Camphor
FDA limits camphor in topical OTC products to 11% and banned camphorated oil products in 1983 due to severe poisoning reports. Oral ingestion is highly toxic — as little as 500 mg can be fatal in children, and 750-1000 mg can cause seizures and death.
What it is
Bicyclic terpene ketone (1,7,7-trimethylbicyclo[2.2.1]heptan-2-one); from Cinnamomum camphora or synthetic.
Topical analgesic and OTC drug ingredient (cough/cold rubs); flavor at ultra-low levels. Not used as a primary food ingredient.
Why it's flagged
- Highly toxic when ingested orally
- Pediatric mortality at 500 mg
- FDA banned camphorated oil
What regulators actually say
"The FDA required that the concentration of camphor in products not exceed 11%, as higher concentrations were not more effective and could cause more serious adverse reactions if accidentally ingested."
"In the pediatric population, exposure to as little as 500 mg is cited as a cause of mortality, and more commonly, 750 to 1000 mg are associated with the development of seizures and death."
Regulatory status
United States — FDA
OTC monograph limits topical use to 11% (21 CFR 341.14); camphorated oil products banned 1983; no GRAS food use at meaningful levels.
European Union — EFSA
EFSA established TDI of 2 mg/kg bw/day for camphor as flavoring; restricted in food.
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