Trade Policy Review 26 Accession Process 102 Total 204
24
Notes: Data collected from WTO online archives
Pre-Accession
Not all pre-Accession proceedings are made public. We identified 102 instances of countries
receiving questions during “Question and Response” processes and INRs in WTO website
archives. INRs involve negotiations by individual members of the WTO with a country being
considered for accession over access to its domestic market for a specific product.[9] 22 of 35
countries who acceded between 1996 and 2019 experienced one or both of these types of
interventions, with 15 of these 22 countries asked questions about their domestic treatment of BMS
products. More than half of the 15 received multiple questions, with Saudi Arabia, Ukraine, and
the Russian Federation asked to answer between 14 and 20 questions. Ten countries applying for
accession engaged in INRs with a WTO member for one or more BMS products. Similar to the
overall patterns discussed above, most of these INRs were granted to advanced economies (the
US, Australia, and the European Union) to negotiate access for their BMS exports to developing
or transitional economies applying for accession.
Post-Accession
Interventions on BMS have taken place across a number of bodies within the WTO. We define
“intervention” as mention of restrictions or proposed restrictions on the marketing, distribution,
and sales of BMS in one member country registered by a committee or council, or by a delegation
from another country, either in person or in writing. 102 such interventions have taken place since
1995.[10]
As Table 2 shows, the vast majority of BMS-related interventions take place in the Committee on
Agriculture, the TBT Committee, and during Trade Policy Reviews, with more than half occurring
in the TBT Committee. Figure 6 shows countries making BMS-related interventions at the WTO
along the horizontal axis, with the countries on the receiving end of the interventions denoted by
colors. It illustrates again the same pattern of interventions generally being made by exporters of
BMS (the US, European Union, Australia, and New Zealand), voicing concerns about policies
implemented or proposed mainly in developing countries.
25
Figure 6. Member countries making vs receiving WTO interventions involving BMS, 1996-2019
Notes: Data collected from WTO online archives. WTO members along horizontal axis make interventions against countries denoted by colors. Quantifying use of new TBT criteria for domestic public health regulation
Figure 7 shows that the number of interventions has grown significantly in the last 5 years. In
addition, their content has changed. Prior to 2014, concerns about measures affecting BMS centred
on questions about the transparency of measures and whether they were discriminatory toward
imports. Since then, interventions have been dominated by TBT-related concerns such as
compliance with Codex/international standards, whether there is a scientific basis for regulation,
and whether regulation is trade restrictive or unfairly imposes costs on foreign suppliers. This is
in line with Thow et al. (2020), who document the importance of Codex in justifications of specific
trade concerns at the WTO levied in regard to policies regulating nutrition labelling in Thailand,
Chile, Peru, Indonesia, and Ecuador.100
0
10
20
30
40
USA EUR AUS NZL JPN KOR ARG RUS CAN IDN CHL UKR DNK TUR
CHN JPN THA ISR PAN HKG IDN EGY OMN PER CAN
Num
ber o
f int
erve
ntio
ns
Country making intervention
26
Figure 7. Percentage of BMS-related interventions mentioning particular concerns, 1996-2019
Notes: Data collected from WTO online archives. Interventions may mention more than one concern and this list is not exhaustive, thus percentages do not add up to 100 percent.
The regime complex and health policy in a BMS importer
One example from Thailand illustrates how these developments impede implementation of the
International Code. Figure 8 is a flowchart showing the progression of interventions against
Thailand after it introduced domestic legislation to restrict inappropriate marketing of BMS.[11]
The first intervention we found were of concerns being expressed about the proposed legislation
during the WTO Trade Policy Review of Thailand’s economy in 2015.[12] During the TPR, both
the US and New Zealand suggested that the proposed legislation does not conform to international
standards and requested an explanation of its scientific rationale. Almost every intervention over
the next 20 months involved a questioning of Thailand’s scientific rationale or a complaint about
the proposed legislation not conforming to Codex standards.
0
10
20
30
40
50
60
70
80
90
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
technical engagement
tariff quota underfill
consumer choice
transparency
trade costs
import discrimination
trade restrictiveness
scientific rational and health/safety basis
Codex and international standards
27
The interventions then come under increasing pressure in the TBT Committee. US delegates
expand their concerns. Australia, the European Union, and New Zealand form a coalition with the
US to echo the concerns, with Canada joining later. The coalition explicitly and repeatedly
references Codex standards in its concerns about whether there is adequate scientific rationale for
the proposed legislation. In November 2016, the coalition added concerns about requirements for
product labelling. At the March 2017 TBT meeting, three of the five coalition members again
voice concerns about compliance with Codex standards and four about trade-restrictiveness.
