Instituto Homem
FDA import alert and refusal historySao Paulo, BrazilFEI 3038228576
Recorded by FDA as INSTITUTO HOMEM
As of October 26, 2026, Instituto Homem is not on any FDA import alert in SupplierRadar's records; FDA refused 6 of its shipment lines on June 16, 2025, most often for unapproved new drug (UNAPPROVED).
Data from FDA public records, last checked . Request a correction
Current status
- Import alerts
- Not listed
- Last import refusal
- Maca (herbal & botanicals, not teas ii) · UNAPPROVED
- Last warning letter
- None found
- Last inspection
- None on record
Every FDA record for Instituto Homem
6 records, newest first. Each line links to the FDA page it came from.
2025
- Import refusalSource
Refused, 6 lines in one entry: Maca (herbal & botanicals, not teas ii); L-arginine (protein) and 3 moreUNAPPROVEDEntry AEK-7180477-5Show 6 linesHide lines
- Refused, Maca (herbal & botanicals, not teas ii)UNAPPROVEDEntry AEK-7180477-5Source
- Refused, L-arginine (protein)UNAPPROVEDEntry AEK-7180477-5Source
- Refused, L-tryptophan (protein)UNAPPROVEDEntry AEK-7180477-5Source
- Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.UNAPPROVEDEntry AEK-7180477-5Source
- Refused, Tribulus (herbal & botanicals, not teas)UNAPPROVEDEntry AEK-7180477-5Source
- Refused, Tribulus (herbal & botanicals, not teas)UNAPPROVEDEntry AEK-7180477-5Source
Refusal charges, in plain English
- UNAPPROVED6 refused lines
Unapproved new drug
The product appeared to be a new drug within the meaning of section 201(p) of the FD&C Act without an approved New Drug Application. FDA can apply this charge to a food or supplement whose labeling presents it for drug uses.
Questions about Instituto Homem
- Is Instituto Homem on an FDA import alert?
- No listing for Instituto Homem appears in the FDA import alerts SupplierRadar checked on October 26, 2026. Country-wide alerts may still apply to its products; see the Brazil page.
- Has FDA refused shipments from Instituto Homem?
- Yes. FDA refused 6 shipment lines from Instituto Homem on June 16, 2025. The most recent, on June 16, 2025, was maca (herbal & botanicals, not teas ii), charged as UNAPPROVED (unapproved new drug).
- Why did FDA refuse Instituto Homem's shipments?
- The most frequent charge is UNAPPROVED (unapproved new drug, 6 lines).
- What is Instituto Homem's FEI number?
- Instituto Homem's FDA Establishment Identifier (FEI) is 3038228576.
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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.