ANVISA decides to initiate administrative proceedings to review rules on food and medicine advertising

ANVISA decides to initiate administrative proceedings to review rules on food and medicine advertising

On August 5, 2026, ANVISA’s Collegiate Board of Directors (DICOL) unanimously decided to initiate administrative regulatory proceedings to review the rules on food and medicine advertising, including RDC 96/2008, which governs advertising, publicity, information, and other practices for the dissemination or commercial promotion of medicines, and RDC 24/2010, concerning food advertising. The decision was made at DICOL’s 14th Ordinary Public Meeting of 2026.

The justification presented by the reporting officer, Director Daniel Pereira, was the need for regulatory updating: the rules were issued in a technological, economic, and regulatory context different from the current one, before the consolidation of practices such as e-commerce, social media, influencer marketing, and marketplaces. According to ANVISA, the review seeks to assess the rules’ alignment with the contemporary environment, good regulatory practices, public health protection, informed consumption, and the reduction of health-related risks.

ANVISA made a point of noting that any potential review does not stem from an acknowledgment that the legal grounds or regulatory objectives of the RDCs are inadequate, but rather from the need to reassess their current relevance in light of today’s market and communication channels. This point is relevant because it preserves the Agency’s institutional position regarding its regulatory authority, even as it agrees to discuss the modernization of the rules. In the meantime, the current rules remain in force.

Why this matters

Currently, the constitutionality of RDC 24/2010 and RDC 96/2008 is being challenged in Direct Action of Unconstitutionality ADI 7,788, filed by the Brazilian Association of Radio and Television Broadcasters (ABERT). The case was assigned to Justice Cristiano Zanin and questions, in essence, whether ANVISA exceeded its authority by imposing restrictions on advertising through a resolution, a matter that, according to the plaintiff, would require a federal law. ABERT also argues that the rules are disproportionate and affect economic freedom. The constitutionality of these rules had already been under discussion in extraordinary appeals with interlocutory appeal, ARE 1,477,940 and ARE 1,480,888, in which the reporting Justices had voted to recognize the validity of the resolutions before requests for further review were made.

In 2025, the Brazilian Supreme Federal Court (STF) held a public hearing in ADI 7,788, chaired by Justice Cristiano Zanin, to hear from public agencies, entities, specialists, and researchers on the regulation of advertising for medicines and foods considered harmful to health. At the hearing, divergent positions were presented: on one side, arguments concerning ANVISA’s authority, health protection, consumer information, and alignment with international recommendations; on the other, arguments relating to legal reservation, free enterprise, freedom of commercial expression, and economic impacts.

In 2026, Justice Cristiano Zanin suspended the proceedings in ADI 7,788 to allow for settlement discussions between ABERT and the Federal Government, with the support of the STF’s Centre for Consensual Conflict Resolution. Since then, the Federal Government, ANVISA, and the other interested parties in ADI 7,788 have been participating in conciliation talks. However, ANVISA’s CEO, Leandro Safatle, understands that the existence of the direct action of unconstitutionality “does not diminish the importance of the Agency presenting its understanding regarding its legal authority to regulate the advertising of products subject to health surveillance when health risks are involved, in line with its mission of health protection and harm prevention.”

Our Life Sciences team remains available to provide further clarification on the matter.

I'm a subscriber
I'm a subscriber