Preprint / Version 1

Sceletium for Managing Anxiety, Depression and Cognitive Impairment:A Traditional Herbal Medicine in Modern-Day Regulatory Systems

Authors

  • Thomas Brendler Department of Botany and Plant Biotechnology, University of Johannesburg, Johannesburg, South Africa; 2Plantaphile, Collingswood NJ, USA; 3Traditional Medicinals Inc., Rohnert Park CA, USA; 4Parceval (Pty) Ltd., Wellington, South Africa; 5Dr. Nigel Gericke Consulting, Damianweg 9, Baden 5400, Switzerland; 6Complementary Medicines Australia, PO Box 450 Mawson ACT 2607, Australia; 7Murmansk Marine Biological Institute of the Russian Academy of Sciences (MMBI RAS), Murmansk, Russia; 8Saint-Petersburg State Chemical Pharmaceutical University, 14a, Prof. Popov, Saint-Petersburg, Russia; 9National Center for Natural Products Research, University of Mississippi, USA; 10National Institute of Complementary Medicine, Western Sydney University, Australia
  • Josef Brinckmann Department of Botany and Plant Biotechnology, University of Johannesburg, Johannesburg, South Africa; 2Plantaphile, Collingswood NJ, USA; 3Traditional Medicinals Inc., Rohnert Park CA, USA; 4Parceval (Pty) Ltd., Wellington, South Africa; 5Dr. Nigel Gericke Consulting, Damianweg 9, Baden 5400, Switzerland; 6Complementary Medicines Australia, PO Box 450 Mawson ACT 2607, Australia; 7Murmansk Marine Biological Institute of the Russian Academy of Sciences (MMBI RAS), Murmansk, Russia; 8Saint-Petersburg State Chemical Pharmaceutical University, 14a, Prof. Popov, Saint-Petersburg, Russia; 9National Center for Natural Products Research, University of Mississippi, USA; 10National Institute of Complementary Medicine, Western Sydney University, Australia
  • Ulrich Feiter Department of Botany and Plant Biotechnology, University of Johannesburg, Johannesburg, South Africa; 2Plantaphile, Collingswood NJ, USA; 3Traditional Medicinals Inc., Rohnert Park CA, USA; 4Parceval (Pty) Ltd., Wellington, South Africa; 5Dr. Nigel Gericke Consulting, Damianweg 9, Baden 5400, Switzerland; 6Complementary Medicines Australia, PO Box 450 Mawson ACT 2607, Australia; 7Murmansk Marine Biological Institute of the Russian Academy of Sciences (MMBI RAS), Murmansk, Russia; 8Saint-Petersburg State Chemical Pharmaceutical University, 14a, Prof. Popov, Saint-Petersburg, Russia; 9National Center for Natural Products Research, University of Mississippi, USA; 10National Institute of Complementary Medicine, Western Sydney University, Australia
  • Nigel Gericke Department of Botany and Plant Biotechnology, University of Johannesburg, Johannesburg, South Africa; 2Plantaphile, Collingswood NJ, USA; 3Traditional Medicinals Inc., Rohnert Park CA, USA; 4Parceval (Pty) Ltd., Wellington, South Africa; 5Dr. Nigel Gericke Consulting, Damianweg 9, Baden 5400, Switzerland; 6Complementary Medicines Australia, PO Box 450 Mawson ACT 2607, Australia; 7Murmansk Marine Biological Institute of the Russian Academy of Sciences (MMBI RAS), Murmansk, Russia; 8Saint-Petersburg State Chemical Pharmaceutical University, 14a, Prof. Popov, Saint-Petersburg, Russia; 9National Center for Natural Products Research, University of Mississippi, USA; 10National Institute of Complementary Medicine, Western Sydney University, Australia
  • Lucy Lang Department of Botany and Plant Biotechnology, University of Johannesburg, Johannesburg, South Africa; 2Plantaphile, Collingswood NJ, USA; 3Traditional Medicinals Inc., Rohnert Park CA, USA; 4Parceval (Pty) Ltd., Wellington, South Africa; 5Dr. Nigel Gericke Consulting, Damianweg 9, Baden 5400, Switzerland; 6Complementary Medicines Australia, PO Box 450 Mawson ACT 2607, Australia; 7Murmansk Marine Biological Institute of the Russian Academy of Sciences (MMBI RAS), Murmansk, Russia; 8Saint-Petersburg State Chemical Pharmaceutical University, 14a, Prof. Popov, Saint-Petersburg, Russia; 9National Center for Natural Products Research, University of Mississippi, USA; 10National Institute of Complementary Medicine, Western Sydney University, Australia
