Regulatory framework

When designing regulation, an initial consideration for policymakers is selection of an appropriate legal framework (table 1).16 Mandatory FOP nutrition labels are specifically recommended by the WHO High Level Commission on Ending Childhood Obesity^{6 7} and provide an important way to overcome suboptimal uptake of voluntary labels.17 Despite sometimes being raised as a barrier to mandatory labels, international trade agreements governed by the WTO do allow governments to implement mandatory measures, provided regulation is crafted carefully to maintain coherence with international trade obligations.21 In each jurisdiction, policymakers must determine whether any existing law restricts implementation of a mandatory label. For example, European Union (EU) legislation may constrain EU member countries from applying mandatory national legislation.31 Where a mandatory label is not legally possible, a voluntary system can be pursued.16

While the majority of labelling schemes in current practice remained voluntary, 10 countries now have mandatory FOP nutrition labels (figure 1). Eight of these were adopted since 2014, including regulations in Ecuador,32 Iran,33 Sri Lanka,34 Mexico,35 Chile,36 Peru,37 Israel38 and Uruguay.39

Label format

For FOP nutrition labelling to promote healthier diets, policymakers must select a label format that consumers can understand and use (table 1). A significant body of public health evidence suggests formats with interpretive elements that show judgement or recommendation are most useful.11 13 14 As outlined in figure 1, these include nutrient-specific interpretive labels and multiple types of summary indicator formats.

Of 31 current FOP nutrition labels, 26 used interpretive elements. Fourteen positive signposts used subjective words (eg, good, healthier), symbols (eg, ticks, hearts) and colour to signal relative healthfulness within category. However, included elements such as the Keyhole symbol did not necessarily hold intuitive meaning (figure 1). While the marketing value of positive signposts makes them appealing to industry, a summary of recent evidence suggests they encourage consumers to overestimate healthfulness and may also facilitate price premiums on healthier options that policymakers may find undesirable for low socioeconomic consumers.17

By contrast, the past 5 years has brought rapid innovation in labels that evaluate product unhealthfulness, which appear more effective in supporting consumers to choose nutritionally favourable products.17 These include 10 nutrient-specific formats which used descriptive words (eg, low, medium, high); meaningful colour (red, yellow, green, black) and salient symbols (eg, stop signs, traffic lights) to illustrate specific nutrient content (figure 1). Recent regulation adopted in Uruguay elected to use ‘excess’ rather than ‘high in’ for specific nutrients,39 reflecting research in that context that ‘high in’ was prone to more positive connotations.40

In a similar manner, Australasia’s HSR41 and France’s NutriScore42 (now also endorsed by Belgium and Spain) indicated both healthfulness and unhealthfulness but did so on a customisable continuum to summarise nutritional quality overall. Nutri-Score used colour to reinforce its evaluation (ie, A was dark green to signify healthiest)42 whereas HSR allowed manufacturers to display the logo in any colour.41 No jurisdiction had yet extended this focus on evaluating unhealthfulness to providing only a summary negative signpost (figure 1).

The remaining five labels (figure 1) were non-interpretive, that is, presented monochrome numerical information. While preferred by industry, consumers cannot understand and use such information,11 13 14 particularly those with lower nutrition literacy, education or members of minority ethnic groups.11 For FOP nutrition labelling to effectively guide consumers towards healthier choices, policymakers should avoid non-interpretive label formats.

Regulatory objectives

The objectives of regulation provide the basis by which policy ‘success’ will be judged, both in routine evaluation and in the event of legal challenge.16 21 Strategic regulatory objectives should reflect measurable pathways of effect, for example, changes in consumer understanding, behaviour and/or food composition (table 1) demonstrable by short-term evaluation. While improved food labelling may contribute to broader goals, for example, prevention of NCDs or longer-term changes in obesity prevalence, difficulty in producing short-term evidence of these outcomes makes them less suited as explicit objectives of regulation.16 21

Current practice summarised in table 2 aligns with WHO Guidance on the objectives of FOP nutrition labelling.11 Where identified, all regulations specified a measurable consumer-focused objective that is, informing and/or helping them make healthier food choices. Uruguay’s law was even more strategic; its objective was to allow consumers to ‘identify foods with excessive amounts of specific nutrients’,39 a threshold foreseeably easier to demonstrate. Seventeen interpretive labelling regulations also contained explicit reference to the additional benefit of incentivising industry reformulation (table 2).

