CRN adopts new voluntary guidelines on melatonin and gummy supplements

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The Council for Responsible Nutrition (CRN; Washington, D.C.) announced the adoption of two sets of voluntary guidelines. The first set of guidelines are for the formulation, labeling, and packaging of melatonin-containing supplements, and the second is relates to the labeling of gummy dietary supplements. CRN’s board of directors adopted the guidelines on March 28, 2024.

In its melatonin guidelines, CRN has recommended that melatonin products carry cautionary label statements alerting consumers about the potential drowsiness, advising them not to consumer melatonin with alcohol, and that these products are intended for occasional use. Additionally, for packaging, CRN recommends child deterrent closures on melatonin products in flavored chewable formats, as they are more likely to be ingested mistakenly by children. With regard to formulation, CRN is also recommending that when manufacturers use an overage of melatonin, that it be informed by data to support stability and safety. Overages are necessary to ensure that the product contains at least 100% of the labeled amounts throughout its shelf life. CRN is not setting any limits but the recommendation ensures that the overage is applied with care, and has scientific rationale. CRN is asking members to adopt these guidelines within 18 months.

According to CRN’s president and CEO, Steve Mister, the melatonin guidelines were motivated by the recent negative press melatonin products have been receiving. For example, a recent paper raised concerns about the number of calls to poison control that had been made related to unintended melatonin consumption by kids. “It's clear to us that for whatever reason parents are very sensitive about melatonin and their kids accidentally getting into the melatonin, whether it's a pediatric product or an adult strength product, there does seem to be a lot of concern now. Now fortunately, most of those cases don't result in any real harm to the child,” explained Mister. “But our members were watching this and said, ‘We have a perception problem with consumers. We need to make sure that they know we're doing everything we can do to keep them safe.’”

For CRN’s gummy guidelines, the association is recommending targeted advisories aimed at both adults and children. These include specific considerations for gummy supplements intended for young children that underscore the importance of using the products under appropriate conditions and guidance. CRN is also recommending cautionary statements about the potential choking hazard of not chewing gummies properly, as well as child deterrent closures. CRN is asking member to adopt these guidelines for gummy supplements within 24 months.