The Official Mexican Standard (October 2019–March 2020)

While the mandate for a FOPNL warning label system was approved through a reform to the General Health Law in October 2019, the new national Standard was concurrently developed. In August 2019, the government established a working group comprised of government officials, health advocates, academics, intergovernmental organisations and the private sector to initially discuss the Standard regulations as described elsewhere^{(Reference White and Barquera11)} and on 8 October 2019, the Ministry of Economy (MoE) and the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), a decentralised body of the Ministry of Health (MoH), published a draft of the Standard. Following this, the MoE and MoH held a public consultation open for a 2-month period (11 October 2019–10 December 2019) for public commentary, in which supporting and opposing stakeholders provided comments regarding the implementation of the new FOPNL Standard (Table 1). A total of 792 comments were submitted. On 10 March 2020, the MoE and MoH, with assistance from the working group, published a summary of the public comments along with their responses, and the final modification to the Standard was officially published on 27 March 2020. Our summary of the key nine provisions, stakeholder groups and positions and final decisions are presented in Table 1 and described below.

Key provision #1 (ban on health claims)

A largely contended provision in the draft Standard was a ban on health claims, which prohibited professional health association claims and endorsements on the labels of products with FOPNL warnings. Opposing stakeholders argued the ban violated Article 32 of the Federal Law for Consumer Protection, which establishes minimum requirements for using product endorsements including evidence-based claims^(16,17,29) . They also insinuated that, since many professional health associations have close ties to the MoH, such a ban would disqualify the MoH’s credibility⁽¹⁸⁾. Supporting stakeholders defended this provision arguing that under the Federal Law for Consumer Protection, all information relating to advertised products must be free of confusing or deceiving elements. In addition, the government would have the right to enforce regulation related to intellectual property based on its legitimate public health interest^(19–21). Supporting stakeholders also argued that evidence had shown that some medical associations (e.g. Mexican Diabetes Federation) that offer endorsements have reportedly received funding from industry actors such as Nestlé representing a clear conflict of interest^(19,20) . Ultimately, the ban was retained in the final Standard as the MoE declared that endorsements and recommendations would only be permitted on products with no FOPNL warnings – in conformity with the Federal Law for Consumer Protection – to promote informed consumption⁽²⁴⁾ (Table 1).

Key provision #2 (warning labels for added sweeteners)

The draft Standard also proposed implementing warning labels for added sweeteners (black octagons with white text warning the excess of this critical nutrient proportional to the size of the label’s main display area ranging up to 3·5 × 3·88 cm² for larger products with a display area > 300 cm²), which would read ‘Contiene edulcorantes, no recommendable en niños’ (contains sweeteners, not recommended for children). The Standard defined sweeteners as any substance other than monosaccharides and disaccharides that provide a sweet flavor; thus, products containing any synthetic or natural sweeteners, non-caloric sweeteners or polyalcohol would display a FOPNL warning. Opposing stakeholders claimed that widely recognised bodies such as the US Food and Drug Administration (FDA) and CODEX Alimentarius deemed sweeteners as safe^(18,22,23) . CODEX, an international standard setting entity for nutritional labelling, has close ties to the food and beverage industry^{(Reference Thow, Jones and Schneider30)}. Furthermore, they argued it would pose unnecessary obstacles to trade, effectively violating the World Trade Organization (WTO) Technical Barriers to Trade (TBT) Agreement – a common argument used by industry actors to block public health policies⁽²⁴⁾. Industry actors also suggested that the phrase ‘Avoid in children’ would restrict the consumption of these products, which would be beyond the authority of implementing this regulation⁽²⁴⁾. Lastly, they argued that this provision would hinder possible reformulation efforts, despite the lack of evidence to support this claim⁽²³⁾. Supporting stakeholders offered evidence surrounding the potential association between sweeteners and NCD and emphasised the importance of implementing visible FOPNL seals, especially since products containing sweeteners are often marketed to children^(19,20) . In response, the MoE agreed to keep the FOPNL redesigned into a smaller caption (a slim black box with white text) in conformity with Article 212 of the General Health Law Article. The MoE supported that sweeteners are not recommended for children, since they can instil a preference for sweet flavours. Nevertheless, the wording of the warning text was amended to ‘No es recomendable para niños’ (not recommended for children) representing another win for opposing stakeholders.

