Novo marco regulatório de suplementos alimentares – do desenvolvimento à implementação
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Data
2020
Autores
Figueiredo, Daniely Paulino Gomes [UNIFESP]
Orientadores
Venturini, Anna Cecília [UNIFESP]
Tipo
Trabalho de conclusão de curso de graduação
Título da Revista
ISSN da Revista
Título de Volume
Resumo
No período precedente a julho de 2018, a categoria de suplementos alimentares possuía um
arcabouço legislativo desatualizado e fragmentado. Estes podiam ser classificados em sete
categorias regulatórias diferentes, o que caracterizava um cenário desfavorável tanto para a
indústria quanto para os consumidores e órgãos reguladores. É nesse contexto que nasce a
necessidade de revisão das legislações aplicáveis à categoria e de elaboração de um marco
normativo alinhado com a realidade do mercado nacional e internacional.
Ao longo do presente trabalho são elucidados os fatores que ocasionaram a elaboração deste
marco regulatório, por meio da contextualização das principais leis que até então regulavam
suplementos alimentares no mercado nacional e discussão das influências herdadas da
legislação europeia e americana na construção das novas normas.
Quanto à adaptação do mercado e impactos mapeados, de acordo com um levantamento
realizado pela Agência Nacional de Vigilância Sanitária (ANVISA), sobressaíram os custos
referentes à reformulação, reenquadramento ou retirada do produto do mercado. Todavia,
para uma implementação menos conturbada possível, a ANVISA estabeleceu medidas que
buscaram a capacitação de sua equipe interna e adotou uma abordagem gradual e transitória
para regularização dos suplementos alimentares pela indústria.
In the period preceding July 2018, the category of dietary supplements had an outdated and fragmented legislative framework. These could be classified into seven different regulatory categories, which characterized an unfavorable scenario for both industry and consumers and regulatory agencies. It is in this context that arises the need to revise the legislation applicable to the category and to develop a normative framework in line with the reality of the national and international market. Throughout this work, the factors that led to the elaboration of this regulatory framework are elucidated, through the contextualization of the main laws that until then regulated food supplements in the national market and discussion of the influences inherited from European and American legislation in the construction of new standards. As for market adaptation and mapped impacts, according to a survey carried out by the National Health Surveillance Agency (ANVISA), the costs related to the reformulation, reframing or withdrawal of the product from the market stood out. However, for the least troubled implementation possible, ANVISA established measures that sought the training of its internal team and adopted a gradual and transitory approach to regulating food supplements by the industry.
In the period preceding July 2018, the category of dietary supplements had an outdated and fragmented legislative framework. These could be classified into seven different regulatory categories, which characterized an unfavorable scenario for both industry and consumers and regulatory agencies. It is in this context that arises the need to revise the legislation applicable to the category and to develop a normative framework in line with the reality of the national and international market. Throughout this work, the factors that led to the elaboration of this regulatory framework are elucidated, through the contextualization of the main laws that until then regulated food supplements in the national market and discussion of the influences inherited from European and American legislation in the construction of new standards. As for market adaptation and mapped impacts, according to a survey carried out by the National Health Surveillance Agency (ANVISA), the costs related to the reformulation, reframing or withdrawal of the product from the market stood out. However, for the least troubled implementation possible, ANVISA established measures that sought the training of its internal team and adopted a gradual and transitory approach to regulating food supplements by the industry.