Raspberry Ketone
Raspberry ketone is listed under 21 CFR 172.515 as an approved synthetic flavoring substance and has held FEMA GRAS status since 1965 when used in the minimum quantity required to produce its intended flavor effect. Weight-loss supplement claims are not supported by clinical evidence and supplement-level doses far exceed flavoring-level intakes; long-term high-dose safety data are limited.
What it is
4-(4-hydroxyphenyl)-2-butanone, a phenolic compound naturally occurring in raspberries; mostly produced synthetically.
Synthetic flavoring agent providing raspberry note.
Why it's flagged
- Supplement doses unstudied long-term
- Unsubstantiated weight-loss marketing
What regulators actually say
"21 CFR 172.515 lists synthetic flavoring substances and adjuvants that may be safely used in food, including 4-(p-hydroxyphenyl)-2-butanone (raspberry ketone), used in the minimum quantity required to produce their intended effects."
Regulatory status
United States — FDA
Permitted as synthetic flavoring per 21 CFR 172.515; FEMA GRAS.
European Union — EFSA
Permitted as flavoring substance in EU (FL no. 07.099).
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