Key provision #3 (warning label display areas)

The draft Standard required smaller products with a label display area of ≤ 20 cm² to carry only one simplified warning label with the digit (e.g. 1, 2, 3) corresponding to the number of critical nutrients (e.g. sugar) they contain. Inevitably, these simplified warning labels would be less interpretative for consumers. In response, opposing stakeholders claimed smaller products should not require a warning label as the proposed dimensions would negatively impact the visibility of other mandatory elements on the label⁽²⁴⁾. Moreover, they argued that products with a main display area < 20 cm² are not legally required to include nutrition facts and should therefore be exempt⁽²⁴⁾. On the other hand, supporting stakeholders urged policy-makers to establish narrower parameters for smaller products with the label size (≤ 10 cm²), given the industry’s previous efforts in Peru to decrease their portion sizes and thereby the size of their packaging in order to evade FOPNL measures^(20,31) . Although opposing stakeholders were unsuccessful at persuading decision-makers to eliminate this requirement, the MoE doubled the parameter (< 40 cm²), allowing larger packages to adopt laxer FOPNL warnings arguing the smaller dimensions would obstruct the warning label visibility in agreement with the industry.

Key provision #4 (warning labels on multipacks)

The draft Standard required that all products sold in multipacks (e.g. 20 individual packs) display a warning label on each individual pack. Opposing stakeholders maintained that since individual products in multipacks are required to include the label ‘Not for individual sale’, they would not be subject to FOPNL requirements⁽²²⁾. Conversely, supporting stakeholders instead concentrated on advocating for an increase in the label size threshold mentioned in the key provision above⁽²⁰⁾. The MoE accepted the industry’s comments without explanation and only required that the outer package comply with the FOPNL specifications.

Key provision #5 (‘product does not contain FOPNL warning labels’ claims)

The draft Standard established that products that did not exceed any of the critical nutrient thresholds would be prohibited from indicating that they were FOPNL-free. Opposing stakeholders requested the elimination of this provision, as they argued that it would violate Article 1 of the Federal Law for Consumer Protection, which calls for clear and accurate information about the content, composition and characteristics of all products^(22,29) . On the other hand, supporting stakeholders defended this measure, arguing that products should not be able to use these claims as an advertising technique to make products appear healthier than they actually are – commonly referred to as a health halo effect⁽²⁴⁾. A stakeholder highlighted the importance of upholding this stipulation, based on Peru’s experience, where ultra-processed products such as Cheetos chips use FOPNL-free claims as advertisement⁽²⁴⁾. Ultimately, the MoE agreed with the industry’s request to eliminate this and grant products without FOPNL warnings the ability to include the text ‘No contiene sellos ni leyendas’ (this product does not contain warning seals or labels) on the main packaging.

Key provision #6 (placement of warning labels on products with a main display area ≤ 60 cm²)

The draft Standard required FOPNL warning labels (octagons) strictly on the upper right corner of their main display area regardless of size allowing consumers to quickly identify products containing an excess of critical nutrients. While some opposing stakeholders falsely claimed a lack of evidence to support the use of FOPNL warning labels altogether, others argued that the placement of these elements would be irrelevant to consumer comprehension^(22,24) . Moreover, some industry actors argued that given the proposed warning label dimensions, producers should be able to place them anywhere on the product’s main display area⁽¹⁷⁾. On the other hand, based on Chile’s experience, supporting stakeholders emphasised the need to refine this measure by establishing a protected area around the warning labels to prevent producers from including additional, potentially contradictory and messages⁽²⁴⁾. Despite these recommendations, the MoE agreed with the industry to modify the provision to allow products with a main display area ≤ 60 cm² to display the corresponding FOPNL elements anywhere on their main display area.

Key provision #7 (Nutrient Profile Model as guiding criteria)

The draft Standard designated the Pan American Health Organization (PAHO) Nutrient Profile Model as the guiding criteria, which establishes critical nutrient cut-offs for FOPNL warning labels. Opposing stakeholders requested policy-makers to modify the nutrient criteria cut-off points⁽²⁴⁾, modify the standardisation of sizes⁽²⁴⁾ and change the wording on the FOPNL warning labels from ‘Excess’, which for the industry appears more negative to ‘High in’⁽²²⁾, which can be enable a positive connotation (e.g. high in fibre)⁽²⁹⁾. If not, opposing stakeholders argued then that the Nutrient Profile Model would have to be modified, claiming it was a violation of the General Health Law and that it would hinder product reformulation^(18,22) . On the other hand, health advocates expressed their endorsement of this model, due to the ample scientific evidence to support it, and its tailored approach to the health needs of the region, especially fighting against NCD^{(19,20,25,26)} . Ultimately, the provision remained unchanged, and the Nutrient Profile Model and the word ‘Excess’ were retained.