Specifications for displaying FOP nutrition labelling on pack

Regulation can specify requirements to enhance visibility and salience of the FOP nutrition label on pack. Examination of current practice identified at least some display specifications in 22 FOP nutrition labelling regulations. Specifications included size, contrast, colour and/or font (table 2). Where display was not explicitly required on the front or principal panel, it sometimes occurred elsewhere (eg, Ecuador),16 weakening visibility.

Only four regulations directed uniform placement, for example, top right (table 2). More common were minimum space requirements around the FOP nutrition label; the Nordic Keyhole also specified separation from competing claims (eg high in protein).18 Chile’s law required removal of marketing tools on pack (eg cartoon characters), for foods carrying a stop sign label.¹⁹ Six regulations incorporated written government endorsement (eg, Ministry of Health); two provided directions for use (eg avoid excessive consumption)(table 2). These progressive examples, along with lessons from refined display specifications in settings such as tobacco control,43 suggest potential for future regulatory innovation.

Included nutrients and/or food components

As part of a comprehensive approach to NCDs, nutrients and/or food components included in regulation should relate to evidence of diet-related risk.1 Current WHO guidance also suggests they be focused on nutrients already required to be declared on back-of-pack.11

Information on current practice was identified in the regulations of 30 labels (table 2). Twenty-eight included one or more nutrients associated with increased NCD risk: sodium (28); saturated fat (22), total sugar (21), trans fat (8), total fat (8) and added sugar (6).

Fewer regulations incorporated food components associated with decreased NCD risk: fibre (15), whole grain (5) and ‘fruit, vegetable, nut and legume’ content (2). This may reflect caution in highlighting packaged sources of these components over whole food counterparts.11

Other components included in current regulations were energy (14), artificial sweeteners (4), calcium (3), protein (3), cholesterol (1), unsaturated fat (1), caffeine (1) and added preservatives (1). Zambia indicated it would address NCDs and micronutrient deficiency,44 though nutrient criteria were not identified. To mitigate the risk of potential challenge, policymakers should ensure all inclusions are informed by health evidence.

Nutrient profiling criteria or scoring system

Nutrient profiling is the science of classifying or ranking foods according to their nutritional composition for reasons related to preventing disease and promoting health.17 For FOP nutrition labelling to successfully guide consumers towards healthier choices, regulation must specify a valid set of nutrient profiling criteria, that is, ones that appropriately evaluate nutritional quality.11 16 17

Nutrient profiling criteria were identified for 22/26 interpretive labels. Positive signposts used nutrient thresholds that varied by category; some had >60 categories (table 2). Nutrient-specific interpretive labels also used nutrient thresholds but across broader categories of ‘foods’ and ‘drinks’ to determine eligibility for a label (eg, stop sign) or its colour coding (eg, red, orange, green). The two overall spectrum ratings used algorithms to score overall nutritional quality, for example, HSR combined points from up to seven food components to generate an overall rating of 0.5–5.0 in one of six categories.41

To produce meaningful scores, regulation must specify a reference amount of the product to be used. Most regulations (20/31) applied criteria per 100 g/100 mL (table 2), consistent with WHO recommendation that this is most useful to facilitate standardised comparisons between products. ‘Per serving’ was used always or sometimes as a basis for nutrient profiling in 12 regulations, with potential to cause consumer confusion.11

Validation of nutrient profiling criteria is important to assess whether they correctly classify product healthfulness. However, some form of validity testing was identified for only six labels (table 2). Five criteria had been assessed against other measures of healthiness (eg, dietary guidelines); only three had been subject to stronger predictive testing of links between scoring criteria and health outcomes.45 Our results support existing calls to improve the science and selection of nutrient profiling criteria to ensure FOP nutrition labelling promotes genuinely healthier choices.11 45

Scope of products included in regulation

WHO guidance suggests regulations apply across most packaged foods to facilitate product comparisons and improve familiarity with the FOP nutrition label.11 Most current regulations (26/31) aligned with this guidance, applying broadly to packaged foods and drinks that carried a nutrient declaration. Some regulations applied beyond packaged food: six applied to unpackaged foods (eg, fruit, vegetables, fresh meat and seafood); five applied to meals served in restaurants or other catering services (table 2).