  • Olga Pozharitskaya Department of Botany and Plant Biotechnology, University of Johannesburg, Johannesburg, South Africa; 2Plantaphile, Collingswood NJ, USA; 3Traditional Medicinals Inc., Rohnert Park CA, USA; 4Parceval (Pty) Ltd., Wellington, South Africa; 5Dr. Nigel Gericke Consulting, Damianweg 9, Baden 5400, Switzerland; 6Complementary Medicines Australia, PO Box 450 Mawson ACT 2607, Australia; 7Murmansk Marine Biological Institute of the Russian Academy of Sciences (MMBI RAS), Murmansk, Russia; 8Saint-Petersburg State Chemical Pharmaceutical University, 14a, Prof. Popov, Saint-Petersburg, Russia; 9National Center for Natural Products Research, University of Mississippi, USA; 10National Institute of Complementary Medicine, Western Sydney University, Australia
  • Alexander Shikov Department of Botany and Plant Biotechnology, University of Johannesburg, Johannesburg, South Africa; 2Plantaphile, Collingswood NJ, USA; 3Traditional Medicinals Inc., Rohnert Park CA, USA; 4Parceval (Pty) Ltd., Wellington, South Africa; 5Dr. Nigel Gericke Consulting, Damianweg 9, Baden 5400, Switzerland; 6Complementary Medicines Australia, PO Box 450 Mawson ACT 2607, Australia; 7Murmansk Marine Biological Institute of the Russian Academy of Sciences (MMBI RAS), Murmansk, Russia; 8Saint-Petersburg State Chemical Pharmaceutical University, 14a, Prof. Popov, Saint-Petersburg, Russia; 9National Center for Natural Products Research, University of Mississippi, USA; 10National Institute of Complementary Medicine, Western Sydney University, Australia
  • Michael Smith Department of Botany and Plant Biotechnology, University of Johannesburg, Johannesburg, South Africa; 2Plantaphile, Collingswood NJ, USA; 3Traditional Medicinals Inc., Rohnert Park CA, USA; 4Parceval (Pty) Ltd., Wellington, South Africa; 5Dr. Nigel Gericke Consulting, Damianweg 9, Baden 5400, Switzerland; 6Complementary Medicines Australia, PO Box 450 Mawson ACT 2607, Australia; 7Murmansk Marine Biological Institute of the Russian Academy of Sciences (MMBI RAS), Murmansk, Russia; 8Saint-Petersburg State Chemical Pharmaceutical University, 14a, Prof. Popov, Saint-Petersburg, Russia; 9National Center for Natural Products Research, University of Mississippi, USA; 10National Institute of Complementary Medicine, Western Sydney University, Australia
  • Ben-Erik Wyk Department of Botany and Plant Biotechnology, University of Johannesburg, Johannesburg, South Africa; 2Plantaphile, Collingswood NJ, USA; 3Traditional Medicinals Inc., Rohnert Park CA, USA; 4Parceval (Pty) Ltd., Wellington, South Africa; 5Dr. Nigel Gericke Consulting, Damianweg 9, Baden 5400, Switzerland; 6Complementary Medicines Australia, PO Box 450 Mawson ACT 2607, Australia; 7Murmansk Marine Biological Institute of the Russian Academy of Sciences (MMBI RAS), Murmansk, Russia; 8Saint-Petersburg State Chemical Pharmaceutical University, 14a, Prof. Popov, Saint-Petersburg, Russia; 9National Center for Natural Products Research, University of Mississippi, USA; 10National Institute of Complementary Medicine, Western Sydney University, Australia

Keywords:

Mesembryanthemum tortuosum, sceletium, anxiety, depression, regulations

Abstract

Modern-day regulatory systems governing conditions for how health products enter national markets constitute a barrier of access for traditional herbal medicines on an international level. Regulatory intentions are focused on ensuring that consumers are being provided with safe, efficacious and high-quality products that, however, collaterally limit opportunities for traditional herbal medicinal products, especially those that do not already have a long-standing tradition of use established in the respective national marketplaces. This case study investigates and compares how a Southern African herbal medicine with great potential as an anxiolytic and mild antidepressant - Mesembryanthemum tortuosum L. [syn. Sceletium tortuosum (L.) N.E.Br.] aerial parts - fares internationally in today’s regulatory environments. It is argued that inadvertent regulatory favoritism combined with the lack of means for adequate protection of intellectual property may obstruct innovation by creating an almost insurmountable economical hurdle for successful product development and introduction of botanicals from developing countries into most of the world’s health product markets. Keywords: Mesembryanthemum tortuosum, sceletium, anxiety, depression, regulations

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