Lemon balm (Melissa officinalis) is a long-used calming herb, familiar from herbal teas, that brands abroad increasingly ask for as a sleep- or relaxation-themed supplement ingredient. It is permitted as a food ingredient in Japan, which makes it a realistic option for a Japan-made product, but the trial evidence behind it comes mostly from patient populations rather than the general public.
This guide is for brand owners planning an oral lemon balm product made in Japan. It covers what the trials show, Japan’s food status for the leaf, 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 lemon balm product made in Japan? We check the full formula against Japanese food law first. See Japan-made supplement OEM.
What the research shows
Small randomised trials in patients recovering from heart surgery and in menopausal women with sleep disturbance found that lemon balm reduced anxiety and improved sleep-related scores, though one trial used lemon balm combined with fennel extract rather than lemon balm alone.
| Study | Design/What was analysed | Reported result |
|---|---|---|
| Double-blind, placebo-controlled trial, Clin Nutr ESPEN 2018 (PMID 29908682) | 80 patients with chronic stable angina, given 3 g/day Melissa officinalis supplement or placebo for 8 weeks, assessed with the DASS-21 scale and Pittsburgh Sleep Quality Index | Significant reduction in depression, anxiety, stress and total sleep-disturbance scores compared with placebo |
| Randomised, double-blind trial, Rev Bras Ginecol Obstet 2021 (PMID 33465795) | 60 postmenopausal women with sleep disturbance, given 500 mg/day of a Melissa officinalis and fennel (Foeniculum vulgare) extract combination, citalopram, or placebo for 8 weeks, assessed with the Menopause-Specific Quality of Life questionnaire | Quality-of-life scores, including the sleep-related vasomotor and psychosocial domains, improved significantly more in the Melissa/fennel group than in either the citalopram or placebo groups |
Both trials are small, run in a single country, and studied people with an existing medical condition (chronic stable angina, menopausal sleep disturbance) rather than the general population, so their results describe those groups specifically. The second trial used a combination product with fennel extract, not lemon balm on its own, which means its result cannot be attributed to lemon balm alone. Neither study reported industry funding in the sources checked. Independent reviewers have generally described the lemon balm evidence base as promising but still needing more, larger trials in healthy populations.
Checked against the published abstracts on 25 September 2026.
What Japanese products say
Lemon balm leaf sits on Japan’s list of substances not automatically judged to be medicines, meaning it is treated as food-usable as long as no medicinal effect is claimed for it.
Under Japan’s food-drug classification system (食薬区分), the Ministry of Health, Labour and Welfare maintains an illustrative list of plant materials that are not judged to be medicines unless a medicinal effect is stated on the label. Lemon balm leaf (メリッサ/レモンバーム) is included on that list, which is why it can be used as a food ingredient in Japan today, provided the product and its labelling avoid medicinal claims. This is a food-eligibility status, separate from and not the same as a Foods with Function Claims notification; this guide did not find a confirmed generic Foods with Function Claims notification specifically for lemon balm.
💬 Need an evidence summary for your regulatory adviser on lemon balm’s food status and the trial evidence behind it? We prepare it with the manufacturing documents. Tell us your market.
Wording that stays on safe ground
Describe lemon balm by what has been studied and in which population, not by the conditions those populations happened to have.
| Safer wording | Wording to avoid |
|---|---|
| ”Studied for everyday anxiety and sleep-related outcomes” | Names of heart conditions, menopause, or sleep disorders as target conditions |
| Stating the amount per serving and whether the product is lemon balm alone or a combination | Attributing a combination-product result to lemon balm alone |
| ”Contains lemon balm” with the amount per serving | ”Clinically proven” without naming the study, its population and its limits |
How lemon balm is formulated
Lemon balm is available as dried leaf, tea-cut material or standardised extract, which fits several dosage forms.
| Dosage form | Why brands choose it | What to weigh up |
|---|---|---|
| Tea or tea bag | Traditional format, familiar to consumers | Taste and steeping consistency |
| Hard capsule | Simple, flavourless, precise dosing | Fill weight needed for gram-level doses used in trials |
| Tablet | Familiar, easy to combine with other ingredients | Tablet size at higher doses |
| Drink or powder stick | Evening-routine products | Taste and extract solubility |
Decisions that shape the specification:
- Source and form. Confirm whether the material is dried leaf, a water/alcohol extract, or a standardised extract, and ask the supplier for its specification.
- Amount per serving. Match the amount to a study you intend to cite; note that one of the trials above used a lemon balm and fennel combination, not lemon balm alone.
- Companion ingredients. Lemon balm is often combined with other relaxation ingredients. Every ingredient in such a formula needs its own check against Japanese food law.
- Your market’s status for lemon balm. Its status as a food ingredient differs between countries. Confirm it before you commit to a formula.
The check that comes first
Every ingredient must be permitted in foods in Japan, or a Japanese factory cannot make the product.
Lemon balm leaf itself is food-eligible in Japan. Companion herbs in a relaxation or sleep formula are where a problem is more likely to arise. See the Japan-made supplement OEM page, and compare with our GABA and L-theanine guides.
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.
- Lemon balm material type (dried leaf, extract) and its specification
- Amount per serving and servings per pack
- Dosage form, and whether the formula combines lemon balm with other botanicals
- Packaging
- Countries you will sell in, and lemon balm’s status there
- First order and annual volume
💬 Ready to design a Japan-made lemon balm product? Send us the concept — amount, form, companion ingredients and the countries you will sell in.
Frequently asked questions
1. Does lemon balm reduce anxiety and improve sleep?
Small trials in patients with heart disease and in menopausal women with sleep disturbance found benefits on anxiety and sleep-related scores. These were patient populations, not the general public, and one trial used lemon balm combined with fennel extract rather than lemon balm alone.
2. Can a Japanese factory make a lemon balm product as a food?
Yes. Lemon balm leaf is on Japan’s list of substances not automatically judged to be medicines, so it can be used as a food ingredient provided no medicinal effect is claimed on the label.
3. Does Japan have a Foods with Function Claims notification for lemon balm?
This guide did not find a confirmed generic notification specifically for lemon balm. Its food-eligible status is separate from, and does not require, a Foods with Function Claims notification.
4. Is the menopause trial evidence about lemon balm alone?
No. That trial used a combination of lemon balm and fennel extract, so its result should not be described as a lemon balm monotherapy effect.
5. Which dosage form suits lemon balm best?
Tea, capsules, tablets and drink formats are all used; the choice mainly depends on whether you want a traditional tea-style product or a more concentrated capsule or tablet.
Sources: “The effects of Melissa officinalis supplementation on depression, anxiety, stress, and sleep disorder in patients with chronic stable angina”, Clin Nutr ESPEN 2018, PMID 29908682; “The Effectiveness of Melissa Officinalis L. versus Citalopram on Quality of Life of Menopausal Women with Sleep Disorder”, Rev Bras Ginecol Obstet 2021, PMID 33465795; Ministry of Health, Labour and Welfare, list of substances not judged to be medicines unless medicinal effects are claimed (食薬区分における成分本質の取扱いの例示), including lemon balm leaf. Checked on 25 September 2026.