Suplementos alimentares comercializados no Brasil: uma abordagem rotular, analítico e toxicológica
Autor(a) principal: | |
---|---|
Data de Publicação: | 2019 |
Tipo de documento: | Tese |
Idioma: | por |
Título da fonte: | Repositório Institucional Manancial UFSM |
Texto Completo: | http://repositorio.ufsm.br/handle/1/20981 |
Resumo: | Consumption of dietary supplements has been increase worldwide, leading billionaires billing for Brazilian industries. Due to this situation, the National Health Surveillance Agency (Anvisa) has developed a new regulatory framework for dietary supplement, in order to regularize, to standardize and reduce the legal barriers of these products. This way, the present work aimed to acquired a certain number of samples marketed as food supplements, for a regulatory analysis, composition evaluation, investigation of the presence of adulterants and for a toxicological study. 44 samples of dietary supplements were purchased via the internet. From these, 97.7% showed irregular claims and 34.2% could not be commercialized as dietary supplements due their ingredients declared on the label. Still, regarding the centesimal composition, only 20 samples described the mandatory nutritional information on the label and, from these, 70% presented nutritional values above the tolerance allowed by the legislation. To investigate of the presence of adulterants in dietary supplements, a HPLC- DAD method was proposed for the determination of 10 non-permitted substances, with time of analysis less than five minutes. The proposed method was validated according to AOAC and Anvisa guidelines, and represented an economy of 40% when compared to LC-MS/MS, and the estimated cost for analysis was US$ 7.00 per sample. From 44 analyzed samples, seven contained at least one adulterant in their composition, such as diuretics, sexual stimulants and anabolic, for example. The adulterated supplements presented common characteristics, such as the acquisition in not specialized market, were imported from other countries, lack of information on the label and use of the claims that induced the presence of drugs in the composition. After this, an in silico prediction study was performed in order to compare with the in vitro cytotoxicity results, and thus, it was able to evaluate if the presence of the found substances is a determining factor for the increase of the toxicity in health cells. Despite the need for further studies regarding the sample matrix, the results indicate that there is a relationship between the multi-ingredients declared in the samples and the adulterants found, considering the cytotoxicity of the products. All seven samples presented cytotoxic effects, proportional to the concentration, by different mechanisms, either reducing cell viability, hemolysis or a significant increase of reactive oxygen species. Since the publication of the regulatory framework, the industries have five years to adapt to the new guidelines, however, is expected that the results shown here serving as a warning to both regulatory agencies and consumers for those irregularly sold products, or which ones that have some nonconformity in their label or even in their composition. The presence of adulterants in food supplements is a serious public health problem that can lead to irreversible health damage to those who consume them. |
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2021-05-25T17:37:56Z2021-05-25T17:37:56Z2019-12-19http://repositorio.ufsm.br/handle/1/20981Consumption of dietary supplements has been increase worldwide, leading billionaires billing for Brazilian industries. Due to this situation, the National Health Surveillance Agency (Anvisa) has developed a new regulatory framework for dietary supplement, in order to regularize, to standardize and reduce the legal barriers of these products. This way, the present work aimed to acquired a certain number of samples marketed as food supplements, for a regulatory analysis, composition evaluation, investigation of the presence of adulterants and for a toxicological study. 