FDA import refusals
FDA import refusals: dietary supplements from Brazil
FDA category: Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties · October 2016 to May 5, 2026
FDA refused 130 dietary supplements shipment lines from Brazil between October 2016 and May 5, 2026, 12 of them in 2026; the most refused products were vitamin and vitamin a, most often for UNAPPROVED (unapproved new drug).
Data from FDA public records, last checked .
- 130
- dietary supplements lines refused since October 2016
- 12
- refused so far in 2026
- 10
- firms with the most records, listed below
Dietary supplements refusals from Brazil by year
Shipment lines FDA refused each year. The table has the same numbers as the chart.
| Year | Refusal lines | vs prior year |
|---|---|---|
| 2026 (to date) | 12 | |
| 2025 | 47 | +292% |
| 2024 | 12 | -20% |
| 2023 | 15 | +114% |
| 2022 | 7 | -22% |
| 2021 | 9 | +29% |
| 2020 | 7 | +133% |
| 2019 | 3 | -67% |
| 2018 | 9 | +29% |
| 2017 | 7 | |
| 2016 (from Oct) | 2 |
Vitamin refusals from Brazil
FDA refused 58 vitamin lines from Brazil between October 2016 and May 5, 2026, 45% of the dietary supplements lines.
| FDA product description | Lines | Share of dietary supplements |
|---|---|---|
| Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c. | 51 | 39.2% |
| Vitamin, n.e.c. | 7 | 5.4% |
Recent vitamin refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Vida NaturalBelo Horizonte, Brazil | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Liotecnica Tecnologia EmSao Pualo, Brazil | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NO ENGLISHNUTRIT LBL | Source | |
| Fagron do Brasil Farmaceuitica LSao Paulo, Brazil | Vitamin, n.e.c | UNAPPROVED | Source | |
| Botane PharmRio De Janeiro, Brazil | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Botane PharmRio De Janeiro, Brazil | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source |
Vitamin a refusals from Brazil
FDA refused 9 vitamin a lines from Brazil between October 2016 and May 5, 2026, 7% of the dietary supplements lines.
| FDA product description | Lines | Share of dietary supplements |
|---|---|---|
| Vitamin a | 9 | 6.9% |
Herbals & botanicals refusals from Brazil
FDA refused 8 herbals & botanicals lines from Brazil between October 2016 and May 5, 2026, 6% of the dietary supplements lines.
| FDA product description | Lines | Share of dietary supplements |
|---|---|---|
| Herbals & botanicals (not teas), n.e.c. | 8 | 6.2% |
Other dietary supplements products refused from Brazil
| Product group | Lines | Share |
|---|---|---|
| Ashwagandha | 7 | 5.4% |
| Vitamin c | 5 | 3.8% |
| Animal by-products and extracts | 4 | 3.1% |
| Biotin | 4 | 3.1% |
| Vegetable protein powder | 4 | 3.1% |
| Coenzyme q10 | 3 | 2.3% |
Why FDA refused dietary supplements from Brazil
FDA records a charge code on each refused line; one line can carry several.
| Charge code | Meaning | Lines | Share |
|---|---|---|---|
| UNAPPROVED | Unapproved new drug | 87 | 44% |
| NUTRIT LBL | Nutrition information missing from label | 24 | 12% |
| DIETARYLBL | Not identified as a dietary supplement | 22 | 11% |
| NO ENGLISH | Required label information not in English | 20 | 10% |
| NOT LISTED | Product not listed with FDA | 11 | 6% |
| LABELING | Fair Packaging and Labeling Act | 10 | 5% |
| LACKS FIRM | Manufacturer name and address missing | 8 | 4% |
| NCONTACT | No U.S. adverse event contact on supplement label | 8 | 4% |
| FRNMFGREG | Appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured,… | 5 | 3% |
| LIST INGRE | Ingredients not listed | 5 | 3% |
Import alerts for dietary supplements that list Brazil firms
Brazil dietary supplements firms with the most FDA records
Counts are FDA records in SupplierRadar's data, not a ranking of quality.
