Pharmaceutical advertising in Brazil: regulatory framework, social media and associated debates

Viviane Kunisawa
Daniel Law, São Paulo
viviane.kunisawa@daniel-ip.com

Mariana Cuzziol
Daniel Law, São Paulo
mariana.cuzziol@daniel-ip.com

Rafael Barros
Daniel Law, São Paulo
rafael.barros@daniel-ip.com

Introduction

The digitalisation of communication, particularly through social media, has transformed how health information and pharmaceutical products reach consumers. Traditional advertising principles, once suited to print or broadcast media, now struggle to address the fluid and decentralised nature of digital communication.

In Brazil, the advertising of pharmaceutical products has long been governed by a framework that treats medicines not as ordinary consumer goods, but as items of sanitary and social relevance. The Brazilian Federal Constitution reflects this protective stance: Article 196 establishes health as a fundamental right and a duty of the state, while Article 220, section 4 mandates that the advertising of medicines and therapies must follow legal restrictions and include appropriate warnings about potential risks.^[1]

Against this backdrop, the rise of digital platforms has created regulatory blind spots. Influencer marketing, viral content and personalised online advertising often bypass the formal structures designed to protect public health and consumer interests. This article analyses how Brazil’s current legal system, particularly the Brazilian Health Surveillance Agency (ANVISA)’s regulatory role, interacts with these new dynamics, and contrasts it with regulatory approaches in the United States and the European Union.

The rise of social media as a health marketing tool: the Brazilian context

Influencer marketing has become a defining feature of digital culture in Brazil, where social media plays a central role in shaping consumption patterns and public opinion. The explosive growth of platforms such as Instagram, TikTok, and YouTube has blurred the line between personal expression and commercial advertising.

Brazilian influencers, especially those promoting ‘lifestyle’ content, often portray luxurious habits and beauty standards far removed from the daily reality of most consumers. Within this content, the casual mention or use of pharmaceuticals – from dietary supplements to prescription drugs – risks normalising self-medication and shaping perceptions of efficacy or safety without proper medical context. This issue became particularly evident during the Covid-19 pandemic, when misinformation about preventive or therapeutic measures spread widely online, undermining public trust in official health communication.

Internationally, similar challenges have prompted regulatory action. For instance, the UK’s Advertising Standards Authority recently^[2] prohibited online pharmacies from advertising weight loss injections, banning terms such as ‘weight loss pen’ and images of injection devices to curb unsafe medical promotion.

In Brazil, a striking example of risky pharmaceutical advertising involved an influencer promoting a ‘Tadalafil gummy’ as ‘100% legalized and approved by ANVISA’. The product, however, had no marketing authorisation and was not registered with the agency. Its promotion, largely through Instagram ‘Stories’ – a format that disappears after 24 hours – made monitoring and enforcement difficult. The campaign targeted young audiences attracted by the influencer’s image and lifestyle, prompting ANVISA to issue an immediate ban on the product’s manufacturing, sale and advertising (Official Gazette, 14 May 2025).

This case illustrates how ephemeral digital content and algorithmic amplification complicate regulatory oversight. It also reignited debates over whether ANVISA’s rules constitute an undue restriction on commercial expression. Industry associations often argue that such rules impose excessive constraints, while consumer and health protection groups defend them as legitimate exercises of the state’s constitutional duty to safeguard public health.

These tensions intersect with Brazil’s Consumer Defence Code (Law No 8,078/1990), which mandates transparency, fairness, and prohibits misleading or abusive advertising. Applied to the digital context, these principles reinforce the need for heightened protection of vulnerable audiences, particularly young consumers, who are against deceptive or inadequately disclosed pharmaceutical promotions.

Regulatory framework – Brazil and comparative law

The regulation of pharmaceutical advertising in Brazil originates from Law No 6,360/1976, which established broad principles for pharmaceutical publicity. It was later complemented by more detailed instruments: Law No 9,294/1996 imposed explicit restrictions on the advertising of medicines, while Decree No 2,018/1996^[3] operationalised those provisions.

