Introduction by Croakey: An investigation published last week by the British Medical Journal has found that infant formula manufacturers have been funding the development of guidelines for the diagnosis and treatment of cows’ milk allergy as well as providing research and consultancy funds to those who wrote them.

That comes, it reports, amid a six-fold increase in sales of infant formula prescribed for babies with cows’ milk protein allergy in the United Kingdom from 2006 to 2016, despite no evidence of a concurrent increase in the prevalence of infants with the allergy.

In this timely Croakey #LongRead below, Dr Julie Smith, Alex Iellamo, and Dr Phillip Baker report on how upcoming deliberations by the international Codex Alimentarius (Codex) Commission will shape global and national regulation and marketing of commercial baby food products for decades to come. They detail the massive market inroads that industry has made in recent decades with commercial milk formulas, and the concurrent risks to breastfeeding rates and baby health, and warn that Australia’s position is at risk of too much industry influence, again.

They conclude:

It is time for the World Health Organisation and the UN’s Food and Agriculture Organisation as co-convenors of Codex to admit and confront the deep conflicts of interest which undermine its formulation of global guidance on food regulation for infants and young children.”

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Dr Julie P Smith, Alex Iellamo, and Dr Phillip Baker write:

In recent days a study in the British Medical Journal has created a storm by identifying how medical guidelines about infant feeding and allergy are shaped by industry and conflicts of interest.

But conflicts of interest in infant feeding go far deeper, into the heart of global and national food policy-making.

The international Codex Alimentarius (Codex) Commission is currently discussing new food standards for commercial milk formulas targeting older infants and young children. Its deliberations, to be continued over the coming year, will shape global and national regulation and marketing of such commercial baby food products for decades to come.

With the milk formula industry strongly represented in Australia’s delegation, conflicts of interest are writ large – risking that its advocacy will reflect what suits manufacturers and exporters, not what is needed to protect health and nutrition of infants and young children worldwide.

Codex and the Code

Codex is the world’s leading food standards commission established by the United Nations’ Food and Agricultural Organisation (FAO) and the World Health Organization (WHO), intended to protect public health and fair practices in an expanding global food trade.

Codex standards are used as a benchmark in World Trade Organisation disputes and for national food standards.

It provides a forum for national regulators to discuss and coordinate how they approach food regulation, and includes consideration of food safety, packaging and labeling. This is to prevent harms to consumers from unsafe food products, and the use of exploitative or misleading food packaging, labeling and nutrition or health claims.

This is crucially important for baby foods. Parents of infants and young children – driven by every instinct in their body and reinforced by strong social and marketing pressure to do the best for their offspring – are particularly vulnerable to persuasive food industry messaging.

The unique vulnerability of infants and toddlers to parents’ decisions is why the 1981 WHO International Code of Marketing of Breastmilk Substitutes was among the earliest attempts by governments to regulate harmful industry marketing practices.

That year, all countries except the United States voted at the World Health Assembly (WHA) to support a resolution calling for regulation  on marketing of commercial breastmilk substitutes.

An ongoing challenge since then has been to ensure such crucial health expert guidance is fully embedded in all relevant Codex standards for commercial food and beverage products for infants and young children.

Regulating harmful marketing

In the 1980s, the Hawke-Keating Labor governments negotiated with formula importers and manufacturers on implementing the WHO International Code in Australia.

The government eventually accepted a “Marketing Agreement on Infant Formula” (MAIF), a weak and limited voluntary agreement by formula industry leaders to restrain marketing to the public.

Until 2014, this was loosely monitored by a panel of government and consumer representatives, with the Health Minister required to report to Parliament on how well the arrangement was working.

Australian food laws were also amended over the decade to prohibit nutrition or health claims on infant formula products.

Notably, the MAIF did not apply to marketing in the form of company-provided ‘information and education’ or product samples to health workers, even though preventing conflicts of interest and commercial influence on infant and young child feeding is essential to avoid subtle product promotion within health services.

However in 2003, the Australian government set out the professional ethical responsibilities of health workers to protect, promote and support breastfeeding in detailed Infant Feeding Guidelines whilst including breastfeeding in the first Australian National Dietary Guideline.

Regulation and counter regulation

The ink had barely dried on the MAIF, but by 1992 the industry had already developed a counter-strategy – infant formula look-alike products known as ‘follow- on’ and ‘toddler’ formula (sometimes ‘growing up milks’). These in effect promoted infant formula and displaced breastfeeding,  but were purported to not be covered by marketing restraints on breastmilk substitutes.

A 2001 industry review as well as additional research exposed the tactic, but it soon spread globally.

In Australia, and beyond, with rapidly rising female labour force participation from the 1980s, lack of paid maternity leave, and increasing  time-pressed parents – just as anxious about feeding ‘picky toddlers’ as they were about feeding their infants – saw sales of these new milk formula products expand rapidly.

