Argentina – advertising and labelling of medical products on social media

Ana Andrés
Beccar Varela, Buenos Aires
aandres@beccarvarela.com

Luciana Malito
Beccar Varela, Buenos Aires
lmalito@beccarvarela.com

Introduction

The growing use of social media as a primary communication channel has blurred traditional distinctions between marketing, education and user engagement in the healthcare sector. In Argentina, this evolution led the National Administration of Drugs, Food and Medical Devices (ANMAT) to revise its longstanding advertising regime, originally established by Disposition No 4980/2005, through the adoption of the new Disposition No 4059/2025, effective as of 13 June 2025.

This new rule represents a significant step in adapting Argentina’s advertising controls to the digital era, as it expressly covers ‘traditional, non-traditional, and digital media’. Its scope includes over-the-counter (OTC) medicines, herbal medicines and medical devices authorised for use without prescription, as well as related products such as dietary supplements and in vitro self-testing kits.

Specific requirements for online and social media advertising

Disposition 4059/2025 expressly incorporates digital platforms into the definition of ‘media’, encompassing social networks, websites, streaming and other online formats. For the first time, Argentine law formally recognises digital advertising within the scope of ANMAT’s control powers, aligning local standards with those of regulatory peers in Brazil and the European Union.

As mentioned, it is important to highlight that Disposition 4059/2025 only applies to OTC products and medical devices available without prescription, and therefore does not cover prescription medicines. Advertising of the latter remains prohibited to the general public under current Argentine law.

At present, there is no specific regulation governing digital or social media advertising of prescription medicines, which sometimes can create a regulatory gap regarding practices such as disease-awareness campaigns or indirect brand visibility in digital environments. This area will likely be further defined through future ANMAT guidance.

Mandatory content

Every advertisement, whether on Instagram, YouTube, TikTok or other channels, must include:

• The product’s commercial name and, where applicable, its active ingredient or sale denomination, as registered with ANMAT;
• A faithful display of the approved label or packaging as authorised;
• The mandatory safety legends, depending on the product category:
  • OTC drugs: ‘READ THE PACKAGE INSERT CAREFULLY AND CONSULT YOUR PHYSICIAN AND/OR PHARMACIST IF YOU HAVE ANY DOUBTS’;
  • Medical devices: ‘READ THE INSTRUCTIONS FOR USE CAREFULLY. CONSULT YOUR PHYSICIAN IF YOU HAVE ANY DOUBTS’;
  • In vitro diagnostic self-tests: ‘SCREENING TEST FOR SELF-DETECTION PURPOSES ONLY…NOT FOR DIAGNOSTIC USE. CONSULT YOUR PHYSICIAN AND/OR PHARMACIST IF YOU HAVE ANY DOUBTS’.

If the advertisement includes one or more healthcare professionals (for example, physicians, dentists or pharmacists) endorsing or recommending the product, their full name, professional title and licence number must be clearly displayed. This requirement seeks to ensure transparency and accountability in the use of professional credentials within commercial communications.

In audiovisual or social media formats, these legends must be clearly visible, contrasting with the background, and displayed long enough for full reading; in oral communications, they must be read at a comprehensible pace.

Influencers and sponsored content

Although not expressly named, the definition of ‘non-traditional advertising’, which includes promotional messages delivered by hosts, actors, or participants in digital content, clearly captures influencer marketing. Any post or video with ‘commercial intent’ promoting a regulated product must therefore comply with the same transparency and content requirements as traditional ads. This implies:

• Sponsored content must identify the promoted product and avoid any misleading implication of impartiality (to prevent ‘hidden advertising’).
• Influencers cannot make therapeutic recommendations or suggest off-label uses.
• Posts cannot include children promoting paediatric-use products or appeal primarily to minors.

Prohibited practices

Article 5 of the mentioned disposition establishes a detailed list of prohibited advertising conducts, which directly apply to online and social media campaigns as well. These include:

• misleading, exaggerated, or ambiguous claims that could distort the consumer’s perception of the product’s characteristics or effects;
• attribution of unauthorised therapeutic, preventive or diagnostic properties;
• the use of ANMAT’s logo or expressions suggesting governmental approval (‘authorised by the health authority’);
• dissemination of messages inducing fear or implying that one’s health would be harmed without using the product; and
• promotion through minors.

Sanctions and enforcement

Violations of Disposition 4059/2025 expose the marketing authorisation holder and, when applicable, the technical director to sanctions under Law No 16,463 (Medicines Act), Decree No 341/92.

Given the explicit inclusion of ‘digital media’, ANMAT now has a firm legal basis to monitor social media. Importantly, ANMAT is empowered to request removal of digital content, suspend online campaigns and initiate administrative actions even where the advertisement is disseminated by third parties (eg, influencers or agencies). This broadens accountability across the entire digital supply chain.

Monitoring mechanisms are also expanding. ANMAT is implementing digital listening tools and partnerships with social media platforms to facilitate takedowns of misleading health-related content.

Current outlook

Argentina’s reform aligns with a broader regional trend towards strengthening the rules on digital health advertising. At the international level, the Food and Drug Administration (FDA) in the United States has issued several guidance documents regarding the advertising of medical products on social media and digital platforms, focusing on the balanced presentation of benefits and risks and the clear identification of the promotional nature of communications.

However, ANMAT still lacks formal criteria on digital transparency and hashtag use, leaving interpretative grey areas in enforcement.

Globally, health authorities are shifting from a reactive enforcement approach, focused on sanctioning infringements after they occur, to a preventive monitoring model, in which early detection, continuous oversight and the promotion of voluntary compliance are prioritised. The inclusion of influencers within the scope of regulated advertising reflects a cultural shift towards more ethical, transparent and responsible health communication.

Conclusion

With the enactment of Disposition 4059/2025, Argentina now regulates the advertising of OTC products and devices across both traditional and digital media, establishing a clearer compliance standard for social media campaigns.

While the rule does not introduce new substantive prohibitions, its explicit recognition of digital platforms constitutes a crucial modernisation step. It sends a clear message: social media is no longer a regulatory blind spot, but a fully governed environment under ANMAT supervision.

Beyond mere compliance, this reform encourages companies to integrate ethical and transparent communication strategies, where the boundary between advertising and health information demands a proactive compliance culture that views digital marketing as an extension of public health responsibility.