🇺🇸 FDA
GRAS · DSHEA dietary supplement · ALA is not subject to a separately authorized qualified health claim (the FDA omega-3 QHC framework targets EPA + DHA specifically)
Flaxseed ALA (Plant Omega-3 · Linum usitatissimum)
Also known as: Alpha-linolenic acid · Flaxseed oil · Linseed ALA · Plant omega-3
Mechanism of action
- Plant-derived ω-3 18-carbon fatty acid; partial enzymatic conversion to EPA (5-10%) and DHA (< 1%) in humans
- Membrane phospholipid integration as ALA itself
- May modestly reduce CVD risk through lipid + blood pressure pathways
Molecular + tissue targets
- Serum / erythrocyte ALA pool
- Modest effects on cardiovascular risk markers at higher dietary intakes
- Vegan / vegetarian ω-3 contribution where EPA + DHA intake is limited
Dosage range
Approximately 1.1-1.6 g ALA per day RDA-equivalent target for adults; higher intakes (4-9 g/day) commonly used in cardiovascular trials. Pan 2012 PMID 23076616 American Journal of Clinical Nutrition systematic review and meta-analysis of 27 observational studies (n = 251,049 individuals, 15,327 CVD events) reported higher ALA exposure associated with moderately lower risk of CVD (pooled RR 0.86, 95% CI 0.77-0.97; dietary intake subset RR 0.90 with significant 10% reduction)
Safety notes
Excellent safety profile; the ALA → EPA conversion is limited so flaxseed ALA is NOT an efficient substitute for direct EPA + DHA supplementation when CVD risk reduction is the goal; flax lignans (sometimes co-extracted) carry distinct phytoestrogen considerations · choose pure flaxseed oil for ALA-only intake
Cross-market regulatory status
🇪🇺 EFSA
Authorized claim Reg 432/2012 ALA contributes to the maintenance of normal blood cholesterol levels (≥ 2 g ALA per serving threshold); CVD outcomes not covered by an ALA-specific authorized claim
🇧🇷 ANVISA
RDC 243/2018 dietary supplement · IN 28/2018 Anexo V framework available for plant omega-3 only at the generic level
Common use cases
- plant-based diet ω-3 contribution
- modest cardiovascular risk reduction at higher dietary intakes
- lipid-lowering adjunct via plant ω-3 pathway
Cross-reference
Health goals: heart health inflammation relief
Lifestyles: plant based senior 60 plus
Full dossier: /ingredients/flaxseed-ala/
Machine-readable JSON: /api/nc/flaxseed-ala.json