| Firm | City | FDA records |
|---|---|---|
| Vida Natural | Belo Horizonte | 11 |
| H. Calil Comercial Ltda | Guapiacu | 7 |
| Day Pharma Eireli | Itu | 6 |
| Manipularium Formulas Famaceutic | Ribeirao Preto | 6 |
| Instituto Homem | Sao Paulo | 6 |
| Alexfarma | Goiania | 6 |
| Apiario Polenectar, Ltda. | Sao Paulo | 5 |
| Day Pharma Eireli- ME | Center | 5 |
| Rocoxon | Sao Paulo | 5 |
| Pharma Sjrp | Sao Paulo | 5 |
Latest dietary supplements refusals from Brazil
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Pharma SjrpSao Paulo, Brazil | Protein n.e.c | UNAPPROVED | Source | |
| Pharma SjrpSao Paulo, Brazil | Nicotinamide (niacinamide) (vitamin) | UNAPPROVED | Source | |
| Pharma SjrpSao Paulo, Brazil | Biotin (vitamin h, coenzyme r) | UNAPPROVED | Source | |
| Pharma SjrpSao Paulo, Brazil | Biotin (vitamin h, coenzyme r) | UNAPPROVED | Source | |
| Pharma SjrpSao Paulo, Brazil | Sunflower lecithin (fats and lipid substances) | UNAPPROVED | Source | |
| Abbott Laboratorios do Brasil LtdaSao Paulo, Brazil | Mecobalamin (vitamin) | NOT LISTEDUNAPPROVED | Source | |
| Vida NaturalBelo Horizonte, Brazil | Biotin (vitamin h, coenzyme r) | UNAPPROVED | Source | |
| Vida NaturalBelo Horizonte, Brazil | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Vida NaturalBelo Horizonte, Brazil | Coenzyme q10 (vit/min/protein/unconventional dietary spec for human/animal, n.e.c.) | UNAPPROVED | Source | |
| Vida NaturalBelo Horizonte, Brazil | Ashwagandha (herbal & botanical teas) | UNAPPROVED | Source | |
| Vida NaturalBelo Horizonte, Brazil | Vitamin c (ascorbic acid) | UNAPPROVED | Source | |
| Liotecnica Tecnologia EmSao Pualo, Brazil | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NO ENGLISHNUTRIT LBL | Source | |
| Fagron do Brasil Farmaceuitica LSao Paulo, Brazil | Vitamin, n.e.c | UNAPPROVED | Source | |
| Sanofi Aventis Parmaceutica LtdaSuzano, Brazil | Ashwagandha (herbal & botanicals, not teas) | NOT LISTEDUNAPPROVED | Source | |
| Botane PharmRio De Janeiro, Brazil | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Botane PharmRio De Janeiro, Brazil | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Legrand Pharma IndustriaHortolandia, Brazil | Dl-phenylalanine (protein) | UNAPPROVED | Source | |
| AlexfarmaGoiania, Brazil | Ashwagandha (herbal & botanicals, not teas) | UNAPPROVED | Source | |
| AlexfarmaGoiania, Brazil | Ashwagandha (herbal & botanicals, not teas) | UNAPPROVED | Source | |
| AlexfarmaGoiania, Brazil | Ashwagandha (herbal & botanicals, not teas) | UNAPPROVED | Source |
Questions about dietary supplements refusals from Brazil
- How many dietary supplements shipments from Brazil did FDA refuse in 2026?
- FDA refused 12 shipment lines of dietary supplements from Brazil in 2026 through May 5, 2026, compared with 47 in 2025.
- Why does FDA refuse dietary supplements from Brazil?
- FDA records a charge code on every refused shipment line. For dietary supplements from Brazil the most frequent are UNAPPROVED (unapproved new drug, 87 lines), NUTRIT LBL (nutrition information missing from label, 24 lines) and DIETARYLBL (not identified as a dietary supplement, 22 lines). A charge describes what FDA's reference table says about one shipment line, not about every firm.
- Which import alerts cover dietary supplements from Brazil?
- As of October 26, 2026, the FDA import alerts for this category that list Brazil firms are Import Alert 54-14 (1 firm) and Import Alert 54-16 (1 firm). General food alerts numbered 99-xx can list Brazil firms too; see the country page.
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SupplierRadar is not affiliated with the U.S. Food and Drug Administration. Data comes from public FDA records and may contain errors. This is not legal advice; importers remain responsible for their supplier evaluations.