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What you don’t know about the Codex can hurt you: How modern trade policy shapes public health governance of infant and young child nutrition
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: The authors thank Karin Lapping, Roger Mathisen, and Elizabeth Zehner for helpful comments.
Conflict of interest statement: Dr. Russ reports a grant from Alive & Thrive/FHI 360 during the conduct of the study.
Keywords: infant formula, breastmilk substitutes, infant and young child feeding, trade policy, commercial determinants of health, political economy
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Abstract
Background: This paper documents how the new emphasis on an international standards-setting
body called the Codex Alimentarius Commission (CAC) as arbitrator for what is science-based
has created what is known as a “regime complex” at the nexus of trade and public health policy.
Implementation of World Trade Organization (WTO) Agreements referencing these standards are
shaping limits on domestic regulation in support of public health in realms like infant and young
child nutrition, posing risks to infant, child, and maternal health.
Methods: Using trade in breastmilk substitutes (BMS) as a case study, we collect data on
interventions by industry interests and exporting governments at the CAC (2016-2019) and WTO
(1995-2019) related to BMS. We assemble and analyse data on lobbying activities in a large
exporting country to quantify expenditures on efforts to influence the US government on issues
related to BMS and trade.
Results: There is an effort by exporters to narrow standards on follow-up formula at the CAC in a
way that conflicts with recommendations in the World Health Organization International Code of
Marketing of Breastmilk Substitutes. At the WTO, exporting countries use complaints of
deviations from the CAC’s international standards to protest adoption of the Code by WTO
members. Industry interests spend millions of dollars annually to influence the US government’s
positions in these proceedings.
Conclusion: Industry interests are magnifying conflicts between standards-setting at the CAC and
health guidelines set by the WHO, posing concerns for the ability of countries to regulate in the
interests of public health.
Key Messages:
Implications for policy makers
• Screening for conflicts of interest in CAC standards-setting should be strengthened.
• Countries should evaluate how language in the WTO jurisprudence related to the
Agreement on Technical Barriers to Trade and other provisions is affecting the ability to
implement regulations in support of public health.
• Arbitration for what satisfies the legal threshold for “science-based” is becoming
politicized and threatens to weaken the precautionary principle used in some countries to
guide regulation for public health and the environment.
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Background
By strengthening the specificity and enforcement of requirements to adhere to international
standards in the design of domestic regulation, the birth of the World Trade Organization (WTO)
in 1995 initiated a quiet but massive shift in the scope for domestic regulation of public health. In
principle, harmonization of standards can help eliminate unnecessary hindrances to trade, leading
to efficiency gains.1 However, the WTO brought a stronger arbitration process for enforcement,
as well as stronger language in the WTO Agreement on Technical Barriers to Trade (TBT)
specifying that domestic regulatory measures not be more trade-restrictive than necessary to
fulfill a legitimate objective. It also required that assessing the appropriateness of any domestic
regulatory measure be based on risk, using available scientific and technical information.2,3 This
reached beyond the primary goal evident in prior agreements of preventing nations from
formulating regulations in a way that discriminated against imported goods. The shift in
language opened the door for countries to levy more complaints against domestic regulatory
measures on the grounds of being “overly trade-restrictive” or “not science-based.”4,5 The
implementation of the WTO Agreements therefore has intensified incentives for private-sector
lobbying over standards used to determine criteria to judge the validity of these complaints.6
These heightened incentives for exporters to lobby for accommodative standards have emerged
before strong protections against conflicts of interest were established in all bodies referenced as
arbitrators of what constitutes a “science-based” standard for public health.7 The evolution of
WTO jurisprudence in deliberations over trade concerns related to public health, combined with
explicit reference to a set of standards called the Codex Alimentarius (Codex) in the WTO
Sanitary and Phytosanitary Agreement (SPS), made a little-known body within the United
Nations family called the Codex Alimentarius Commission (CAC) the main arbitrator of science
for food safety in trade policy.8,9 The proportion of specific trade concerns related to food raised
in WTO committees citing deviation from Codex standards increased more than fivefold between
2007 and 2016.10 The Codex, with a “dual mandate” to serve both public health and facilitate
trade, has now become a tool to fight against domestic measures that exporters feel hinder
market access across a wide variety of industries, from baby foods to pesticides.
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This paper documents how the new emphasis on this international standards-setting body as
arbitrator for what is science-based has created what is known as a “regime complex” at the
intersection of trade and public health policy. 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.” 6,11 To do so, we focus
on commercial breastmilk substitutes as a case study, examining recent treatment of related
standards within the CAC and the WTO. Our research illustrates a system now rife with
conflicting authority over public health governance. Industry interests and certain government
agencies have been increasingly exploiting the ambiguity within the CAC—where screening for
conflicts of interests is sorely lacking7—and steadily marginalizing public health advocates in
international standards-setting, presenting serious concerns for infant, child, and maternal health.
Nowhere has this shift in policy had more jarring effects than on efforts to protect and promote
breastfeeding. 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.”12 Few interventions can surpass
breastfeeding as a positive health measure for children. Not breastfeeding is estimated to cause
595,379 child (6 to 59 months) deaths annually from diarrhoea and pneumonia and 98,243 adult
deaths from breast and ovarian cancers and type-2 diabetes.13,14 Although the rate of exclusive
breastfeeding in the first 6 months improved globally from 33% in 1995 to 42% in 2018,15 this is
an insufficient rate of progress to meet the World Health Assembly’s global target of 50% by
2025. Thus, the World Health Organization-UNICEF Global Strategy for Infant and Young
Child Feeding12 calls on governments and other actors to protect, promote, and support
breastfeeding.
One factor contributing 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.16 This includes any milk products
marketed for consumption by children up to 36 months of age. Numerous studies document the
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prevalence of inappropriate BMS marketing in both advanced and developing countries,17,18
which can depress rates of breastfeeding. Exposure to marketing— including product labelling
practices, engagement with health professionals, and direct-to-consumer advertising —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.18–20
The WHO-UNICEF Global Strategy includes enacting and enforcing provisions of the 1981
International Code of Marketing of Breast-Milk Substitutes21 and subsequent World Health
Assembly (WHA) resolutions, hereafter called the International Code. The International Code is
a response to a longstanding concern that the marketing and promotion of BMS undermines
breastfeeding and harms infant, child and maternal health in all countries.21 The International
Code is further supported by state obligations under the Convention on the Rights of the Child,22
including Article 24 on the right to health and nutritious food.
Figure 1. The Regime Complex for Infant and Young Child Nutrition
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Figure 1 illustrates the international health-trade regime complex that influences breastfeeding
and use of BMS worldwide. There are two regimes, the global public health regime for infant
and young child nutrition and the international trade policy regime. In the middle lies the Codex
Alimentarius, a compilation of international standards for food quality, safety, and labelling. For
the purpose of this research study, the global public health regime contains three agencies of the
United Nations system: UNICEF, WHO, and FAO. The WHA is the main governing body of the
WHO, whose mandate includes establishing and monitoring international health standards,
which guides health policy development among member states.23 The WHO and the FAO are
charged with jointly administering the Codex through the Codex Alimentarius Commission
(CAC). The CAC’s 187 member countries plus the EU populate the CAC and its committees and
vote on the final standards.
