Phosphatidylserine (PS) has one of the longer track records among brain-focused ingredients, and brands abroad ask for it because it carries both a United States qualified health claim and a presence in Japanese Foods with Function Claims. Few of them realise the ingredient sold today is not the one those early studies used.
This guide is for brand owners planning an oral phosphatidylserine product made in Japan. It covers the shift from bovine to soy-derived PS, what the trials actually show, how Japan frames the ingredient, and how to formulate the product.
Health supplements are foods, not medicines, and are not a substitute for medical treatment. Nothing here is a claim that any product prevents, treats or cures a disease.
💬 Planning a phosphatidylserine product made in Japan? We check the full formula against Japanese food law first. See Japan-made supplement OEM.
Why the source changed, and why it matters
Almost all of the positive early trial evidence for phosphatidylserine used a bovine cortex-derived material that has since left the market, while today’s supplements use a chemically different soy-derived form.
The original clinical work on PS, mostly Italian trials from the 1980s and 1990s, used phosphatidylserine extracted from cow brain cortex. That material largely disappeared from commercial use after bovine spongiform encephalopathy (BSE, “mad cow disease”) raised concerns about products derived from bovine neural tissue, and manufacturers moved to phosphatidylserine produced from soy lecithin by an enzymatic reaction with L-serine. Bovine cortex-derived PS and soy-derived PS are not identical: they differ in their attached fatty acids, and the bovine form carried more of the long-chain polyunsaturated fatty acids present in animal neural tissue. Trials run specifically on soy-derived PS give a more current picture of what today’s ingredient does, and they are mixed.
What the research shows
Trials of soy-derived phosphatidylserine on memory are mixed: one placebo-controlled Japanese trial found a memory benefit in a subgroup with lower baseline scores, while an earlier European trial of the same soy-derived form found no significant effect on any measure.
| Study | Design/What was analysed | Reported result |
|---|---|---|
| Randomised, double-blind, placebo-controlled trial, J Clin Biochem Nutr 2010 (PMID 21103034) | 78 elderly Japanese adults (50-69) with memory complaints, given 100 mg or 300 mg/day soy-derived PS or placebo for 6 months | Neuropsychological scores rose in all groups including placebo; in the subgroup with relatively low baseline scores, memory scores rose significantly in the PS groups but not in placebo, driven mainly by delayed verbal recall; no adverse effects reported |
| Randomised, placebo-controlled trial, Nutr Neurosci 2001 (PMID 11842880) | 120 adults over 57 meeting stringent criteria for age-associated memory impairment, given 300 mg or 600 mg/day soy-derived PS or placebo for 12 weeks | No significant differences between treatment and placebo groups on any outcome measure, including the primary measures of delayed recall and recognition |
Both trials used the current soy-derived form of PS, small to moderate sample sizes, and memory-complaint or memory-impairment populations rather than the general public. The 2010 trial’s positive result was limited to a subgroup analysis rather than the full sample, which is a weaker form of evidence than a pre-specified primary outcome. Neither trial reported industry funding in the sources checked.
Checked against the published abstracts on 25 September 2026.
What Japanese products say
Japan has accepted Foods with Function Claims notifications for soy-derived phosphatidylserine describing support for memory (word recall) in healthy middle-aged and older adults whose memory has been declining, a narrower and more specific claim than a general brain-health statement.
Under Japan’s Foods with Function Claims system, the notifying business is responsible for the scientific evidence behind its stated function and submits it to the Consumer Affairs Agency before sale. Notified wording for soy-derived PS in Japan centres on maintaining the memory function of recalling words in healthy people whose memory has already been in decline — a specific, function-based claim, not a general “supports the brain” statement and not a dementia claim.
Separately, the United States FDA has permitted two qualified health claims for phosphatidylserine since 2003: that consumption “may reduce the risk of cognitive dysfunction in the elderly” and that it “may reduce the risk of dementia in the elderly.” Both must carry an FDA-mandated disclaimer stating that the supporting research is very limited and preliminary and that FDA has concluded there is little scientific evidence for the claim. A brand should not treat a qualified claim’s approval as proof of the underlying science; the disclaimer exists precisely because the evidence is thin.
💬 Need an evidence summary for your regulatory adviser that separates Japanese notifications from other markets’ claim rules? We prepare it with the manufacturing documents. Tell us your market.