Key provision #8 (standardised portions)

The draft Standard also established a standardised serving size of 100 g or 100 ml as reference for all nutrition information on prepackaged foods and beverages, as recommended by the WHO⁽³²⁾. However, opposing stakeholders argued that critical nutrients should be listed per ‘typical’ portion sizes^(17,22) , a strategy used to arbitrarily declare smaller portions on the product label than what is commonly consumed by the general population, often resulting in confusion^{(Reference Stern, Tolentino and Barquera33)}. On the contrary, supporting stakeholders applauded this measure as it intended to promote consumer comprehension and allow for easier comparison of the nutritional value across products^{(19–21,26,27)} . Despite industry opposition, standardised serving portions remained unchanged, after the MoE stated that this provision was founded on the Federal Law for Consumer Protection.

Key provision #9 (ban on cartoon characters)

Lastly, the draft Standard put forth a ban on all cartoon characters and children-targeted advertising elements on products with one or more FOPNL warning labels. In response, opposing stakeholders threatened that this ban would violate local and international laws and agreements (e.g. the Federal Copyright Law and the World Intellectual Property Organization Copyright Treaty)^{(16,17,22,23)} . Supporting stakeholders expressed their ample support for this evidence-based measure, as they argued that it was endorsed by entities such as UNICEF and the WHO^{(19,21,25–27)} . Furthermore, supporting stakeholders in academia provided assistance for the political feasibility of this provision by offering evidence that it would not infringe on any international trade laws (e.g. WTO)⁽²⁴⁾. In response, the MoE recognised that the use of characters and other advertising elements promote the consumption of products that pose a risk to the health of children, thus securing this ban.

Implementation of the NOM-051 (the Standard): Phase 1 (October 2020–September 2023)

While the finalised Standard outlined that FOPNL would be rolled out in three phases, this study covers the first phase (October 2020–September 2023). Initially in October 2020, manufacturers were required to place warning labels on the front of packages and from April 2021 the ban on children-targeted advertisement would begin⁽³⁴⁾.

Monitoring, enforcement and compliance

In July 2020, the MoE and MoH released a document delineating broadly the criteria for implementing the Standard⁽³⁵⁾. This agreement appointed the MoE, MoH (COFEPRIS) and the Federal Consumer Protection Agency (PROFECO) as regulatory authorities. In late 2020, PROFECO officials suggested that sanctions for non-compliance with the Standard could range from $2500 USD to nearly $40 000 USD, while deceiving claims on the product packaging could be fined up to $50 000 USD^{(Reference De la Rosa and Ochoa36)}.

After 4 months of implementing the Standard during the first phase, in March 2021, the head of PROFECO reported to the media that 99 per cent of the processed food and beverage industry had fully complied with the Standard^{(Reference De la Rosa37)}. When asked if they had fined the few companies that had not fully complied, the head of PROFECO reiterated that there had been no need to apply sanctions as the companies had eventually complied with the labelling standard^{(Reference De la Rosa37)}.

In the interest of monitoring compliance independently, the civil society organisation El Poder del Consumidor conducted a study between March and May 2021 where they monitored the implementation of FOPNL in ten grocery stores in three states (Queretaro, Mexico City and Morelos)⁽³⁸⁾. Their goal was to observe the changes on the labels with respect to the warning labels of critical nutrients and the display of cartoon characters by comparing photographs of food products before and after the Standard was implemented⁽³⁸⁾. They collected information on thirty-five milk products, seventy-three cereal boxes, and sixty-two sugar-sweetened beverages (excluding milk) and overall concluded FOPNL implementation was successful and the usage of cartoon characters on unhealthy products had decreased. However, they documented that the industry had created ‘double fronts’ by making the front and back of the product packaging identical with only one side carrying the warning labels. They recommended grocery stores implement monitoring measures to identify double fronts so that products with warning labels are showcased properly and not deceive consumers⁽³⁸⁾ (Fig. 2).