The Codex has a “dual mandate,” to both support public health and facilitate fair and free trade
by setting 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. In
principle, the Codex is part of the global public health regime only, with FAO and WHO
administering the CAC, and the CAC and its committees setting Codex standards outside of the
international trade regime. However, because Codex standards are used as benchmarks by WTO
arenas, it is drawn into the trade regime.
Both the WTO agreements and many preferential (bilateral and other regional) trade agreements
integrating provisions of these WTO agreements either implicitly or explicitly reference the
Codex.10,24 Sub-arbitration-level pressure against adoption of the International Code into
domestic law can occur within a variety of WTO committees, including the TBT Committee,
SPS Committee, and the TRIPS Council, bodies which each oversee the agreement of the same
name shown in Figure 1. Due to uncertainty surrounding how Codex standards might be
interpreted or enforced in trade dispute settlement processes, national governments may also be
subject to ‘regulatory chill,’ where just the possibility of trade sanctions or costly arbitration is
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enough to deter regulatory action,4,25 especially in preferential trade agreements containing
investor protections in the form of investor-state dispute settlement (ISDS) provisions.
Within both regimes are member governments and their industry constituents. We document
how industry actors work to influence in the international arenas of the respective public health
and trade regimes, and how this in-turn reflects influence and outcomes in national arenas for a
BMS importer and exporter. With this multi-tiered approach, our research addresses 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.26 Here, we examine how relevant international trade policies, processes, rules and
standards are used by commercial actors (and the governments that represent them) across
multiple national and international institutional arenas to obstruct public health policies that
support breastfeeding. Second, we go beyond the tendency of trade policy scholars to focus only
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.
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.27,28 The analysis involved five steps.
Step 1: Describing global BMS Production, Trade and Breastfeeding Rates
We used quantitative data from UN Comtrade and Victora et. al (2016)13 to describe the origins
and destinations of BMS exports and examined breastfeeding rates across groups of countries,
and the extent of implementation of the International Code as reported annually by the WHO.29
For trade statistics we used HS code 190110 for dairy-derived formula in accordance with the
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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 isolate these in data on trade flows.
Step 2: Collecting Data on Positions of Actors within Multilateral Arenas
Next, we examined the workings of institutions involved in shaping global 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 Alimentarius
and the WTO. Since the focus of our study is trade policy, we conducted an especially
exhaustive search for interventions at the WTO, described in Supplemental File 1. Supplemental
File 1 also contains a table describing the WTO bodies where we document interventions related
to BMS.
Step 3: Synthesis of Interventions within Multilateral Arenas
We then categorized and quantified various types of recent interventions pertaining to BMS sales
and marketing in committees with jurisdiction over BMS at the Codex Alimentarius Commission
(the Nutrition and Foods for Special Dietary Uses Committee and the Food Labelling
Committee) and the WTO (a range of committees), 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.
Step 4: Collection of Data on Industry Actors within US National Arena
Next, 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 it plays in
funding the United Nations System, wielding disproportionate influence in WHO technical and
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global health policy-making processes30 and the standards and processes governing BMS
markets.
We retrieved bulk raw data on US 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,
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] We searched archives from the US Trade Representative and US Department of
Agriculture for mention about where policy actions had achieved aims coinciding with private-
sector stakeholder positions. See Supplemental File 2 for full details.
Step 5: Analysis of Data
In Step 5, we generate descriptive statistics to illustrate the trade and public health regime
complex on breastfeeding and BMS consumption by tallying the types and frequency of
interventions at the WTO, mapping patterns of lobbying expenditures over time, and creating
charts with data detailing major themes or alliances in deliberative processes at the CAC and the
WTO. A replication package with data and Stata v13 code is available from the corresponding
author upon request.
Results
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We organized the findings as follows. First, we describe the geography of BMS importers and
exporters. 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—both direct through an industry association and indirect through
representative governments—in shaping international standards for follow-up formula. Third, we
examine the treatment of BMS within the trade policy regime, presenting 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
and health policy arenas.
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 1983,31 growing to US$23
billion by 2005. Industry estimates suggest it reached $47 billion in 2017 and will grow further
to $100 billion by 2026.32,33 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).
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 the top milk-powder exporter, followed by the US and
the Netherlands.
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
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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.
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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,
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.
with the main exception being China, which serves markets in Nigeria, Indonesia, Pakistan, and
Malaysia.
The transnationalisation of the BMS industry and its marketing practices is a driver of global
sales expansion.17,18,34 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.34
Assuming that a sum between 3-10% of sales33,35 is spent on marketing, we estimate that global
BMS marketing expenditure was between US$1.68 and US$5.56 billion in 2013.32 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 education and social messaging campaigns.17
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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, Figures 2 and 3 show exports of BMS and its
milk powder components being concentrated in advanced economies where Figure 5 shows low
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 document
widespread violations of the International Code36 and also find that claims in marketing messages
regarding the benefits of BMS are often inaccurate or misleading.37,38
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 between the public health and international trade regimes
The World Health Assembly and World Health Organization
The design and adoption of the original International Code and its subsequent resolutions have
been highly politicised. Industry actors actively fought the adoption of the International Code in
1981 and sought to weaken its language prior to adoption.39,40 When it was eventually passed by
118 member states at the World Health Assembly, the US was the only country to vote against it,
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after having acted to weaken its language and to ensure its introduction on an opt-in basis, rather
than a stronger opt-out basis. After the vote, the BMS industry circulated its own interpretations
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)
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of the International Code which health advocates interpreted as instructions to aid marketers in
circumventing it.41
The WHA reviews the International Code every two years, revising and refining it through new
resolutions in response to evolving industry marketing practices and WHO technical guidance.
These efforts to strengthen provisions of the International Code have been similarly subjected to
international political dynamics. The most recent contestation occurred in 2018 when Ecuador
set out to introduce a resolution encouraging governments to strengthen their efforts to
implement the International Code, and urging the WHO to provide greater support for national
monitoring and enforcement. Responding to concerns raised by its domestic industry
stakeholders,42,43 the US acted to prevent Ecuador from introducing its proposed resolution by
threatening punitive trade sanctions and the 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.44
Eventually, Russia introduced a version of the proposed resolution, withstanding resistance from
the US in the form of a contentious series of procedural manoeuvres. This included proposing an
unsuccessful alternative resolution that excluded reference to the International Code 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.45,46
A revised version of Russia’s proposed resolution, with guidance to support breastfeeding but
without language on enforcement, eventually passed as WHA71.9.44,47,48
The Codex Alimentarius
Beyond the International Code, the Codex 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 CAC to “give full consideration to WHO guidelines and
recommendations, including the [International Code] and relevant WHA resolutions.”[6]
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Administered by the WHO and FAO, the Codex is maintained by a Codex Secretariat and various
committees of the CAC.49
In addition to representatives of member country governments and officials of the Codex
Secretariat, WHO and FAO, representatives of inter-governmental organizations (IGOs) and non-
governmental organizations (NGOs) are able to attend the various 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. Two committees have primary jurisdiction over
BMS: the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) and
the Codex Committee on Food Labelling (CCFL). (See Supplemental File 3 for a description of
the CAC’s organizational structure.) Figure 7 shows the prominence of industry participation
during the annual meetings of these two committees in 2019. Industry representatives within
member country government delegations (with full voting rights) as well as industry-advocate
observers made up more than 40 percent of total participants in the CCNFSDU meeting—nearly
Figure 7. Attendance at Codex Committee Meetings Discussing BMS Standards in 2019
Notes: Data gathered from participant lists in REP19/FL and REP20/NFSDU.
