QLS Participates in Brazil’s ANVISA Public Consultation in Support of Evidence-Based Nicotine Product Regulation

Brazil’s health regulator ANVISA has opened a landmark public consultation on nicotine products. QLS has formally submitted its contribution, and international participation is welcome.

QLS has formally submitted its contribution to Consulta Dirigida no. 6/2026, the public consultation opened by ANVISA, Brazil’s national health regulatory authority, on nicotine pouches and oral nicotine products.

This consultation is part of the first stage of a regulatory review process. ANVISA is gathering detailed evidence and stakeholder input to inform a Regulatory Impact Analysis (RIA), which will serve as the basis for defining a future regulatory framework for these products, as set out in Brazil’s Regulatory Agenda 2026-2027.

The consultation closes today, 29 June 2026, at 18:00 Brasilia time (22:00 UK time). The form is available in English, and international contributions are accepted.

Why Brazil Is a Pivotal Country for Tobacco Harm Reduction

Brazil is one of the most strategically important countries for tobacco harm reduction (THR) in Latin America and the world. With a population of over 200 million and a significant proportion of adult smokers, the regulatory choices made in Brasilia will have consequences far beyond its borders, shaping policy debates across the region and influencing how other nations approach nicotine regulation.

For over a decade, Brazil has maintained one of the most restrictive regulatory stances on vaping products in the world, effectively prohibiting their commercialisation. Rather than protecting public health, this approach has produced well-documented unintended consequences:

• A large and expanding illicit market operating entirely outside quality controls, traceability requirements, or age verification.
• Paradoxically, high rates of vaping product use among young people, who access unregulated products through informal channels with no barriers whatsoever.

The international evidence is consistent: prohibition-based models have repeatedly failed to prevent consumption. They eliminate oversight without eliminating use, leaving consumers, including young people, exposed to products of unknown composition and no regulatory protection.

A Historic Regulatory Process

This consultation is precisely the kind of science-driven, participatory process that sound regulation requires. ANVISA is seeking structured, evidence-based input before defining how Brazil will regulate nicotine products going forward. This is not a vote or a survey. It is a formal call for detailed information, and it deserves serious, substantive responses.

QLS welcomes this initiative and commends ANVISA for taking a methodical, evidence-seeking approach to one of the most consequential public health questions in Brazil today.

QLS’s Submission

QLS produced a comprehensive, detailed document addressing the main questions raised by ANVISA. Our submission covers:

• The toxicological distinction between combustible tobacco and smoke-free alternatives, and why these products cannot be treated as equivalent for regulatory purposes.
• The public health rationale for a risk-proportionate regulatory framework.
• International regulatory comparisons, including jurisdictions that have moved from prohibition to structured frameworks with age restrictions, product standards, and traceability requirements.
• Specific evidence on the performance of different regulatory models, including Sweden’s experience and lessons from Latin America.

The core argument is straightforward: millions of Brazilian lives could be meaningfully protected by a regulatory framework that reflects the actual risk profile of different nicotine products, supports adult smokers who wish to switch to substantially less harmful alternatives, and establishes the controls necessary to protect young people.

Read our full submission below.

There Is Still Time to Participate

The consultation form is available in English at the link below. International organisations, researchers, and individuals with relevant expertise are encouraged to submit their own contributions. Every evidence-based voice that reaches ANVISA strengthens the foundation for the regulation Brazil urgently needs.

Access the ANVISA Consultation (English version)

The consultation closes on 29 June 2026 at 18:00 Brasilia time (22:00 UK / BST). Contributions are accepted in English. Personal data is handled in accordance with Brazil’s General Data Protection Law (Lei no. 13.709/2018).