WHO guidance also suggests FOP nutrition labelling may not be appropriate for some foods.11 While exclusions were often not clearly specified in current regulation, no FOP nutrition labelling was allowed on infant formula; other frequent exclusions were foods for special dietary or medical uses, supplements and alcoholic beverages (online supplementary appendix 1). Foods not displaying nutrient declarations (eg, herbs, tea, small packs) were commonly exempted (but not necessarily excluded) (table 2).

Some exclusions varied by label format: for example, Chile and Uruguay excluded products with no added sugars, sodium or saturated fat, meaning intrinsic sources of these nutrients did not carry stop-sign warnings.19 39 Conversely, the positive Keyhole was not permitted on snacks.18

Findings suggest some flexibility for policymakers to determine national scope, provided decisions are justified by health evidence and apply equally to local and imported products.21

Policy coherence

Recognising no single action will be sufficient to address the global burden of unhealthy diets; policymakers should support and frame FOP nutrition labelling as part of a comprehensive suite of measures to promote healthier diets.16 21 To maximise public health impact, the substance of regulation should be aligned with existing measures, for example, food-based dietary guidelines (table 1).11

We identified 16 FOP nutrition labels that were supported by education campaigns to promote label use and/or broader nutrition messages, but only six that explicitly identified FOP nutrition labelling as part of broader nutrition, NCD or development plans (table 2). There is potential for innovative regulation to extend utility of FOP nutrition labelling beyond the point of food purchase: six regulations integrated labelling with other interventions, including Chile who stopped foods carrying labels from being sold in schools or marketed to children,19 and France’s agreement to make Nutri-Score mandatory in all food advertisements from 2021.42

Drafting regulatory rules and scheme design

WHO recommends that governments initiate FOP nutrition labelling and retain specific responsibility for setting regulatory objectives, scope and nutrient scoring criteria (table 1).11 Government-led development is perceived as more credible by consumers.17

All mandatory and most voluntary current regulations were initiated by governments, typically through health ministries or statutory food authorities. Five governments noted early engagement across sectors (eg, trade, agriculture, education)(table 3), which is recommended to promote whole-of-government coordination.16 21 Three voluntary regulations were initiated by civil society, two by industry and one was multistakeholder.

During policy development, government-led stakeholder engagement can facilitate due process and assist development of feasible and acceptable regulation.11 At the same time, there is a need to ensure that public health policymaking is conducted with safeguards to appropriately manage conflicts of interest.46

We identified at least some detail on stakeholder engagement for 19 FOP nutrition labels. Mandatory regulations followed standard procedures for legislative development. In jurisdictions with functioning rule of law, these typically embed principles of good governance such as due process and public consultation. While useful in promoting accountability, these procedures are not necessarily failsafe: in Mexico, lack of transparency during public consultation raised concern that industries were more heavily consulted than academics or civil society organisations.47 Mexico subsequently adopted a non-interpretive label (figure 1). Voluntary regulations were also frequently preceded by public consultation, but in limited cases also elevated industry to collaborator or member of committees developing the substance of regulation (table 3). Beyond a right to be heard through consultation, these collaborative arrangements create additional need for safeguards to ensure health objectives are not undermined by commercial interests.

The particular need to maintain the scientific integrity of committees developing nutrient profiling criteria is recognised in WHO recommendations that this process run parallel but independent and siloed from broader stakeholder engagement.11 Where detail was identified for current regulations, only 4/22 governments engaged industry in nutrient profiling development (table 3). They include Australia and New Zealand’s HSR system, where a government-commissioned independent review recently recommended industry be distanced from future nutrient profiling updates.41 The need for nutrient profiling to remain free from commercial interests can be seen elsewhere in the industry-led Choices Programme, which created a separate ‘independent scientific committee’ specifically for this task.48

