Implementing a Food Labeling and Marketing Law in Chile

ABSTRACT In 2012, Chile passed a law intended to reduce obesity in the country. It included several novel features, such as a front-of-package label, limitations to marketing and advertising, and policies targeting schools. The law required the creation of a regulation to address its implementation. Between 2012 and 2015, a process was carried out to generate this regulation that finally came into force in June 2016. This process confronted several difficulties: the involvement of multiple actors, political changes in national government, and endless negotiations to define the operational details of the regulation. The end result was one of the most discussed health policies of recent years in Chile. This article tells the story of the process defining this regulation, carried out between 2012 and 2015. It describes its evolution from a legal perspective but also reveals the trade-offs faced by the team in charge of providing the operational definitions for the implementation of the law. The article presents the main challenges as well the strategies used by the team at the Ministry of Health to overcome the many difficulties that arose during the process of implementing Chile’s food labeling and marketing law. The experience of the Chilean reform may provide practical information and lessons for other countries and policy makers embarking on the task of preventing and reducing obesity. Although the Chilean experience has its own particularities, it also suggests common difficulties for similar reform processes in terms of technical challenges—such as the definition of concepts and the scope of regulation—and political challenges—like the opposition of the food industry and conflicts of interest among governmental institutions.


Introduction
In 2012, Chile passed the Law 20,606 to regulate the nutritional content of food and its marketing in the country.The law was intended to curb the high rates of obesity in Chile: 25% of adults were obese in 2010 and 23% of schoolchildren were obese in 2012. 1,2The law was first in the world to include three components in one policy.First, it mandates a front-of-package label (FoPL) for food products that are "high in" a certain level of calories, sugars, sodium, and saturated fat. 3 Second, it regulates the advertising and marketing of products with FoPL, particularly limiting advertisements targeting audiences younger than 14 years old.Finally, the law prohibits all products that exceed the thresholds of critical nutrients from being sold in schools.
Despite the industry's pushback and implementation challenges, Chile's Law 20,606 was finally implemented through a regulation published in June 2016.Since then, the Ministry of Health (MoH) has published an annual assessment of the law's implementation and the achievements of the regulation.In 2017, the report demonstrated that during its first year there were high levels of compliance from the industry and schools, and 92.4% of people rated the FoPL as good or very good. 4,5n 2018, the MoH report found that a majority of consumers consider the labels when buying food: 58.4% of people say they choose foods with fewer warning stamps (FoPL). 6ue to the initial successes of Chile's law, other countries may turn to Chile when formulating their own food reform and obesity prevention efforts.The Organization for Economic Cooperation and Development (OECD) estimates that one in five children are either overweight or obese and 18% of adults are obese in OECD countries. 7he severity of the obesity problem has led countries to search for strategies to improve the health of their populations, and Chile's comprehensive law establishing FoPL and additional marketing regulations can serve as a model for future policies.
It is important to recognize that the Chilean reform was not an easy process, particularly considering that its design and implementation process had no precedent in Chile or other countries.Although the Chilean experience has its own particularities, it also suggests common difficulties for similar reform processes in terms of technical challenges-such as the definition of concepts and the scope of regulation-and political challenges-like the opposition of the food industry and conflict of interest among governmental institutions.The goal of this article is to present the technical and political challenges faced by policy makers through the process that generated the regulation for implementing Law 20,606, identifying the actors, bottlenecks, and strategies used to move this reform from theory to practice.Information was collected from public documents as well as the experience from two of the authors (LR and TP) who were actively involved in the process of implementing the law from the Ministry of Health during 2015-2018.