0
50
100
150
200
250
300
350
400
450
FL NFSDU
Government UN-IGOs and Codex
Industry and industry-advocate NGOs Public-health and consumer-driven NGOs
Academia Non-UN IGOs
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matching the number of officials from national governments, WHO, FAO, and the CAC
Secretariat combined. Industry participants made up exactly one third of all attendees in the CCFL
meeting. Often, industry participants attend as part of a member government delegation.
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.50 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.
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), which began in 2017. Two of three co-chairs were representatives of top
BMS producer-exporter countries (New Zealand and France), a common practice in Codex
processes.7 During the meetings, members were divided on whether the uniform standard for
products made for persons 6 to 36 months of age should be divided into two standards: one for
formula for “older infants” (6-12 months) and one for formula for “young children” (12-36
months). As a compromise, the CCNFSDU decided to have one standard with two sections. This
is helpful for the achievement of health objectives because it opens 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 uniform standards for all formula products in the 6-36 months
range. In the revised draft, products for older infants have higher nutritional standards 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.
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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 the words “formula” or “formulated” to be included. Public health
proponents have argued that this would confuse consumers, risking inappropriate use for babies
0-12 months old and falsely suggesting nutritional adequacy or special health benefits.[7] The
debate over the name of these product is also closely related to a debate over “cross-promotion.”
Cross-promotion refers to the marketing of follow-on and toddler formula that simultaneously
promotes use of infant formula because companies label and brand the products in a similar way.
Research shows that even in advanced economies, cross-promotion can lead parents to feed
infants with follow-up and toddler formula instead of the infant formula, which has stricter
nutritional requirements. The confusion of parents puts infant health at risk.51–53
The relevance of the International Code to the Codex has also been a point of contention.
Proponents of breastfeeding have sought to reference the International Code in the Preamble to the
revised Codex standard and frequently cite the International Code and related supporting evidence
to justify their positions. But as seen in Table 1, BMS industry proponents have sought to prevent
citation of the International Code in the standard. They also rejected a number of recommendations
during deliberation of the standard, including the prohibition of cross-promotion of infant formula
and products for young children and the categorisation and regulation of products for young
children (13-36 months) as breastmilk substitutes. Public health advocates succeeded in ensuring
that a footnote was inserted into the standard noting that “In some countries these products are
regulated as breast milk substitutes.”54 In principle, this acknowledgment in the Codex that some
countries regulate products for young children as BMS—if it survives final deliberations in the
FUF review and is not deleted in future reviews—provides grounds to argue that such regulations
are consistent with international standards. The US opposed the footnote, arguing that the use of
footnotes when it is difficult to reach consensus is generally problematic, as Codex standards
should be “global in nature.”54
The ability to limit the sugar content in formula for older infants and to prevent use of sucrose,
fructose, and other sweeteners in both formula for older infants and follow-up formula similarly
each hang by two footnotes. The footnote allowing these limits on the use of sweeteners in the
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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
Notes: Positions from 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
standards for follow-up formula allows “national and/or regional authorities” to limit non-lactose
carbohydrates to 1.25g/100 kcal, less than the Codex maximum of 2.5g/100 kcal and remains
contested.54
The CCFL is also consequential for implementation of the International Code where contentious
debates are occurring 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 to the standard for follow-up formula would be consistent with standards
on labelling. These consultations resulted in replacing some text with references to the labelling
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 2018.6,35,55,56 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 nutrients such as fat, sugar and salt.6,57
The most recent draft contained language that any regulatory 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. A number of member countries have
subsequently expressed concern that the evolving new Codex standard is already in conflict with
the WHO guidelines.58 For instance, WHO guidelines expressly urge that BMS products contain
no front-of-pack nutritional claims,59 but a provision exempting BMS products from the new
Codex front-of-package labelling standard is still under contention within CCFL’s deliberations.58
Thow et. al (2019) explore in 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 incurring the risk of inciting a trade dispute.6
Conflicts over standards and governance between the WHO, Codex, and WTO
Indeed, discrepancies already exist between Codex standards and the public health guidelines of
its parent bodies (WHO and FAO) that are generating growing institutional frictions within both
21
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.60 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.61 The meeting ended without discussion of
the issue, but the topic was raised again 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.62 A WHO representative argued that
international food standard setting was also 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.62,63
However, 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.64 Argentina and the US argued again at a WTO SPS Committee meeting
in March 2018 that because the Codex is explicitly cited in the WTO SPS Agreement, it takes
precedence over FAO and WHO standards, using this as an argument for Codex independence
from its parent bodies, with member-driven processes and decisions.65
At the same time some WTO members arguing that the Codex must be an independent standards-
setting organization, they concurrently have been organizing within WTO committee deliberations
to change its governance, funding, 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, some members have expressed concern that these funds are not
from sustainable sources and are too little, requiring the CAC to turn often to member states and
even industry for donations.62 In response, WHO officials at the CAC have noted hesitation
developing within the WHO to increase funding for CAC processes because Codex guidelines
22
“were not always developed consistent with WHO policies, guidelines, and recommendations.”66
Recently, Canada, the EU, and the US have 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 CAC risk-assessment bodies.65
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
CAC. 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.67 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:67
Mexico’s communication is one example of how, in practice, the politics of trade influences the
Codex standards, rather than only “available scientific and technical information” as specified
within the TBT Agreement as the yardstick to determine the appropriateness of domestic
regulatory measures for public health. Table 1 documents how countries eventually lined up on
this issue at the CCNFSDU. In the end, while the 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” from the draft standard.54 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
23
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 to the extent that they rest any possible WTO arbitration over these matters
on the provisions of the Codex. Concerns over implementation of the International Code have
arisen in various units of the WTO, especially the SPS Committee and TBT Committee. They have
also arisen during the Accession process by which countries apply to become members of the
WTO as well as during periodic, routine reviews of countries 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.
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 8 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.
Table 2. Interventions regarding BMS made by WTO members, 1995-2019
Committee, Council, or Process Interventions Agriculture 15 Council for Trade in Goods 1 Sanitary and Phytosanitary 6 Technical Barriers to Trade 58 Trade Policy Review 29 TRIPS Council 1 Accession Process 135 Total 245
Notes: Data collected from WTO online archives.
24
Pre-Accession
Not all pre-Accession proceedings are made public. However, we were able to identify 135
instances of countries receiving questions during “Question and Response” processes and Initial
Negotiating Rights (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.[8] 30 of 35 countries who participated as an applicant in the
Accession process between 1996 and 2019 experienced one or both of these types of interventions,
with 18 of these 30 countries asked specific questions about their domestic treatment of BMS
Figure 8. 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.
