STF Resumes Judgment on Anvisa’s Regulatory Authority in Tobacco Case

The resumption of the judgment by the Federal Supreme Court (“STF”) on the validity of the resolution issued by the National Health Surveillance Agency (“Anvisa”) banning the use of additives in cigarettes once again brings to the forefront the debate over the limits of regulatory agencies’ authority. More than a specific case concerning the tobacco sector, the discussion addresses the extent to which the Administration may act.

The dispute concerns Resolution RDC No. 14/2012, issued by Anvisa, which prohibited the use of certain substances in smoking products. Anvisa’s rationale is based on evidence that, according to the Agency, demonstrates that these additives would make cigarette use more palatable and increase the product’s attractiveness, encouraging smoking initiation, particularly among young people.

More specifically, Article 6 of Resolution RDC No. 14/2012 provides as follows:

Article 6. The importation and sale in the country of tobacco-derived smoking products containing any of the following additives are prohibited:

I – synthetic and natural substances, in any form (pure substances, extracts, oils, absolutes, balsams, among others), with flavoring or aromatic properties capable of conferring, intensifying, modifying, or enhancing the flavor or aroma of the product, including additives identified as flavoring or aromatic agents:

a) by the Joint FAO/WHO Expert Committee on Food Additives – JECFA; or

b) by the Flavor and Extract Manufacturers Association – FEMA.

II – processing aids for flavoring and aromatic agents;

III – additives with nutritional properties, including:
a) amino acids;
b) vitamins;
c) essential fatty acids; and
d) minerals, except those proven to be essential for the manufacture of tobacco-derived products.

IV – additives associated with purported stimulating or invigorating properties, including taurine, guarana, caffeine, and glucuronolactone;

V – pigments (or colorants);

VI – fruits, vegetables, or any product derived from the processing of fruits and vegetables, except activated carbon and starch;

VII – sweeteners, artificial sweeteners, honey, molasses, or any other substance capable of conferring a sweet aroma or flavor, other than sugars;

VIII – seasonings, herbs and spices, or any substance capable of conferring the aroma or flavor of seasonings, herbs, and spices;

IX – ameliorants; and

X – ammonia and all of its compounds and derivatives.

The issue is being considered under Theme 1,252, defined by the STF as follows: “The authority of the National Health Surveillance Agency – ANVISA to issue rules restricting the importation and sale of cigarettes, specifically those set forth in the Board of Directors’ Resolution (RDC) No. 14/2012, insofar as it prohibits the use of certain additives.”

So far, the votes are tied, with three Justices supporting Anvisa’s authority to regulate the matter as provided for in RDC No. 14/2012, and three Justices opposing it. The Rapporteur, Justice Dias Toffoli, voted in favor of the validity of RDC No. 14/2012, on the grounds that Anvisa acted within the scope of its authority. The legal proposition put forward by the Justice was as follows:

“RDC No. 14/2012 issued by Anvisa is based on technical criteria and studies and is supported by Article 196 of the Constitution and Articles 7, item XV, and 8, §1, item X, of Law No. 9,782/99, in prohibiting the importation and sale of smoking products, whether or not derived from tobacco, containing additives used to flavor or aromatize such products.”

Justices Edson Fachin and Cristiano Zanin joined the Rapporteur’s position. Justice Zanin, however, raised reservations regarding the legal proposition to be established, emphasizing that the resolution does not entail a ban on a category of product, but rather the establishment of technical parameters concerning its composition. Justice Zanin proposed the following:

“1) Pursuant to the applicable regulatory framework, ANVISA has the authority to regulate and impose restrictions on components used in the stages and/or processes involved in the production of ‘cigarettes, cigarillos, cigars and any other smoking product, whether or not derived from tobacco,’ such as flavoring and aromatic additives.

2) ANVISA’s RDC No. 14/2012 is characterized by generality, abstraction, technicality, necessity for the implementation of the national health surveillance policy, and consistency with the constitutional and legal framework, and is supported by Articles 196 and 200 of the Federal Constitution and Articles 8, main provision and §1, item X, of Law No. 9,782/99; Article 6, §1, I, of Law No. 8,080/1990; and Article 9 of the Framework Convention on Tobacco Control.”

Throughout his opinion, Justice Zanin adopted the approach of assessing whether the RDC in question banned or regulated the product, taking the latter position. In the Justice’s view, “(…) the challenged Resolution regulates the stages of the production process and the components of ‘cigarettes, cigarillos, cigars and any other smoking product, whether or not derived from tobacco,’ as a whole, establishing guidelines regarding the limits of certain contents and even allowing specific additives at certain stages of the production process.” He therefore concluded that the resolution merely regulates the composition of the products, rather than banning types of smoking products or restricting the production and consumption of additives considered individually.

In the opposite direction, Justice Alexandre de Moraes dissented, taking the view that Anvisa exceeded its regulatory authority by imposing a restriction with the practical effect of a ban, without specific legislative authorization – a matter falling within the competence of the National Congress. Justices Gilmar Mendes and Luiz Fux joined this position.

Adopting a more concise and objective approach to the legal and regulatory limits at issue, Justice Alexandre de Moraes assessed the practical effects of the RDC. He noted that “there was an absolute prohibition on the use of additives in all tobacco-derived smoking products marketed in Brazil, as well as an absolute prohibition on the importation and sale in the country of tobacco-derived smoking products containing any of the additives listed in Article 6.” Based on this premise, the Justice concluded that “In so acting, ANVISA violated the principle of legality twice over and disregarded the standards established by the National Congress.”

First, by generally classifying the product as posing an imminent health risk (Item XV of Article 7 of Law No. 9,782/99), when the legislation itself expressly classifies it as a product that “poses a risk to public health.” And, as a result of the first illegality, by imposing an absolute prohibition on its use, sale, and importation, when the legislation also expressly authorizes such activities as a general rule, while providing for various restrictions.

Another relevant point highlighted in Justice Alexandre’s opinion is the following passage: “The regulatory authority is permitted to establish restrictions, but not to completely prohibit access to consumption (…).” This reasoning is based on the understanding that, in practice, the RDC does not regulate but rather completely prohibits the products, which falls outside Anvisa’s authority. The Justice proposed the following legal proposition:

“The Board of Directors’ Resolution (RDC) No. 14/2012 is unconstitutional because it exceeded the limits of the regulatory authority of the National Health Surveillance Agency (ANVISA), since, under Article 8 of Law No. 9,782/99 and Law No. 9,294/1996 (the Anti-Smoking Law, as amended by Federal Laws No. 10,167/2000, 10,702/2003, and 12,546/2011), the regulatory authority was not granted the power to completely prohibit the importation, sale, and consumption of cigarettes based on the prohibition of certain additives. Rather, it was granted administrative authority to issue rules governing and overseeing products and services that pose a risk to public health, such as cigarettes, cigarillos, cigars, and any other smoking product, whether or not derived from tobacco.”

The judgment will resume this Friday (May 1), with Justice André Mendonça presenting his review vote, leaving the outcome still open.

Depending on the solution adopted, the STF may determine not only the fate of RDC No. 14/2012, but also establish clearer parameters regarding the scope of regulatory agencies’ normative authority in Brazil, particularly that of Anvisa, which oversees and regulates a wide range of products, including food products, which have also been the subject of several debates related to public health.

In this context, the STF’s decision is likely to have effects extending beyond the specific case at hand. By defining the boundaries of Anvisa’s authority, the STF will also signal the degree of technical autonomy that will be recognized for regulatory agencies in formulating and implementing control and regulatory rules, particularly in sensitive matters directly related to public health policies.

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