On June 12, 2025, Argentina's National Administration of Drugs, Food and Medical Devices (ANMAT) issued Order No. 4059/2025, establishing a new regulatory framework for public advertising of a broad range of products, including cosmetics. This regulation governs advertisements distributed through various media channels that directly target consumers. Effective immediately upon publication, it aims to improve transparency, precision, and clarity in advertising, while protecting public health with enforceable standards across media platforms.1
Key Highlights of the Order
The Order sets out overarching principles to govern advertising practices for regulated products. It mandates that only products authorized by ANMAT can be advertised, and that all promotional content be accurate, objective, non-misleading, and grounded in approved information. The Order also emphasizes the use of accessible language in advertising, and assigns accountability to the marketing authorization holder for ensuring regulatory compliance across all advertising channels.
Built upon these principles, the Order further specifies two sets of detailed obligations—elements that shall appear in public advertising, and practices that are expressly prohibited—which are described in detail below:
1) Required Elements in Public Advertising
Article 4 of the Order outlines a positive list of mandatory elements for advertisements aimed at the public, as summarized in the following section:
Advertisements shall present the product's authorized identification details, and display the product label as approved;
Advertisements shall contain category-specific statements as stipulated;
Scientific, technical, and bibliographic references included in any advertisement shall be made accessible to ANMAT, and provided in Spanish;
When multiple products or claimed effects are featured in an advertisement, each shall be distinctly identified as authorized;
Where one or more professionals (e.g., physician, dentist, or pharmacist) are shown to endorse the product, their license number shall be disclosed;
Advertisements can include a phone number or website to address consumer inquiries, provided the information is accurate and compliant.
2) Prohibited Practices in Public Advertising
Following the positive list, the Order also establishes a set of practices to prevent misleading or unethical advertising. Specifically, advertisements shall not:
Contain false, exaggerated, or ambiguous information that could mislead consumers and influences their purchasing decisions;
Claim properties or uses of the product that are not authorized by ANMAT;
Misrepresent medicinal products as general consumer goods such as food or cosmetics, and vice versa;
Provoke fear by implying health consequences if the product is not used;
Include statements such as "Authorized by ANMAT" or any similar claims, nor display the ANMAT logo;
Present expert endorsements or claims of safety, efficacy, or clinical validation, without supporting evidence;
Involve children in promoting products intended for pediatric use, either directly or indirectly;
Target children primarily or exclusively, unless accompanied by a suggestion for adult guidance or supervision;
- Violate principles established to protect public health.
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