ANVISA just restricted a bestselling ingredient category over liver injury reports
If your product line includes curcumin or turmeric extract, this is essential reading before you plan a Brazil launch. In April 2026, ANVISA published IN 438/2026, setting Brazil’s first defined safety range for curcumin in supplements, following international reports of suspected liver injury linked to high-absorption formulations. This is a real, recent enforcement action, not a routine list update.
Which ingredients are approved in Brazil? The direct answer
ANVISA maintains a positive list of approved supplement ingredients under IN 28/2018, covering nutrients, bioactive substances, enzymes, and probiotics. If your ingredient isn’t on this list, it requires a formal safety assessment before it can legally be used. The list is actively maintained, and in 2026 ANVISA used it to respond to a real safety signal: curcumin.
The curcumin restriction, in detail
Normative Instruction 438/2026, published April 22, 2026, was motivated by post-market monitoring that identified suspected cases of liver injury (hepatotoxicity) associated with curcumin or curcuminoid supplements, particularly formulations using absorption-enhancing technologies that push curcuminoid levels well above typical dietary exposure. ANVISA had already issued a pharmacovigilance alert in March 2026 based on international safety assessments before finalizing this rule.
| Requirement | Detail |
|---|---|
| Minimum daily intake | 80mg of total curcuminoids |
| Maximum daily intake | 130mg curcumin, or 120mg tetrahydrocurcuminoids |
| Calculation basis | Sum of curcumin, desmethoxycurcumin, and bisdemethoxycurcumin (total curcuminoids) |
| Mandatory label warning | Not for use by pregnant or breastfeeding women, children, or people with liver, biliary, or gastric ulcer conditions; consult a doctor if on medication |
| Adaptation deadline | 6 months from publication (October 22, 2026) |
Why this matters beyond curcumin specifically
This is a useful case study in how ANVISA actually operates: it monitors the market continuously, not just at initial approval, and can tighten limits on an already-approved ingredient in response to a real safety signal, with a defined adaptation window, not an open-ended grace period. A brand assuming “approved once, approved forever” for any high-potency or novel-delivery ingredient is working from an outdated assumption.
What counts as an approved ingredient, generally
Nutrients
Vitamins, minerals, proteins, carbohydrates, dietary fibers, and fatty acids, each with population-specific minimum and maximum limits.
Bioactive substances
Compounds like caffeine, coenzyme Q10, lycopene, curcumin, and lutein, evaluated individually for safety and permitted claims.
Enzymes
Digestive and metabolic enzymes approved for supplementation, subject to the same dosage limit framework.
Probiotics
Specific bacterial strains, not general species, approved individually. A strain not explicitly listed is not automatically covered.
ANVISA’s ingredient list is a living document, not a static PDF
Between 2025 and 2026 alone, IN 28/2018 was amended multiple times: IN 373/2025 (new probiotic strains), IN 431/2026 (constituent and claim expansions), and IN 438/2026 (curcumin safety limits). A brand relying on a summary written even six months ago risks working from outdated information. This is precisely why we track ANVISA’s Diário Oficial da União publications directly, rather than citing secondary sources.
Not sure your formula clears the current rules?
Ingredient rules change more often than most international teams expect. Get a direct, current read on your specific formulation from a pharmacist who tracks ANVISA’s official publications in real time.
Read the Full Market Entry Guide →Related Reading
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References: ANVISA, Normative Instruction (IN) No. 438/2026, published April 22, 2026 (curcumin safety limits). ANVISA, official notice, “Anvisa atualiza regras para suplementos que contêm cúrcuma,” April 2026. IN No. 431/2026 (April 1, 2026). IN No. 373/2025 (June 9, 2025). IN No. 28/2018, original constituent lists and labeling.
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