Comparing technology and regulatory landscape of probiotics as food, dietary supplements and live biotherapeutics
Application of beneficial microorganisms as probiotics targets a broad range of intended uses, from maintaining health and supporting normal bodily functions to curing and preventing diseases. Currently, three main regulatory fields of probiotic products can be defined depending on their intended us...
| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2023-12-01
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| Series: | Frontiers in Microbiology |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fmicb.2023.1272754/full |
| _version_ | 1797386156495601664 |
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| author | Irina Spacova Sylvie Binda Jessica Anne ter Haar Solange Henoud Sophie Legrain-Raspaud James Dekker Jordi Espadaler-Mazo Philippe Langella Rebeca Martín Marco Pane Arthur C. Ouwehand |
| author_facet | Irina Spacova Sylvie Binda Jessica Anne ter Haar Solange Henoud Sophie Legrain-Raspaud James Dekker Jordi Espadaler-Mazo Philippe Langella Rebeca Martín Marco Pane Arthur C. Ouwehand |
| author_sort | Irina Spacova |
| collection | DOAJ |
| description | Application of beneficial microorganisms as probiotics targets a broad range of intended uses, from maintaining health and supporting normal bodily functions to curing and preventing diseases. Currently, three main regulatory fields of probiotic products can be defined depending on their intended use: the more similar probiotic foods and probiotic dietary supplements, and live biotherapeutic products. However, it is not always straightforward to classify a probiotic product into one of these categories. The regulatory nuances of developing, manufacturing, investigating and applying each category of probiotic products are not universal, and not always apparent to those unfamiliar with the various global probiotic regulatory guidelines. Various global markets can be significantly different regarding legislation, possible claims, market value and quality requirements for the development and commercialization of probiotic products. Furthermore, different probiotic product categories are also linked with variable costs at different stages of product development. This review outlines the current landscape comparing probiotic foods, probiotic dietary supplements, and live biotherapeutics as probiotic products from a regulatory lens, focusing on product development, manufacturing and production, and clinical research agenda. The aim is to inform and promote a better understanding among stakeholders by outlining the expectations and performance for each probiotic product category, depending on their intended use and targeted geographical region. |
| first_indexed | 2024-03-08T22:04:55Z |
| format | Article |
| id | doaj.art-19d1698df7b34e20b1e3ce031e57c340 |
| institution | Directory Open Access Journal |
| issn | 1664-302X |
| language | English |
| last_indexed | 2024-03-08T22:04:55Z |
| publishDate | 2023-12-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Microbiology |
| spelling | doaj.art-19d1698df7b34e20b1e3ce031e57c3402023-12-19T10:22:17ZengFrontiers Media S.A.Frontiers in Microbiology1664-302X2023-12-011410.3389/fmicb.2023.12727541272754Comparing technology and regulatory landscape of probiotics as food, dietary supplements and live biotherapeuticsIrina Spacova0Sylvie Binda1Jessica Anne ter Haar2Solange Henoud3Sophie Legrain-Raspaud4James Dekker5Jordi Espadaler-Mazo6Philippe Langella7Rebeca Martín8Marco Pane9Arthur C. Ouwehand10Research Group Environmental Ecology and Applied Microbiology, Department of Bioscience Engineering, University of Antwerp, Antwerp, BelgiumRosell Institute for Microbiome and Probiotics, Montreal, QC, CanadaInternational Probiotics Association, Los Angeles, CA, United StatesRosell Institute for Microbiome and Probiotics, Montreal, QC, CanadaGnosis by Lesaffre, Marcq-en-Baroeul, FranceFonterra Research and Development Centre Co., Ltd., Palmerston North, New ZealandDepartment of R&D, AB-Biotics SA (Kaneka Group), Barcelona, SpainUniversité Paris-Saclay, INRAE, AgroParisTech, Micalis Institute, Jouy-en-Josas, FranceUniversité Paris-Saclay, INRAE, AgroParisTech, Micalis Institute, Jouy-en-Josas, FranceProbiotical Research, Novara, ItalyGlobal Health and Nutrition Science, IFF Health, Kantvik, FinlandApplication of beneficial microorganisms as probiotics targets a broad range of intended uses, from maintaining health and supporting normal bodily functions to curing and preventing diseases. Currently, three main regulatory fields of probiotic products can be defined depending on their intended use: the more similar probiotic foods and probiotic dietary supplements, and live biotherapeutic products. However, it is not always straightforward to classify a probiotic product into one of these categories. The regulatory nuances of developing, manufacturing, investigating and applying each category of probiotic products are not universal, and not always apparent to those unfamiliar with the various global probiotic regulatory guidelines. Various global markets can be significantly different regarding legislation, possible claims, market value and quality requirements for the development and commercialization of probiotic products. Furthermore, different probiotic product categories are also linked with variable costs at different stages of product development. This review outlines the current landscape comparing probiotic foods, probiotic dietary supplements, and live biotherapeutics as probiotic products from a regulatory lens, focusing on product development, manufacturing and production, and clinical research agenda. The aim is to inform and promote a better understanding among stakeholders by outlining the expectations and performance for each probiotic product category, depending on their intended use and targeted geographical region.https://www.frontiersin.org/articles/10.3389/fmicb.2023.1272754/fullprobioticsupplementdrugregulationpharmabioticsmanufacturing |
| spellingShingle | Irina Spacova Sylvie Binda Jessica Anne ter Haar Solange Henoud Sophie Legrain-Raspaud James Dekker Jordi Espadaler-Mazo Philippe Langella Rebeca Martín Marco Pane Arthur C. Ouwehand Comparing technology and regulatory landscape of probiotics as food, dietary supplements and live biotherapeutics Frontiers in Microbiology probiotic supplement drug regulation pharmabiotics manufacturing |
| title | Comparing technology and regulatory landscape of probiotics as food, dietary supplements and live biotherapeutics |
| title_full | Comparing technology and regulatory landscape of probiotics as food, dietary supplements and live biotherapeutics |
| title_fullStr | Comparing technology and regulatory landscape of probiotics as food, dietary supplements and live biotherapeutics |
| title_full_unstemmed | Comparing technology and regulatory landscape of probiotics as food, dietary supplements and live biotherapeutics |
| title_short | Comparing technology and regulatory landscape of probiotics as food, dietary supplements and live biotherapeutics |
| title_sort | comparing technology and regulatory landscape of probiotics as food dietary supplements and live biotherapeutics |
| topic | probiotic supplement drug regulation pharmabiotics manufacturing |
| url | https://www.frontiersin.org/articles/10.3389/fmicb.2023.1272754/full |
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