Melatonin
Hormone regulating sleep-wake cycles. No FDA-established RDI; declared as "† Daily Value not established" on Supplement Facts labels.
FDA Reference Data
About Melatonin
Melatonin is a hormone naturally produced by the pineal gland. As a dietary supplement ingredient, it has no FDA-established Reference Daily Intake (RDI). On Supplement Facts labels, melatonin amounts are declared in mg with the † symbol, and the legend "Daily Value not established" appears at the bottom of the panel per FDA 21 CFR 101.36(b)(2)(iii). Typical supplement doses range from 0.3 mg (low-dose, physiologic) to 10 mg (high-dose, sleep aid). Per 21 CFR 101.36(b)(2)(iii) rounding rules, melatonin < 10 mg rounds to 0.1 mg; ≥ 10 mg rounds to 1 mg.
Common Supplement Forms
Frequently Asked Questions
Why does melatonin show "†" instead of %DV on Supplement Facts labels?
The FDA has not established a Reference Daily Intake (RDI) for melatonin. Per 21 CFR 101.36(b)(2)(iii), supplement ingredients without an established RDI must display the † symbol next to the declared amount, and the legend "Daily Value not established" must appear at the bottom of the Supplement Facts panel. This indicates the ingredient is intentionally declared without a %DV value.
What is a typical melatonin dose on a Supplement Facts label?
Common supplement doses range from 0.3 mg (physiologic dose, mimics natural production) to 10 mg (sleep aid dose). The FDA does not restrict maximum melatonin dose in dietary supplements, but practitioners typically recommend starting with the lowest effective dose (0.3-1 mg) 30-60 minutes before bedtime.
What are the FDA rounding rules for melatonin?
Per 21 CFR 101.36(b)(2)(iii): melatonin < 10 mg rounds to the nearest 0.1 mg (e.g., 1.45 mg → 1.5 mg); ≥ 10 mg rounds to the nearest 1 mg (e.g., 10.4 mg → 10 mg). Trailing zeros (e.g., "3.0 mg") are non-compliant unless aligned with the rounding increment.
Can melatonin be combined with other sleep-support ingredients?
Yes. Melatonin is frequently combined with L-Theanine, Chamomile, Passion Flower, Valerian, or GABA in sleep-support formulas. When combined as a proprietary blend per 21 CFR 101.36(b)(3), constituents must be listed in descending order by weight with only the total blend weight shown. ReguSift's Sleep Support template demonstrates this formatting.
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Building a supplement with Melatonin?
ReguSift extracts ingredients from your COA, calculates %DV, formats proprietary blends, and generates a print-ready Supplement Facts label — including Melatonin auto-formatted per FDA 21 CFR 101.36.