Presenter Information

Rahul Pawar, FDAFollow

Document Type

Oral Presentation

Location

Oxford Convention Center, 102 Ed Perry Boulevard Oxford, MS 38655

Event Website

https://oxfordicsb.org/

Start Date

15-4-2024 2:15 PM

End Date

15-4-2024 2:30 PM

Description

In the United States, melatonin products are widely available to consumers as dietary supplements. During the past few decades, melatonin products have gained increased popularity primarily as a sleep aid, with a variety of product forms available for different age groups of consumers. Recent reports have highlighted a rise in melatonin ingestion among children reported to poison control centers across the U.S. The increased use of melatonin-containing dietary supplements and reported deviation from labeled quantities has emphasized the need for additional research to better understand products in the marketplace.
The objective of this work was to measure the melatonin content in products sold as dietary supplements and targeted towards children, evaluate if the analytical method is accurate across different product forms and to determine if product forms have an impact on melatonin stability. From a list of 200 products identified through searches on internet and dietary supplement databases, 110 products were randomly selected for the study. Melatonin concentration and percent label claim was evaluated to inform safety assessments and investigate potential factors for underreported concentrations, including product stability and matrix influences. Sample preparation was optimized for analyte extraction from diverse product types such as gummies, liquids, and tablets using a Quick, Easy, Cheap, Effective, Rugged, and Safe (QuEChERS) procedure with identification by liquid chromatography-tandem mass spectrometry (LC-MS/MS). The targeted method was validated for the qualitative determination of serotonin and quantification of melatonin, N1-acetyl-N2-formyl-5-methoxykynuramine (AFMK), and N1-acetyl-5-methoxykynuramine (AMK) in dietary supplements labeled to contain melatonin and applied to product analysis. Although the first step in this study was the quantification of melatonin and evaluation of label claim, initial results on product stability will also be discussed. In the United States, melatonin products are widely available to consumers as dietary supplements. During the past few decades, melatonin products have gained increased popularity primarily as a sleep aid, with a variety of product forms available for different age groups of consumers. Recent reports have highlighted a rise in melatonin ingestion among children reported to poison control centers across the U.S. The increased use of melatonin-containing dietary supplements and reported deviation from labeled quantities has emphasized the need for additional research to better understand products in the marketplace.
The objective of this work was to measure the melatonin content in products sold as dietary supplements and targeted towards children, evaluate if the analytical method is accurate across different product forms and to determine if product forms have an impact on melatonin stability. From a list of 200 products identified through searches on internet and dietary supplement databases, 110 products were randomly selected for the study. Melatonin concentration and percent label claim was evaluated to inform safety assessments and investigate potential factors for underreported concentrations, including product stability and matrix influences. Sample preparation was optimized for analyte extraction from diverse product types such as gummies, liquids, and tablets using a Quick, Easy, Cheap, Effective, Rugged, and Safe (QuEChERS) procedure with identification by liquid chromatography-tandem mass spectrometry (LC-MS/MS). The targeted method was validated for the qualitative determination of serotonin and quantification of melatonin, N1-acetyl-N2-formyl-5-methoxykynuramine (AFMK), and N1-acetyl-5-methoxykynuramine (AMK) in dietary supplements labeled to contain melatonin and applied to product analysis. Although the first step in this study was the quantification of melatonin and evaluation of label claim, initial results on product stability will also be discu

Publication Date

April 2024

Accessibility Status

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Apr 15th, 2:15 PM Apr 15th, 2:30 PM

A survey of melatonin in dietary supplement products sold in the U.S.

Oxford Convention Center, 102 Ed Perry Boulevard Oxford, MS 38655

In the United States, melatonin products are widely available to consumers as dietary supplements. During the past few decades, melatonin products have gained increased popularity primarily as a sleep aid, with a variety of product forms available for different age groups of consumers. Recent reports have highlighted a rise in melatonin ingestion among children reported to poison control centers across the U.S. The increased use of melatonin-containing dietary supplements and reported deviation from labeled quantities has emphasized the need for additional research to better understand products in the marketplace.
The objective of this work was to measure the melatonin content in products sold as dietary supplements and targeted towards children, evaluate if the analytical method is accurate across different product forms and to determine if product forms have an impact on melatonin stability. From a list of 200 products identified through searches on internet and dietary supplement databases, 110 products were randomly selected for the study. Melatonin concentration and percent label claim was evaluated to inform safety assessments and investigate potential factors for underreported concentrations, including product stability and matrix influences. Sample preparation was optimized for analyte extraction from diverse product types such as gummies, liquids, and tablets using a Quick, Easy, Cheap, Effective, Rugged, and Safe (QuEChERS) procedure with identification by liquid chromatography-tandem mass spectrometry (LC-MS/MS). The targeted method was validated for the qualitative determination of serotonin and quantification of melatonin, N1-acetyl-N2-formyl-5-methoxykynuramine (AFMK), and N1-acetyl-5-methoxykynuramine (AMK) in dietary supplements labeled to contain melatonin and applied to product analysis. Although the first step in this study was the quantification of melatonin and evaluation of label claim, initial results on product stability will also be discussed. In the United States, melatonin products are widely available to consumers as dietary supplements. During the past few decades, melatonin products have gained increased popularity primarily as a sleep aid, with a variety of product forms available for different age groups of consumers. Recent reports have highlighted a rise in melatonin ingestion among children reported to poison control centers across the U.S. The increased use of melatonin-containing dietary supplements and reported deviation from labeled quantities has emphasized the need for additional research to better understand products in the marketplace.
The objective of this work was to measure the melatonin content in products sold as dietary supplements and targeted towards children, evaluate if the analytical method is accurate across different product forms and to determine if product forms have an impact on melatonin stability. From a list of 200 products identified through searches on internet and dietary supplement databases, 110 products were randomly selected for the study. Melatonin concentration and percent label claim was evaluated to inform safety assessments and investigate potential factors for underreported concentrations, including product stability and matrix influences. Sample preparation was optimized for analyte extraction from diverse product types such as gummies, liquids, and tablets using a Quick, Easy, Cheap, Effective, Rugged, and Safe (QuEChERS) procedure with identification by liquid chromatography-tandem mass spectrometry (LC-MS/MS). The targeted method was validated for the qualitative determination of serotonin and quantification of melatonin, N1-acetyl-N2-formyl-5-methoxykynuramine (AFMK), and N1-acetyl-5-methoxykynuramine (AMK) in dietary supplements labeled to contain melatonin and applied to product analysis. Although the first step in this study was the quantification of melatonin and evaluation of label claim, initial results on product stability will also be discu

https://egrove.olemiss.edu/icsb/2024_ICSB/Schedule/7