Wagner Fernandes · CRF-RO 4509Licensed Pharmacist, Brazil · Founder, FarmaCerto
FDA vs ANVISA, in one sentence
The FDA regulates dietary supplements as a category of food, with no pre-market approval required. ANVISA regulates supplements under RDC 243/2018, and most products require notification, sometimes full registration, before they can legally be sold. This single structural difference is where most US brands lose time and money when entering Brazil.
The 5 differences that actually matter
1
Pre-market approval vs. post-market responsibility
United States (DSHEA)The FDA does not approve supplements before they’re sold. In many cases, a company can lawfully launch without notifying the FDA at all. The manufacturer is responsible for safety and truthful labeling.
Brazil (RDC 243/2018)Most standard supplements require notification to ANVISA before market entry. Higher-risk products, or those with ingredients outside the approved list, require full registration, a longer, more complex process.
2
Structure/function claims aren’t universal
United StatesDSHEA permits structure/function claims, statements describing how an ingredient affects the body’s structure or function, like “supports immune health,” as long as they don’t claim to treat or cure disease.
BrazilANVISA maintains its own specific list of permitted claims under IN 28/2018. A literal translation of a US claim is not automatically compliant, and unauthorized claims are one of the most common compliance failures we see.
3
Approved ingredient lists don’t match
United StatesBroadly permissive for ingredients already part of the food supply. New Dietary Ingredients (introduced after 1994) require a 75-day pre-market notification, but the underlying list of what’s usable is extensive.
BrazilANVISA maintains its own approved ingredient list under IN 28/2018, with specific maximum dosage limits. An ingredient legal and common in the US may not be pre-approved for Brazil, or may only be permitted at a lower dose.
4
Facility registration vs. product notification
United StatesFacilities that manufacture, process, package, or store supplements must register with the FDA under 21 CFR 1.227, and follow cGMP requirements. This is a facility-level requirement.
BrazilANVISA’s notification and registration requirements apply at the product level, not just the facility. Each product formulation needs its own pathway through the regulatory system.
5
Local representation is mandatory in Brazil, not in the US
United StatesA US-based company can register a facility and market supplements domestically without a separate local legal entity for that purpose.
BrazilA legally registered Brazilian company must be responsible for importation, distribution, and post-market surveillance. A foreign brand cannot notify or register products directly without this local presence.
⚠️ The mistake that costs the most timeThe single most common error we see is a brand assuming their existing US label, claims, and ingredient list can simply be translated into Portuguese and submitted. Because DSHEA is permissive by design and RDC 243/2018 is a pre-market gatekeeping system, a label built for the US market frequently contains claims or ingredient combinations that trigger rejection or reclassification in Brazil, sometimes as a pharmaceutical product, which is a substantially longer and more expensive pathway.
Quick reference table
| Aspect | United States (FDA/DSHEA) | Brazil (ANVISA/RDC 243/2018) |
|---|---|---|
| Pre-market approval | Not required | Notification or registration required |
| Claims framework | Structure/function claims permitted | Specific approved claim list (IN 28/2018) |
| Ingredient list | Broad, NDI notification for new ingredients | Specific approved list, dosage limits apply |
| Registration level | Facility-level (cGMP) | Product-level |
| Local representation | Not required | Mandatory Brazilian legal entity |
From the pharmacy counterWhat I see most often with international products that do reach Brazilian shelves is a labeling gap, not a formula problem. The ingredients are usually fine. The claims, serving guidelines, or missing local labeling elements are what stall the process. This is worth planning for before a batch is anywhere near a Brazilian port, not after.
Full guide: Entering the Brazilian market
For the complete breakdown of ANVISA requirements, local representation, and how content strategy fits into a successful Brazil market entry, see our complete guide.
Read the Full Brazil Market Entry Guide →Related Reading
Brazil’s $4.6 Billion Supplement Market OpportunityFrequently Asked Questions
Yes, this is the most critical difference. Under DSHEA, the FDA does not pre-approve supplements before they reach the market. Under RDC 243/2018, most Brazilian supplements require notification before market entry, and higher-risk products require full registration.
Not directly. RDC 243/2018 has its own specific list of permitted claims under IN 28/2018, and a literal translation of a US claim is not automatically compliant.
No. ANVISA maintains its own approved ingredient list under IN 28/2018. An ingredient legal in the US may not be on Brazil’s approved list, or may have different dosage limits.
Not exactly equivalent. The FDA’s NDI notification applies only to genuinely new ingredients. ANVISA’s notification pathway applies to the product itself, even when using already-approved ingredients.
No. A US-based company can market supplements domestically without a separate entity. ANVISA requires a legally registered Brazilian company responsible for importation, distribution, and post-market surveillance.
References: U.S. FDA, “Dietary Supplements,” Center for Food Safety and Applied Nutrition. Dietary Supplement Health and Education Act (DSHEA) of 1994. 21 CFR 1.227, facility registration requirements. ANVISA RDC No. 243/2018, “Requisitos Sanitários dos Suplementos Alimentares.” Normative Instruction (IN) No. 28/2018, approved ingredient lists and claims.
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