Estudo sobre as informações disponibilizadas ao consumidor nos produtos contendo plantas medicinais e comercializados como suplementos alimentares em Portugal: comparação entre a legislação brasileira e portuguesa e uma proposta de harmonização
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2023
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O crescente interesse por parte do mercado de suplementos alimentares na
incorporação de plantas medicinais em seus produtos, vem crescendo na mesma medida
em que vem ocorrendo um aumento da procura por parte dos consumidores pelo seu uso,
quer seja como prevenção ou ainda em tratamentos, mesmo que de forma complementar
para inúmeros males. Ainda que a prevenção e o tratamento sejam por definição função do
medicamento e não do suplemento alimentar. Apesar da contraposição entre o cultural
imaginário dos consumidores, de que os produtos que contenham plantas medicinais, são
naturais e, portanto, não poderiam causar nenhum problema à sua saúde, à realidade de
que a composição dos produtos ofertados no mercado, são cada vez mais concentrados e
padronizados em marcadores bioativos distante do balanço que a natureza produz.
Saber se o controlo de qualidade das plantas medicinais em qualquer que seja o
produto onde o consumidor as encontre, através da padronização a ser utilizada e em
especial quanto às orientações e precauções disponibilizadas seria capaz de garantir a
segurança em seu uso, esse foi o objetivo deste estudo. Com base nos resultados públicos
de um inquérito realizado pelo Deco Proteste, no ano de 2021, realizou-se um estudo
exploratório e descritivo através da análise e pesquisa das plantas medicinais mais
frequentemente utilizadas em categorias de saúde apontadas pelo estudo, que inquiriu,
quanto ao consumo de suplementos alimentares e a sua forma de aquisição. As categorias
mais procuradas foram consideradas e referenciadas neste estudo.
Metodologicamente, foram inicialmente selecionados os quatro fitoterápicos mais
citados em cada uma das categorias selecionadas, a saber: imunidade; energia (cansaço);
energia (menopausa); energia (disfunção sexual); sistema nervoso (cognição/memória);
sistema nervoso (ansiedade e stress); desempenho desportivo e perda de peso. Realizou-se
uma revisão das legislações vigentes: brasileira, europeia e portuguesa, e em seguida foi
descrito um referencial teórico para cada uma das plantas, além de uma pesquisa
bibliográfica que utilizou descritores que associavam o nome científico da planta à categoria.
Em seguida foi realizado um levantamento junto a uma loja especializada em
produtos para a saúde na categoria do autocuidado, legalmente classificados como
suplemento alimentar, que continham plantas medicinais na sua composição. Foram
selecionados os dois produtos mais indicados/consumidos para cada uma das categorias
selecionadas. Sendo que nas categorias energia (cansaço) e energia (disfunção sexual),
foram incluídos produtos com indicações diferenciadas entre os géneros masculino e
feminino. As informações disponibilizadas ao consumidor nestes produtos foram
confrontadas com as contidas nos compêndios oficiais e publicações científicas, e serviram
como base para a proposta de se avaliar a necessidade de adequação dessas informações.
No total nesse estudo foram identificadas sessenta e três plantas, dentro dos critérios
de avaliação do presente estudo, sendo que quinze delas foram encontradas tanto na
pesquisa on-line quanto na loja especializada. Prioritizou-se então aprofundar os estudos
das plantas contempladas em ambas as pesquisas. As informações disponibilizadas nestes
produtos foram confrontadas com as contidas nos compêndios oficiais e publicações
científicas e serviram como base para a proposta de se avaliar a necessidade de
adequação.
Foram construídas duas tabelas, com base nas quinze plantas selecionadas, a
primeira comparou as plantas com as indicações, encontradas na pesquisa on-line e nos
produtos. E uma segunda que consolidou as informações importantes relativas às plantas e
que deveriam constar dos pedidos de registo, nos rótulos/embalagens e/ou folhetos
informativos quanto aos cuidados ou restrições do seu uso. Das informações tabuladas,
pode-se concluir que plantas como a Camellia sinensis e o Panax ginseng não devem ser
utilizadas por pacientes hipertensos, diabéticos ou se houver necessidade de seu uso, este
deverá ser monitorizado a fim de não acarretar risco de agravamento da sua condição de
saúde e que a Echinaceae purpurea não deve ser utilizada por períodos prolongados, ou
ainda, que o uso do Ginkgo biloba deva ser suspenso em período pré-operatório pela
possibilidade de ocorrerem distúrbios hemorrágicos.