Wording that stays on safe ground
Describe phosphatidylserine by the specific function studied — word recall in people whose memory has declined — not by cognitive dysfunction or dementia as conditions.
| Safer wording | Wording to avoid |
|---|---|
| ”Studied for word-recall memory support in adults with declining memory" | "Reduces the risk of dementia” or “cognitive dysfunction” without your market’s own approved claim wording and disclaimer |
| ”Soy-derived phosphatidylserine” (stating the source) | Implying the product is the same material used in 1990s bovine-derived trials |
| ”Contains phosphatidylserine” with the amount per serving | ”Clinically proven” without naming the study, its population and its limits |
How phosphatidylserine is formulated
Soy-derived PS is an oily phospholipid rather than a simple water-soluble compound, which shapes which dosage forms suit it best.
| Dosage form | Why brands choose it | What to weigh up |
|---|---|---|
| Soft capsule | Handles an oily, phospholipid-rich material well | Standard choice for PS internationally |
| Hard capsule with powder blend | Simple to combine with other brain-focus ingredients | PS content and flow properties of the blend |
| Tablet | Familiar, easy to dose precisely | May need excipients to bind an oily active |
| Powder stick or sachet | Combination “brain” formulas | Taste and oxidation stability of the PS material |
Decisions that shape the specification:
- Source and content. Confirm the material is soy-derived (bovine-derived PS is not a viable commercial source today) and ask the supplier for its PS content and fatty-acid profile.
- Amount per serving. Match the amount to a study you intend to cite; the Japanese and international trials above used different daily amounts.
- Companion ingredients. PS is often combined with other brain-focus ingredients. Every ingredient in such a formula needs its own check against Japanese food law.
- Stability and packaging. Phospholipids are prone to oxidation; sourcing, blending and packaging should account for shelf-life stability.
- Your market’s status for PS. Confirm PS’s status as a food or supplement ingredient in each market you plan to sell in before committing to a formula, including any specific claim wording that market permits.
The check that comes first
Every ingredient must be permitted in foods in Japan, or a Japanese factory cannot make the product.
Soy-derived phosphatidylserine is used in Japanese Foods with Function Claims, so this check is about the companion ingredients and claim wording, not PS itself. See the Japan-made supplement OEM page, and compare with our ginkgo biloba and PQQ guides for other brain-focus ingredients.
Before you ask for a quotation
A factory can quote accurately once the source, the amount, the form, the companions and the packaging are fixed.
- Confirmation that the material is soy-derived, and its PS content
- PS amount per serving and servings per pack
- Dosage form and any companion ingredients
- Packaging and any stability requirements
- Countries you will sell in, and PS’s status and permitted claim wording there
- First order and annual volume
💬 Ready to design a Japan-made phosphatidylserine product? Send us the concept — source, amount, form, companion ingredients and the countries you will sell in.
Frequently asked questions
1. Is today’s phosphatidylserine supplement the same material used in the 1990s studies?
No. Most of the original positive trials used phosphatidylserine derived from bovine brain cortex, a source phased out after BSE concerns. Today’s commercial PS is derived from soy lecithin and differs in its fatty-acid profile from the bovine-derived material.
2. Does soy-derived PS improve memory?
The trial evidence is mixed. A 2010 Japanese trial found a memory benefit only in the subgroup of participants with lower baseline scores; an earlier European trial of the same soy-derived form found no significant effect on any measure. Describe PS as studied for word-recall memory, not as a proven memory enhancer.
3. What does the US FDA claim for phosphatidylserine actually say?
FDA allows two qualified claims — for reducing the risk of cognitive dysfunction and of dementia in the elderly — but both must be paired with a disclaimer stating the evidence is very limited and preliminary. The claim’s existence is not the same as strong evidence.
4. Does Japan allow a phosphatidylserine memory claim?
Japan’s Foods with Function Claims system has accepted notifications for soy-derived PS describing support for word-recall memory in healthy adults whose memory has been declining. This is a Japanese regulatory mechanism for products sold in Japan, not a global endorsement.
5. Which dosage form suits phosphatidylserine best?
Soft capsules are the most common choice internationally because PS is an oily phospholipid. Hard capsules, tablets and powder sticks are also used, generally in combination formulas.
Sources: “Soybean-derived phosphatidylserine improves memory function of the elderly Japanese subjects with memory complaints”, J Clin Biochem Nutr 2010, PMID 21103034; “The influence of soy-derived phosphatidylserine on cognition in age-associated memory impairment”, Nutr Neurosci 2001, PMID 11842880; US FDA qualified health claim letters on phosphatidylserine and cognitive dysfunction/dementia (2003); Consumer Affairs Agency notifications for Foods with Function Claims for soy-derived phosphatidylserine. Checked on 25 September 2026.