IN THE NEWS

Melatonin: Are There New Labeling Requirements for Dietary Supplements?

Headlines are making waves in the major online media outlets regarding the labeling of melatonin supplements. Some information is accurate, and some may be misleading.

The Council for Responsible Nutrition (CRN), a leading association for the dietary supplements and functional food industry, adopted two sets of voluntary guidelines for supplements on March 28, 2024, with a press release published on April 15, 2024, on this topic.

The two new voluntary guidelines are focused on:

1. The formulation, labeling, and packaging of melatonin-containing dietary supplements that are marketed for sleep support.

2. The labeling of gummy dietary supplements.

These guidelines are an addition to a plethora of other voluntary guidelines and best practices the CRN has developed for the supplement industry. All the guidelines established by the CRN are designed to ensure the highest of standards for supplements and speak to their commitment to the consumers purchasing them.

Guideline #1- Formulation, labeling, and packaging of melatonin

The CRN established these voluntary guidelines, proposing that their CRN members adopt the guidelines within 18 months, which include:

1. Enhanced labeling instructions, including that melatonin may cause drowsiness, should not be taken with alcohol, and is intended for occasional or intermittent use.

2. Disclosure of additional amounts of melatonin beyond the listed label amount that may be added to support stability and safety.

3. Child-deterrent packaging, especially on products that are flavored chewable forms and most appealing to children.

Guideline #2- Labeling of gummy dietary supplements

The CRN established these voluntary guidelines that are designed for all gummy supplements and are not inclusive of only melatonin gummy supplements. They are proposing that their CRN members adopt the guidelines within 24 months, which include:

1. Targeted advisory, using the products with appropriate guidance for an appropriate condition.

2. Avoiding potential choking hazards, specifically for products intended for use in children under the age of 4.

3. Updated packaging to be child deterrent

To read more about the Council for Responsible Nutrition’s voluntary guidelines on melatonin and other supplements, visit: https://crnusa.org/self-regulation/voluntary-guidelines-best-practices

SNHI’s commitment to consumer safety

Symphony Natural Health Institute (SNHI) has reported on the top five concerns of gummy melatonin supplements which was followed up with another post when the safety of melatonin gummies made the news again in April 2023, along with reporting on the overall safety of melatonin for children.

Furthermore, there is additional, evidence-based information on melatonin use for when it may be indicated for children, such as in autism and ADHD. Overall safety of melatonin use in the pediatric population is also available.

​

By Kim Ross, DCN

Reviewed by Deanna Minich, PhD

April 17, 2024