The Council for Responsible Nutrition is asking its members to adopt the voluntary guidelines—which include implementing child-deterrent packaging and clearer labeling—within 18 months.


Summary: The Council for Responsible Nutrition (CRN) has introduced new voluntary guidelines for melatonin supplements marketed for sleep support, emphasizing child-deterrent packaging and clearer labeling, to enhance consumer safety. These guidelines address issues such as overages during manufacturing and recommend cautionary label statements. CRN urges its members to adopt these guidelines within 18 months.

Key Takeaways: 

  • The Council for Responsible Nutrition has adopted new voluntary guidelines focused on the formulation, labeling, and packaging of melatonin-containing dietary supplements.
  • These guidelines include recommendations for cautionary label statements, addressing intentional overages during manufacturing, and implementing child-deterrent packaging to prevent unsupervised access by children.
  • The updated melatonin guidelines aim to ensure that consumers have access to products that are responsibly formulated, labeled, and packaged.

The Council for Responsible Nutrition (CRN), a trade association for the dietary supplement and functional food industry, has adopted new voluntary guidelines focused on the formulation, labeling, and packaging of melatonin-containing dietary supplements marketed for sleep support.

The updated melatonin guidelines provide recommendations addressing intentional overages during manufacturing, child-deterrent packaging, and precautionary label statements for melatonin-containing products. These guidelines are designed to ensure that consumers have access to products that are responsibly formulated, labeled, and packaged. 

Key Updated Recommendations for Melatonin Supplements:

  • 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.
  • Overages During Manufacturing: While recognizing that federal regulations require dietary supplement to contain at least 100 percent 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.
  • Child deterrent packaging: While 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. This recommendation provides parents and caregivers with a tool to prevent unsupervised access to these products.
  • CRN members are being asked to adopt these guidelines for melatonin-containing supplements within 18 months.

“These are just the latest in a series of voluntary guidelines that CRN members have adopted that underscore CRN’s unwavering commitment to the well-being of consumers and the integrity of the dietary supplement market,” says CRN president and CEO Steve Mister in a release. “By setting these high standards, we help our members offer products that are responsibly manufactured and marketed, and widely trusted by consumers.”

CRN urges its members and the broader industry to adopt these guidelines as soon as practicable, with specific implementation timelines provided for each set of guidelines to facilitate a smooth transition.

Additionally, CRN adopted another set of guidelines dedicated to the labeling of gummy dietary supplements

With the growing popularity of gummy dietary supplements among consumers of all ages, CRN’s new guidelines for gummy supplements specifically address the unique aspects of these products. The new recommendations focus on labeling clarity, reducing unsupervised access by children, addressing potential choking hazards for small children, and ensuring products are used as intended.

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