Melia Azadirachta Seed Oil
Neem oil has known reproductive and hepatic toxicity at higher doses, and ingestion of even small amounts has caused toxic encephalopathy and metabolic acidosis in infants and young children. Topical use is generally tolerated, but oral consumption is not recommended without medical guidance, particularly during pregnancy.
What it is
Oil from the seed of the neem tree (Azadirachta indica / Melia azadirachta), containing azadirachtin and other limonoids.
Not commonly a food ingredient; used as a botanical insecticide, in cosmetics, and in traditional medicine. Some traditional uses as a condiment in South Asia.
Why it's flagged
- Encephalopathy and metabolic acidosis reported in infants/young children after ingestion of small amounts
- Reproductive toxicity (abortifacient at high doses)
- Hepatic toxicity at higher oral doses
What regulators actually say
"Neem oil poisoning is well-documented as a cause of toxic encephalopathy and metabolic acidosis in infants and young children following ingestion."
Regulatory status
United States — FDA
Not GRAS for food use; cold-pressed neem oil registered as biopesticide by EPA
European Union — EFSA
Not authorized as a novel food in EU
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