44 samples of dietary supplements were purchased via the internet. From these, 97.7% showed irregular claims and 34.2% could not be commercialized as dietary supplements due their ingredients declared on the label. Still, regarding the centesimal composition, only 20 samples described the mandatory nutritional information on the label and, from these, 70% presented nutritional values above the tolerance allowed by the legislation. To investigate of the presence of adulterants in dietary supplements, a HPLC- DAD method was proposed for the determination of 10 non-permitted substances, with time of analysis less than five minutes. The proposed method was validated according to AOAC and Anvisa guidelines, and represented an economy of 40% when compared to LC-MS/MS, and the estimated cost for analysis was US$ 7.00 per sample. From 44 analyzed samples, seven contained at least one adulterant in their composition, such as diuretics, sexual stimulants and anabolic, for example. The adulterated supplements presented common characteristics, such as the acquisition in not specialized market, were imported from other countries, lack of information on the label and use of the claims that induced the presence of drugs in the composition. After this, an in silico prediction study was performed in order to compare with the in vitro cytotoxicity results, and thus, it was able to evaluate if the presence of the found substances is a determining factor for the increase of the toxicity in health cells. Despite the need for further studies regarding the sample matrix, the results indicate that there is a relationship between the multi-ingredients declared in the samples and the adulterants found, considering the cytotoxicity of the products. All seven samples presented cytotoxic effects, proportional to the concentration, by different mechanisms, either reducing cell viability, hemolysis or a significant increase of reactive oxygen species. Since the publication of the regulatory framework, the industries have five years to adapt to the new guidelines, however, is expected that the results shown here serving as a warning to both regulatory agencies and consumers for those irregularly sold products, or which ones that have some nonconformity in their label or even in their composition. The presence of adulterants in food supplements is a serious public health problem that can lead to irreversible health damage to those who consume them.O consumo de suplementos alimentares vem crescendo mundialmente, levando a faturamentos bilionários a cada ano. Devido à grande demanda, a Agência Nacional de Vigilância Sanitária (Anvisa) publicou o marco regulatório dos suplementos alimentares a fim de regularizar, padronizar e diminuir os entraves legais destes produtos. Dessa forma, o presente trabalho teve por objetivo elencar e adquirir produtos comercializados como suplementos alimentares, para a realização de uma análise regulatória, avaliação das suas composições nutricionais e não nutricionais, investigação da presença de adulterantes e realização de um estudo toxicológico. Com isso, foram adquiridas 44 amostras de suplementos alimentares em lojas virtuais brasileiras. Dessas, 97,7% estavam irregulares quanto as alegações atribuídas e 34,2% não poderiam ser comercializadas como suplementos alimentares devido aos ingredientes declarados. Quanto a composição centesimal 20 amostras (45,54%) continham as informações nutricionais obrigatórias nos rótulos e dessas, 70% (n = 14) apresentavam valores de nutrientes acima da tolerância permitida pela legislação. Para a investigação da presença de adulterantes em suplementos alimentares, foi proposto um método por HPLC-DAD para a determinação de 10 substâncias não permitidas, com tempo de análise inferior a cinco minutos. O método proposto foi validado de acordo com as diretrizes da AOAC e Anvisa e representou uma economia de 40% quando comparado a outros métodos convencionais, sendo que o gasto estimado para análise foi de US$ 7,00 para cada amostra. Das 44 amostras analisadas, sete (15,90%) continham pelo menos um adulterante, como diuréticos, estimulantes sexuais e anabolizantes. Os suplementos adulterados possuíam características comuns entre si, como comercialização em mercado negro, matéria-prima ou produto de origem importada, ausência de informações nos rótulos e alegações que induziam a presença de substâncias farmacológicas. Posteriormente, foi realizado um estudo de predição in silico dos adulterantes a fim de comparar com os resultados da citotoxicidade in vitro e, dessa forma, poder inferir se a presença das substâncias encontradas é fator determinante para aumento da toxicidade dos suplementos alimentares. Apesar da necessidade de maiores estudos com relação a matriz das amostras, os resultados indicam que há uma relação entre os multiigredientes declarados nas amostras e os adulterantes encontrados, quanto à citotoxicidade. Todas as sete amostras estudadas apresentaram efeitos citotóxicos por diferentes mecanismos e proporcionais à concentração. Foram observadas diminuição de viabilidade celular, hemólise célula aumento