CRN Announces Melatonin Supplement Guidelines


The new guidelines set serving size recommendations and label advisories for melatonin supplements for sleep support.


The Council for Responsible Nutrition (CRN; Washington DC) announced on Tuesday its recommended guidelines for the labeling and formulation of sleep support dietary supplements containing melatonin.

A naturally occurring hormone that helps regulate sleep and wake cycles, melatonin is also a popular ingredient in dietary supplements used for sleep support. The new guidelines from CRN include serving size recommendations for melatonin supplements, label advisories for conditions of use, and a suggested implementation calendar.

In addition to complying with applicable labeling laws and regulations, CRN recommends that melatonin-containing supplements marketed for sleep support should be “formulated and labeled to provide not more than 10 milligrams of melatonin per day when used in accordance with the directions for use,” according to a press release.

The Institute of Medicine and Health Canada have both set 10 mg of melatonin or less as safe thresholds for daily, short-term use, says CRN.

CRN’s new melatonin guidelines also call for product labeling that includes the following statements or similar language:

·      Consult a healthcare professional:
     -   If you are experiencing long-term sleep difficulties.
     -   Before use in children.
     -   Before use in pregnant or nursing women, those with a medical condition, and those taking medication.

·      Do not drive or operate machinery when taking melatonin.

A task force of CRN members considered the guidelines for several months before CRN’s Board of Directors unanimously approved them at its June meeting. CRN recommends that dietary supplement companies comply with the recommendations by June 18, 2016, twelve months from when they became effective.

“With the current popularity and wide usage of melatonin supplements for sleep support, CRN wanted to clarify responsible labeling and marketing practices for its member companies, and for the industry, by developing science-based voluntary guidelines to help ensure these products best serve consumers safely,” said Andrea Wong, PhD, vice president, scientific and regulatory affairs, CRN. “CRN encourages all dietary supplement manufacturers and marketers to follow these recommendations.”

The melatonin guidelines are the latest of CRN’s proactive, self-regulatory initiatives, which already include guidelines for caffeine-containing dietary supplements, iodine quantity in multivitamin/mineral supplements for pregnancy and lactation, and labeling of protein in dietary supplements and functional foods.


Read more:

Cognitive Health, Dietary Supplements, and Sleep: Melatonin 

FDA Cracks Down on another Melatonin-Brownie Maker


Michael Crane
Associate Editor
Nutritional Outlook Magazine


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