APRIL 15, 2024
Two new CRN guidelines for melatonin-containing and gummy supplements recommended for private label and store brands too
Two new voluntary guidelines adopted by the Council for Responsible Nutrition (CRN) were announced today: one that provides recommendations for all supplements that contain melatonin, and another that addresses all gummy dietary supplements. Although directed toward CRN members, these voluntary programs are encouraged for adoption by all dietary supplement marketers, including private label and store brands who may not be members of CRN.
These guidelines add to the association’s robust self-regulatory framework designed to uphold the highest standards of consumer safety and product transparency in the dietary supplement marketplace:
Updated melatonin guidelines for melatonin-containing supplements for sleep support address:
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Serving Size: Recommended serving size should not exceed 10 mg melatonin per day when taken in accordance with directions for use.
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Labeling Instructions: The revised melatonin guidelines call for cautionary label statements alerting consumers that melatonin may cause drowsiness, not to take with alcohol, and that the products are intended for intermittent or occasional use only.
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Overages During Manufacturing: While recognizing that federal regulations require dietary supplement to contain at least 100% of their labeled amounts throughout shelf life, the guidelines recommend that any overages of melatonin added during manufacturing be informed by data to support stability and safety.
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Child deterrent packaging: Although federal regulations do not require child deterrent closures for melatonin-containing products, CRN’s revised guidelines call for industry members to adopt child deterrent packaging for products containing melatonin that are in flavored chewable forms that could be especially attractive to children.
CRN members are asked to adopt these guidelines for melatonin-containing supplements within 18 months.
New gummy dietary supplement guidelines aim to ensure these products are used as intended and to reduce childhood choking or unsupervised ingestion of these products. They include:
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Targeted Advisories: Detailed labeling advisories for products aimed at both adults and children include specific considerations for gummy supplements intended for young children, underscoring the importance of using these products under appropriate conditions and guidance.
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Avoiding Potential Choking Hazards: For products intended for children under four years of age, the guidelines recommend a precautionary statement that if not chewed properly, the product could present a potential choking hazard.
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Packaging Considerations: The recommendations ask manufacturers to consider packaging gummy products in containers with child deterrent closures by evaluating various product attributes like ingredient profiles, serving amounts, and total package contents, when making their packaging choices.
CRN members are asked to adopt these guidelines for gummy supplements within 24 months.
These guidelines reflect CRN members’ dedication to enhancing responsible marketing practices and ensuring the highest standards for consumer products.
“By setting these high standards, CRN helps our members offer products that are responsibly manufactured and marketed, and widely trusted by consumers,” said CRN President and CEO Steve Mister, “These are the latest in a series of guidelines CRN has issued that underscore our unwavering commitment to the well-being of consumers and the integrity of the dietary supplement market.”
CRN is urging the broader industry, along with its members, to adopt these guidelines as soon as practicable, with specific implementation timelines provided for each set of guidelines to facilitate a smooth transition.