ANVISA’s Resolution No 96/2008 remains the central regulatory instrument governing the marketing of both over-the-counter and prescription drugs. It imposes strict requirements to ensure that advertising aligns with public health objectives. ^[4]

However, recent judicial developments have questioned the extent of ANVISA’s authority.^[5] In 2024, the Brazilian Superior Court of Justice (STJ) ruled that ANVISA had exceeded its regulatory mandate by creating overly restrictive advertising rules. The court emphasised that commercial speech, even when regulated, cannot be subject to prior censorship, and that such restrictions should be enacted through legislative – not administrative – means. Although this decision did not invalidate RDC No 96/2008, it limited its application to the specific case and signalled the judiciary’s growing scrutiny over administrative regulation of communication.^{[6] [7]}

The issue remains unresolved in the pending constitutional case ADI 7,788, which challenges the legality of ANVISA’s restrictions on the grounds of unconstitutionality. The Supreme Federal Court’s eventual ruling will likely redefine the balance between regulatory authority, public health protection and freedom of commercial expression.

Comparatively, Brazil’s system sits between the permissive US model and the restrictive European approach. In the US, the Food and Drug Administration (FDA) allows direct-to-consumer advertising of prescription drugs under the ‘fair balance’ rule (21 CFR section 202.1), requiring equal presentation of benefits and risks. The EU, in contrast, prohibits such advertising entirely under Directive 2001/83/EC, Article 88(1). Brazil’s emphasis on precaution and consumer protection aligns more closely with the European model, reflecting a public health-oriented rationale.

Key regulatory obligations and labelling requirements in Brazil

Pharmaceutical companies in Brazil must ensure that all claims are consistent with the product’s approved registration dossier, and include clear, accurate and visible information about contraindications, active ingredients and side effects. These obligations derive both from sanitary and consumer protection laws.

Yet, consumer law alone is insufficient to address the public health risks posed by the mass promotion of medical products on digital platforms. The viral, fast-paced nature of social media can amplify misinformation and encourage unsupervised drug use. If the Supreme Court ultimately limits ANVISA’s regulatory authority, swift legislative action will be necessary to ensure continued compliance with Article 220, section 4 of the Constitution – which imposes a duty on the State to regulate advertising of medicines and therapies to protect collective health.

Good regulatory and industry practices for the digital era

Compliance in pharmaceutical advertising increasingly requires adapting traditional obligations to digital formats. Risk disclosures and contraindications must be presented in clear, accessible and conspicuous formats – not hidden in links or secondary screens.

Beyond formal compliance, litigation has become a strategic tool for companies to manage reputational and regulatory risks. A recent example involved the manufacturer of lisdexamfetamine dimesylate (Venvanse), which sued an influencer for promoting off-label ‘microdosing’ practices. The company alleged unlawful promotion and misrepresentation of therapeutic value, eventually reaching a private settlement. This case illustrates how tort and consumer protection law can complement ANVISA’s enforcement powers by deterring misleading or unsafe advertising practices.

Future challenges and comparative policy options

The future of pharmaceutical advertising regulation in Brazil will depend on how institutions adapt to the evolving digital ecosystem. Regulators must find a balance between innovation and protection – addressing privacy, manipulation and the exploitation of personal vulnerabilities while respecting constitutional guarantees of free expression.

Potential pathways include adopting hybrid models: combining the US-style ‘content balance’ rules for permissible advertising with EU-inspired prohibitions for prescription-only products; creating explicit exceptions for public health campaigns; or imposing accountability at the platform level through transparency and reporting obligations.

A modernised framework must ensure that health communication online remains trustworthy, evidence-based, and socially responsible.

Conclusion

Brazil’s pharmaceutical advertising regime rests on three main pillars: the constitutional right to health, the sanitary law framework and ANVISA’s regulatory authority. While the current system prioritises precaution and consumer protection, the rise of social media and influence-driven marketing has exposed gaps that require renewed regulatory attention.

The ongoing ADI 7,788 case before the Supreme Federal Court will likely define the boundaries of administrative competence and the permissible scope of pharmaceutical advertising. Whatever the outcome, it will serve as a reference point for balancing public health imperatives with freedom of expression and economic activity.

Ensuring coherent, transparent and adaptive regulation will be essential for protecting public health while enabling legitimate commercial communication in Brazil’s rapidly changing digital landscape.