PQQ (pyrroloquinoline quinone) has moved from a research chemical into Japanese cognition and anti-ageing formulas over the past decade, and brands abroad now ask for it by name. It is usually positioned alongside CoQ10 or NMN in a “cellular energy” or healthy-ageing story.
This guide is for brand owners planning a PQQ product made in Japan. It covers what the human trials show, how PQQ is regulated in the EU, US and Japan, how the ingredient is usually formulated, and what to fix before asking for a quotation.
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 PQQ product made in Japan? We check the full formula against Japanese food law first. See Japan-made supplement OEM.
What the research shows
Human trials of PQQ are small, and only one used a placebo comparison and a dose within the levels regulators have authorised.
| Study | Design | Reported result |
|---|---|---|
| Randomised, double-blind, placebo-controlled trial, Journal of the American Nutrition Association 2022, 41(8):796-809 (PMID 34415830) | 64 healthy Japanese adults aged 40 to under 80; PQQ disodium salt 21.5 mg/day or placebo for 12 weeks; 58 completed | Significant improvements on several Cognitrax cognitive domains (memory, attention, reaction time, cognitive flexibility, executive function, motor speed) and on two secondary cognitive measures versus placebo |
| Open-label trial, Functional Foods in Health and Disease 2012, Vol 2 No 8 (DOI 10.31989/ffhd.v2i8.81) | 17 adults; PQQ 20 mg/day for 8 weeks; no placebo group | Significant improvement in sleep inventory and mood scores after supplementation; the change in sleep score correlated with a change in the cortisol awakening response |
| Randomised, double-blind, placebo-controlled trial, Journal of Nutrition, Health and Aging 2024, 28(8):100287 (PMID 38908296) | 34 older adults with measurable cognitive decline; a combined dihydrogen-and-PQQ mixture or placebo twice daily for 6 weeks | Significant rise in serum BDNF and in one cognitive subscale domain versus placebo; brain oxygenation also increased |
Three points to keep in view:
- Design. Only the 2022 trial was placebo-controlled at a dose within the range regulators have authorised. The 2012 sleep trial was open-label, with no placebo group to compare against.
- Size and combination. All three trials are small. The 2024 trial tested PQQ only as part of a mixture with dihydrogen (molecular hydrogen), so its result cannot be credited to PQQ alone.
- Funding. The 2012 sleep trial’s lead author was employed by an ingredient manufacturer. Read the funding and affiliation statement of any study you plan to cite.
Checked against the published abstracts on 25 September 2026.
What Japanese products say
PQQ has been sold as a food ingredient in Japan for over a decade and has been notified under the Foods with Function Claims system, first for cognitive function and more recently for muscle strength and physical function.
Under Japan’s Foods with Function Claims system, the business that notifies a product is responsible for the scientific evidence behind its stated function, and submits it to the Consumer Affairs Agency before sale. Wording in these notifications describes everyday functions — supporting memory or cognitive performance as part of healthy ageing — not medical conditions.
Two lessons for a brand abroad:
- The Japanese wording is deliberately modest. It speaks of supporting a function, not reversing decline. Copying it into stronger language in your own market goes beyond what either the notifications or the trials above support.
- A Japanese notification is not a global endorsement. It is a Japanese regulatory mechanism for products sold in Japan. Your label abroad follows your own market’s rules.
💬 Need an evidence summary for your regulatory adviser that separates Japanese notifications from independent trials? We prepare it with the manufacturing documents. Tell us your market.
Wording that stays on safe ground
Describe PQQ by what has been studied and at what dose, not by conditions it would treat or reverse.
| Safer wording | Wording to avoid |
|---|---|
| ”Studied for cognitive performance at 21.5 mg per day” | Names of cognitive or memory disorders, or “reverses” ageing |
| ”Studied in relation to sleep quality” | Names of sleep disorders, or “cures” sleep problems |
| ”Contains PQQ” with the amount per serving | ”Clinically proven” without naming the study, its design and its limits |
How PQQ is formulated
PQQ disodium salt is a stable, water-soluble powder dosed in single-digit to low double-digit milligrams, so it suits capsules, tablets and drinks alike.
| Dosage form | Why brands choose it | What to weigh up |
|---|---|---|
| Hard capsule or tablet | Small daily serving, low cost per day | Pairs easily with CoQ10 or NMN in a combined formula |
| Powder stick or drink | Fits a daily “cellular energy” drink format | Taste; PQQ’s reddish-brown colour affects appearance |
| Soft capsule | Combines with oil-soluble companions | Shell material and dietary suitability |
Decisions that shape the specification:
- Source and form. PQQ used in foods is commonly produced by fermentation and supplied as the disodium salt, a reddish-brown powder. Ask the supplier for its specification and purity.