significativo na liberação de espécies reativas de oxigênio. A partir da publicação do marco regulatório as indústrias têm cinco anos para se adaptarem as novas regras. Contudo, espera-se que os resultados aqui demonstrados sirvam de alerta, tanto para as agências regulatórias quanto para os consumidores, principalmente em relação aos produtos vendidos de forma irregular, ou que apresentam alguma não conformidade em seu rótulo, ou até mesmo na sua composição. A presença de adulterantes em suplementos alimentares é um grave problema de saúde pública, que pode acarretar em danos irreversíveis à saúde da população.porUniversidade Federal de Santa MariaCentro de Ciências da SaúdePrograma de Pós-Graduação em Ciências FarmacêuticasUFSMBrasilCiências da SaúdeAttribution-NonCommercial-NoDerivatives 4.0 Internationalhttp://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessSuplementos alimentaresAdulterantesToxicidadeRegulamentaçãoDietary supplementsAdulteransToxicityRegulationCNPQ::CIENCIAS DA SAUDE::FARMACIASuplementos alimentares comercializados no Brasil: uma abordagem rotular, analítico e toxicológicaDietary supplements commercialized in Brazil: a rotular, analytical and toxicology approachinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/doctoralThesisSilva, Carine Vianahttp://lattes.cnpq.br/2004872342535591Machado, Michel MansurXXXXXXXXXXXXXXXSagrillo, Michele RoratoXXXXXXXXXXXXXXXXXXEmanuelli, TatianaXXXXXXXXXXXXXXXFlores, Liziane MaahsXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXDal Molin, Thaís Ramos40030000000560088e93e45-5e33-4094-a525-3ae55aa2e39e642803a4-4b5d-42f1-859c-9a6c1636123d0fde5880-3df4-4149-b64f-3ad7966388071998b090-e036-483d-8880-138523b412bc7457e618-e257-4f1d-b319-f589826321847a0c6acf-7b57-472d-8839-e925b59ccd32reponame:Repositório Institucional Manancial UFSMinstname:Universidade Federal de Santa Maria (UFSM)instacron:UFSMCC-LICENSElicense_rdflicense_rdfapplication/rdf+xml; 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dc.title.por.fl_str_mv |
Suplementos alimentares comercializados no Brasil: uma abordagem rotular, analítico e toxicológica |
dc.title.alternative.eng.fl_str_mv |
Dietary supplements commercialized in Brazil: a rotular, analytical and toxicology approach |
title |
Suplementos alimentares comercializados no Brasil: uma abordagem rotular, analítico e toxicológica |
spellingShingle |
Suplementos alimentares comercializados no Brasil: uma abordagem rotular, analítico e toxicológica Dal Molin, Thaís Ramos Suplementos alimentares Adulterantes Toxicidade Regulamentação Dietary supplements Adulterans Toxicity Regulation CNPQ::CIENCIAS DA SAUDE::FARMACIA |
title_short |
Suplementos alimentares comercializados no Brasil: uma abordagem rotular, analítico e toxicológica |
title_full |
Suplementos alimentares comercializados no Brasil: uma abordagem rotular, analítico e toxicológica |
title_fullStr |
Suplementos alimentares comercializados no Brasil: uma abordagem rotular, analítico e toxicológica |
title_full_unstemmed |
Suplementos alimentares comercializados no Brasil: uma abordagem rotular, analítico e toxicológica |
title_sort |
Suplementos alimentares comercializados no Brasil: uma abordagem rotular, analítico e toxicológica |
author |
Dal Molin, Thaís Ramos |
author_facet |
Dal Molin, Thaís Ramos |
author_role |
author |
dc.contributor.advisor1.fl_str_mv |
Silva, Carine Viana |
dc.contributor.advisor1Lattes.fl_str_mv |
http://lattes.cnpq.br/2004872342535591 |
dc.contributor.referee1.fl_str_mv |
Machado, Michel Mansur |
dc.contributor.referee1Lattes.fl_str_mv |
XXXXXXXXXXXXXXX |
dc.contributor.referee2.fl_str_mv |
Sagrillo, Michele Rorato |
dc.contributor.referee2Lattes.fl_str_mv |
XXXXXXXXXXXXXXXXXX |
dc.contributor.referee3.fl_str_mv |
Emanuelli, Tatiana |
dc.contributor.referee3Lattes.fl_str_mv |
XXXXXXXXXXXXXXX |
dc.contributor.referee4.fl_str_mv |
Flores, Liziane Maahs |
dc.contributor.referee4Lattes.fl_str_mv |
XXXXXXXXXXXXXXXXXX |
dc.contributor.authorLattes.fl_str_mv |
XXXXXXXXXXXXXXXX |
dc.contributor.author.fl_str_mv |
Dal Molin, Thaís Ramos |
contributor_str_mv |
Silva, Carine Viana Machado, Michel Mansur Sagrillo, Michele Rorato Emanuelli, Tatiana Flores, Liziane Maahs |
dc.subject.por.fl_str_mv |
Suplementos alimentares Adulterantes Toxicidade Regulamentação |
topic |
Suplementos alimentares Adulterantes Toxicidade Regulamentação Dietary supplements Adulterans Toxicity Regulation CNPQ::CIENCIAS DA SAUDE::FARMACIA |
dc.subject.eng.fl_str_mv |
Dietary supplements Adulterans Toxicity Regulation |
dc.subject.cnpq.fl_str_mv |
CNPQ::CIENCIAS DA SAUDE::FARMACIA |
description |