From Ideas to Practice: Challenges in Implementing a Food Policy in Chile
Legal Milestones: The Long Road to Reform Chile's discussion about reform started in 2006 with the publication of the plan to address the Global Strategy against Obesity (EGO-Chile). 8This document outlined some ideas-such as the use of FoPL-that promoted the debate around the need of a new food policy.The process of designing and writing the law was carried out from 2006 to 2012, and included the presentation of the bill in the National Congress of Chile and an intense legislative, academic, and social debate.Law 20,606 was approved and published in July 2012 but required several clarifications regarding its operational definitions.
For this reason, the text of the law established a period of "one year after its official publication" to generate a regulation as the legal document that describes the operational details to implement the law.The legal process, from the law's publication to the final implementation stage, is shown in Figure 1.
The first attempt to operationalize the law was a document establishing the graphics, logo, and messages to be used by the FoPL (regulation Decree 28, shown as the first X in Figure 1), which was supposed to enter into force in June 2015. 9owever, the policy discussion shifted in 2014 when Michelle Bachelet started her second term as president.The new authorities of the MoH decided that the previous regulation was not enough to comply with the requirements of the law: it was vague about the scope of the regulation, excluded some products, and established cutoff values of critical nutrients that were not justified by any evidence.These problems were made explicit in a new legal body (Decree 103, shown as the second X in Figure 1), and Decree 28 was repealed four days before it entered into force. 10Consequently, a new regulation was needed to implement the law; again, a deadline of one year was established for this new legal requirement.
With this new deadline, the MoH created two expert committees to help generate a final version of the regulation and propose recommendations to overcome the shortcomings of the previous one.One group worked on the FoPL, with the goal of defining its scope of application (i.e., products that would be included and excluded for the FoPL, as well as the thresholds for critical nutrients); the second group was devoted to define the other aspects of the law (i.e., food marketing and advertising).In parallel, the MoH started the process of defining the logo that would be used in the FoPL.Once these discussions finished, the new proposals were put together in a new regulation (Decree 13 of 2015), whose draft was shared with national and international stakeholders. 11he new regulatory body established a process of gradual implementation of the law in three waves: initial implementation one year after its publication (2016), a second modification of the limits 24 months after its publication (2018), and full implementation with the final cutoff values by June 2019.
The several stages of this implementation process added many players to the reform.Although different frameworks can be used to classify key actors, according to their role in the process, in this case, they can be grouped into six broad categories: 12,13 1) industry; 2) international organizations; 3) academia; 4) public institutions (including the Ministries of Health, Finance, Foreign Affairs, Economy, Social Development, and Agriculture); 5) civil society; and 6) the media.However, the positions of each group of actors regarding different aspects of the reform were heterogeneous: there were both advocates and opponents within each group, as described in the next sections.

Technical Challenges
Since Law 20,606 was the first of its kind to tackle FoPL, limits on advertising, and bans in schools, there was no precedent regarding how to define several technical aspects of the regulation.Previously, other countries had established similar regulations, such as France and the UK.However, in these cases the regulations were voluntary, and both the decision process and technical choices in the regulations were unknown to the public. 14,15nforcing these changes through a law in Chile required evidence-based and transparent criteria for each decision.
A first challenge was defining the scope of the regulation, i.e., which products would be affected by the law.To address this issue, MoH experts performed a literature review and defined a methodology based on the share of "natural" contents in each product; based on this methodology, it was decided that only products with additional critical nutrients (including imported products) would be subject to regulation, leaving aside all natural products and food served in restaurants.
A second challenge was the establishment of the cutoff values of critical nutrients for each product.This decision was relevant because these limits define not only which products will have labels (FoPL) but also the products that will be allowed to be advertised and sold in schools.Again, there were no established procedures or benchmarks to be used in this decision.In order to address this problem, the MoH assembled a committee of academic experts to review the available scientific evidence, in order to define the appropriate limits of critical nutrients, based on the natural composition of nutrients in each product.This committee decided that the limits would be established per 100 g or 100 ml to demonstrate the quality of the food.This decision was important because it established the limits based on product composition, not its expected consumption.
Third, the MoH collected various studies through a competitive open-call to determine the degree of understanding and responsiveness of consumers toward several FoPL logo designs.The study concluded that a black octagon with white letters-certified by the Ministry of Health-was the most effective. 16inally, there was a problem in defining what "advertising and marketing aimed at children under 14 years old" entailed.8][19] In Chile, the debate revolved around two issues: establishing the meaning of "advertising" and "aimed at children under 14 years old."In order to deal with the former challenge, previous studies, based on the tobacco regulation, were used. 20o address the latter challenge, the decision regarding how to define "aimed at children under 14 years old" was based on the opinion of an expert committee, literature review, and recommendations of international organizations.Considering this information, the scope of the regulation included all advertising platforms like packaging and branding, digital media, and the internet, due to their influence on young audiences. 21