- Amount per serving. The one placebo-controlled cognitive trial above used 21.5 mg/day; the sleep trial used 20 mg/day. Match the amount to any study you intend to cite.
- Your market’s status for PQQ. In the EU, PQQ disodium salt is an authorised novel food for food supplements aimed at the adult population, with a maximum level of 20 mg/day and a mandatory label statement that the product should not be consumed by pregnant or lactating women. In the United States, PQQ disodium salt has been the subject of GRAS notices for which FDA stated it had no questions, covering use in energy, sport and electrolyte drinks, certain bottled and fortified waters, and non-milk meal-replacement beverages at up to 8-20 mg per serving — a narrower food-category scope than a general supplement ingredient. Confirm the current status for your own market before you commit to a formula.
- Companion ingredients. PQQ is often paired with CoQ10 or NMN in healthy-ageing formulas. Each companion needs its own check against Japanese food law and your market’s rules.
The check that comes first
Every ingredient must be permitted in foods in Japan, or a Japanese factory cannot make the product.
PQQ disodium salt itself is used in Japanese foods, but a combined healthy-ageing formula is only as sound as its weakest companion ingredient. See the Japan-made supplement OEM page, and compare with our CoQ10 and NMN guides if you are planning a combined product.
Before you ask for a quotation
A factory can quote accurately once the amount, the form, the companions and the packaging are fixed.
- PQQ amount per serving and servings per pack
- Dosage form
- Companion ingredients and their amounts
- Packaging
- Countries you will sell in, and PQQ’s status there
- First order and annual volume
💬 Ready to design a Japan-made PQQ product? Send us the concept — amount, form, companion ingredients and the countries you will sell in.
Frequently asked questions
1. Is there strong evidence that PQQ improves cognition?
One placebo-controlled trial in 64 healthy adults aged 40 to under 80 found improvements on several cognitive measures at 21.5 mg/day over 12 weeks. It is a single trial, so describe PQQ as studied for cognitive performance, not as a proven treatment.
2. Does PQQ help sleep?
A small open-label trial in 17 adults reported improved sleep scores at 20 mg/day over 8 weeks, with no placebo group for comparison. Treat this as preliminary.
3. Is PQQ authorised in the EU?
Yes. PQQ disodium salt is an authorised novel food for food supplements aimed at adults, with a maximum level of 20 mg/day and a required label statement excluding pregnant and lactating women.
4. Is PQQ recognised in the United States?
FDA has stated it has no questions about GRAS notices covering PQQ disodium salt in specific food and drink categories, such as energy and sport drinks and certain fortified waters, at defined use levels. This is narrower than a blanket approval for all supplement formats.
5. Which dosage form suits PQQ best?
PQQ disodium salt is stable and water-soluble, so capsules, tablets and drinks are all used. Its reddish-brown colour is worth checking against your target format and packaging.
Sources: “Effect of Dietary Pyrroloquinoline Quinone Disodium Salt on Cognitive Function in Healthy Volunteers: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study”, Journal of the American Nutrition Association 2022, 41(8):796-809 (PMID 34415830); “Effects of Oral Supplementation with Pyrroloquinoline Quinone on Stress, Fatigue, and Sleep”, Functional Foods in Health and Disease 2012, Vol 2 No 8 (DOI 10.31989/ffhd.v2i8.81); “The impact of six-week dihydrogen-pyrroloquinoline quinone supplementation on mitochondrial biomarkers, brain metabolism, and cognition in elderly individuals with mild cognitive impairment: a randomized controlled trial”, Journal of Nutrition, Health and Aging 2024, 28(8):100287 (PMID 38908296); Commission Implementing Regulation (EU) 2018/1122 on pyrroloquinoline quinone disodium salt as a novel food; FDA GRAS Notice 709 for pyrroloquinoline quinone disodium salt; Consumer Affairs Agency notifications for Foods with Function Claims. Checked on 25 September 2026.