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
25
products. More than half of the 18 received multiple questions, with Saudi Arabia, Ukraine, and
the Russian Federation asked to answer between 15 and 20 BMS-related 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 by Accession
applicants who were developing or transitional economies to advanced economies (the US,
Australia, and the European Union) requesting additional access for their BMS exports.
Post-Accession
Interventions related to BMS have taken place across a number of bodies within the WTO. We
define “intervention” as a complaint or expression of concern about 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. 110
such interventions have taken place since 1995.[10]
Quantifying use of new TBT criteria for domestic public health regulation
Figure 9 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.68
The regime complex and health policy in a BMS importer
One example from Thailand illustrates how these developments impeded implementation of the
International Code. Figure 10 is a flowchart showing the progression of interventions against
Thailand after it introduced domestic legislation to restrict inappropriate marketing of BMS. The
first interventions consisted of concerns expressed about the proposed legislation during the WTO
26
Figure 9. Percentage of BMS-related interventions mentioning particular concerns, 1996-2019
Notes: Data collected from WTO online archives. Percentages do not add up to 100 percent, as interventions may mention more than one concern and this list is not exhaustive.
Trade Policy Review of Thailand in 2015.[9] Both the US and New Zealand suggested that the
proposed legislation did not conform to international standards and requested an explanation of its
scientific rationale. Almost every one of the 21 interventions 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.
Criticisms of Thailand’s proposed legislation continued in the TBT Committee. US delegates
expanded their concerns at the March 2016 meeting, posing questions about the scientific rationale,
the use of criminal penalties, and the application of restrictions to follow-up formula. At the June
meeting, Australia, the European Union, and New Zealand formed a coalition with the US to echo
these concerns, with Canada joining later. The coalition explicitly and repeatedly referenced
Codex standards in its concerns about whether there was adequate scientific rationale for the
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
Figure 10. Interventions at the WTO involving Thailand’s proposed domestic legislation to regulate the marketing of BMS
Notes: Data sourced from WTO online archives. Text in light blue bars at top and bottom are descriptors of the complaints levied by countries shown as having intervened against Thailand’s proposed legislation in each meeting. Interventions are denoted by an arrow from a meeting to an intervening country. Text is matched to intervening country by color.
28
proposed legislation. In November 2016, the coalition added concerns about Thailand’s
requirements for product labelling, with the US asking whether measures complied with
Thailand’s own laws on food labelling. At the March 2017 TBT meeting, three of the five coalition
members again voiced concerns about compliance with Codex standards and four complained
about trade-restrictiveness.
This is a rare case where we can see the original proposed legislation and the final version of the
legislation as passed as reported by the US Department of Agriculture Foreign Agricultural Service
(FAS), included here in Supplemental File 3. Both the US Department of Agriculture and the US
Trade Representative69 detailed the changes integrated into to the proposed law before it was
passed that may benefit US exporters. In particular, the US Department of Agriculture Foreign
Agricultural Service70 notes that
“The approved legislation limits the prohibition on advertising to just food for
infants and supplementary food for infants. Advertising for food for young children
is now permitted as long it does not cause the public to believe the product is for
infants or cause the public to believe that the product was suitable for feeding
infants. The approved legislation reduces the maximum criminal penalty of
imprisonment from 3 years to 1 year and the maximum fine from 300,000 baht to
100,000 baht for violations of the advertising prohibitions.” [10]
These changes weakened the law by exempting drinks for children 13 months and older
from being regulated in the same way as infant formula, including allowing demonstrations
of follow-up formula in health centers, and by reducing criminal penalties for violations of
marketing restrictions. This exemption can be a loophole for cross-marketing. Reducing
the penalty may weaken the enforcement mechanism.
Industry influence in the regime complex through the national arena of the United States
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 influences the position the US government takes in
international fora. The US is home to several of the world’s largest BMS manufacturers, and a
large dairy industry that supplies ingredients used in BMS manufacturing.
29
Political contributions by the BMS industry
The “Big-6” BMS manufacturing conglomerates—Abbott-Alere, Dannon-Nutricia, Kraft-Heinz,
Nestle-Gerber-Wyeth, Perrigo-PBM, and RB-Mead Johnson—as a group have made substantial
political contributions over the last three decades to candidates for the US Congress, candidates
for President, and Political Action Committees. 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 our
tabulations. In the 1990s, Kraft-Heinz was the major donor within this group, then Nestle-Gerber-
Wyeth and RB-Mead Johnson in the 2000s. In the last ten years, Abbott’s contributions have
steadily grown and now dominate industry political contributions. Total political contributions
from the Big-6 BMS conglomerates 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.
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 11
shows total expenditures on lobbying activity where the lobbyist reports a BMS-related subject in
their disclosure between 2007 and 2018. Total annual expenditure on lobbying federal agencies
and elected officials in the federal government (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 not always
provide detail on the topics discussed, possibly why there are some apparent gaps in disclosed
trade-related BMS lobbying in Figure 11. However, it is clear that since 2016, BMS-related
lobbying has been focused on trade, as opposed to exclusively domestic market access concerns
(such as participation in the Women, Infants, and Children supplemental nutrition program).
30
In Figure 12, we show lobbying expenditures that are possibly linked to US interventions at the
WTO or toward other countries in bilateral or regional talks, 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 (later part of Nestle), 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 Representative,
and the Department of Agriculture.
Figure 11. 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.
Some disclosures contain explicit descriptions of non-WTO/WHO issues linked to the lobbying
activity. For instance, in 2007 Bristol-Myers-Squibb summarised the purpose of lobbying as
31
“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. These are listed in greater detail in Baker et al (2021). The list includes 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.
Figure 12. BMS producer interest group expenditure on lobbying related to possible policy interventions at the WTO or in bilateral or regional discussions
Notes: Data sourced from the Center for Responsive Politics, and author calculations
Discussion
Our findings elucidate a trading system in which there is a net North-South flow of BMS
products.[11] A large contingent of developing and transitional economies is striving to restrict
32
inappropriate marketing of BMS by implementing the WHO’s International Code. But in doing
so, they run into opposition from BMS exporters that is channelled through the institutions of the
international trade regime. At the center of this turmoil between the international public health and
trade regimes is the CAC which sets standards for the composition, labelling, and marketing of
BMS products and therefore is ideally situated to help resolve these conflicts by providing
international benchmarks.
Recent advances in the economics of international trade show that under conditions where lobbies
have sufficient influence over international standards relative to domestic standards, trade
agreements requiring harmonized standards can be detrimental to economic welfare.71 In principle,
the CAC is administered by the FAO and WHO, both of which have strong procedures to limit
industry influence or screen for conflicts of interest, with a mandate to protect public health. In
practice, CAC processes lack strong screening for conflicts of interest.7 Conflicts of interest among
industry participants need not always outweigh the benefits of added information from industry
input into health policy.72 However, our analysis of the review of the standard for follow-up
formula shows that BMS and milk-powder exporting countries and industry actors flooding the
CCNFSDU as observers and as member-country delegates intentionally strive to shape standards
in conflict with WHO policies and guidelines in ways that can harm infant and maternal health.
