Francisco Ignacio Rubio Rubio, María Dolores Cabezas López, María Isabel Valverde Merino, Fernando Martínez Martínez, María José Zarzuelo Romero
{"title":"西班牙社区药房关于更年期食品补充剂的法律框架分析","authors":"Francisco Ignacio Rubio Rubio, María Dolores Cabezas López, María Isabel Valverde Merino, Fernando Martínez Martínez, María José Zarzuelo Romero","doi":"10.1016/j.gaceta.2023.102290","DOIUrl":null,"url":null,"abstract":"<div><h3>Objective</h3><p>To analyze the legal framework for the marketing of specific food supplements prescribed and indicated for menopause symptoms, so that it is verified if according to the effects on health that they produce, should be considered in the category of food supplements, or in others included in our legal system.</p></div><div><h3>Method</h3><p>An exhaustive review of the legal frameworks applicable to food supplements used both in Spain and in Europe, collecting those aspects that are related to legal concepts such as the definition of medicine for human use, medicine based on medicinal plants, or the so-called “frontier products”.</p></div><div><h3>Results</h3><p>There is a large number of products that can be called “frontier products”, they can fit into different product categories, they can fit into different product categories, since some of the plants in their formulation are also authorized for use as industrial medicines or medicines based on traditional medicinal plants.</p></div><div><h3>Conclusions</h3><p>There are currently specific food supplements for menopause that raise reasonable doubts about their inclusion in other legal categories, both as medicines for human use, or as herbal medicines, so the legislator would need to enable more agile mechanisms and more frequent reviews of the new certainties that science finds, and that can change the status of these products.</p></div>","PeriodicalId":12494,"journal":{"name":"Gaceta Sanitaria","volume":null,"pages":null},"PeriodicalIF":1.5000,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Análisis del marco legal sobre complementos alimenticios para la menopausia en farmacias comunitarias españolas\",\"authors\":\"Francisco Ignacio Rubio Rubio, María Dolores Cabezas López, María Isabel Valverde Merino, Fernando Martínez Martínez, María José Zarzuelo Romero\",\"doi\":\"10.1016/j.gaceta.2023.102290\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Objective</h3><p>To analyze the legal framework for the marketing of specific food supplements prescribed and indicated for menopause symptoms, so that it is verified if according to the effects on health that they produce, should be considered in the category of food supplements, or in others included in our legal system.</p></div><div><h3>Method</h3><p>An exhaustive review of the legal frameworks applicable to food supplements used both in Spain and in Europe, collecting those aspects that are related to legal concepts such as the definition of medicine for human use, medicine based on medicinal plants, or the so-called “frontier products”.</p></div><div><h3>Results</h3><p>There is a large number of products that can be called “frontier products”, they can fit into different product categories, they can fit into different product categories, since some of the plants in their formulation are also authorized for use as industrial medicines or medicines based on traditional medicinal plants.</p></div><div><h3>Conclusions</h3><p>There are currently specific food supplements for menopause that raise reasonable doubts about their inclusion in other legal categories, both as medicines for human use, or as herbal medicines, so the legislator would need to enable more agile mechanisms and more frequent reviews of the new certainties that science finds, and that can change the status of these products.</p></div>\",\"PeriodicalId\":12494,\"journal\":{\"name\":\"Gaceta Sanitaria\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.5000,\"publicationDate\":\"2023-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Gaceta Sanitaria\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S0213911123000043\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"HEALTH CARE SCIENCES & SERVICES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Gaceta Sanitaria","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0213911123000043","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"HEALTH CARE SCIENCES & SERVICES","Score":null,"Total":0}
Análisis del marco legal sobre complementos alimenticios para la menopausia en farmacias comunitarias españolas
Objective
To analyze the legal framework for the marketing of specific food supplements prescribed and indicated for menopause symptoms, so that it is verified if according to the effects on health that they produce, should be considered in the category of food supplements, or in others included in our legal system.
Method
An exhaustive review of the legal frameworks applicable to food supplements used both in Spain and in Europe, collecting those aspects that are related to legal concepts such as the definition of medicine for human use, medicine based on medicinal plants, or the so-called “frontier products”.
Results
There is a large number of products that can be called “frontier products”, they can fit into different product categories, they can fit into different product categories, since some of the plants in their formulation are also authorized for use as industrial medicines or medicines based on traditional medicinal plants.
Conclusions
There are currently specific food supplements for menopause that raise reasonable doubts about their inclusion in other legal categories, both as medicines for human use, or as herbal medicines, so the legislator would need to enable more agile mechanisms and more frequent reviews of the new certainties that science finds, and that can change the status of these products.
期刊介绍:
Gaceta Sanitaria (Health Gazette) is an international journal that accepts articles in Spanish and in English. It is the official scientific journal of the Sociedad Española de Salud Publica y Administración Sanitaria (Spanish Society of Public Health and Health Administration) (SESPAS).
The Journal publishes 6 issues per year on different areas of Public Health and Health Administration, including:
-Applied epidemiology-
Health prevention and promotion-
Environmental health-
International health-
Management and assessment of policies and services-
Health technology assessments-
Health economics.
The editorial process is regulated by a peer review system. It publishes original works, reviews, opinion articles, field and methodology notes, protocols, letters to the editor, editorials, and debates.