Political Challenges
Once the MoH had a final draft of the regulation, the Ministry entered into national and international public consultations, as well as with civil society through citizen forums, dialogs, and student parliaments.The MoH organized participatory dialogs in all the country's regions, with special emphasis on school communities.For civil society, social media was used as a tool to communicate the proposal and collect people's experiences.Industry representatives were also invited to listen to the proposals and express their concerns.After finishing the process, more than 350 suggestions were received with almost 10% of them coming from the industry.
Citizens, international organizations and part of the academia celebrated and supported the initiative.From a societal perspective, the law was perceived as a way to protect the children of Chile.However, there was great resistance from the food and advertising industries, both through formal channels-such as interviews through the Lobby Law (a law that regulates the interactions between particular interest groups and authorities) with technical levels and political authorities-as well as through informal channels and mass media.Additionally, in 2014 and during a two-month period, the law and its regulations were presented to several international organizations, such as the OECD, the Food and Agriculture Organization (FAO), the Pan American Health Organization and the World Health Organization, and the World Trade Organization (WTO), as well as in multiple academic and governmental seminars in different countries.This massive diffusion about the law and its related regulation generated an ample national and international debate.
One of the main arguments against the regulation was its potential negative effects on business, particularly for small and medium enterprises (SMEs).The industry focused particularly on the expected increase in production costs, as a result of changing the composition of their products, as well as required modifications in labeling and packaging.The main conflict with the industry was the adoption of FoPL instead of continuing to use the existing Guideline Daily Amounts (GDA) labels.The proposal to continue the GDA labels instead of the new FoPL had no support from either academia or the MoH.Instead, both labels were used: the "high in" labels in the front and the GDA nutritional facts in the back.Measures of flexibility and gradualness were included in the regulation to navigate this complex scenario and respond to the industry's resistance.Also, the language of the labels was changed from "excess of" to "high in".The final process established that, even though the law must enter into force within a year, the thresholds for what would be considered as "high in" would be adjusted gradually over a period of four years, meaning that the law would be fully implemented by June 2019. 11he agreement also established that SMEs would have a grace period of three years.This concession diminished some of the industry's resistance and allowed the process to keep moving forward.
Despite the fear that this grace period of three years would be used by the industry to counterattack and develop new attempts to undermine the implementation of the law, the process finished successfully in June 2019 when the last adjustment to the nutrients' cutoff values took place.
Besides the pressure from the food industry, the regulation also faced important opposition from other public institutions, especially the Ministry of Economy, the Ministry of Agriculture, and the Ministry of Foreign Affairs.These three ministries were concerned about the effects that this regulation could have in terms of its economic impact and international relations with other countries.These disputes were solved through the implementation of a high-level committee chaired by the MoH, whose role was to present the public health arguments to implement the law and respond to other ministries' questions.Several meetings between the technical and political teams of these institutions were held, where the main consensus was the need to adopt a common position as government and country.The message that reducing obesity in Chile was a national endeavor and that this law was necessary to improve the country's health-particularly children's health-was key to sealing the alliances with other ministries in the government.

Practical Lessons
Here we propose five lessons learned during the almost seven-year period after the law was approved in 2012 until it came into full implementation in 2019: (1) Broad scope of regulation: one law, three components One of the main features of Chile's law is that it went significantly beyond FoPL.The law was presented as a package of three elements: FoPL, advertising, and restricted sales in schools.This feature had at least three advantages: a. Acknowledging that obesity is a multifaceted problem that requires a comprehensive approach: multidimensional interventions had shown better results in helping reduce obesity in other contexts. 22,23.Avoiding repetitive actions: discussing the three elements increased the efficiency of the process and gave it an internal coherence, thus focusing more on the goal (reducing obesity) and less on the particular strategies to achieve it (e.g., FoPL or advertising restrictions).c.Using elements of the law for negotiation: since the law included several components, each one with several dimensions to be determined, the elements of the law were used to barter, establishing trade-offs and compromise.In fact, the initial project included a fourth component-regulation of mandatory physical activity in schools-that was abandoned during the process as part of the negotiations.
(2) Separating law from its implementation: theoretical grounds versus operational details e1753159-4 A second characteristic of the process in Chile is that the initial law, which outlined the reform process, was designed in a vague way, which separated the question of "should we reform?"from that of "how to reform?"The main benefits of this decision were: a. Establishing a legal milestone with a political consensus: the law demonstrated agreement that there was the "need to regulate," thereby preventing the process from being stopped in its initial stage.This decision allowed a rapid transition from political debate to technical discussion.b.Separating the law and its implementation created flexibility for potential changes: since a law is harder to change, discussion was centered around the need for a national strategy to deal with obesity, a problem of a more permanent nature.Implementation details, on the other hand, were placed in the regulation, allowing for adjustments in the future.c.Giving more time and flexibility to gather evidence: the law established a timeframe of one year to determine the details of implementation.This period was key in building consensus, negotiating with stakeholders, and proposing evidence-based alternatives.
(3) Time for consensus: using academia as a mediator As shown in Figure 1 and Table 1, the entire process -from legislative adoption to full implementationtook several years (including changes in government) and faced multiple challenges.Both elements, time and technical consensus, have been identified as key factors for the success of reform processes. 24In this aspect, two insights are important: a.Given the novelty of the process, particularly regarding technical decisions, the implementers at the MoH sought continuing advice from academics to elaborate and validate proposals.This strategy increased the likelihood of acceptance, avoiding a debate based exclusively on opinions and particular interests.b.The participation of academia as an active player was facilitated by the availability of time for making decisions.As previously discussed, this time to reach consensus was possible due to several modifications in the implementation deadline.In turn, this flexibility was possible because of the strategy of debating a regulation that was already supported by a law.In this environment, difficulties could delay the process but could not stop movement forward.
(4) Strategic negotiation: Reducing battle fronts and increasing allies One key issue that allowed full implementation to occur was reducing resistance against the proposal.Two main strategies were used: • What limits should be defined?
• Using standardized measures (nutrients by each 100 grams) • Setting the limit so it helps establishing a threshold aligned with healthy nutrition vs. one that ends up damaging the industry • Using an expert committee • Recommendations from interna- tional organizations

