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DMAA as a Dietary Ingredient

DMAA as a Dietary Ingredient DMAA (1,3-dimethylamylamine) is an aliphatic amine added to some dietary supplement (DS) products. We are responding to the Research Letter by Cohen,1 in which he discussed natural occurrence of DMAA, as well as labeling it a potent “amphetamine derivative” linked in case reports and the news media to adverse cardiovascular toxic effects. We would like to offer the following points in the interest of moving forward the discussion of the health effects of DMAA within the context of sound toxicological and risk assessment principles. We begin by correcting the assertion by Cohen1 that DMAA is an amphetamine derivative. DMAA is not synthesized from amphetamine or amphetamine-like compounds, nor does it possess a terminal benzyl constituent found in amphetamine and catechols that is needed to induce specific neurotransmitter release cascades, in addition to providing adrenergic neuronal stimulation. Cohen1 cited a Health Canada review that concluded there is no credible evidence of DMAA as a plant constituent. However, other studies not considered by Health Canada have reported confirmation of the presence of DMAA in the geranium plant (68-496 ng/g, Fleming et al2) and oil (14 ppb–13 ppm, Li et al3). Cohen1 discussed DMAA hazards by referencing case studies but did not consider the dose response for DMAA or multiple published clinical studies of the effects from DMAA intake levels recommended by a DS manufacturer. He cited cases of DMAA abuse that presented with cardiovascular pathologic conditions involving unknown or higher than DS label–recommended levels of DMAA consumption. Cohen1 mentioned 1 of 6 published clinical trials of volunteers consuming DMAA-containing products for up to 10 weeks4 but did not note that increases in observed blood pressure were approximately 15% above resting baseline levels and transient. None of the adverse effects reported in the case studies occurred during this or any of the other 5 clinical studies involving subjects consuming DMAA. The clinical studies also reported clinical chemical, hematologic, urinalysis, and metabolic panels indicating no effect on liver and renal function after extended use at recommended intake levels. Any discussion on the safety of DMAA in particular and DS in general is informative only if appropriate data weighting is used when comparing controlled experimental exposure studies with case reports of questionable estimates of DS intake. The call by Cohen1 for immediate recall of all DMAA-containing products is not based on data analysis using sound principles of risk assessment. Back to top Article Information Correspondence: Dr Rodricks, Environ International Corporation, 4350 Fairfax Dr, Ste 300, Arlington, VA. 22203 (jrodricks@environcorp.com). Conflict of Interest Disclosures: The authors' opinions in this letter arise following data analysis funded by USPLabs LLC. Drs Rodricks and Lumpkin provided interpretation of safety data for DMAA and DMAA-containing products. References 1. Cohen PA. DMAA as a dietary supplement ingredient. Arch Intern Med. 2012;172(13):1038-103922566490PubMedGoogle ScholarCrossref 2. Fleming HL, Ranaivo PL, Simone PS. Analysis and confirmation of 1,3-DMAA and 1,4-DMAA in geranium plants using high performance liquid chromatography with tandem mass spectrometry at ng/g concentrations. Anal Chem Insights. 2012;7:59-7823225994PubMedGoogle Scholar 3. Li JS, Chen M, Li ZC. Identification and quantification of dimethylamylamine in geranium by liquid chromatography tandem mass spectrometry. Anal Chem Insights. 2012;7:47-5822915838PubMedGoogle Scholar 4. Whitehead PN, Schilling BK, Farney TM, et al. Impact of a dietary supplement containing 1,3-dimethylamylamine on blood pressure and blood borne markers of health: a 10-week intervention study. Nutr Metab Insights. 2012;5:33-39Google Scholar http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA Internal Medicine American Medical Association

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Publisher
American Medical Association
Copyright
Copyright © 2013 American Medical Association. All Rights Reserved.
ISSN
2168-6106
eISSN
2168-6114
DOI
10.1001/jamainternmed.2013.2533
Publisher site
See Article on Publisher Site

Abstract

DMAA (1,3-dimethylamylamine) is an aliphatic amine added to some dietary supplement (DS) products. We are responding to the Research Letter by Cohen,1 in which he discussed natural occurrence of DMAA, as well as labeling it a potent “amphetamine derivative” linked in case reports and the news media to adverse cardiovascular toxic effects. We would like to offer the following points in the interest of moving forward the discussion of the health effects of DMAA within the context of sound toxicological and risk assessment principles. We begin by correcting the assertion by Cohen1 that DMAA is an amphetamine derivative. DMAA is not synthesized from amphetamine or amphetamine-like compounds, nor does it possess a terminal benzyl constituent found in amphetamine and catechols that is needed to induce specific neurotransmitter release cascades, in addition to providing adrenergic neuronal stimulation. Cohen1 cited a Health Canada review that concluded there is no credible evidence of DMAA as a plant constituent. However, other studies not considered by Health Canada have reported confirmation of the presence of DMAA in the geranium plant (68-496 ng/g, Fleming et al2) and oil (14 ppb–13 ppm, Li et al3). Cohen1 discussed DMAA hazards by referencing case studies but did not consider the dose response for DMAA or multiple published clinical studies of the effects from DMAA intake levels recommended by a DS manufacturer. He cited cases of DMAA abuse that presented with cardiovascular pathologic conditions involving unknown or higher than DS label–recommended levels of DMAA consumption. Cohen1 mentioned 1 of 6 published clinical trials of volunteers consuming DMAA-containing products for up to 10 weeks4 but did not note that increases in observed blood pressure were approximately 15% above resting baseline levels and transient. None of the adverse effects reported in the case studies occurred during this or any of the other 5 clinical studies involving subjects consuming DMAA. The clinical studies also reported clinical chemical, hematologic, urinalysis, and metabolic panels indicating no effect on liver and renal function after extended use at recommended intake levels. Any discussion on the safety of DMAA in particular and DS in general is informative only if appropriate data weighting is used when comparing controlled experimental exposure studies with case reports of questionable estimates of DS intake. The call by Cohen1 for immediate recall of all DMAA-containing products is not based on data analysis using sound principles of risk assessment. Back to top Article Information Correspondence: Dr Rodricks, Environ International Corporation, 4350 Fairfax Dr, Ste 300, Arlington, VA. 22203 (jrodricks@environcorp.com). Conflict of Interest Disclosures: The authors' opinions in this letter arise following data analysis funded by USPLabs LLC. Drs Rodricks and Lumpkin provided interpretation of safety data for DMAA and DMAA-containing products. References 1. Cohen PA. DMAA as a dietary supplement ingredient. Arch Intern Med. 2012;172(13):1038-103922566490PubMedGoogle ScholarCrossref 2. Fleming HL, Ranaivo PL, Simone PS. Analysis and confirmation of 1,3-DMAA and 1,4-DMAA in geranium plants using high performance liquid chromatography with tandem mass spectrometry at ng/g concentrations. Anal Chem Insights. 2012;7:59-7823225994PubMedGoogle Scholar 3. Li JS, Chen M, Li ZC. Identification and quantification of dimethylamylamine in geranium by liquid chromatography tandem mass spectrometry. Anal Chem Insights. 2012;7:47-5822915838PubMedGoogle Scholar 4. Whitehead PN, Schilling BK, Farney TM, et al. Impact of a dietary supplement containing 1,3-dimethylamylamine on blood pressure and blood borne markers of health: a 10-week intervention study. Nutr Metab Insights. 2012;5:33-39Google Scholar

Journal

JAMA Internal MedicineAmerican Medical Association

Published: Apr 8, 2013

Keywords: diet

References