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REVIEW article

Front. Pharmacol.
Sec. Ethnopharmacology
Volume 15 - 2024 | doi: 10.3389/fphar.2024.1426210
This article is part of the Research Topic Global Excellence in Ethnopharmacology: North and South America View all 5 articles

A U.S. Pharmacopeia (USP) Overview of Pan American Botanicals Used in Dietary Supplements and Herbal Medicines

Provisionally accepted
Roy Upton Roy Upton 1*Ignacio Agudelo Ignacio Agudelo 2*Yadira Cabrera Yadira Cabrera 3*Armando Caceres Armando Caceres 4Angela Calderon Angela Calderon 5Fernando Calzada Fernando Calzada 6*Rosa Camacho Rosa Camacho 7*Fernando Da Costa Fernando Da Costa 8Cecilia Dobrecky Cecilia Dobrecky 9*Roberto Enciso Roberto Enciso 10*Marcela Escobar Marcela Escobar 11Mina Fakhary Mina Fakhary 12Edward Fletcher Edward Fletcher 13Quanyin Gao Quanyin Gao 14*Olga Lock Olga Lock 15*Rachel Mata Rachel Mata 16Mirtha Parada Mirtha Parada 17*Wilmer Perera Wilmer Perera 18Luis M. Pombo Luis M. Pombo 19Eike Reich Eike Reich 20Eric Sanchez Eric Sanchez 21*Mario J. Simirgiotis Mario J. Simirgiotis 22Christian Sood Christian Sood 23*Virginie T. Amiguet Virginie T. Amiguet 24*Martha Villar Martha Villar 25*Ricardo Ghelman Ricardo Ghelman 26*MARIANA C. SCHVEITZER MARIANA C. SCHVEITZER 26Caio F. Schlechta Portella Caio F. Schlechta Portella 26Adriana Wolffenbüttel Adriana Wolffenbüttel 26*Bettina Ruppelt Bettina Ruppelt 26*Fabiana Souza Frickmann Fabiana Souza Frickmann 26*Jannette Gavillan-Suarez Jannette Gavillan-Suarez 27Kristin Allen Kristin Allen 28*Luis D. Alvarado Luis D. Alvarado 29*Nandakumara Sarma Nandakumara Sarma 30*Robin Marles Robin Marles 31*Maria Monagas Maria Monagas 30*Mirtha Navarro-Hoyos Mirtha Navarro-Hoyos 29*
  • 1 American Herbal Pharmacopoeia, Scotts Valley, California, United States
  • 2 Facultad de Farmacia y Bioquímica. Departamento de Farmacología. Cátedra de Farmacobotánica. Universidad de Buenos Aires, Buenos Aires, Argentina
  • 3 Ministerio de Salud Publica del Ecuador, Cuenca, Ecuador
  • 4 Laboratorios Farmaya, Ciudad de Guatemala, Guatemala
  • 5 Department of Drug Discovery and Development, Harrison College of Pharmacy, Auburn University, Auburn, AL, United States
  • 6 Unidad de Investigación Médica en Farmacología, UMAE Hospital de Especialidades 2° Piso CORSE. Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social, Cuidad de Mexico, Mexico
  • 7 Direccion General de Medicamentos, Insumos y Drogas (DIGEMID), Ministerio de Salud Publica del Peru, Lima, Peru
  • 8 Faculdade de Ciencias Farmaceuticas de Ribeirao Preto, Universidad de Sao Paulo, Ribeirao Preto, San Pablo, Brazil
  • 9 Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica. Cátedra de Tecnología Farmacéutica I, Buenos Aires, Argentina
  • 10 Farmacopea de los Estados Unidos Mexicanos, Cuidad de Mexico, Mexico
  • 11 Facultad de Farmacia, Universidad de Valparaiso, Valparaiso, Chile
  • 12 Pharmavite LLC, Valencia, CA, United States
  • 13 Native Botanicals Inc., Banner Elk, NC, United States
  • 14 Herbalife, Quality Control Labs, Los Angeles, CA, United States
  • 15 Federacion Latinoamericana de Asociaciones Quimicas (FLAQ), Lima, Peru
  • 16 Facultad de Quimica, Universidad Autonoma de Mexico (UNAM), Cuidad de Mexico, Mexico
  • 17 Agencia Nacional de Medicamentos (ANAMED), Instituto de Salud Publica de Chile, Gran Santiago, Chile
  • 18 CAMAG Scientific Inc., Wilmington, NC, United States
  • 19 Centro de Investigacion Fundacion Universitaria Juan N. Corpas, Bogota, Colombia
  • 20 CAMAG Laboratory, Muttenz, Switzerland
  • 21 Medical Sciences Campus, University of Puerto Rico, San Juan, Puerto Rico
  • 22 Instituto de Farmacia, Facultad de Ciencias, Universidad Austral de Chile, Valdivia, Chile
  • 23 The Reena Group, Mississauga, Canada
  • 24 Health Canada, Ottawa, Ontario, Canada
  • 25 CICMEC, Gerencia de Medicina Complementaria, Seguro Social de Salud-EsSalud and Departamento de Medicina Preventiva y Salud Pública, Facultad de Medicina, Universidad Mayor de San Marcos, Lima, Peru
  • 26 Natural Products Committee of the Brazilian Academic Consortium or Integrative Health (CABSIN), San Pablo, Brazil
  • 27 TRAMIL Program, San Jose, Puerto Rico
  • 28 Department of Drug Discovery and Development, Harrison School of Pharmacy, Auburn University, Auburn, Alabama, United States
  • 29 Bioactivity & Sustainable Development (BIODESS) Group, Department of Chemistry, University of Costa Rica (UCR), San Jose, Costa Rica
  • 30 United States Pharmacopeial Convention (USP). Dietary Supplements and Herbal Medicines, Rockville, MD, United States
  • 31 United States Pharmacopeia (USP) Botanical Dietary Supplements and Herbal Medicines Expert Committee, United States Pharmacopeia (USP), Rokcville, MD, United States