Fig. 2 Example of the food and beverage industry using double fronts by making the front and back of the product packaging identical with only one side carrying the warning labels

In June 2021, the MoE and MoH (COFEPRIS) and PROFECO published a manual to provide transparency and standardise the criteria surrounding the new specifications of labelling (e.g. ingredient lists, nutritional information and labelling examples) for enforcement⁽³⁹⁾. In July 2021, PROFECO and COFEPRIS officials met with Confederation of Industrial Chambers of the United Mexican States (CONCAMIN) executives nine times to discuss manuals, guides and technical sessions to assist with properly implementing FOPNL⁽⁴⁰⁾. As a result, on 26 July 2021, PROFECO and COFEPRIS officials held a technical session workshop open to the public, which summarised a detailed draft of the new specifications and fielded questions⁽⁴⁰⁾. When asked about products being displayed incorrectly on shelves, government officials suggested it was up to vendors to enforce the correct display of products at the point of sale, while avoiding the topic of verifications or sanctions⁽⁴⁰⁾. Following the lack of information presented during the session, a couple days later the MoE’s director took more of a cooperative rather than confrontational approach as he assured the press that the government did not seek to sanction companies but rather work with them to ensure the labelling was complied with.

In late 2021 and early 2022, the media also reported that government agencies were further monitoring the second stage (banning cartoon characters) of implementation. As of November 2021, at least fifty product and retailer brands – such as Coca-Cola FEMSA, Grupo Bimbo, and Nestlé – had been found possibly non-compliant with the Standard, yet it remains unclear whether COFEPRIS or PROFECO formally issued sanctions^{(Reference Rueda41)}. Nevertheless, in January 2022, COFEPRIS and PROFECO carried out two raids, during verification visits across the nation to supervise non-compliance by Kellogg Company Mexico⁽⁴²⁾. During the first raid, over 9000 products that did not display the appropriate warning seals and labels were confiscated at 75 points of sale⁽⁴²⁾. The second raid was carried out at a Kellogg’s distribution centre in Queretaro state, where over 370 000 products were confiscated⁽⁴²⁾. However, it is still unclear what was the final result of these raids.

Barriers and challenges to implementation

One of the main challenges to implement the Standard has been industry pushback to delay the implementation of the Standard. Initially, the food and beverage industry attempted to block and delay the Standard by filing injunctions (amparos). In October 2020, ConMéxico claimed that on behalf of thirty companies, including key opposing vocal food and beverage corporations Grupo Bimbo and Coca Cola, it was filing an injunction against the government claiming that there were violations to right to information, health and the overall process conducted for the modification of the Standard^{(Reference Echeverría43)}. As the banning of cartoon characters was set to go into effect in April 2021, ConMéxico again filed an injunction claiming that this would violate advertising freedoms of expression and intellectual property^{(Reference Echeverría44)}. In April 2021, the MoE claimed that fifty injunctions against the Standard had been filed. While the injunctions have not been publicly disclosed and appear to remain pending, the MoE and MoH continued to implement and enforce the Standard^{(Reference Echeverría44)}.

However, despite the pending injunctions, the industry was still able to delay the implementation and enforcement of the Standard. Initially, the first phase was supposed to begin in October 2020 but due to complaints by the industry that there was a short 6 months (April 2020–September 2020) to comply with the new regulations, especially during COVID-19, enforcement of the Standard was pushed back 2 months until 1 December 2020^{(Reference Echeverría43)}. Secondly, the banning of cartoon characters was originally set to begin on 1 April 2021 but was again delayed 2 months. On 11 March 2021, the National Regulatory Improvement Commission (CONAMER) published an interinstitutional agreement in an effort to establish a 2-month grace period (1 April–31 May 2021) during which producers, importers or traders would not be sanctioned for still advertising cartoon characters on their products⁽⁴⁵⁾. The agreement was also distributed to the US Department of Agriculture (USDA) Foreign Agricultural Service and the Global Agricultural Information Network (GAIN) to support the grace period. Eventually the grace period of 2 months was granted as the second stage did not enter into force until 1 June 2021.

It appears that the biggest challenge to implementing FOPNL has been the industry’s ability to exploit the Standard´s loopholes in regard to implementing FOPNL. Since the beginning of implementation, the application of double fronting on packaged foods has prevented consumers from seeing some of the warning labels. Another loophole is that some companies have found ways to promote their brands’ cartoon characters on the package despite the warning label requirement. For example, Grupo Bimbo put their mascot bear as a seal on the product itself (e.g. pancake) visible through a transparent wrapper rather than on the packaging or on a promotional container attached to the package^{(Reference Rocha46)} (Fig. 3). Grupo Bimbo also made a partnership with Pétalo, a hygiene and cleaning company, where they put both Bimbo and Pétalo’s mascot on napkins^{(Reference Rocha46)}. Media reported that this product generated a boom in sales as many consumers used memes to say ‘Soy inevitable’ (I am unavoidable), which can also be found on social media at #ositoBimbo^{(Reference Rocha46)}.