The success of industry interests in shaping parts of Codex standards in ways that conflict with
WHO recommendations strongly suggests that industry has more influence at the CAC than in
other parts of the public health regime shown in Figure 1—namely, the UN bodies that have
committed to support the International Code—or in countries with political will to adopt the
International Code in domestic regulation. Figures 11 and 12 show that much of BMS-related
lobbying in the United States is related to trade and coincides with US interventions at the WTO
(many of which mention Codex or international standards). This is also strongly suggestive of the
intention of industry to influence the application and enforcement of international standards
through national governments. These are the conditions in which Maggi and Ossa (2020) show
that harmonizing standards through trade agreements can reduce welfare.71
33
At the same time, measured by the increasing prevalence of trade complaints citing deviation from
Codex standards, domestic regulatory standards are growing increasingly subordinate to Codex
benchmarks since the WTO Agreements and arbitration went into force. In the case of BMS, we
see this clearly in Figure 6 above. In the current review of the standard for follow-up formula, the
right to regulate marketing of BMS products for young children 13-36 months as BMS in the same
way as products for infants 0 to 12 months, as stipulated in the International Code, hangs on a
contested footnote acknowledging that “some countries” do so. Yet we see Thailand’s attempt to
adopt similar restrictions in its Milk Code thwarted after a barrage of sub-arbitration-level
complaints within the WTO TBT Committee. Our example of the proposed versus final Milk Code
in Thailand demonstrates that trade complaints referencing the Codex need not reach arbitration to
be effective in watering down legislation.
A contested footnote also applies for countries who wish to restrict sugars to less than 2.5g per
100kcal or prevent companies from adding sucrose to follow-up formulas. Outside the scope of
our study, additional challenges for advocates of the International Code lie in the mounting battles
across multiple Codex committees over cross-promotion, food packaging, and cautionary nutrition
labelling.
Lester notes that this general push toward insisting that food safety regulations be “science-based”
presents additional challenges. The movement 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.5 Equally
problematic, science evolves and scientists may have differing approaches to assessing health
risks.
An example is the question of when a hazard-based approach is adequate to assess the legitimacy
and proportionality of public health measures, versus when a risk-based approach to assessment is
necessary. The hazard-based approach calls into question the safety of using a substance or practice
that may cause harm. This approach is closely related to the precautionary principle, a premise
with origins in German legislation to reduce air pollution crafted in the 1970s. The principle was
later embedded in the Maastricht Treaty in 1992 and in national laws in Belgium, France,
34
Germany, the Netherlands, Sweden, and outside the EU in Australia. The precise definition of the
precautionary principle varies across countries, but it uniformly embodies the goal of avoiding
harm in situations clouded by scientific uncertainty.73
A risk-based approach goes beyond the hazard-based approach, attempting also to quantify the
actual impact of the hazard on real people by taking into account the probabilities of various
degrees of exposure and adverse effects.74 The four steps of a full risk assessment as performed to
provide scientific advice for the CAC are hazard identification, hazard characterization (or dose-
response assessment), exposure assessment, and risk characterization.75 As the Joint Meeting on
Pesticide Residues that provides scientific advice to the CAC explains, a lion is a hazard, but a
lion viewed in a zoo presents little risk.76
While the risk-based approach is clearly superior insofar as it brings more information to bear in
judging the safety of a substance or practice, it is not always an appropriate bar for judging the
legitimacy or proportionality of a public health measure for trade policy. First, it is not always
feasible or ethical to conduct a risk-based assessment. Second, the extra steps required beyond the
identification of the hazard make it more challenging and costly. By pushing within the CAC for
regulatory decisions to be made only on the basis of a risk assessment, industry and exporter
countries are not only increasing the burden of proof required to justify a regulation, but also
weakening the general standing of the precautionary principle in WTO jurisprudence. Third, a
strong movement has arisen among some members of the CAC to create “harmonized” approaches
to risk assessment and require the standard to be adopted across agencies and national
governments, which may sweep away diversity in experimental design or probability estimates.77
Finally, the approach as practiced at the CAC largely ignores consumer perceptions and
preferences for risk in formulation of risk assessment policy rules used to guide the risk
assessments,78,79 while we see a heavy influence of industry interests in formulation of risk
assessment policy rules in the case of the review of the Codex FUF standard above. All of these
issues can lead to unnecessary harm if Codex standards are treated as a ceiling rather than a floor
for public health policy measures.
35
In the current setting, scientific processes are likely to become increasingly subject to conflicts of
interest. We observe instances above of WTO members in the SPS Committee and the TRIPS
Council 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, where restrictions on participation of industry interests are
tighter. Organizing at WTO to marshal alternative sources of funding or encourage mandatory
allocations from WHO core funding may become a way to further weaken CAC observance of
FAO and WHO health guidelines and introduce trade policy aims as a bigger influence in scientific
processes and deliberations. If the US ever reduced or withdrew funding from WHO, as it recently
threatened, and diverted a portion of these funds directly to the CAC, this in particular could
weaken the commitment of the CAC to the public health half of its mandate.
Industry influence within the WHO itself also is likely to intensify through new avenues for direct
participation. Inflows of private-sector funding may become even more important if member
countries like the US curtail contributions. In 2016, the WHA also approved a Framework of
Engagement with Non-State Actors (FENSA), allowing greater non-state actor participation,
including by businesses and business-interest NGOs.[12] Stakeholders involved in advocating for
breastfeeding under the International Code oppose loosening restrictions on participation of the
BMS industry in WHA processes80 in light of the industry’s past history of working to weaken the
Code, arguing that FENSA does not include adequate safeguards against conflicts of interest.41,81,82
We discuss these issues of conflicts of interest and politicization of science through the trade
regime in the context of BMS, but they are more general. The ambiguities and conflicts evident in
the regime complex governing infant and young child nutrition are not unlike those of the regime
complex governing environmental issues.9,78,83 The arenas of the battles are similar—WTO
committees, the Codex, the domestic political arena, and various preferential trade agreements.
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.9,84 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.4
36
Since 2016, the Codex Executive Committee has been urgently pushing the WHO to provide
increased funding for an “enhanced work programme” to harmonize risk assessment across the
FAO, the WHO, and the CAC’s joint scientific committees, focusing on risk-based assessments
for food safety standards. Part of the agenda is to push national governments to adopt the same
risk-based approach to food safety. The issue of harmonization of standards and its institutional
context within the regime complex for public health and trade deserves much more research to
understand the costs and benefits of such initiatives.
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 200685 and the legislature
adopted the Expanded Breastfeeding Promotion Act of 2009.86 Thailand adopted its Milk Code
restricting marketing in 2017.87 Vietnam passed adopted statutes in 2012 and 2014 restricting
advertising and establishing public policies in support of breastfeeding.88,89
[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] A companion report for that resolution16 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).90
37
[7] 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.
[8] Table S1.5 in Supplemental File 1 presents data by country receiving questions or requests for
INRs.
[9] 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.69
[10] The web address where this document was posted is no longer works, so we include the full
document in Supplemental File 4, along with the original website address. It is particularly rare
because the FAS uploaded the “redlined” revisions to the original.
[11] BMS inputs and products are largely (though not exclusively) produced and promoted by
multinational firms headquartered in advanced economies such as Australia, France, Germany,
New Zealand, and the US. Production in developing countries is increasing.