The final, formatted version of the article will be published soon.

    The United States Pharmacopeial Convention (USP) is a nonprofit, scientific, standard-setting organization, and world leader in establishing quality, purity, and testing standards for medicines, foods, and dietary supplements. USP quality standards are used in more than 140 countries and are legally recognized by more than 40 countries. Currently, there is renewed interest in herbal medicines globally, and health policies are being implemented worldwide for the use of complementary and traditional medicine. In response, USP has developed a robust body of monographs that can be used to guide industry and regulators in ensuring the quality and safety of botanical ingredients used in dietary supplements and herbal medicines. Throughout the Pan American regions, there is a strong tradition of using botanicals as herbal medicines and, as in other regions, a growing desire for botanical dietary supplements. This underscores the need for public quality standards to ensure quality, reduce the flow of substandard and adulterated products, and ensure public health and safety. In April 2022, USP launched the Pan America Botanical Dietary Supplements and Herbal Medicines Expert Panel, with experts representing 12 different countries. The Expert Panel's work focuses on developing quality control standards for the most important botanical ingredients used in the respective countries, ingredients that are also of global importance. This article provides an overview of the state of botanical dietary supplements and herbal medicines in different Pan American regions with a focus on the regulatory status of herbal products, the development of national quality and research initiatives, and policies related to agriculture conservation and sustainability, among other topics.Pharmacopeias are officially recognized sources of quality standards for identity, strength, purity, and limits of contaminants for ingredients and preparations used as medicines. Until approximately the 1930s, the majority of medicines formally accepted in medical practice throughout most of the world were derived from botanical ingredients. These medicines comprised a mix of crude Galenical preparations (teas, pills, tinctures, syrups, etc.) and substances isolated from plants (e.g., digitalis glycosides). Even today, the majority of the global population utilizes

    Keywords: botanicals, Dietary Supplements, Standards, quality, herbal medicines

    Received: 30 Apr 2024; Accepted: 29 Jul 2024.

