Strategies associated with promoting healthier patterns without resorting to more robust enforcement measures align with behavioral economists’ notion of nudging. A nudge is a contextual modification that predicts and alters behavior without eliminating alternative choices. In this sense, soft regulations use nudging to influence people into making better choices through behavioral stimuli without limiting the individual’s private scope of choice, as done by strong regulations.

Front-of-package labeling (FOPL) regulation exemplifies both nudging and soft regulation. This type of measure offers standardized and clear information for consumers to make better purchase decisions. This regulation aims to address concerns about the risk of consuming products high in critical nutrients (e.g., sugar, sodium, and saturated fat), as well as substances derived from food or synthesized in a lab (e.g., colorings, flavorings, and enhancers) without prohibiting or restricting their commercialization.

Against the backdrop of escalating consumption of these harmful products, often known as ultra-processed products, there is a correlation with the rise of noncommunicable diseases (NCDs). In that regard, NCDs — encompassing cardiovascular problems, cancers, and diabetes — stand as primary contributors to global and Brazilian mortality rates. The World Health Organization (WHO) asserts that addressing the NCD crisis is intertwined with ensuring the right to food, emphasizing that the quality of food provided must meet basic needs for an individual’s healthy development. Therefore, regulatory policies, such as the FOPL, are crucial to preventing NCDs and protecting public health, while empowering consumers with the necessary tools and information to evaluate the quality of the products available on supermarket shelves.

The Brazilian Experience

The Brazilian experience in shaping and implementing a FOPL regulatory policy underscores its importance. Additionally, it imparts valuable lessons regarding the fact that soft regulations are not immune to resistance from the food and beverage industry.

In 2020, the Brazilian Health Surveillance Agency (ANVISA) introduced the FOPL regulation into the country’s legal framework to “facilitate the comprehension of nutrition labeling by Brazilian consumers to make food choices,” according to the regulatory impact assessment report. Although the national strategy plan to combat the growing cases of NCDs encompassed the initiative, reducing NCDs associated with the consumption of ultra-processed products was not a primary objective for ANVISA when shaping the regulation.

While the FOPL regulation effectively improves health and protects consumer law, studies in Brazil [1] [2] reveal that citizens predominantly consume ultra-processed products. Considering this situation, it is necessary to understand potential challenges that may endanger the regulation’s effectiveness. A risk analysis may assess potential threats to this significant health regulatory measure.

Lessons from Tobacco Control

In this sense, tobacco control measures offer valuable insights into how regulations can manage the risk of legal challenges. Strong regulations, like those implemented in the context of tobacco control, often involve a significant degree of intrusion into individuals’ private choices, inevitably affecting market dynamics. The impact of strong regulations is evident in two notorious legal cases discussing health regulations filed before Brazilian and international courts.

In the first lawsuit, the constitutional action ADIN No. 4.874 targeted the Brazilian regulation implemented by ANVISA, which prohibited additives in tobacco. Intended to protect public health, the regulation aimed to discourage the consumption of and addiction to tobacco products by restricting additives that mask nicotine’s taste and its smoke’s unpleasant smell. However, the National Industry Confederation challenged ANVISA’s power to approve the regulation before the Brazilian Federal Supreme Court. The Supreme Court ultimately decided that ANVISA did not violate jurisdiction rules. The Rapporteur Justice also affirmed ANVISA’s authority to implement a tobacco-control measure since the law that created the agency establishes its power to regulate, control, and supervise the products that pose a risk to public health, including smoking products.

The second legal dispute occurred when Indonesia requested consultations with the United States at the World Trade Organization’s (WTO) Dispute Settlement Body (DSB) over the U.S. law prohibiting flavored cigarettes other than tobacco or menthol. Indonesia argued that the measure violated obligations regarding equal treatment arising from the Technical Barriers to Trade Agreement (TBT Agreement), as it banned clove cigarettes made in Indonesia, while exempting menthol cigarettes produced in the United States. The DSB ruled in favor of Indonesia and recognized the inconsistency between the tobacco-control measure and the TBT Agreement. While acknowledging the United States’ legitimate health objective of preventing youth smoking by banning clove cigarettes, the DSB emphasized that such measures should comply with the national treatment obligation — stipulating that imported products must not receive treatment less favorable than domestic products.

These cases show that strong regulations can face several obstacles, such as costly and lengthy disputes concerning their legitimacy. Conversely, softer regulations are neither shielded from opposition nor attempts to suspend their effectiveness.

One example is the Australian soft FOPL regulation discouraging the consumption of hazardous products through the Tobacco Plain Packaging (TPP) measures. TPP standardized the design and packaging of tobacco products, prohibited the use of health-implying trademarks, and included visual warnings about tobacco consumption risks. However, the measure faced intense opposition within the WTO to its implementation, where it was challenged as more restrictive than necessary to protect public health, potentially violating intellectual property rights. However, the DSB found that the TPP measures were consistent with WTO law, given that promoting public health is a legitimate objective for state members, even when such measures create restrictions on international trade. Australia’s TPP measures were challenged by several countries — signaling that even soft regulations are not immune from opposition.

Looking Ahead

Despite its nudging-based approach, FOPL regulation can suffer strong pushback from industry players in its shaping and implementation processes, as evidenced by the examples above. Although the future of implementing new food labeling regulations in Brazil is uncertain, the government must ensure the regulations’ enforcement and refrain from suspending them due to the food industry’s opposition. As a signatory to the International Covenant on Economic, Social and Cultural Rights, Brazil must follow the duties of progressivity and the prohibition of retrogression, which prohibit states from undermining the level of protection already achieved for human rights. Therefore, to fulfill its international obligations, Brazil must uphold the food labeling system reform and other protective measures that benefit the population’s health.