Regulatory framework for dietary supplements and the public health challenge

The new regulatory framework for dietary supplements in Brazil prompted this analysis of the current outlook of these products and the challenges posed by the new guidelines. We conducted a qualitative, observational and descriptive study of dietary supplements commercialized in Brazilian online sto...

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Bibliographic Details
Published in:	Revista de saúde pública Vol. 53; p. 90
Main Authors:	Molin, Thaís Ramos Dal, Leal, Gabriela Camera, Müller, Larissa Sabo, Muratt, Diana Tomazzi, Marcon, Gabriela Zanella, Carvalho, Leandro Machado de, Viana, Carine
Format:	Journal Article
Language:	English
Published:	Brazil Faculdade de Saúde Pública da Universidade de São Paulo 01-01-2019 Universidade de São Paulo
Subjects:	Brazil Commerce - legislation & jurisprudence Commerce - standards Dietary Supplements - standards Food Ingredients - standards Health Policy & Services Humans Legislation, Food - standards Original Product Labeling - legislation & jurisprudence Product Labeling - standards Public Health Qualitative Research Brazil Comercialização de Produtos Qualidade de Produtos para o Consumidor, legislação & jurisprudência Suplementos Nutricionais Agência Nacional de Vigilância Sanitária
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Summary:	The new regulatory framework for dietary supplements in Brazil prompted this analysis of the current outlook of these products and the challenges posed by the new guidelines. We conducted a qualitative, observational and descriptive study of dietary supplements commercialized in Brazilian online stores with the help of the Google® search tool. We considered the ingredients on the labels, the effects attributed to these products and the commercial claims used as a means of promoting them to assess the necessary changes for the legal framework in the new guidelines. Finally, with the help of a database, we compared the effects declared by the manufacturers and attributed to certain ingredients with the scientific evidence described in literature. In total, we purchased 44 dietary supplements from Brazilian online stores (n = 7). Of the samples studied, 34.2% could not be classified in the category Dietary Supplements, as recommended by the new regulation of the Brazilian Health Regulatory Agency due to the presence of prohibited substances; 16% of products should be commercialized as medicines. Regarding the commercial appeals, 97.7% had banned expressions. Numerous claims of effects attributed to certain products were characterized as consumer fraud because they have no scientific evidence. The necessary changes represent a major regulatory and production challenge due to the wide range of dietary supplements and markets, an effort that aims to protect the consumers' health. Some previous gaps in the regulatory framework were not fully solved.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 ObjectType-Undefined-3 Conflict of interest: The authors declare no conflicts of interest. Authors’ Contribution: Study design and planning: TRDM, LSB, DTM, CV. Data collection, analysis and interpretation: TRDM, LSB, DTM, GCL, GZM. Writing and proofreading of the manuscript: TRDM, GCL, LMC, CV. Approval of the final version: LMC, CV. Public responsibility for the content of the article
ISSN:	0034-8910 1518-8787 1518-8787
DOI:	10.11606/S1518-8787.2019053001263