This is a rare case where we can see the original proposed policy and the changes made to the final
version as reported here by the US Department of Agriculture Foreign Agricultural Service (FAS),
included here in Appendix 3. Both the US Department of Agriculture and the US Trade
Representative80 detailed the changes that occurred to the draft law that may benefit US exporters
as the provisions of the law were weakened.[13]
Industry influence in the regime complex through the national arena of a BMS exporter
Trade regime theory considers interactions between and within the parallel or overlapping
domestic and international fora. Here we describe how the political influence of the BMS industry
within US domestic political arenas may influence the position the US government takes in
international fora, and how industry influences BMS marketing regulations in other countries
through direct bilateral action.
Political contributions by the BMS industry
The “Big-6” BMS manufacturers—Abbot, Dannone, Kraft-Heinz, Nestle, Perrigo, and RB (Mead
Johnson)—make substantial political contributions. There has been a lot of changing of hands of
some firms over the last two decades, so we account carefully for mergers and acquisitions in the
tabulations. In the 1990s, Kraft-Heinz was the major donor within this group, then Nestle and
Reckitt-Benckhiser/Meade Johnson in the 2000s. In the last ten years, Abbot’s contributions have
steadily grown since 1999 and now dominate industry political contributions. Total political
contributions from the Big-6 BMS firms peak at close to $6 million in 2000, but averaged about
US$2 million per year in the 1990-1999, US$3 million per year 2000-2012s, and have been steady
at $1 million per year 2013-2018.
28
Figure 8. Interventions at the WTO involving Thailand’s proposed domestic legislation to regulate the marketing of BMS
Notes: Data sourced from WTO online archives
29
In the 1990s, a greater proportion of donations went to Republican candidates for office. Since
2008, donations have been evenly divided between Republicans and Democrats. More funds went
to candidates for the House of Representatives than for the Senate or White House and most
recipients of funds won their election.
Industry lobbying for BMS-related interventions
Expenditures on lobbying activity dwarf political contributions in the typical year. Figure 9 shows
total expenditures on lobbying activity where the lobbyist reports a BMS-related subject in their
disclosure. Total annual expenditure on lobbying (distinct from political contributions to
candidates discussed above) can exceed $12 million, though it averages about $7 million, more
than three times the average level of political contributions over the last decade. Disclosures do
Figure 9. BMS-related lobbying expenditures
Notes: Data sourced from the Center for Responsive Politics; author calculations of phrase-filtered BMS-related lobbying expenditure, plus lobbying by BMS manufacturers and their associations with disclosures noting particular countries in periods where events linked to BMS regulation took place.
0
2
4
6
8
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2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019
Trade-related Non-trade related
Lobb
ying
exp
endi
ture
(milli
on U
S do
llars
)
30
not always provide detail on the topics discussed, possibly why some apparent gaps exist in
disclosed trade-related BMS lobbying between 2009 and 2016 in Figure 9. However, it is clear
that since 2016, BMS-related lobbying has been focused on trade.
In Figure 11, we show lobbying expenditures that are possibly linked to US interventions at the
WTO, with the links suggested both by general disclosure of issues reported and by timing relative
to interventions at the WTO. The largest expenditures by far are from Abbot Laboratories,
followed by a group of organizations representing dairy interests, as well as the Infant Nutrition
Council of America, which is funded by BMS exporters Abbott Nutrition, Gerber Products
Company, Perrigo Nutritionals, and Reckitt Benckiser (Mead Johnson). Lobbying activity by BMS
producers is spread across the federal government, especially in the House of Representatives, the
Senate, and at various times, the Food and Drug Administration, State Department, US Trade
Figure 11. BMS producer interest group expenditure on lobbying related to possible policy interventions
Notes. Data sourced from the Center for Responsive Politics, and author calculations
0
2
4
6
8
10
12
14
2006 2007 2008 2009 2012 2013 2014 2015 2016 2017 2018 2019
Abbott Laboratories Bristol-Myers Squibb Grocery Manufacturers AssnInternational Dairy Foods Assn National Milk Producers Federation Dairy Farmers of AmericaFonterra Cooperative Group Nestle SA Edge Dairy Farmer CooperativeSoutheast Dairy Farmers Assn Cooperative Network Kraft Heinz CoMead Johnson Nutritional Pennyslvania Farm Bureau Western United DairymenIdaho Dairymen's Assn National All-Jersey Inc Oregon Farm BureauInfant Nutrition Council of America
Inte
rven
tion-
rela
ted
lobb
ying
exp
endi
ture
(milli
on U
S do
llars
)
31
Representative, and the Department of Agriculture. Some disclosures contain explicit descriptions
of non-WTO/WHO issues linked to the lobbying activity. For instance, in 2007 Bristol-Myers-
Squibb described the purpose of lobbying as “Philippines/Ban on Advertising and Marketing” and
“lobbied to ensure compliance with laws allowing advertising and marketing of infant formulas.”
