According to the vote of the Reporting Director Daniel Pereira, the initiative is aligned with the discussions of the Direct Action of Unconstitutionality (ADI) #7,788. Filed by the Brazilian Association of Radio and Television Broadcasters (ABERT), the lawsuit challenges the constitutionality of RDCs #96/2008 and #24/2010 and is currently pending before the Brazilian Supreme Court (STF).

During the deliberations, the Reporting Director emphasized that Anvisa’s participation in the conciliation proceedings established by the Brazilian Supreme Court within the scope of the ADI does not mean that the agency acknowledges any constitutional defects in the current rules. On the contrary, the agency reiterated its constitutional and statutory authority to regulate, supervise, and control the advertising of products subject to health surveillance.

The Reporting Director also emphasized that the regulation of the advertising of medicines and food is essential to protect public health, promote informed consumption, and mitigating health risks.

Despite defending the validity and relevance of the current RDCs, Anvisa considered it appropriate to evaluate their alignment with the contemporary regulatory environment.

During the meeting, it was emphasized that both rules were enacted more than fifteen years ago, in a substantially different context from the current one. According to the Reporting Director, major transformations in communication and commerce have occurred since then. He highlighted the rise of e-commerce, social media, influencer marketing, marketplaces, and targeted digital advertising.

In the food sector, Anvisa also noted the evolution of the regulatory framework and public policies aimed at nutritional transparency and the promotion of healthy eating habits. RDC #429/2020 and Normative Instruction #75/2020, which established new nutrition labeling rules, were cited among other regulations, in addition to RDC #632/2022, regarding the restriction and gradual ban of industrially produced trans fats.

According to the Reporting Director, any eventual review of the rules would not stem from the inadequacy of their foundations or regulatory objectives, but rather from the need to assess their continued relevance and compliance with existing regulatory best practices.

The opening of the regulatory proceedings will allow for the necessary studies to be conducted for an eventual review of the rules, while adhering to the regulatory model adopted by Anvisa.

As highlighted during the meeting, the process will include Regulatory Impact Assessments, evidence gathering, and public participation mechanisms, such as public consultations. The final stage will be the deliberation by the Board of Directors.

The Directors also emphasized that the opening of the proceedings does not affect the validity of the rules currently in force, nor does it diminish Anvisa’s regulatory authority over the matter.

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