Melatonin Gummy Update — Rick Kingston response and other updates

May 3, 2023

Dear Colleagues —

We continue to follow the Pieter Cohen melatonin gummies issue. Here are updates of note:

1)  Rick Kingston (SafetyCall) provided this very helpful insight with regard to poison control centers and interpretation of reports of exposures. Thank you, Rick. This provides helpful context:

“It’s unfortunate that the reference to Poison Control Center calls did not provide context for the reported exposures.  In fact, when you look at the actual outcomes associated with exposure calls to poison control centers, the safety of melatonin becomes more evident.  As an example, in the most recently published poison control data from 2021, there were 54,669 single ingredient exposures reported and 44,868 were in children 5 years of age and under.  Although these numbers sound daunting, the medical outcomes for all reported melatonin exposures, including those involving adults, reveal that the vast majority of outcomes were minor in nature (9,449) or reported no adverse effects at all (up to 82.7%).  If you combine the minor effects with the no effect outcomes they account for 99.7% of all exposures.  As regards the number of reported exposures, it’s not uncommon for younger children to accidentally ingest a variety of substances that are inherently safe.  Parents may take them to emergency clinics out of an abundance of caution.  This is especially true when there are reports of exposures for a given substance and isolated incidents where more serious effects have been reported.  In these circumstances care givers may be more inclined to have the child checked out by a professional.  Despite those emergency room visits and other incidents that are managed at home, you need to look at the totality of the experience, including the medical outcomes.  When looking at melatonin, the exposure numbers are in favor of demonstrating safety, not unreasonable risk or injury.”

2)  This study has generated a tremendous amount of national media. The usual effect is to reinforce the impression that supplements are not regulated. This, in fact, may have been one of the motivations for this particular study. Given that, we are working with Pattern to evaluate the effect this study and associated news media may have had on sales of melatonin gummies on Amazon. This is one of the fairly rare events where we have a specific study tied to heavy media coverage where we can now evaluate the direct effect on sales through Pattern’s technology. We will report back on this by mid-May.

3)  Finally, we would propose to invite several experts on the manufacture of dietary supplement gummies to help our members understand the particular difficulty of manufacturing gummies in general and the challenge of establishing overages to meet expiration dates. The water activity of gummies is quite high, given their composition, which can lead to degradation of the dietary ingredients. This issue has been lost in the media coverage, and we feel it is important to raise the issue and also point out the continuing problem created by FDA’s requirement for 100% potency of listed dietary ingredients to the end of expiration date. We have heard from many members that this causes continuous problems in establishing overages and specifications, and UNPA’s position is to continue to seek a change of this requirement to both minimize the economic cost of overages and the complexity of trying to meet the 100% requirement.

We welcome your thoughts on any of the above.