An Analysis for Adulteration and Contamination of Over-the-Counter Weight-Loss Products

Abstract

Six Australian and five overseas complementary medicines (CM) and meal replacement shake products were analysed for potential adulteration with two common active pharmaceutical ingredients, caffeine and sibutramine, using thin-layer chromatography and mass spectrometry. The declared amount of caffeine in each product was also reviewed. Finally, the products were examined for heavy metal contamination using inductively coupled plasma-mass spectrometry. The results showed that there was no detected adulteration of either caffeine (for those products that did not list caffeine as an ingredient) or sibutramine in the 11 products; however, based on the product labels, one Australian and one overseas (two in total) CM product contained more than the maximum daily safety limit (400 mg) of caffeine. Potentially excessive lead and/or chromium was detected in six products, including four Australian products and two products purchased online. One Australian CM product appeared to contain these heavy metals at concentrations at, or exceeding, the safety limits specified in the United States Pharmacopeia or set by the World Health Organization. The overconsumption of caffeine and heavy metals has the potential of causing significant health effects in consumers.

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Correspondence to Nial J. Wheate.

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Wong, P.H.B., Harnett, J.E., Clases, D. et al. An Analysis for Adulteration and Contamination of Over-the-Counter Weight-Loss Products. AAPS PharmSciTech 22, 78 (2021). https://doi.org/10.1208/s12249-021-01946-7

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Key Words

  • adulteration
  • heavy metal
  • contamination
  • complementary medicine
  • patient safety