RESUMO
Diverse terms have been used in the literature to refer to the health benefits obtained from the administration of non-viable microorganisms or their cell fragments and metabolites. In an effort to provide continuity to this emerging field, the International Scientific Association of Probiotics and Prebiotics (ISAPP) convened a panel of experts to consider this category of substances and adopted the term postbiotic, which they defined as a "preparation of inanimate microorganisms and/or their components that confers a health benefit on the host." This definition does not stipulate any specific health benefit, finished product, target population or regulatory status. In this perspective article, we focused on postbiotics developed for pharmaceutical uses, including medicinal products and medical devices. We address how this field is regulated for products based on inanimate microorganisms, marketing considerations and existing examples of postbiotics products developed as cosmetics for the skin, for vaginal health, and as orally consumed products. We focus on the European Union for regulatory aspects, but also give examples from other geographical areas.
RESUMO
The term postbiotic was defined by the International Scientific Association of Probiotics and Prebiotics (ISAPP) as "a preparation of inanimate microorganisms and/or their components that confers a health benefit on the host." Although the ISAPP definition is widely cited, some concerns were aired after publication, and alternative definitions of postbiotic, as well as different terms for inactivated microbes, have been previously suggested. This paper addresses questions about the ISAPP definition that have been raised in different forums, including scientific meetings, social media commentary and personal communications. We focus on the rationale, scope, wording, composition and commercial implementation, as well as what is expected of postbiotics regarding safety, efficacy, quantification and mechanisms of action. We hope that exploring these questions will further clarify the definition and its scope and support a common understanding of the concept of postbiotics.
RESUMO
The scientific community has proposed terms such as non-viable probiotics, paraprobiotics, ghostbiotics, heat-inactivated probiotics or, most commonly, postbiotics, to refer to inanimate microorganisms and/or their components that confer health benefits. This article addresses the various characteristics of different definitions of 'postbiotics' that have emerged over past years. In 2021, the International Scientific Association for Probiotics and Prebiotics (ISAPP) defined a postbiotic as "a preparation of inanimate microorganisms and/or their components that confers a health benefit on the host". This definition of postbiotic requires that the whole or components of inactivated microbes be present, with or without metabolic end products. The definition proposed by ISAPP is comprehensive enough to allow the development of postbiotics from different microorganisms, to be applied in different body sites, encouraging innovation in a promising area for any regulatory category and for companion or production animals, and plant or human health. From a technological perspective, probiotic products may contain inanimate microorganisms, which have the potential to impart a health benefit. However, their contribution to health in most cases has not been established, even if at least one probiotic has been shown to confer the same health benefit by live or inanimate cells.