CRN Adopts Guidelines for Responsible Melatonin Usage and Gummies
04.15.24
The new guidelines cover labeling, overages, child-deterrent packaging, and more.
The Council for Responsible Nutrition (CRN) has adopted two new sets of voluntary guidelines for melatonin products and gummy supplements, designed to promote the responsible formulation and use of these products.
The new guidelines, written to account for the unique aspects of these products, also make recommendations focused on labeling, child-deterrent packaging, and more.
CRN asked its membership and the broader industry to adopt these guidelines as soon as practicable, within a specific timeline to allow for a smooth transition.
Melatonin Guidelines
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.
While federal regulations require that dietary supplements contain at least 100% of their labeled amounts through shelf life, the guidelines recommend that any overages of melatonin added during manufacturing be informed by data to support stability and safety.
While federal regulations don’t 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 especially attractive to children. This recommendation could help prevent unsupervised access to these products.
CRN asked its membership to adopt these guidelines for melatonin supplements within 18 months.
Gummy Supplements
CRN recommended in its guidance for products aimed at both adults and children specific considerations for gummies.
For products intended for children under four years old, the guidelines recommend a precautionary statement that, if not chewed properly, the product could present a potential choking hazard.
The recommendations also ask manufacturers to consider packaging gummy products in containers with child-deterrent closures and evaluating various product attributes like ingredient profiles, serving amounts, and total package contents in their packaging choices.
CRN asked its members to adopt these guidelines within 24 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,” said Steve Mister, president and CEO of CRN. “By setting these high standards, we help our members offer products that are responsibly manufactured and marketed, and widely trusted by consumers.”
CRN’s full series of guidelines aims to enhance the safety and efficacy of dietary supplements and functional foods across various categories. These include guidelines for caffeine-containing supplements, enzymes dietary products, the provision of product information for e-commerce, products for pregnant and lactating women, and probiotics.
Other guidelines address complex areas such as proprietary blends, protein labeling, and a prohibition on SARMs-containing supplements.
CRN Members also must participate in the Supplement OWL, a voluntary label registry managed by CRN.
The new guidelines, written to account for the unique aspects of these products, also make recommendations focused on labeling, child-deterrent packaging, and more.
CRN asked its membership and the broader industry to adopt these guidelines as soon as practicable, within a specific timeline to allow for a smooth transition.
Melatonin Guidelines
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.
While federal regulations require that dietary supplements contain at least 100% of their labeled amounts through shelf life, the guidelines recommend that any overages of melatonin added during manufacturing be informed by data to support stability and safety.
While federal regulations don’t 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 especially attractive to children. This recommendation could help prevent unsupervised access to these products.
CRN asked its membership to adopt these guidelines for melatonin supplements within 18 months.
Gummy Supplements
CRN recommended in its guidance for products aimed at both adults and children specific considerations for gummies.
For products intended for children under four years old, the guidelines recommend a precautionary statement that, if not chewed properly, the product could present a potential choking hazard.
The recommendations also ask manufacturers to consider packaging gummy products in containers with child-deterrent closures and evaluating various product attributes like ingredient profiles, serving amounts, and total package contents in their packaging choices.
CRN asked its members to adopt these guidelines within 24 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,” said Steve Mister, president and CEO of CRN. “By setting these high standards, we help our members offer products that are responsibly manufactured and marketed, and widely trusted by consumers.”
CRN’s full series of guidelines aims to enhance the safety and efficacy of dietary supplements and functional foods across various categories. These include guidelines for caffeine-containing supplements, enzymes dietary products, the provision of product information for e-commerce, products for pregnant and lactating women, and probiotics.
Other guidelines address complex areas such as proprietary blends, protein labeling, and a prohibition on SARMs-containing supplements.
CRN Members also must participate in the Supplement OWL, a voluntary label registry managed by CRN.