Consumption of dietary supplements has been increase worldwide, leading billionaires billing for Brazilian industries. Due to this situation, the National Health Surveillance Agency (Anvisa) has developed a new regulatory framework for dietary supplement, in order to regularize, to standardize and reduce the legal barriers of these products. This way, the present work aimed to acquired a certain number of samples marketed as food supplements, for a regulatory analysis, composition evaluation, investigation of the presence of adulterants and for a toxicological study. 44 samples of dietary supplements were purchased via the internet. From these, 97.7% showed irregular claims and 34.2% could not be commercialized as dietary supplements due their ingredients declared on the label. Still, regarding the centesimal composition, only 20 samples described the mandatory nutritional information on the label and, from these, 70% presented nutritional values above the tolerance allowed by the legislation. To investigate of the presence of adulterants in dietary supplements, a HPLC- DAD method was proposed for the determination of 10 non-permitted substances, with time of analysis less than five minutes. The proposed method was validated according to AOAC and Anvisa guidelines, and represented an economy of 40% when compared to LC-MS/MS, and the estimated cost for analysis was US$ 7.00 per sample. From 44 analyzed samples, seven contained at least one adulterant in their composition, such as diuretics, sexual stimulants and anabolic, for example. The adulterated supplements presented common characteristics, such as the acquisition in not specialized market, were imported from other countries, lack of information on the label and use of the claims that induced the presence of drugs in the composition. After this, an in silico prediction study was performed in order to compare with the in vitro cytotoxicity results, and thus, it was able to evaluate if the presence of the found substances is a determining factor for the increase of the toxicity in health cells. Despite the need for further studies regarding the sample matrix, the results indicate that there is a relationship between the multi-ingredients declared in the samples and the adulterants found, considering the cytotoxicity of the products. All seven samples presented cytotoxic effects, proportional to the concentration, by different mechanisms, either reducing cell viability, hemolysis or a significant increase of reactive oxygen species. Since the publication of the regulatory framework, the industries have five years to adapt to the new guidelines, however, is expected that the results shown here serving as a warning to both regulatory agencies and consumers for those irregularly sold products, or which ones that have some nonconformity in their label or even in their composition. The presence of adulterants in food supplements is a serious public health problem that can lead to irreversible health damage to those who consume them. |
publishDate |
2019 |
dc.date.issued.fl_str_mv |
2019-12-19 |
dc.date.accessioned.fl_str_mv |
2021-05-25T17:37:56Z |
dc.date.available.fl_str_mv |
2021-05-25T17:37:56Z |
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doctoralThesis |
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por |
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por |
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400300000005 |
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600 |
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Attribution-NonCommercial-NoDerivatives 4.0 International http://creativecommons.org/licenses/by-nc-nd/4.0/ info:eu-repo/semantics/openAccess |
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Attribution-NonCommercial-NoDerivatives 4.0 International http://creativecommons.org/licenses/by-nc-nd/4.0/ |
eu_rights_str_mv |
openAccess |
dc.publisher.none.fl_str_mv |
Universidade Federal de Santa Maria Centro de Ciências da Saúde |
dc.publisher.program.fl_str_mv |
Programa de Pós-Graduação em Ciências Farmacêuticas |
dc.publisher.initials.fl_str_mv |
UFSM |
dc.publisher.country.fl_str_mv |
Brasil |
dc.publisher.department.fl_str_mv |
Ciências da Saúde |
publisher.none.fl_str_mv |
Universidade Federal de Santa Maria Centro de Ciências da Saúde |
dc.source.none.fl_str_mv |
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MD5 MD5 MD5 MD5 MD5 |
repository.name.fl_str_mv |
Repositório Institucional Manancial UFSM - Universidade Federal de Santa Maria (UFSM) |
repository.mail.fl_str_mv |
ouvidoria@ufsm.br |
_version_ |
1808854730642817024 |