Recalls, Availability, and Content of Dietary Supplements Following FDA Warning Letters

Cohen, Pieter A.; Avula, Bharathi; Katragunta, Kumar; Khan, Ikhlas A.

doi:10.1001/jama.2022.9734

Cited by 11 publications

(5 citation statements)

References 3 publications

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“…Despite the banning, BMPEA, a synthetic stimulant created as a potential substitute for amphetamine, has continuously been added to food supplements [54]. As a structural analogue of amphetamine, it is on the list of prohibited substances of the WADA, and analytical methods for its detection and differentiation from amphetamine in urine samples have been developed [45,55].…”

Section: Stimulantsmentioning

confidence: 99%

Notifications and Health Consequences of Unauthorized Pharmaceuticals in Food Supplements

Amidžić,

Banović Fuentes,

Banović

et al. 2023

Pharmacy

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Health concerns associated with the consumption of food supplements rise in parallel with the rise in the popularity and market availability of these products. In pursuit of data related to the unauthorized presence of pharmaceuticals in food supplements, the Rapid Alert System for Food and Feed (RASFF) database was searched for the 2011–2022 period. The most “popular” pharmaceuticals for the adulteration of food supplements were phosphodiesterase-5 inhibitors (235 records); anorexics and laxatives (76), including sibutramine and its active metabolite N-didesmethyl sibutramine, phenolphthalein and 2,4-dinitrophenol; stimulants, among which 1,3-dimethylamine (97), and synephrine (53) were the most numerous; nootropic drugs (24); anabolics and prohormones (16); and cannabinoid cannabidiol (14) (pending authorization as a novel food ingredient). Over 65% of notifications of interest were classified as serious risks, and over 80% of these were alert or border rejection notifications, mainly generated as a result of official control on the market. The alarming number of RASFF notifications should be considered a public health issue, demanding clear and targeted recommendation for action for the legislature and authorities. A harmonized nutrivigilance system should be considered as a tool to detect and scrutinize the adverse health effects of food supplements, along with measures to improve their safety, quality, and testing.

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Section: Stimulantsmentioning

confidence: 99%

Notifications and Health Consequences of Unauthorized Pharmaceuticals in Food Supplements

Amidžić,

Banović Fuentes,

Banović

et al. 2023

Pharmacy

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“…In a recent examination of 25 commercial supplements, actual melatonin quantity ranged from 74% to 347% of the labeled content. 3 Additionally, incidence of melatonin ingestion reported to poison control centers increased 530% from 2012 to 2021, 4 largely occurring among children younger than 5 years. Current data are lacking on the prevalence of melatonin use and the frequency, dosing, and timing of melatonin administration in US youth.…”

mentioning

confidence: 99%

Characteristics of Melatonin Use Among US Children and Adolescents

Hartstein,

Garrison,

Lewin

et al. 2024

JAMA Pediatr

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“…Previous studies have examined over-the-counter melatonin oral formulations (liquids, pills, tablets, and gummies) and found startling inconsistencies in the amount detected, up to almost five times the dosage listed on the label (Cohen, Avula, Wang, Katragunta, & Khan, 2023; Erland & Saxena, 2017). Dr. Teal’s lotions, bubble baths, and sprays have no information on the labels about the amount of melatonin in the products, how much of the products consumers should use, or how often consumers should use them.…”

Section: Discussionmentioning

confidence: 99%

Impact of an over-the-counter “sleep lotion” on salivary melatonin levels and sleep quality: a randomized controlled trial

Ponce,

Razon,

Chao

et al. 2023

Preprint

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Many over-the-counter products such as bubble baths, room sprays, and lotions claim they contain the pineal hormone melatonin and promote sleep. In this randomized, controlled, double-blind crossover trial we compared the impact of a commercial sleep lotion versus a placebo control lotion. Our sample of 63 undergraduate college students scored an average of 6.3 ± 2.7 on the Global Pittsburgh Sleep Quality Index, with 65% above the cutoff of 5 indicating poor sleep quality in the previous 30 days. Participants applied lotions on two different nights, one hour before bedtime. To assess whether melatonin was absorbed through the skin and circulating systemically, we conducted enzyme linked immunosorbent assays on saliva samples to quantitate melatonin levels. We also assessed sleep quality the night after lotion application with a modified Pittsburgh Sleep Quality Index. The melatonin-containing sleep lotion dramatically impacted salivary melatonin levels, increasing them up to ~1000 fold compared to the placebo control lotion. Sleep quality in the overall group was not impacted by the lotion, but in a subsample of the poor sleepers, the lotion improved sleep quality. High Performance Liquid Chromatography of the sleep lotion revealed the presence of 2.4 ± 0.1 mg melatonin/g lotion, or a 0.24 ± 0.01% formulation. Caution should be taken by consumers using over-the-counter melatonin lotions because the undisclosed dosage is high and well absorbed by the skin. Clinicaltrials.gov IDNCT06053385

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Recalls, Availability, and Content of Dietary Supplements Following FDA Warning Letters

Abstract: This study examines the frequency of product recalls and the presence of FDA-prohibited drugs in supplements after FDA warning letters.

Cited by 11 publications

References 3 publications

Notifications and Health Consequences of Unauthorized Pharmaceuticals in Food Supplements

Notifications and Health Consequences of Unauthorized Pharmaceuticals in Food Supplements

Characteristics of Melatonin Use Among US Children and Adolescents

Impact of an over-the-counter “sleep lotion” on salivary melatonin levels and sleep quality: a randomized controlled trial

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