Constam ainda informações quanto à forma em que estas quinze plantas encontram se disponibilizadas no mercado brasileiro e no português. Enquanto todas podem ser
comercializadas como suplemento alimentar em Portugal, somente a Glycine max e a Linum
usitatissimum, encontram-se nesta mesma categoria no Brasil. Já plantas como: Melissa
officinalis, Panax ginseng, Paullinia cupana e Zingiber officinale se encontram categorizadas
como medicamento fitoterápico de registo simplificado no Brasil. E plantas como Camellia
sinensis, Lepidium meyenii, Rhodiola rosea, Sambucus nigra, Tribulus terrestres e Withania
somnifera somente podem ser utilizadas se prescritas por profissionais de saúde habilitados
para a sua prescrição e plantas como Echinacea purpúrea, Ginkgo biloba e a Valeriana
officinalis dependem de uma prescrição médica. Em Portugal não há restrição para o seu
uso sem prescrição em suplementos alimentares.
PALAVRAS-CHAVE
Suplementos alimentares, padronização de extratos botânicos, plantas medicinais na
imunidade, plantas medicinais na energia (cansaço/menopausa/disfunção sexual), plantas
medicinais no sistema nervoso (cognição/ansiedade e stress), plantas medicinais no
desempenho desportivo, plantas medicinais na perda de peso
The growing interest by the food supplement market in the incorporation of medicinal plants in their products has been growing in the same measure that there has been an increase in consumer demand for their use, either as prevention or in treatments, even if in a complementary way for uncounted diseases. Even though prevention and treatment are defined as the function of the medicine and not of the food supplement. Despite the opposition between the cultural imaginary of consumers that products containing medicinal plants are natural and, therefore, could not cause any problem to their health, the reality that the composition of the products offered in the market are increasingly concentrated and standardized in bioactive markers far from the balance that nature produces. To know if the quality control of medicinal plants in any product where the consumer finds them, through the standardization to be used and especially regarding the guidelines and precautions made available would be able to guarantee safety in their use, this was the objective of this study. Based on the public results of a survey conducted by Deco Proteste, in the year 2021, an exploratory and descriptive study was conducted through the analysis and research of the most frequently used medicinal plants in health categories pointed out by the study, which inquired about the consumption of food supplements and their form of acquisition. The most popular categories were considered and referenced in this study. Methodologically, the four phytotherapies most cited in each of the selected categories were initially selected, namely: immunity; energy (fatigue); energy (menopause); energy (sexual dysfunction); nervous system (cognition/memory); nervous system (anxiety and stress); sports performance, and weight loss. A review of the current Brazilian, European, and Portuguese legislation was carried out, and then a theoretical reference was described for each of the plants, in addition to bibliographical research that used descriptors that associated the scientific name of the plant with the category. Thereafter, a survey was conducted at a store specializing in health products in the category of self-care, legally classified as a food supplement, which contained medicinal plants in their composition. The two products most indicated/consumed for each of the selected categories were selected. In the categories energy (fatigue) and energy (sexual dysfunction), products with differentiated indications between men and women were included. The information made available to the consumer in these products was compared with the information contained in official compendia and scientific publications and served as a basis for the proposal to assess the need for adequacy of this information. Altogether, sixty-three plants were identified in this study, within the evaluation criteria of the present study, and fifteen of them were found both in the online research and in the specialized store. It was then prioritized to deepen the studies of the plants contemplated in both researches. The information made available in these products was compared to the information contained in the official compendia and scientific publications and served as the basis for the proposal to evaluate the need for adequacy. Hence, two tables have been developed, based on the fifteen plants selected, the first one compared the plants with the indications, found in the online research and on the products. And the second one that consolidated the important information regarding the plants and that should appear in the registration applications, in the labels/packaging and/or information leaflets regarding the care or restrictions of their use. From the tabulated information, it can be concluded that plants such as Camellia sinensis and Panax ginseng should not be used by hypertensive patients, diabetics or if there is need for its use, it should be monitored in order not to carry risk of worsening their health condition, as well as that Echinaceae purpurea should not be used for prolonged periods, or that the use of Ginkgo biloba should be suspended in the preoperative period because of the possibility of haemorrhagic disorders. Also, there is information about the form in which these fifteen plants are available in the Brazilian and Portuguese markets. While all of them can be sold as food supplements in Portugal, only Glycine max and Linum usitatissimum can be found in this same category in Brazil. Plants such as Melissa officinalis, Panax ginseng, Paullinia cupana and Zingiber officinale are categorized as herbal medicine with simplified registration in Brazil. Plants such as Camellia sinensis, Lepidium meyenii, Rhodiola rosea, Sambucus nigra, Tribulus terrestris and Withania somnifera can only be used if prescribed by health professionals qualified to prescribe them, and plants such as Echinacea purpurea, Ginkgo biloba and Valeriana officinalis depend on a medical prescription. In Portugal there is no restriction for their use without prescription in food supplements. KEYWORDS Food supplements, standardization of botanical extracts, medicinal plants in immunity, medicinal plants in energy (fatigue/menopause/sexual dysfunction), medicinal plants in the nervous system (cognition/anxiety and stress), medicinal plants in sports performance, medicinal plants in weight loss