    Copyright: © 2024 Upton, Agudelo, Cabrera, Caceres, Calderon, Calzada, Camacho, Da Costa, Dobrecky, Enciso, Escobar, Fakhary, Fletcher, Gao, Lock, Mata, Parada, Perera, Pombo, Reich, Sanchez, Simirgiotis, Sood, Amiguet, Villar, Ghelman, SCHVEITZER, Schlechta Portella, Wolffenbüttel, Ruppelt, Souza Frickmann, Gavillan-Suarez, Allen, Alvarado, Sarma, Marles, Monagas and Navarro-Hoyos. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence:
    Roy Upton, American Herbal Pharmacopoeia, Scotts Valley, 95067, California, United States
    Ignacio Agudelo, Facultad de Farmacia y Bioquímica. Departamento de Farmacología. Cátedra de Farmacobotánica. Universidad de Buenos Aires, Buenos Aires, Argentina
    Yadira Cabrera, Ministerio de Salud Publica del Ecuador, Cuenca, Ecuador
    Fernando Calzada, Unidad de Investigación Médica en Farmacología, UMAE Hospital de Especialidades 2° Piso CORSE. Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social, Cuidad de Mexico, Mexico
    Rosa Camacho, Direccion General de Medicamentos, Insumos y Drogas (DIGEMID), Ministerio de Salud Publica del Peru, Lima, Peru
    Cecilia Dobrecky, Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica. Cátedra de Tecnología Farmacéutica I, Buenos Aires, Argentina
    Roberto Enciso, Farmacopea de los Estados Unidos Mexicanos, Cuidad de Mexico, Mexico
    Quanyin Gao, Herbalife, Quality Control Labs, Los Angeles, CA, United States
    Olga Lock, Federacion Latinoamericana de Asociaciones Quimicas (FLAQ), Lima, Peru
    Mirtha Parada, Agencia Nacional de Medicamentos (ANAMED), Instituto de Salud Publica de Chile, Gran Santiago, Chile
    Eric Sanchez, Medical Sciences Campus, University of Puerto Rico, San Juan, Puerto Rico
    Christian Sood, The Reena Group, Mississauga, Canada
    Virginie T. Amiguet, Health Canada, Ottawa, Ontario, Canada
    Martha Villar, CICMEC, Gerencia de Medicina Complementaria, Seguro Social de Salud-EsSalud and Departamento de Medicina Preventiva y Salud Pública, Facultad de Medicina, Universidad Mayor de San Marcos, Lima, Peru
    Ricardo Ghelman, Natural Products Committee of the Brazilian Academic Consortium or Integrative Health (CABSIN), San Pablo, Brazil
    Adriana Wolffenbüttel, Natural Products Committee of the Brazilian Academic Consortium or Integrative Health (CABSIN), San Pablo, Brazil
    Bettina Ruppelt, Natural Products Committee of the Brazilian Academic Consortium or Integrative Health (CABSIN), San Pablo, Brazil
    Fabiana Souza Frickmann, Natural Products Committee of the Brazilian Academic Consortium or Integrative Health (CABSIN), San Pablo, Brazil
    Kristin Allen, Department of Drug Discovery and Development, Harrison School of Pharmacy, Auburn University, Auburn, AL 36849-5506, Alabama, United States
    Luis D. Alvarado, Bioactivity & Sustainable Development (BIODESS) Group, Department of Chemistry, University of Costa Rica (UCR), San Jose, Costa Rica
    Nandakumara Sarma, United States Pharmacopeial Convention (USP). Dietary Supplements and Herbal Medicines, Rockville, MD, United States
    Robin Marles, United States Pharmacopeia (USP) Botanical Dietary Supplements and Herbal Medicines Expert Committee, United States Pharmacopeia (USP), Rokcville, MD, United States
    Maria Monagas, United States Pharmacopeial Convention (USP). Dietary Supplements and Herbal Medicines, Rockville, MD, United States
    Mirtha Navarro-Hoyos, Bioactivity & Sustainable Development (BIODESS) Group, Department of Chemistry, University of Costa Rica (UCR), San Jose, Costa Rica

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.