[12] 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 involve80 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.41
References 1. Grossman GM, McCalman P, Staiger RW. The `New’ Economics of Trade Agreements: From Trade
Liberalization to Regulatory Convergence? Econometrica. Forthcoming. https://www.econometricsociety.org/publications/econometrica/2020/09/01/new-economics-trade-agreements-trade-liberalization-regulatory. Accessed December 8, 2020.
2. World Trade Organization. Agreement on Technical Barriers to Trade. Vol Articles 2.2 and 2.3. https://www.wto.org/english/docs_e/legal_e/17-tbt.pdff.
3. General Agreement on Tariffs and Trade (Tokyo Round Codes). Agreement on Technical Barriers to Trade. https://www.wto.org/english/docs_e/legal_e/tokyo_tbt_e.pdf.
4. Lester S. Finding the Boundaries of International Economic Law. Journal of International Economic Law. 2014;17:3-9. doi:10.1093/jiel/jgu011.
5. Lester S. Food Regulation, Science, Protectionism, and Regulatory Autonomy/Sovereignty. International Economic Law and Policy Blog. 25 2020. https://ielp.worldtradelaw.net/2020/06/food-regulation-science-and-trade-policy.html.
38
6. Thow AM, Jones A, Schneider CH, Labonté R. Global Governance of Front-of-Pack Nutrition Labelling: A Qualitative Analysis. Nutrients. 2019;11(2):268. doi:10.3390/nu11020268.
7. Halabi SF. The Codex Alimentarius Commission, Corporate Influence, and International Trade: A Perspective on FDA’s Global Role. American Journal of Law and Medicine. 2015;41(2-3):406-421. doi:10.1177/0098858815591525.
8. Thow AM, Jones A, Hawkes C, Ali I, Labonté R. Nutrition labelling is a trade policy issue: lessons from an analysis of specific trade concerns at the World Trade Organization. Health Promotion International. 2017;33:561-571. doi:10.1093/heapro/daw109.
9. Millstone E. Science, Risk, and Governance: Radical rhetorics and the realities of reform in food safety governance. Research Policy. 2009;38:624-636. doi:10.1016/j.respol.2009.01.012.
10. Food and Agriculture Organization of the United Nations, Secretariat of the Codex Alimentarius Commission. Trade and Food Standards. 2017. https://www.wto.org/english/res_e/publications_e/tradefoodfao17_e.htm. Accessed September 9, 2020.
11. Alter KJ, Raustiala K. The Rise of International Regime Complexity. Annu Rev Law Soc Sci. 2018;14(1):329-349. doi:10.1146/annurev-lawsocsci-101317-030830.
12. WHO. Global Strategy for Infant and Young Child Feeding. 2003. https://www.who.int/maternal_child_adolescent/topics/child/nutrition/global/en/#:~:text=The%20Global%20Strategy%20for%20Infant,infant%20and%20young%20child%20feeding. Accessed July 3, 2020.
13. Victora CG, Bahl R, Barros AJD, et al. Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. The Lancet. 2016;387(10017):475-490. doi:10.1016/S0140-6736(15)01024-7.
14. Walters DD, Phan LTH, Mathisen R. The cost of not breastfeeding: global results from a new tool. Health Policy and Planning. 2019;34(6):407-417. doi:10.1093/heapol/czz050.
15. UNICEF. Children, Food, and Nutrition: Growing Well in a Changing World. New York, NY: UNICEF; 2019.
16. WHO. Maternal, Infant, and Young Child Nutrition: Guidance on Ending the Inappropriate Promotion of Foods for Infants and Young Children. Geneva: World Health Organization; 2016.
17. Piwoz EG, Huffman SL. The Impact of Marketing of Breast-Milk Substitutes on WHO-Recommended Breastfeeding Practices. Food Nutr Bull. 2015;36(4):373-386. doi:10.1177/0379572115602174.
18. Rollins NC, Bhandari N, Hajeebhoy N, et al. Why invest, and what it will take to improve breastfeeding practices? The Lancet. 2016;387(10017):491-504. doi:10.1016/S0140-6736(15)01044-2.
19. Sobel HL, Iellamo A, Raya RR, Padilla AA, Olivé J-M, Nyunt-U S. Is unimpeded marketing for breast milk substitutes responsible for the decline in breastfeeding in the Philippines? An exploratory survey and focus group analysis. Social Science & Medicine. 2011;73(10):1445-1448. doi:10.1016/j.socscimed.2011.08.029.
39
20. Pries AM, Huffman SL, Mengkheang K, et al. Pervasive promotion of breastmilk substitutes in Phnom Penh, Cambodia, and high usage by mothers for infant and young child feeding: Pervasive promotion of breastmilk substitutes. Maternal & Child Nutrition. 2016;12:38-51. doi:10.1111/mcn.12271.
21. WHO. International Code of Marketing of Breast-milk Substitutes. Geneva. 1981. https://apps.who.int/iris/bitstream/handle/10665/40382/9241541601.pdf?sequence=1. Accessed July 3, 2020.
22. UNICEF. Convention on the Rights of the Child.; 1989. https://www.unicef.org/child-rights-convention/convention-text#.
23. Ruger JP, Yach D. The Global Role of the World Health Organization. Glob Health Gov. 2009;2(2):1-11.
24. Molina AC, Khoroshavina V. TBT Provisions in Regional Trade Agreements: To What Extent Do They Go beyond the WTO TBT Agreement? World Trade Organization; 2015. https://www.wto.org/english/res_e/reser_e/ersd201509_e.pdf. Accessed September 9, 2020.
25. Janeba E. Regulatory chill and the effect of investor state dispute settlements. Rev Int Econ. June 2019:roie.12417. doi:10.1111/roie.12417.
26. WHO, UNICEF. International Trade Agreements and Implementation of the International Code of Marketing of Breast-Milk Substitutes: Frequently Asked Questions.; 2020.
27. Yin RK. Applications of Case Study Research.; 2011.
28. Yin RK. Case Study Research and Applications: Design and Methods. Sixth edition. Los Angeles: SAGE; 2018.
29. WHO. Marketing of Breast-Milk Substitutes: National Implementation of the International Code. World Health Organization; 2018. https://www.who.int/nutrition/netcode/resolutions/en/.
30. Lee K. The World Health Organization (WHO). London ; New York: Routledge; 2009.
31. Post JE. Assessing the Nestlé Boycott: Corporate Accountability and Human Rights. California Management Review. 1985;27(2):113-131. doi:10.2307/41165133.
32. Coriolis. Understanding the Infant Formula Value Chain. Aukland: Coriolis Research, Strategy, and Consulting; 2014. https://coriolisresearch.com/pdfs/coriolis_dairy_infant_formula_value_chain.pdf. Accessed July 3, 2020.
33. Fortune Business Insights. Infant Formula Market Size, Share and Industry Analysis, Distribution Channel, and Regional Forecast 2019-2026.; 2019.
34. Baker P, Smith J, Salmon L, et al. Global trends and patterns of commercial milk-based formula sales: is an unprecedented infant and young child feeding transition underway? <sup/>. Public Health Nutr. 2016;19(14):2540-2550. doi:10.1017/S1368980016001117.
