Flaxseed Oil, Alpha-Linolenic Acid & Oleic Acid

Flaxseed oil reference formula with 1,200 mg of oil per serving, stating alpha-linolenic acid at 540 mg and oleic acid at 132 mg, developed as a softgel.

Flaxseed Oil, Alpha-Linolenic Acid & Oleic Acid is a reference formula for brands building a plant-based oil softgel with example amounts of 1,200 mg of flaxseed oil per serving, stated with 540 mg of alpha-linolenic acid (ALA) and 132 mg of oleic acid. The two fatty acids are components of the oil itself, so the development work centers on the oil grade and its fatty acid profile, keeping a highly unsaturated oil stable against oxidation, and the softgel shell that holds it.

Softgel is the only format because flaxseed oil is a liquid fill that suits an oil-filled shell. The reference labels in this set are softgels, with a few liquids, so the page is built around a softgel.

Ingredient Composition

IngredientPer ServingRaw Material FormAlternative Form (same amount of active)
Flaxseed Oil1200 mg (example amount)Refined or cold-pressed flaxseed oil; specification 1,200 mg per serving, fatty acid profile, peroxide and anisidine values set with the supplierFlaxseed oil with a higher ALA content, which changes the ALA delivered per softgel
Alpha-Linolenic Acid540 mg (example amount)Delivered by the flaxseed oil; specification ALA content of the oil at about 45% by weightA concentrated ALA oil, which is a separate raw material
Oleic Acid132 mg (example amount)Delivered by the flaxseed oil; specification oleic acid content of the oil at about 11% by weightA blend with a higher oleic oil, which changes the profile

Amounts are stated as mg of oil and mg of each fatty acid per serving. The fatty acids are not added separately: 540 mg is 45% of 1,200 mg and 132 mg is 11%, so the specification sets the oil’s fatty acid profile and the label amounts follow from the oil weight. The reference label also lists linoleic acid at 132 mg and other fatty acids at 60 mg.

Intended Benefits & Formula Rationale

This formula is designed for products positioned around plant-based omega-3 nutrition. Flaxseed oil is included as the single source so that the oil grade, the amount and the shell system can be set without interaction with other actives.

Intended Benefit DirectionKey IngredientsFormulation Rationale
Cardiovascular fatty acid nutritionFlaxseed Oil, Alpha-Linolenic AcidA meta-analysis of 19 randomized trials with 1,183 participants with overweight or obesity found that alpha-linolenic acid supplementation significantly reduced C-reactive protein, triglycerides and systolic blood pressure but significantly increased LDL cholesterol, and that the effect was more prominent at 3 g per day or more from flaxseed oil or flaxseed [1]. Evidence: Mixed

The trials behind [1] used amounts above this serving and included participants with overweight or obesity, so amount, claims and target market for a finished product are brand decisions reviewed for each sales market.

Available Formats

The reference formula is built for a softgel version only; the serving is set by the number of softgels.

FormatUnitPer ServingPack SizeOther Ingredients (typical)Suitability
Softgel1 softgel1200 mg flaxseed oil60 or 120 softgelsMixed tocopherols, gelatin or plant-based shell, glycerinLead and only format; oil as the fill

Raw Material Input & Fill (Design Estimate)

Design estimates. The input is the labeled oil weight at an assumed 100% of the oil as purchased, so 1,200 mg of oil per softgel is used as the input; the fatty acid profile follows from the oil and is fixed in the specification.

FormatRaw Material Input per UnitDesign FillBalance for ExcipientsVerification Before Scale-Up
Softgel1200 mg flaxseed oil1250 mg per softgel50 mg antioxidantFill weight, shell integrity, peroxide value, fatty acid profile

Liquid, capsule and powdered versions are separate projects, because a bottled oil uses its own dosing and nitrogen-flushed packaging, and a powdered oil needs encapsulation work.

Formulation Considerations

Oxidation-prone oil. Flaxseed oil is highly unsaturated and oxidizes quickly in light, heat and air. The fill carries an antioxidant, the oil is handled under nitrogen, and peroxide and anisidine values are set as incoming limits and checked on the finished unit.
Softgel shell and fill size. A 1,200 mg fill needs a larger softgel, and the shell is chosen for oxygen barrier and for the brand’s gelatin or plant-based claim. Shell compatibility with the oil is checked early.
Fatty acid profile. ALA and oleic acid vary with seed variety and refining, so the specification states the profile as a range and the label amounts are checked against it by assay.
Evidence and tier. The meta-analysis in [1] reports a rise in LDL cholesterol alongside other changes, and its subgroup with a clearer effect used 3 g per day or more, which is above this serving. Dose limit and label wording are reviewed per market, ahead of any product development.

Customization Options

Brands adjust the oil amount, the profile, the softgel count and the add-ons.

ParameterRangeNote
Flaxseed oil per serving1000, 1200 or 2400 mgExamples for the brand; softgel count changes with the amount
ALA content of the oilAbout 45% to 50%Changes the ALA delivered per softgel
ShellGelatin or plant-basedChanges the oxygen barrier and the label claim
Pack size60 to 120 softgelsSet by the brand
Add-onsVitamin E, fish oilFish oil adds EPA and DHA in the same fill and makes the product a different concept

The pilot run confirms fill weight and shell integrity, oxidation values of the first units, and the ALA and oleic acid content against the specification.

Technical Status & Data Sources

ItemStatusDetails
Reference formulaNIH DSLDThe ingredient and amount come from a labeled product in the NIH DSLD (Flaxseed Oil 1200 mg + Alpha-Linolenic Acid 540 mg + Oleic Acid 132 mg on the label of CF000701; example DSLD labels 4889, 17432, 35381). The label names the ingredients as flaxseed oil, alpha-linolenic acid and oleic acid among its fatty acids; flaxseed oil is set as the raw material for all three.
SpecificationSet in formulationFlaxseed oil, 1,200 mg per serving, with alpha-linolenic acid at about 45% and oleic acid at about 11%; fatty acid profile, peroxide, anisidine and acid values and heavy-metal limits are fixed with the supplier. Unit size, fill weight and stability are set in formulation.
Data sourceNIH DSLDDSLD v9.4.0, downloaded 2026-01-10: 50,824 reference formulas merged from on-market labels with complete ingredient amounts. Counts show how labels are distributed.
Market reviewPer marketDose limits, labeling and claims are reviewed for each sales market before a finished product is developed.
ReferencesSources[1] Yin S, Xu H, Xia J, et al. Effect of alpha-linolenic acid supplementation on cardiovascular disease risk profile in individuals with obesity or overweight: a systematic review and meta-analysis of randomized controlled trials. Adv Nutr. 2023;14(6):1644-1655. DOI · PubMed

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