Melatonin As A Food Supplement: What The Label Should Tell You

Melatonin sits in an unusual regulatory space, and it is sold in India in more
than one form. Knowing which you are buying changes how you should use it.

Two routes to market

In India you will encounter melatonin in two contexts:

• As a nutraceutical or food supplement, sold online and in retail,
regulated by the FSSAI
• As a pharmaceutical preparation, dispensed through pharmacies and
regulated under drug rules
The distinction matters. A pharmaceutical preparation should be taken as
directed by a doctor or pharmacist. A food supplement is intended for selfdirected use within labelled guidance.
Melatonin's classification varies internationally — treated as a supplement in
some markets and as a prescription medicine in others. This inconsistency is a
common source of confusion when buying online from overseas.

What an FSSAI-licensed label should carry

• An FSSAI licence number, printed clearly on the pack
• The melatonin quantity per serving, stated in milligrams
• How many units constitute one serving
• A full ingredient list including excipients
• Manufacturer name and address, plus country of origin
• Batch number and expiry date
• Vegetarian or non-vegetarian mark, which is a legal requirement in India
• Any prescribed advisory or cautionary statements
The absence of an FSSAI number on a supplement sold in India is sufficient
reason not to buy it.

Why buying from overseas is risky

Melatonin products bought from international marketplaces are common in
India and carry real drawbacks.
• They may not carry Indian labelling or an FSSAI licence
• Doses are frequently much higher, since 5 mg and 10 mg dominate some
overseas markets
• Independent testing in several markets has repeatedly found melatonin
content differing substantially from the label
• Authenticity is harder to verify through grey-market channels
• Customs treatment of imported supplements can be inconsistent
A domestically licensed product at a sensible dose is a better purchase than an
imported one at a strength you did not need.

Reading the dose properly

Check whether the stated milligram figure is per tablet or per serving, and how
many tablets make a serving. A product advertising 10 mg may define that as
two 5 mg tablets.
Also check the release format. Immediate-release and extended-release
behave differently and suit different problems — onset versus maintenance.
And remember that most research supporting melatonin used doses at the
lower end. A higher label figure is not a quality indicator.

Combination products

Many Indian melatonin products combine it with other ingredients. Some
pairings have a coherent rationale:
• Magnesium — a genuine role in sleep-related pathways, and a sensible
companion
• L-theanine — reasonable evidence for relaxation without sedation
• Chamomile or valerian — traditional use, weaker and mixed clinical
evidence
• Vitamin B6 — participates in melatonin synthesis
Check that individual quantities are stated. 'Proprietary sleep blend' language
without a breakdown makes it impossible to know what you are taking, which
matters more than usual when one component is a hormone.

A buying checklist

• FSSAI licence number present
• Melatonin milligrams per serving stated clearly
• Serving size stated in units
• Manufacturer and country of origin named
• Full excipient list disclosed
• Vegetarian mark present
• Individual quantities for any combination ingredients
• A dose at the lower end unless you have a specific reason otherwise
This article is for general information and is not medical advice. Consult a
qualified doctor before starting melatonin, particularly if you take regular
medication.