Prohibited Stimulants in Dietary Supplements After Enforcement Action by the US Food and Drug Administration

doi:10.1001/jamainternmed.2018.4846

. 2018 Dec 1;178(12):1721-1723.

doi: 10.1001/jamainternmed.2018.4846.

Prohibited Stimulants in Dietary Supplements After Enforcement Action by the US Food and Drug Administration

Pieter A Cohen^{1

2}, Anita Wen³, Roy Gerona⁴

Affiliations

¹ Department of Medicine, Cambridge Health Alliance, Somerville, Massachusetts.
² Department of Medicine, Harvard Medical School, Boston, Massachusetts.
³ Department of Nutrition, University of California, Davis.
⁴ Clinical Toxicology and Environmental Biomonitoring Laboratory, University of California, San Francisco.

PMID: 30422217
PMCID: PMC6583602
DOI: 10.1001/jamainternmed.2018.4846

Prohibited Stimulants in Dietary Supplements After Enforcement Action by the US Food and Drug Administration

Pieter A Cohen et al. JAMA Intern Med. 2018.

. 2018 Dec 1;178(12):1721-1723.

doi: 10.1001/jamainternmed.2018.4846.

Authors

Pieter A Cohen^{1

2}, Anita Wen³, Roy Gerona⁴

Affiliations

¹ Department of Medicine, Cambridge Health Alliance, Somerville, Massachusetts.
² Department of Medicine, Harvard Medical School, Boston, Massachusetts.
³ Department of Nutrition, University of California, Davis.
⁴ Clinical Toxicology and Environmental Biomonitoring Laboratory, University of California, San Francisco.

PMID: 30422217
PMCID: PMC6583602
DOI: 10.1001/jamainternmed.2018.4846

Abstract

This analysis of dietary supplements purchased in 2014 and purchased again in 2017 examines whether stimulants that were initially present were still present after issuance of public notices by the US Food and Drug Administration to remove potentially hazardous ingredients.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Gerona and Dr Cohen were subjects of a civil suit brought by Hi-Tech Pharmaceuticals, a supplement company, regarding β-methylphenylethylamine; Dr Gerona’s case was dismissed and the jury found in Dr Cohen’s favor. Dr Cohen has collaborated in research with NSF International and received research support from Consumers Union. No other disclosures were reported.

Comment in

Regulating the Dietary Supplement Industry: The Taming of the Slew.
Incze M, Katz MH. Incze M, et al. JAMA Intern Med. 2018 Dec 1;178(12):1723. doi: 10.1001/jamainternmed.2018.5097. JAMA Intern Med. 2018. PMID: 30357259 No abstract available.

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References

1. Cohen PA, Bloszies C, Yee C, Gerona R. An amphetamine isomer whose efficacy and safety in humans has never been studied, β-methylphenylethylamine (BMPEA), is found in multiple dietary supplements. Drug Test Anal. 2016;8(3-4):328-333. doi:10.1002/dta.1793 - DOI - PubMed
1. US Food and Drug Administration Methylsynephrine in dietary supplements. April 2016. https://www.fda.gov/Food/DietarySupplements/ProductsIngredients/ucm49328.... Accessed May 15, 2018.
1. US Food and Drug Administration Stimulant potentially dangerous to health, FDA warns. April 11, 2013. https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm347270.htm. Accessed May 15, 2018.
1. US Food and Drug Administration DMBA in dietary supplements. April 2015. https://www.fda.gov/Food/DietarySupplements/ProductsIngredients/ucm44471.... Accessed May 15, 2018.
1. Harel Z, Harel S, Wald R, Mamdani M, Bell CM. The frequency and characteristics of dietary supplement recalls in the United States. JAMA Intern Med. 2013;173(10):929-930. doi:10.1001/jamainternmed.2013.379 - DOI - PubMed

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[1] Cohen PA, Bloszies C, Yee C, Gerona R. An amphetamine isomer whose efficacy and safety in humans has never been studied, β-methylphenylethylamine (BMPEA), is found in multiple dietary supplements. Drug Test Anal. 2016;8(3-4):328-333. doi:10.1002/dta.1793 - DOI - PubMed

[2] Cohen PA, Bloszies C, Yee C, Gerona R. An amphetamine isomer whose efficacy and safety in humans has never been studied, β-methylphenylethylamine (BMPEA), is found in multiple dietary supplements. Drug Test Anal. 2016;8(3-4):328-333. doi:10.1002/dta.1793 - DOI - PubMed

[3] US Food and Drug Administration Methylsynephrine in dietary supplements. April 2016. https://www.fda.gov/Food/DietarySupplements/ProductsIngredients/ucm49328.... Accessed May 15, 2018.

[4] US Food and Drug Administration Methylsynephrine in dietary supplements. April 2016. https://www.fda.gov/Food/DietarySupplements/ProductsIngredients/ucm49328.... Accessed May 15, 2018.

[5] US Food and Drug Administration Stimulant potentially dangerous to health, FDA warns. April 11, 2013. https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm347270.htm. Accessed May 15, 2018.

[6] US Food and Drug Administration Stimulant potentially dangerous to health, FDA warns. April 11, 2013. https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm347270.htm. Accessed May 15, 2018.

[7] US Food and Drug Administration DMBA in dietary supplements. April 2015. https://www.fda.gov/Food/DietarySupplements/ProductsIngredients/ucm44471.... Accessed May 15, 2018.

[8] US Food and Drug Administration DMBA in dietary supplements. April 2015. https://www.fda.gov/Food/DietarySupplements/ProductsIngredients/ucm44471.... Accessed May 15, 2018.

[9] Harel Z, Harel S, Wald R, Mamdani M, Bell CM. The frequency and characteristics of dietary supplement recalls in the United States. JAMA Intern Med. 2013;173(10):929-930. doi:10.1001/jamainternmed.2013.379 - DOI - PubMed

[10] Harel Z, Harel S, Wald R, Mamdani M, Bell CM. The frequency and characteristics of dietary supplement recalls in the United States. JAMA Intern Med. 2013;173(10):929-930. doi:10.1001/jamainternmed.2013.379 - DOI - PubMed

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Prohibited Stimulants in Dietary Supplements After Enforcement Action by the US Food and Drug Administration

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Prohibited Stimulants in Dietary Supplements After Enforcement Action by the US Food and Drug Administration

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Conflict of interest statement

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