What's at stake
ANVISA (Brazilian health regulator) published over the past few years a regulatory package consolidating rules for food supplements — harmonizing definitions, technical requirements, permitted claims and labeling. The rule gives industry a transition window — which closes on September 1, 2026.
After that date, only fully compliant products may be manufactured, imported or sold.
What needs to be in compliance
Compliance isn't just about labels. In practice:
- Composition — permitted ingredients, daily limits by category, vitamins and minerals within authorized ranges
- Labeling — front-of-pack nutrition info, only permitted claims, mandatory warnings
- Electronic notification — protocol via electronic petitioning (SOLICITA) with all required information
- Good Manufacturing Practices (GMP) — facility must have valid, auditable GMP
- Technical documentation — analytical reports, technical sheet, quality control, traceability
International companies without a Brazilian tax ID can keep products in the market through a local registration holder. Wissen provides this service for clients in the European Union, USA, Latin America and Asia.
Risks of missing the deadline
- Compulsory product recall from the market
- Sanitary fine by ANVISA — varies by company size
- Suspension of manufacturing until compliance
- Precautionary seizure in more serious cases
- No new notifications allowed while existing items aren't compliant
What to do now
- SKU inventory — how many products does your company have? Which are notified? Which aren't?
- Gap analysis — compare current composition/label with the new rule
- Per-SKU compliance plan — some only need a new label, others require reformulation
- Realistic timeline — including lab analyses, design, printing and re-notification
- Technical validation with experienced consultancy before filing
The earlier the diagnosis starts, the less rework — and the lower the risk of being off-shelf during the compliance period.