From the mid 2000s, a global ‘white gold’ boom was underway  as Chinese as well as Australian parents bought into the ‘clean, green and clever’ marketing lines.

This was despite ongoing warnings from the World Health Assembly on the responsibility of industry to comply fully with the WHO International Code regarding breastmilk substitutes, and also the obligation on governments to apply appropriate measures to prevent their inappropriate promotion.

In 2013 WHO issued a statement that, as well as being unnecessary, these powdered milk products for older infants and young children are potentially harmful:

“…follow-up formula is unsuitable when used as a breast-milk replacement from six months of age onwards. Current formulations lead to higher protein intake and lower intake of essential fatty acids, iron, zinc and B vitamins than those recommended by WHO for adequate growth and development of infants and young children.”

The same was reaffirmed in 2018 when WHO issued a clarification on the classification of follow-up formulas for children 6 to 36 months as breast milk substitutes:

‘… the International Code aims to safeguard breastfeeding by ending inappropriate marketing and distribution of breast-milk substitutes. Because continued breastfeeding to two years and beyond saves lives and promotes the health of both the mother and baby, it is important that this protection include follow-up formula.

‘Convenience food’ marketing

Similar warnings were being sounded in Australia.

A 2007 parliamentary inquiry noted the added costs to the public health system from marketing which discouraged breastfeeding, and recommended that the WHO International  Code be ‘fully implemented’ in Australia.

A 2011 consultant’s report commissioned by the Health Department recommended banning the misleading use of packaging and branding which conflated infant formula (for babies aged less than 12 months) with toddler formula, a marketing tactic known as ‘cross promotion’.

This recommendation fell on deaf ears and formula promotion to busy, health-conscious families became more aggressive, and moved online.

By 2015, the Australian Competition and Consumer Commission (ACCC) was warning that such marketing of toddler formula was potentially a breach of consumer law.

In late 2017 at a Western Pacific Regional meeting of the WHA in Brisbane, Australia considered a report from WHO experts warning of the harmful effects of marketing on children, and noting that voluntary industry measures were proving ineffective.

‘Marketing activity’, as WHO documented, was pervasive and now included manipulating social and other mass media (paid ‘influencers’) to promote unhealthy commercial foods for children including breastmilk substitutes. Harmful food marketing activity identified by WHO in the region included behind-the-scenes industry political lobbying (‘stakeholder marketing’).

The impact of government policy was also to be seen in Australia when the Abbott Coalition government attempted to curtail maternity leave access, a move that baby food industry analysts predicted would result in decreased breastfeeding rates and Australian mothers turning to milk formula as a substitute.

Finally, instead of strengthening Australia’s weak, narrow, and voluntary industry regulatory system,  the Abbott government abruptly ended public monitoring and oversight of the MAIF by abolishing the panel in 2014.

The large formula companies organised an alternative consumer complaints arrangement, similarly named ‘MAIF’, but there is no government monitoring role or accountability to Parliament. Many companies selling these products do not participate, or comply.

Online marketing of milk formula products is now rife, globally as well as in Australia, breaching the WHO International Code and other public health guidance.

China is a major export market for Australasian baby food companies. Booming sales of toddler formula in China, alongside direct and sometimes corrupt marketing of milk formula products to doctors, saw breastfeeding rates halved there between 1999 and 2013, and milk formula sales escalating in Asia.

Though this is purportedly in part due to fears of Chinese milk products following the melamine contamination over a decade ago, sophisticated marketing is driving product sales.

Regular coverage in the Australian media about empty supermarket shelves by Chinese buyers also promotes the misguided idea that toddler milk is a necessary and highly valued product. This is despite the WHO guidance and further WHA resolutions reinforcing that these products are unnecessary and possibly harmful and should not be inappropriately promoted.

In 2016, the WHA passed a new Resolution (69.9) on inappropriate promotion of foods for infants and young children (despite US opposition). It reiterated that products for older babies and toddlers, such as ‘follow up’ formulas and ‘growing up’ milks, were covered by the longstanding global regulatory guidance on marketing of breastmilk substitutes – the WHO International Code and subsequent relevant WHA Resolutions.

It also clarified once and for all that industry should restrain its marketing of these milk products in the same way that industry should restrain its marketing of breastmilk substitutes for younger babies. Responsibility to only market ‘appropriately’ had been accepted by industry in 1981.

In mid-2018, the US baby milk industry, emboldened by the new Trump Administration (and the appointment of a pharmaceutical industry CEO to lead the US health department) tried to prevent a usually uncontroversial World Health Assembly resolution on support for breastfeeding. US opposition to the resolution shocked the global health and wider community.

The UN Office of the Human Rights Commissioner has meanwhile also drawn attention to breastfeeding as a human right, and to the importance of avoiding the conflicts of interest involved where industry has a seat at the policy table.

Codex is a core instrument for protecting the nutrition and health of infants and young children against harm from commercial food products, yet conflicts of interest are deeply entrenched in current practice.