35. Boza S, Guerrero M, Barreda R, Espinoza M. Recent Changes in Food Labelling Regulations in Latin America: The Cases of Chile and Peru. World Trade Institute; 2017.
40
https://www.wti.org/research/publications/1053/recent-changes-in-food-labelling-regulations-in-latin-america-the-cases-of-chile-and-peru/.
36. Forsyth S. Non-compliance with the International Code of Marketing of Breast Milk Substitutes is not confined to the infant formula industry. Journal of Public Health. 2013;35(2):185-190. doi:10.1093/pubmed/fds084.
37. Aguayo VM. Monitoring compliance with the International Code of Marketing of Breastmilk Substitutes in west Africa: multisite cross sectional survey in Togo and Burkina Faso. BMJ. 2003;326(7381):127-127. doi:10.1136/bmj.326.7381.127.
38. Waterston T. Monitoring the marketing of infant formula feeds. BMJ. 2003;326(7381):113-114. doi:10.1136/bmj.326.7381.113.
39. Fee E, Cueto M, Brown TM. At the Roots of The World Health Organization’s Challenges: Politics and Regionalization. Am J Public Health. 2016;106(11):1912-1917. doi:10.2105/AJPH.2016.303480.
40. Lidén J. The World Health Organization and Global Health Governance: post-1990. Public Health. 2014;128(2):141-147. doi:10.1016/j.puhe.2013.08.008.
41. Richter J. Holding Corporations Accountable. New York, NY: Palgrave, St. Martin’s Press, LLC; 2001.
42. Kennedy M. Trump Administration Denies Threatening Ecuador over a Breastfeeding Resolution. NPR.org. https://www.npr.org/2018/07/10/627647536/did-the-u-s-threaten-ecuador-over-a-breastfeeding-resolution. Published July 10, 2018. Accessed August 25, 2020.
43. Johnson C, Erickson A. U.S. Effort to Weaken International Breast-feeding Resolution Has a Long History. Washington Post. https://www.washingtonpost.com/news/to-your-health/wp/2018/07/09/u-s-effort-to-weaken-an-international-breast-feeding-resolution-has-a-long-history/. Published July 9, 2018. Accessed August 25, 2020.
44. Jacobs A. Opposition to Breastfeeding by U.S. Stuns the World. The New York Times. https://www.nytimes.com/2018/07/08/health/world-health-breastfeeding-ecuador-trump.html. Published July 8, 2018. Accessed July 3, 2020.
45. Herrera A. Reactions after US tries to weaken UN breastfeeding measure: Breastfeeding is already “pretty damned hard.” PRI The World. https://www.pri.org/stories/2018-07-10/reactions-after-us-tries-weaken-un-breastfeeding-measure-breastfeeding-already. Published July 10, 2018. Accessed August 20, 2020.
46. Proposed Alternative WHA 71 Decision Point for Maternal, Infant and Young Child Nutrition. May 2018. http://www.babymilkaction.org/wp-content/uploads/2018/05/DRAFT-USA-_Nutrition-DP-Text_WHA71_Item-12.6.pdf. Accessed August 30, 2020.
47. IBFAN Penang. Scrutinising the 2018 WHA Resolution on IYCF: How to Salvage? International Code Documentation Centre. June 2018. https://www.ibfan-icdc.org/scrutinisng-the-2018-wha-resolution-on-iycf-how-to-salvage/.
41
48. Haelle T. Dairy Industry Trumps Infant Health with U.S. Rejection of Breastfeeding Resolution. Forbes. July 2018. https://www.forbes.com/sites/tarahaelle/2018/07/10/dairy-industry-trumps-infant-health-with-u-s-rejection-of-breastfeeding-resolution/#6cce7a8fadcc. Accessed August 30, 2020.
49. FAO and WHO. Understanding Codex. 5th ed. Food and Agriculture Organization of the United Nations and World Health Organization; 2018. http://www.fao.org/3/ca1176en/CA1176EN.pdf. Accessed July 3, 2020.
50. Koletzko B, Shamir R. Standards for infant formula milk. BMJ. 2006;332(7542):621-622. doi:10.1136/bmj.332.7542.621.
51. Cattaneo A, Pani P, Carletti C, et al. Advertisements of follow-on formula and their perception by pregnant women and mothers in Italy. Arch Dis Child. 2015;100(4):323-328. doi:10.1136/archdischild-2014-306996.
52. Berry NJ, Jones S, Iverson D. It’s all formula to me: women’s understandings of toddler milk ads. Breastfeed Rev. 2010;18(1):21-30.
53. Smith J, Blake M. Infant food marketing strategies undermine effective regulation of breast-milk substitutes: trends in print advertising in Australia, 1950-2010. Australian and New Zealand Journal of Public Health. 2013;37(4):337-344. doi:10.1111/1753-6405.12081.
54. Joint FAO/WHO Standards Programme. Report of the Forty-First Session of the Codex Committee on Nutrition and Foods for Special Dietary Purposes. Rome, Italy: Codex Alimentarius Commission; 2020. http://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FMeetings%252FCX-720-41%252FReport%252FAdoption%252FREP20_NFSDUe.pdf.
55. Cororaton, Orden D. The Importance of Technical Barriers to Agri-Food Trade: Evidence from the TBT Specific Trade Concerns Raised at the WTO. Virginia Tech Global Issues Initiative; 2019. https://vtechworks.lib.vt.edu/handle/10919/91418.
56. Joint FAO/WHO Food Standards Programme Codex Committee on Food Labelling. Proposed Draft Guidelines on Front-of-Pack Nutrition Labelling. May 2020. http://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FMeetings%252FCX-714-45%252Fdocuments%252Ffl45_06e_final.pdf. Accessed August 30, 2020.
57. Joint FAO/WHO Standards Programme. Report of the Forty-Fifth Session of the Codex Committee on Food Labelling. Geneva, Switzerland: Codex Alimentarius Commission; 2019. http://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FMeetings%252FCX-714-45%252FFinal%252520Report%252FREP19_FLe.pdf.
58. Joint FAO/WHO Food Standards Programme Codex Committee on Food Labelling. Replies to CL 2019/14-FL Proposed Draft Guidelines on Front-of-Pack Nutrition Labelling. May 2019. http://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FMeetings%252FCX-714-45%252Fdocuments%252FFL45_06_add1e_rev1.pdf. Accessed August 30, 2020.
42
59. WHO. Guilding Principles and Framework Manual for Front-of-Pack Labelling for Promoting Healthy Diet. May 2019. https://www.who.int/nutrition/publications/policies/guidingprinciples-labelling-promoting-healthydiet/en/. Accessed August 30, 2020.
60. FAO and WHO. Report of the Sevety-First Session of the Executive Committee of the Codex Alimentarius Commission. Rome, Italy: Joint FAO/WHO Standards Programme Codex Alimentarius Commission http://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FMeetings%252FCX-702-71%252FReport%252FREP16_ExeE.pdf. Accessed August 19, 2020.