The growing interest by the food supplement market in the incorporation of medicinal plants in their products has been growing in the same measure that there has been an increase in consumer demand for their use, either as prevention or in treatments, even if in a complementary way for uncounted diseases. Even though prevention and treatment are defined as the function of the medicine and not of the food supplement. Despite the opposition between the cultural imaginary of consumers that products containing medicinal plants are natural and, therefore, could not cause any problem to their health, the reality that the composition of the products offered in the market are increasingly concentrated and standardized in bioactive markers far from the balance that nature produces. To know if the quality control of medicinal plants in any product where the consumer finds them, through the standardization to be used and especially regarding the guidelines and precautions made available would be able to guarantee safety in their use, this was the objective of this study. Based on the public results of a survey conducted by Deco Proteste, in the year 2021, an exploratory and descriptive study was conducted through the analysis and research of the most frequently used medicinal plants in health categories pointed out by the study, which inquired about the consumption of food supplements and their form of acquisition. The most popular categories were considered and referenced in this study. Methodologically, the four phytotherapies most cited in each of the selected categories were initially selected, namely: immunity; energy (fatigue); energy (menopause); energy (sexual dysfunction); nervous system (cognition/memory); nervous system (anxiety and stress); sports performance, and weight loss. A review of the current Brazilian, European, and Portuguese legislation was carried out, and then a theoretical reference was described for each of the plants, in addition to bibliographical research that used descriptors that associated the scientific name of the plant with the category. Thereafter, a survey was conducted at a store specializing in health products in the category of self-care, legally classified as a food supplement, which contained medicinal plants in their composition. The two products most indicated/consumed for each of the selected categories were selected. In the categories energy (fatigue) and energy (sexual dysfunction), products with differentiated indications between men and women were included. The information made available to the consumer in these products was compared with the information contained in official compendia and scientific publications and served as a basis for the proposal to assess the need for adequacy of this information. Altogether, sixty-three plants were identified in this study, within the evaluation criteria of the present study, and fifteen of them were found both in the online research and in the specialized store. It was then prioritized to deepen the studies of the plants contemplated in both researches. The information made available in these products was compared to the information contained in the official compendia and scientific publications and served as the basis for the proposal to evaluate the need for adequacy. Hence, two tables have been developed, based on the fifteen plants selected, the first one compared the plants with the indications, found in the online research and on the products. And the second one that consolidated the important information regarding the plants and that should appear in the registration applications, in the labels/packaging and/or information leaflets regarding the care or restrictions of their use. From the tabulated information, it can be concluded that plants such as Camellia sinensis and Panax ginseng should not be used by hypertensive patients, diabetics or if there is need for its use, it should be monitored in order not to carry risk of worsening their health condition, as well as that Echinaceae purpurea should not be used for prolonged periods, or that the use of Ginkgo biloba should be suspended in the preoperative period because of the possibility of haemorrhagic disorders. Also, there is information about the form in which these fifteen plants are available in the Brazilian and Portuguese markets. While all of them can be sold as food supplements in Portugal, only Glycine max and Linum usitatissimum can be found in this same category in Brazil. Plants such as Melissa officinalis, Panax ginseng, Paullinia cupana and Zingiber officinale are categorized as herbal medicine with simplified registration in Brazil. Plants such as Camellia sinensis, Lepidium meyenii, Rhodiola rosea, Sambucus nigra, Tribulus terrestris and Withania somnifera can only be used if prescribed by health professionals qualified to prescribe them, and plants such as Echinacea purpurea, Ginkgo biloba and Valeriana officinalis depend on a medical prescription. In Portugal there is no restriction for their use without prescription in food supplements. KEYWORDS Food supplements, standardization of botanical extracts, medicinal plants in immunity, medicinal plants in energy (fatigue/menopause/sexual dysfunction), medicinal plants in the nervous system (cognition/anxiety and stress), medicinal plants in sports performance, medicinal plants in weight loss
Descrição
Orientação: Maria Do Céu Costa; coorientação: Ana Cecília Bezerra Carvalho
Palavras-chave
MESTRADO EM PRODUTOS DE SAÚDE E SUPLEMENTOS ALIMENTARES, SUPLEMENTOS ALIMENTARES, DIETARY SUPPLEMENT, EXTRATOS VEGETAIS, VEGETAL EXTRACTS, PLANTAS MEDICINAIS, MEDICINAL PLANTS