Methyl Salicylate
Methyl salicylate is approved by the FDA as a synthetic flavoring substance generally recognized as safe at low food-flavoring levels under 21 CFR 172.515. It is highly toxic at concentrated doses: as little as 4 mL of pure oil of wintergreen has been linked to fatalities in young children, and concentrated topical products require warning labels.
What it is
An ester of salicylic acid (oil of wintergreen); used as a flavoring agent and as an analgesic in topical preparations.
Flavoring (mint/wintergreen character) at low levels.
Why it's flagged
- Highly toxic in concentrated form — small amounts (~4 mL pure oil) can be fatal to young children
- FDA-required warning labels on >5% topical products
What regulators actually say
"The synthetic flavoring substance ... methyl salicylate ... may be safely used in food in accordance with the following conditions: (a) They are used in the minimum quantity required to produce their intended effect."
"Drug preparations containing more than 5 percent methyl salicylate ... shall bear a label warning ... 'Keep out of the reach of children.'"
Regulatory status
United States — FDA
GRAS as synthetic flavoring substance under 21 CFR 172.515; warning required on drug products >5% under 21 CFR 201.314
European Union — EFSA
Authorized as a flavoring substance (FL 09.749) in the EU
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