Unlike the Framework Convention on Tobacco Control’s Article 5.3 in a tobacco control context,49 there is currently no binding international law requiring government to exclude the food industry from health policy development. Available guidance includes a proposed approach for prevention and management of conflicts of interest in national nutrition policymaking discussed by the WHO Executive Board in 2018.46 In Canada, where FOP nutrition labelling regulations are currently being developed, government has introduced new standards for transparency of stakeholder communications for healthy eating initiatives. In addition to publishing responses to formal consultations, all meetings and correspondence with stakeholders including industry are published on the government’s website. Any documents provided during meetings are also accessible to the public upon request.50 Divergence in current practice more broadly highlights the need for further guidance for policymakers on appropriate engagement with the food industry in the governance of FOP nutrition labelling.23

Administration

To promote accountability, labelling regulations should be administered by government or an independent body with requisite authority to monitor and enforce regulation (table 1). Evaluation of current practice suggested governments administered 25/31 current labelling schemes. Three were administered by civil society organisations, which were independent but may lack authority or resource to enforce regulation (table 3). HSR and Choices used multistakeholder committees, again creating need for conflict of interest safeguards. In the context of administrative committees, appropriate measures could include conducting meetings publicly with publicly available minutes, and stakeholders recusing themselves from decisions where a conflict exists (eg, where an industry representative is required to assess the compliance of one of their members with regulation).

Monitoring and evaluation

Structured, regular review ensures regulation is meeting its objectives and supports continuous improvement. Best-practice requires policymakers to set a framework during development that includes baseline data, performance indicators and appropriate timeframes (table 1).

The absence of systematic monitoring and evaluation with publicly available outcomes was a key limitation of current practice in our evaluation. Government-supported monitoring was reported for just over half of regulations; only one-third of regulations had been subject to some form of evaluation. There was suboptimal monitoring of outcomes necessary to demonstrate achievement of regulatory objectives: 10 labels monitored consumer understanding and use, 7 monitored reformulation. Only 11 monitored industry uptake, necessary to judge impact and compliance with regulation (table 3).

Some newer regulations showed elements of stronger practice. HSR had a government-appointed independent reviewer with publicly available Terms of Reference.41 Nutri-Score was implemented with publicly funded evaluation using a variety of data sources.42 Governments of Chile and Israel proposed evaluation with independent academics;36 Israel also planned to obtain sales data (online supplementary appendix 1).

FOP nutrition label performance was also subject of ad hoc independent research. For example, the HSR website noted 45 peer-reviewed papers between 2014 and 2019.41 While contributing valuable insight, this work does not obviate the need for systematic government-supported evaluation.

Specific evaluation of nutrient profiling criteria is necessary to ensure regulation evolves with nutrition science.11 Only one-third of current regulations had relevant mechanisms to trigger this process. Legislation in Chile, Israel and Peru incorporated progressively lowering nutrient thresholds to incentivise continuing industry reformulation; Finland had also updated salt warning legislation. Five positive signposts reviewed criteria at prespecified intervals; Keyhole criteria had been updated five times.18 HSR’s algorithm was a focus of its 5-year review.41

Enforcement

Effective enforcement of regulation promotes compliance with regulation (table 1). Sanctions or rewards were identified in only around half of FOP nutrition label regulations but provided insight into the range of options available (table 3). Ten labels licensed products prior to market sometimes with associated cost (online supplementary appendix 1), though utility of this feature may be practically limited to positive signposts. Other incentives for voluntary uptake included listing participating companies on government websites.

Once on shelves, at least seven regulations audited products for compliance. Sanctions for non-compliance varied widely. Positive signposts could withdraw approval for use. Four labels used written requests to manufacturers for amendment (table 3). Non-compliance with Ecuador’s label could result in cancellation of advertising permits.32 In South Korea, Sri Lanka and Uruguay, general sanctions under relevant Food Acts applied, for example, fines and potentially jail sentences (online supplementary appendix 1). Even in voluntary systems, legal action was possible, for example, to protect misuse of trademarked logos. HSR was the only system identified that had its own complaints handling mechanism.41

For all systems, lack of identified information on whether sanctions are being used suggests potential to strengthen enforcement action and/or improve transparency of activity.