RESUMO
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.
Assuntos
Farmácias , Feminino , Humanos , União Europeia , Espanha , Suplementos Nutricionais , MenopausaRESUMO
Objetivo: Realizar un análisis sobre el marco legal de los complementos alimenticios prescritos e indicados para la sintomatología de la menopausia, verificando si de acuerdo con los efectos sobre la salud que producen deben ser considerados como complementos alimenticios o bien en otras categorías recogidas en el ordenamiento jurídico español. Método: Se realiza una revisión de los marcos jurídicos aplicables a los complementos alimenticios utilizados en España y Europa, recogiendo aquellos aspectos que resulten aplicables o relevantes para los utilizados durante la menopausia, y la relación que guarden con conceptos jurídicos como la definición de medicamento de uso humano, medicamento a base de plantas medicinales o los denominados «productos frontera». Resultados: Existe una gran cantidad de productos que pueden ser considerados «productos frontera» y pueden encajar en categorías de productos diferentes, ya que algunas de las plantas en su formulación también se encuentran autorizadas para su uso como medicamentos industriales o medicamentos de plantas medicinales tradicionales. Conclusiones: Existen complementos alimenticios para la menopausia que suscitan dudas razonables sobre su inclusión en otras categorías legales, tanto como medicamentos de uso humano o como medicamentos a base de plantas, por lo que el legislador necesitaría habilitar mecanismos más agiles y revisiones más frecuentes de las nuevas certezas que la ciencia encuentre, y que pueda cambiar la consideración de estos productos. (AU)
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. (AU)