When checking the issue focus of each lobbying expenditure, a number of issues emerged that do
not appear among the WTO interventions. We describe these in greater detail in the Supplementary
materials. They include concerns about enforcement actions across a number of countries, as well
as discussions about WHO initiatives around “infant formula regulatory issues” and “pediatric
nutrition,” or trade and unspecified “WHO initiatives” as they related to intellectual property.
Discussion Our findings elucidate a trading system in which there is a North-to-South net flow of BMS
products. A large contingent of developing and transitional economies is striving to restrict
inappropriate marketing of BMS by implementing the WHA’s International Code. In doing so,
they run into challenges that are channelled through the institutions of the international trade
regime from BMS exporters. BMS inputs and products are largely produced and promoted by
multinational firms headquartered in advanced economies such as Australia, France, Germany,
New Zealand, and the US.
At the center of this turmoil between the international public health and trade regimes is the Codex
which sets standards for the composition, labelling, and marketing of BMS products. These
standards can restrict the scope of domestic legislation due to their explicit or implicit reference in
WTO Agreements, as well as preferential trade agreements. In principle, the Codex is administered
by the FAO and WHO with a mandate to protect public health through science-based food safety
standards. Yet because the Codex also acts as a standard-setting body for the international trade
regime, and because of the heavy influence of industry actors permitted through the committees
of the Codex Commission, its standards sometimes conflict with FAO/WHO policies and
guidelines as they relate to BMS.
Perhaps the biggest challenges for advocates of the International Code at present lie in the
mounting battles across multiple Codex committees over cross-promotion, food packaging and
32
labelling, and to what degree they will preserve members’ right to regulate in the interest of public
health. In the current review of the standard for follow-up formula, the right to regulate marketing
of BMS products for children 13-36 months as BMS in the same way as standard infant formula,
as stipulated in the International Code, hangs on a mere footnote acknowledging that some
countries do so. The same is true for countries who wish to restrict sugars to less than 2.5g per
100kcal. Every line and footnote can become of enormous import for leeway to regulate according
to international public health standards set by other UN bodies.
Codex standards have grown to such extreme import largely because the wording and evolving
interpretation of the TBT Agreement has narrowed the parameters for domestic regulation. Lester
(2014) points out that recent interpretations increasingly emphasize necessity (is a domestic policy
measure the least trade-restrictive measure possible) and proportionality (does a measure restrict
trade to a degree that is proportionate to the stated policy objective?), and present a much higher
bar for domestic public health regulation.24 We see these higher bars reflected in increasing
numbers of interventions about BMS mentioning Codex, international standards, trade-
restrictiveness, and trade costs.
Lester also notes that current US trade policy is oriented toward insisting that food safety
regulations be “science-based.” This creates even more stringent constraints upon domestic
regulation by challenging regulations that may not only exist to discriminate against exports, but
also those that exist to protect animal welfare or the environment.22 The “science-based” or
interchangeable Codex/international standards criterion is often used in complaints at the WTO
about national efforts to implements the International Code since 2014 in Figure 6. Some public
health advocates also have expressed concern that industry places the threshold for science-based
as randomized control trials, which can present ethical obstacles in some health-related contexts.
Industry-friendly comments in the ongoing review of the Codex Standard for Follow-up Formula
appear implicitly to take a risk-based approach to evaluating each element of a BMS product for
safety: Glucose is safe, therefore there is no need to prohibit its use in favour of carbohydrates
with no sweet taste… Sugars other than lactose are safe, so there is no need to put highly restrictive
caps on their use… A particular-sized dose of the product is not toxic to an infant or young child,
33
therefore its use is not unsafe and the concern should be for standards that are overly restrictive of
its sale. Public health advocates take an approach to appraising safety that more closely resembles
hazard-based assessments: Although it is hard to tell whether any one child will be adversely
affected, over-consumption of sugars or the development of a trained preference for sweet tastes
are linked to increased rates of obesity in aggregate and therefore to non-communicable diseases
and early deaths… Aggressive or inappropriate marketing may reduce aggregate rates of
breastfeeding, which is known to contribute in aggregate to worse health outcomes, therefore it
would follow that marketing should be restricted in the interest of public health. These are two
very different ways of thinking about the scientific basis for food safety—whether some level of
population exposure is likely to result in harm to a subpopulation, versus whether any one
individual is likely to suffer adverse health effects from a prescribed level of exposure.81
Our findings show how various sub-arbitration-level committee processes of the WTO can affect
a country’s ability to implement the International Code. We observe instances in the SPS
Committee and the TRIPS Council of WTO members organizing to influence the governance
structure and funding of the CAC and its scientific advice, rather than working exclusively through
their country counterpart delegates to the parent bodies, the FAO and WHO. Since CAC and
CCEXEC meeting summaries suggest that WHA and WHO are reluctant to solidify funding to
support CAC technical advice and processes while Codex standards evolve in conflict with WHO
public health guidance, organizing at WTO to marshal alternative sources of funding or encourage
allocations from WHO core funding without resolving these issues may become a way to further
weaken Codex observance of FAO and WHO health guidelines.
