ANMAT Disposition No. 11378/2024
Health Law – Life Sciences and Administrative Law Report | ANMAT Disposition No. 11378/2024
On December 26 of this year, Disposition 11378/2024 (the “Disposition”) was published in the Official Gazette, through which the National Administration of Drugs, Food, and Medical Technology (“ANMAT”) established a new specific regulatory framework for the advertising, promotion, and sponsorship of packaged food and non-alcoholic beverages containing at least one warning seal, including precautionary legends about sweeteners and/or caffeine.
Through this Disposition, ANMAT repeals and replaces Disposition 6924/22 (the “Previous Disposition”), which regulated the advertising, promotion, and sponsorship of this category of products. In effect, the new Disposition updates and enhances the previous one, incorporating the experience gained during its implementation. Differences from the Previous Disposition include:
1- Advertising aimed at children and adolescents
As in the Previous Disposition, the new Disposition states that advertising, promotion, and/or sponsorship aimed at children and adolescents is identified by elements appealing to their interest. However, unlike the Previous Disposition, it now specifies that this applies when the communication includes habits, behaviors, lifestyles, language, colors, soundtracks, and/or themes that capture their interest. Additionally, children are defined as those under 13 years old, and adolescents as those aged 13 to 16.
2- Sworn Declaration
The obligation to advertise products that did not comply with the Sworn Declaration required by Decree 151/2022 has been removed.
3-Scope of prohibitions
The Disposition defines the terms “children’s characters,” “celebrities,” “interactive elements,” and “digital downloads.” Since both regulations prohibit including these concepts in advertising, their definitions clarify their scope for those intending to advertise regulated products.[1]
[1] Children’s Characters: Characters featuring human actors, cartoons, licensed characters, or caricatures from any origin and animation technique, specifically directed at children and/or adolescents.
Celebrities: This term includes actors, musicians, and social media influencers, provided their association is specifically targeted at children and/or adolescents.
Interactive Element: A component, in this case of advertising, that facilitates interaction between the user and the company.
Digital Download: The transfer of files or data from a server to a destination device, provided such exchange or transfer serves an advertising purpose.
Additionally, the Disposition outlines scenarios in which the presence of children or adolescents will not be considered advertising, promotion, and/or sponsorship.
Unlike the Previous Disposition, the prohibition against advertising products by giving away food or non-alcoholic beverages with a warning seal for free has been removed. Similarly, the prohibition against promoting product purchases motivated by donations or humanitarian purposes has also been eliminated.
4- Label modification
Regarding the prohibition on modifying labels, the Disposition states that “label modification” occurs when a product is presented in an advertisement with the omission of any expression, word, symbol, or seal from the approved label. In short, the product must appear exactly as approved.
5- Comparative advertising
The Previous Disposition prohibited comparative advertising techniques suggesting that a product had superior attributes or was the only viable option within its category. The new Disposition removes this prohibition, allowing comparative advertising techniques.
6- Digital media advertising compliance
Both Dispositions address the advertising, promotion, and/or sponsorship of packaged food and non-alcoholic beverages containing at least one (1) warning seal through digital media.
While both require product owners to ensure compliance with third-party-created content, the new Disposition introduces exceptions to the owner’s responsibility, including: (i) when organic content is generated by a third party without connection to an ongoing campaign or promotion; (ii) when content is intended for international, regional, or global markets and is not deliberately republished or promoted locally by the product owner; and (iii) when it can be proven that the content is not sponsored by the product owner.
In short, the Disposition reflects the National Executive Branch’s commitment to promoting healthy and transparent eating practices, now providing greater clarity for product owners regarding permitted and prohibited advertising behaviors.
Sincerely,