Label design
• What is the best symbol to facilitate people's interpretation?
• What is the best sentence?
• Label as information for consumers vs. label as con- sumption inhibitor • Studies requested by the MoH (through a competitive and open call) • Consumers' studies Restrictions to advertising and branding • How to define "advertising targeted to younger than 14 years audience"?
• What kinds of advertising platforms should be included/ excluded?
• Restrictions to marketing as a tool to protect children vs. barriers to free market competition • Does the reform work against brand building?
• Using an expert committee to review international experiences • Experiences from tobacco regulation a. Gradual implementation in time and scope: allowing a gradual implementation of the law and an (temporary) exemption for SMEs served to appease some of the arguments used by the industry regarding the excessive costs of the reform.Gradualness in implementation (Table 2) was also crucial to avoid short-term opposition and permit the debate to move forward.b.Convincing key actors to support the initiative: instead of seeing FoPL as a constraint, some companies began using it as a marketing strategy.Once big players of the industry started adopting FoPL, the rest followed.Within the context of a regulation, this early adoption strategy (or the decision of not fighting back from key actors) can be seen as a form of "self-regulation" but where the standards are determined by the government instead of the industry.This represents an interesting approach in an area where industry self-regulation has been insufficient. 25,26) Goal-centered debate: Setting a common goal beyond the particular objectives of the regulation Although the law and its regulation have several aspects, it was designed with a single goal in mind: reducing obesity rates in the country, particularly among children.The advantages of this strategy are: a.As stated before, one of the key features of Law 20,606 was that it was built not around the idea of implementing a FoPL regulation but as a required step to solve the problem of obesity, particularly among children.This was the argument used every time detractors complained about the reform.The law is not about regulating; it is about investing in Chile's future.b.Additionally, providing a transparent and open debate facilitated the process of defining the law's implementation.In this regard, the media played an important role.Every time a conflict arose, the arguments were publicly exposed and discussed.In order to gain supporters, officials not only used a potent message (reduce child obesity) but also presented the law, particularly the FoPL, not as a constraint to competition and marketing but as a tool to improve consumers' right to information.

Conclusions
The process of implementing Law 20,606 in Chile was long and complex, but the law overcame many obstacles and enemies.Despite its expected difficulties, the law became fully implemented in 2019.This is a powerful message for other countries that seek a similar reform process: the road is full of pitfalls but it is feasible.
The implementation of Chile's law is an important step in the road toward reducing obesity in the country, but several challenges remain.The law will require a well-designed system of monitoring and evaluation to ensure its correct implementation and measure the impact of the initiative over time.In a similar vein, the regulation will require adjustments to incorporate new scientific evidence (e.g., changing the thresholds or the messages) and expand its scope (e.g., application of the law to restaurants, online food services, and others).In addition, the process will require adjustment to mitigate unintended consequences, including, for example, changes in the composition of some products that could increase the presence of non-regulated ingredients, such as artificial sweeteners.Future modifications of this regulation should take into account these issues to increase its effectiveness.
Finally, Chile should also move forward in adopting complementary measures in order to implement multidimensional interventions to fight obesity in the population.In this line, it is important to re-consider some measures originally proposed in the law (and subsequently removed), such as the increase in hours of physical activity in schools, incentives for healthy food, and promotion of healthy environments.

Table 1 .
Challenges, questions and strategies that emerged during the process.

Table 2 .
11resholds established for different nutrients and period of application.11