If the US withdraws funding from WHO, as it has recently promised, and diverts a portion of these
funds directly to Codex, this in particular could weaken the commitment of the CAC to the public
health half of its mandate. We document a flood of attempts by industry to influence the US
government on the subject of BMS; WHO initiatives related to infant and pediatric nutrition; and
protection of intellectual property which includes branding and advertising under TRIPS. Much of
the expenditure related to these attempts to influence coincide with observed US interventions at
the WTO expressing concern about measures that may affect trade in BMS or related supply-
chains.
34
The ambiguities and conflicts evident in the regime complex governing infant and young child
feeding are therefore similar to those of the regime complex governing environmental issues.82
The arenas of the battles are similar—WTO committees, the TRIPS Council, Codex, the domestic
political arena, and various RTAs. The scientific debate bears some resemblance, as well. The US
is pushing aggressively for adherence to a risk-based approach to setting maximum residual limits
for pesticides, for instance, while even within US jurisprudence, the issue has not been settled.[14]
WTO Jurisprudence related to the TBT Agreement is also evolving quickly, with many open
questions as to how broadly trade law should apply to and interfere with domestic regulations for
public health.24 The recent battle to insert language restricting labelling into the US-Mexico-
Canada Free Trade Agreement is a sign that industry proponents are working on ways to restrict
domestic regulation through RTAs, as well.83
Conclusions Together these findings provide new knowledge on the political economy of trade rules and public
health policy. They are an extension of observed lobbying and political influence in the trade
literature on “protection for sale.”84–88 They are also highly relevant to the political science
literature on business power in global governance,89 the rapidly growing scholarship on the
political economy of food systems and public health,90,91 and on the commercial determinants of
health.92,93
Endnotes [1] The US Federal Election Campaign Act of 1971, the Lobbying Disclosure Act of 1995, and
the Honest Leadership and Open Government Act of 2007 governing election and lobbying
oversight combine to require more detailed disclosures than in many countries.
[2] We further inspected lobbying disclosure notes flagged in the word search for BMS issues
that were not linked to happenings at the WTO but which pointed to BMS-related activities in
specific countries. In this way, we found several specific market access challenges facing BMS
producers in US trading partner countries (see Appendix 2 for further details).
[3] See Panel A of Table S1 for detail.
[4] The Philippine Department of Health tightened restrictions in 200694 and the legislature
adopted the Expanded Breastfeeding Promotion Act of 2009.95 Thailand adopted its Milk Code
35
restricting marketing in 2017.96 Vietnam passed adopted statutes in 2012 and 2014 restricting
advertising and establishing public policies in support of breastfeeding.97,98
[5] Using these data, the correlation between the percentage of infants breastfed at 12 months
and exports is -0.40, significant at the 5 percent level. The correlation between imports and the
rate of breastfeeding is -0.20, half as large and statistically different than the correlation for
exports.
[6] Stakeholders involved in advocating for breastfeeding under the International Code opposed
participation of the BMS industry in WHA processes because of the clear conflicts of interest it
would involve54 and the industry’s past history of working to weaken the initial provisions of the
Code, and then circulating a watered-down interpretation of the International Code after it was
adopted.46
[7] A companion report for that resolution5 cites relevant Codex provisions including the
‘commodity-specific’ 1981 Standard on Infant Formula (CXS 72-1981), the 1987 Standard on
Follow-up Formula (CXS 156-1987) and a number of ‘horizontal standards’ including the
Standard for Labelling of and Claims for Foods for Special Medical Purposes (CXS 180-1991)
under the Codex Committee on Food Labelling (CCFL).99
[8] Public health advocates note that the drinks often have excessive levels of sugar and are not
necessary or especially beneficial to health compared to, for instance, less expensive cow’s milk.
[9] Table S3 in Appendix 2 presents data by country—which countries receive questions or
requests for INRs and which countries ask or request them.
[10] If we also include queries about broader dairy issues that may encompass BMS supply chains,
the number reaches 135. We focus on the narrower category (interventions that explicitly mention
BMS) for the remainder of this paper.
[11] We include a similar flowchart for interventions against China in the Supplemental materials.
[12] This suggests that Thailand did not notify the WTO of its proposed policy when it was drafted,
an observation confirmed within a 2018 report to Congress by the US Trade Representative.80
[13] The web address where this document was posted is no longer works, so we include the full
document in the Appendix, along with the original website address. It is particularly rare because
the FAS uploaded the “redlined” revisions to the original.
[14] The California Supreme Court recently ruled against the use of glyphosates as an herbicide using a
hazard-based study, despite risk-based assessments supporting their use as safe.
36
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