Fig. 3 Example of Grupo Bimbo putting their mascot bear as a seal on the product itself or on a promotional container attached to the package

Another challenge is that food and beverage companies have found ways to promote their brands’ cartoon characters on other mediums than the package. In response to the ban on cartoon characters, Kellogg announced that El Tigre Toño (Tony the Tiger), Melvin and Sam would continue to live on social media (e.g. Instagram and Twitter)⁽⁴⁷⁾. On 4 May 2021, the Kellogg’s characters appeared on Twitter and users complained to the government, but PROFECO responded by stating that the ban of characters was only applicable to the product packaging and asked that these complaints be sent to Kellogg⁽⁴⁷⁾. The company also used its Instagram account (@AmigosKelloggs) to tell users to be on the lookout for these characters, even starting the hashtag #SiempreCercadeTi (Always Near You) on the same social media platform⁽⁴⁷⁾. Two months later, Kellogg’s hosted a drone light show in Mexico City, where its most popular characters and the phrase ‘Always Near You’ were displayed for almost half an hour. This event was also livestreamed on their Instagram account. This continues to be advertised and as of 1 August 2022 has accumulated nearly 10 000 followers⁽⁴⁷⁾.

Food and beverage companies are also seeking to influence purchasing decisions by attempting to bypass warning labels and provide their own information on food while promoting their brands. In February 2021, media reported that companies such as Grupo Bimbo, Lala, Mondelez, Pinsa, among others, have implemented a new barcode functionality in their packaging, where the consumer, scanning with their cell phone, can expand on the information about the products via the app InfoCode^{(Reference Rodriguez48)}. InfoCode has more than 200 000 products, and eight out of ten users follow a specific brand for information representing another loophole where companies can promote their brands’ cartoon characters^{(Reference Rodriguez48)}.

Evaluations

To date, there have only been a few evaluations conducted on FOPNL in Mexico. Immediately following the initial implementation of FOPNL, the newspaper Reforma conducted a phone survey between 10/9/20 to 10/12/20, in which they asked 400 adults about their thoughts regarding the new FOPNL⁽⁴⁹⁾. Although food companies were granted a grace period to implement the new FOPNL by 1 December 2020, half of the adults surveyed said they better understood the nutritional information of products based on the FOPNL, while 31 % did not know or did not answer and 19 % said it did not make nutritional information easier to understand⁽⁴⁹⁾. Furthermore, almost half of survey participants said FOPNL would help reduce childhood obesity⁽⁴⁹⁾.

In June 2021, the INSP announced it would design a cohort study that evaluates participants’ diets and the type of foods they consumed and their quality before and after the implementation of FOPNL. The study also aims to examine changes in the perception of healthiness and preference of products due to warnings. They are currently conducting this study, and the results are expected to be published in 2023.

On 1 August 2022, the National Health and Nutrition Survey (ENSANUT) 2021 conducted by the National Institute of Public Health (INSP) was presented by the Health Ministry. Among other public health topics, ENSANUT 2021 integrated a questionnaire to evaluate the approval, understanding, use and changes in food purchases after the implementation of FOPNL. The results showed that warning labelling system was the element most consulted by consumers for product information (66·7 %), and a large part of respondents (82·3 %) could correctly identify that a soda drink contained excess sugars. Furthermore, 87·5 % of respondents recognised the presence of critical nutrients on soda products that could cause health damage and 79·2 % responded that they would not give products with warning labels to a child. The population’s perception of the measure was also evaluated, resulting in a national level of ‘good/very good’ (74 %) to identify the excess of calories, critical nutrients or the presence of additives associated with health damage in packaged foods and bottled beverages. Finally, parents were asked about the type of labelling that would help them choose a healthier packaged food and/or bottled beverage for their children, and 60·5 % responded that the FOPNL warning labelling system was the best option. Regarding the changes in the food purchases after FOPNL implementation, 88 % of the parents reported making changes. Of this group, 63 % reduced their purchases of products with warning labels, and 25 % completely stopped buying these products.