61. FAO and WHO. Relations between FAO and WHO Policies, Strategies and Guidelines and Codex Work. Rome, Italy: Joint FAO/WHO Standards Programme Executive Committee of the Codex Alimentarius Commission; 2016. http://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FMeetings%252FCX-702-71%252FWD%252Fex71_13e.pdf. Accessed August 19, 2020.
62. FAO and WHO. Report of the Seventy-Third Session of the Executive Committee of the Codex Alimentarius Commission. Geneva, Switzerland: Joint FAO/WHO Food Standards Programme Codex Alimentarius Commission; 2017. http://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FMeetings%252FCX-702-73%252FReport%252FREP17_EXEC2.pdf. Accessed August 19, 2020.
63. FAO and WHO. Joint FAO/WHO Food Standards Programme Report. Geneva, Switzerland: Codex Alimentarius Commission; 2017. http://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FMeetings%252FCX-701-40%252FREPORT%252FREP17_CACe.pdf. Accessed September 19, 2020.
64. Committee on Sanitary and Phytosanitary Measures. Summary of the Meeting of 2-3 November 2017. World Trade Organization; 2017. https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/G/SPS/R88.pdf&Open=True.
65. Committee on Sanitary and Phytosanitary Measures. Summary of the Meeting of 1-2 March 2018. World Trade Organization; 2018. https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/G/SPS/R90.pdf&Open=True.
66. Joint FAO/WHO Food Standards Programme Codex Alimentarius Commission. Report of the Seventy-First Session of the Executive Committee of the Codex Alimentarius Commission. Rome, Italy; 2016. http://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FMeetings%252FCX-702-71%252FReport%252FREP16_ExeE.pdf.
67. Council for Trade-Related Aspects of Intellectual Property Rights. Cross Promotion: Communication from Mexico. November 2019. https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/IP/C/W660.pdf.
68. Thow AM, Jones A, Huckel Schneider C, Labonté R. Increasing the public health voice in global decision-making on nutrition labelling. Global Health. 2020;16(1):3. doi:10.1186/s12992-019-0533-3.
69. United States Trade Representative. Foreign Trade Barriers. Executive Office of the President of the United States; 2018:504.
43
https://ustr.gov/sites/default/files/files/Press/Reports/2018%20National%20Trade%20Estimate%20Report.pdf.
70. US Department of Agriculture Foreign Agricultural Service. Thailand’s Milk Code Passed the National Legislative Assembly. Bangkok, Thailand; 2017:14.
71. Maggi G, Ossa R. Are Trade Agreements Good for You? National Bureau of Economic Research; 2020. DOI 10.3386/w27252.
72. Chan D, Dickstein MJ. Industry Input in Policymaking: Evidence from Medicare. Quarterly Journal of Economics. 2019;134(3):1299-1342. doi:https://doi.org/10.1093/qje/qjz005.
73. European Parliamentary Research Service. The Precautionary Principle: Definitions, applications, and governance. 2015;(PE 573.876). doi:10.2861/821468.
74. Barlow SM, Boobis AR, Bridges J, et al. The role of hazard-and risk-based approaches in ensuring food safety. Trends in Food Science & Technology. 2015;(46):176-188. doi:http://dx.doi.org/10.1016/j.tifs.2015.10.007.
75. FAO and WHO. Risk Assessment and Its Role in Risk Analysis. In: Principles and Methods for the Risk Assessment of Chemicals in Food. Environmental Health Criteria. ; 2009.
76. Joint FAO/WHO Meeting on Pestide Residues (JMPR) Secretariat. WHO | Frequently asked questions on pesticide residues. May 2016. http://www.who.int/foodsafety/faq/en/. Accessed August 20, 2020.
77. Kriebel D, Tickner J, Epstein P, et al. The Precautionary Principle in Environmental Science. Environmental Health Perspectives. 2001;109(9):871-876. doi:10.1289/ehp.01109871.
78. Hassauer C, Roosen J. Toward a Conceptual Framework For Food Safety Criteria: Analyzing evidence practices using the case of plant protection measures. Safety Science. 2020;127(104683). doi:10.1016/j.ssci.2020.104683.
79. FAO and WHO. FAO/WHO Scientific Support to Codex (Increasing Sustainability). Joint FAO Food Standards Programme Executive Committee of the Codex Alimentarius Commission 71st Session; 2016.
80. Irwin R, Smith R. Rituals of global health: Negotiating the World Health Assembly. Global Public Health. 2019;14(2):161-174. doi:10.1080/17441692.2018.1504104.
81. Khazan O. The Epic Battle between Breast Milk and Infant-Formula Companies. The Atlantic. July 2018. https://www.theatlantic.com/health/archive/2018/07/the-epic-battle-between-breast-milk-and-infant-formula-companies/564782/. Accessed August 25, 2020.
82. Baby Milk Action. IBFAN Initial Evaluation of the Implementation of FENSA (Extranet). November 2020. http://www.babymilkaction.org/policy/consultations/ibfan-initial-evaluation-of-the-implementation-of-fensa-extranet. Accessed August 25, 2020.
83. Young OR. Effectiveness of international environmental regimes: Existing knowledge, cutting-edge themes, and research strategies. PNAS. 2011;108(50):19853-19860. doi:10.1073/pnas.1111690108.
44
84. Lee RM, Smith CW, Elliott ME. The Evolving Argument Surrounding Federal Preemption of Proposition 65. Pillsbury Law News and Insights Alert. June 2020. https://www.pillsburylaw.com/en/news-and-insights/evolving-argument-federal-preemption-proposition-65.html.
85. Republic of the Philippines Department of Health. Revised Implementing Rules and Regulations of Executive Order No.51, Otherwise Known as The “Milk Code”, Relevant International Agreements, Penalizing Violations Thereof, and for Other Purposes. Vol 2006-0012. https://extranet.who.int/nutrition/gina/sites/default/files/PHL%202006%20Revised%20Implementating%20Rules%20and%20Regulations%20of%20Executive%20Order%20No.51%20%28the%20Milk%20Code%29_0.pdf. Accessed August 13, 2020.
86. Congress of the Philippines. Expanded Breastfeeding Act of 2009. Vol 10028.; 2009. https://lawphil.net/statutes/repacts/ra2010/ra_10028_2010.html. Accessed August 13, 2020.
87. His Majesty King Vajiralongkorn Bodindradebayavarangkun of Thailand. Control of Marketing of Infant and Young Child Food Act.; 2017. http://origin.searo.who.int/thailand/news/control-marketing-of-infant-and-young-child-food-act(2017).pdf.
88. National Assembly of the Socialist Republic of Viet Nam. Law on Advertising.; 2012. https://extranet.who.int/nutrition/gina/sites/default/files/VNM%202012%20Law%20on%20Advertising_0.pdf. Accessed August 14, 2020.
89. The Government of the Socialist Republic of Vietnam. Decree on the Trading in and Use of Nutritious Products for Infants, Feeding Bottles and Teats. Vol 100/2014/ND-CP.; 2014. http://extwprlegs1.fao.org/docs/pdf/vie167953.pdf. Accessed August 14, 2020.
90. Arendt M. Codex Alimentarius : What Has It To Do With Me? J Hum Lact. September 2018:089033441879465. doi:10.1177/0890334418794658.