Melatonin

Origin of Ingredient

produced by the pineal gland; supplement material is synthetic

History of Ingredient

Melatonin moved from food, biochemical or specialist use into modern supplements as purification, fermentation, extraction and standardisation technologies developed.

Scientific Makeup of Ingredient

N-acetyl-5-methoxytryptamine

UK Legal Claim

• Melatonin contributes to the alleviation of subjective feelings of jet lag.
• Melatonin contributes to the reduction of time taken to fall asleep. Conditions: Sleep-latency claim: 1 mg close to bedtime. Jet-lag claim: at least 0.5 mg per quantified portion, taken close to bedtime on the first day of travel and first few days at destination.

EU Legal Claim

• Melatonin contributes to the alleviation of subjective feelings of jet lag.
• Melatonin contributes to the reduction of time taken to fall asleep. Conditions: Sleep-latency claim: 1 mg close to bedtime. Jet-lag claim: at least 0.5 mg per quantified portion, taken close to bedtime on the first day of travel and first few days at destination.

US Legal Claim

FDA does not pre-approve ordinary dietary-supplement structure/function claims. Example for regulatory review only (NOT FDA-approved wording): “Supports restful sleep.” The marketer must hold substantiation, avoid disease claims, use the DSHEA disclaimer and notify FDA within 30 days after first marketing.

00:00:00

August 24, 2024

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