🇺🇸 FDA
GRAS · qualified health claim docket 2003Q-0401 (CHD); Vascepa (icosapent ethyl) Rx for hypertriglyceridemia
Also known as: Marine omega-3 · EPA+DHA fish oil · Long-chain omega-3
EPA+DHA 250-500 mg/day general; REDUCE-IT 4g/day pure EPA prescription for high-risk CVD
Atrial fibrillation risk at sustained high-dose mixed EPA+DHA (STRENGTH 2020 PMID 33190147); bleeding theoretical with anticoagulants
GRAS · qualified health claim docket 2003Q-0401 (CHD); Vascepa (icosapent ethyl) Rx for hypertriglyceridemia
Authorized claims for EPA+DHA cardiovascular
RDC 243/2018 dietary supplement · IN 28/2018 Anexo V 2 alegações funcionais: "Fonte de ômega 3" (Anexo III ≥ 37,5 mg EPA+DHA/dia adultos ≥ 19 anos · gestantes/lactantes ≥ 45 mg/dia com ≥ 30 mg DHA per Anexo III nota i) + "Os ácidos graxos ômega 3 EPA e DHA auxiliam na redução dos triglicerídeos" (≥ 1.500 mg EPA+DHA/dia)
Health goals: heart health cognitive support inflammation relief
Lifestyles: senior 60 plus pregnancy
Full dossier: /ingredients/fish-oil/
Machine-readable JSON: /api/nc/fish-oil.json