A Anvisa publicou em 1º de novembro de 2024, Instrução Normativa nº 332/2024 que estabelece as advertências sanitárias e mensagens a serem utilizadas nas embalagens de produtos fumígenos derivado do tabaco. As imagens e mensagens presentes na Instrução Normativa já podem ser utilizadas à critério do fabricante, no entanto seu uso será obrigatório a partir de 1° de novembro de 2025.
Com a finalidade de orientar os fabricantes quanto à correta aplicação dos novos conjuntos gráficos, a Anvisa disponibilizou um manual contendo orientações para que os fabricantes possam fazer a inserção dos conjuntos gráficos corretamente.
As orientações podem ser acessadas em Instrução Normativa – IN nº 332/2024 — Agência Nacional de Vigilância Sanitária – Anvisa
Brief
On November 1, 2024, the Anvisa published Instructional Regulation No. 332/2024 establishing health warnings and messages to be used on packaging of tobacco-derived products. The images and messages in the regulation can already be used at the manufacturer's discretion, but their use will become mandatory from November 1, 2025. A manual was made available by Anvisa to guide manufacturers on correctly applying the new graphic sets. The manual is designed to assist manufacturers in accurately implementing the new warning labels on tobacco product packaging.
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Purpose
Anvisa published Instruction Normativa No. 332/2024 on November 1, 2024, to establish health warnings and messages for packaging of tobacco-derived products. This regulation aims to inform manufacturers about the correct application of new graphic sets.
Effects on Industry
The implementation of this regulation will have a significant impact on the tobacco industry. From November 1, 2025, the use of images and messages from the Instruction Normativa will be mandatory for all tobacco product packaging. This change is expected to result in a substantial increase in packaging costs for manufacturers, which may lead to higher prices for consumers.
Relevant Stakeholders
The stakeholders affected by this update include:
- Tobacco manufacturers: They must comply with the new regulations and update their packaging designs accordingly.
- Consumers: The increased cost of tobacco products due to mandatory health warnings and messages will directly impact consumer purchasing decisions.
- Regulators: Anvisa, as the regulatory agency, is responsible for enforcing compliance with the Instruction Normativa.
Next Steps
To comply with this update, manufacturers must:
- Update their packaging designs to include images and messages from the Instruction Normativa by November 1, 2025.
- Ensure that all tobacco products are sold in compliant packaging after the deadline.
- Maintain accurate records of packaging changes to demonstrate compliance with regulations.
Any Other Relevant Information
Anvisa has made a manual available to guide manufacturers on correct application of new graphic sets. This resource is essential for manufacturers to avoid potential fines or penalties for non-compliance. Additionally, Anvisa will continue to monitor and enforce compliance with the Instruction Normativa, ensuring that tobacco product packaging meets the required health warning and messaging standards.
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