Australian policymaking and conflicts of interest

Currently on the table for discussion at Codex is whether to include the 2016 WHO guidance on ending inappropriate promotion of foods for infants and young children in the Codex standard for follow on and toddler formulas.

Half the 4 member Australian delegation to Codex in 2018 were personnel from major milk formula industry representatives. In 2017 there were three – Nestle, Aspen and Fonterra – in the six member delegation (see this $ article).

Industry influence in the past has been of concern.

For example, in 2017, when follow-up formulas were considered, Codex documents reveal that the Australian delegation promoted watering down incorporation of the WHO International Code and relevant WHA Resolutions into the proposed Codex standard, and resisted lowering the current protein content to levels which scientific experts consider appropriate.

Purportedly to account for inadequate diets in some countries, the Australian delegation also sought to strengthen opportunities for marketing this unnecessary product by including product definitions such as for ‘where nutrient intakes may not be adequate’.

The Australians lined up closely within ‘the quartet’ of formula manufacturer countries led by the US (plus New Zealand and Canada), and with industry, resisting protection of breastfeeding in the standard.

Other countries like the Philippines and Bangladesh, supported consistently by Norway, took contrary positions, seeking amendments to the standard to more strongly protect exclusive and continued breastfeeding in line with WHO guidance.

In December 2018, the Australian delegation continued to support the US position of watering down or excluding WHO guidance and relevant WHA resolutions,  and allowing labeling with cross promotion, against the advocacy of public health and consumer organisations, and against Norway and many developing countries  that are urging to protect and support breastfeeding.

Looming lose-lose

A dilemma for civil society is that introducing a standard for regulating questionable products such as toddler milk formulas could facilitate their marketing. Indeed, industry can be better off with weak regulation than with no regulation, and may seek to achieve it.

One way of ensuring weak regulation is for industry to dominate and influence official delegations to Codex. A second opportunity then arises through industry lobbying (‘stakeholder marketing’) on national measures to ensure ineffectual implementation of Codex standards.

This is illustrated by the Lactalis baby milk scare in 2017-18. Despite the Codex Code of Practice on powdered infant formula, intended to minimise risk to children of bacterial infection, contaminated formula products affecting more than 80 countries and sickening dozens of children in France alone were still being sold weeks after their recall. The Code of Practice is not always followed, controls may be lacking, and recalls may not be effective, depending on national regulatory practice.

A Codex standard also protects industry because consumer complaints or even litigation and enforcement efforts can be defended by companies on the basis they comply with a regulatory standard.

Industries which market products consumers are wary of – think of the vernacular ‘snake oil merchants’ – can benefit immensely from the stamp of approval bestowed by a thin veneer of international and national regulation.

Consumers commonly believe that if a product is regulated, it must be safe and useful. ‘The Government wouldn’t let them sell it if was harmful’, is a widely held belief.

Weakly regulated marketing that harms children, even while pretending to help, will continue to underpin inappropriate promotion of unhealthy baby food products at the expense of peoples’ health, and at the cost of higher disease burdens on families and the future health system.

What needs to be done?

1. The Codex Commission must meet its public health remit by firstly ensure its recommendations on milk formula products align with the existing WHO International Code and related WHA Resolutions for protecting, promoting and supporting breastfeeding.
2. Codex governance must recognise and respond to concerns of consumer associations and civil society organizations on the need to uphold the highest standards for avoiding conflict of interests in food policy, including on breastfeeding protection policies and guidance.
3. Governments as signatories to human rights instruments must act to implement the WHO International Code and relevant WHA resolutions in full, including by enacting and enforcing legislation.

This will not happen while the milk formula industry decides ‘what is on the menu’ for food policy in the form of Codex standards, as well as being ‘invited to dinner’ at the national food policymaking table.

It is time for FAO and WHO as co-convenors of Codex to admit and confront the deep conflicts of interest which undermine its formulation of global guidance on food regulation for infants and young children.

Most importantly, it must ensure that governments, including Australia’s, do not continue to allow the milk formula industry the opportunity to participate in official Codex delegations.

Codex guidance of national regulations on infant and young child food products is currently a deceit of those who believe that food regulation prioritises food safety and public health and is based on scientific expert, rather than local industry advice and interests.

Dr Julie P Smith is an ARC Future Fellow, and Professor (Associate) at the Australian National University. She was awarded ARC ‘Discovery’ and ‘Linkage’ funding for projects on the economics of breastfeeding and markets in mothers milk, surveying maternal time use and breastfeeding support in workplaces and childcare.

Alex Iellamo is an independent consultant with extensive expertise in infant and young child feeding policies and practices, particularly in emergencies, and on the WHO International Code. He is presently working for Save the Children, UK.

Dr Phillip Baker is Alfred Deakin Postdoctoral Research Fellow at the Institute for Physical Activity and Nutrition (IPAN) at Deakin University.