Suplementos Alimentares: aspectos legais, sanitários e os riscos à saúde pública.

Abstract

This dissertation aimed to analyze the legislative compliance of the commercialization of dietary supplements based on medicinal plants requiring medical prescription, according to the Herbal Formulary of the Brazilian Pharmacopoeia, marketed in grain stores and natural product shops in the municipality of Medianeira, Western Paraná, Brazil. The study was based on the hypothesis that products containing substances with pharmacological potential were being marketed as dietary supplements, often in disagreement with current health regulations, potentially posing risks to public health, especially in situations requiring medical prescription and professional monitoring. Despite the increasing consumption of dietary supplements and herbal products in Brazil, their integration into clinical practice and the regulatory context still showed limitations and challenges related to safety, inspection, and rational use. The research adopted a qualitative and quantitative approach through literature review and a descriptive observational field study. Aspects related to labeling, regulatory classification, therapeutic claims, presence of medicinal plant mixtures, and commercialization practices of the identified products were evaluated. The level of knowledge of the establishment managers regarding the regulations applicable to dietary supplements and medicinal plants was also analyzed. The results revealed the commercialization of products containing medicinal plants requiring medical prescription presented as dietary supplements, as well as the presence of nonconformities related to labeling, sanitary designation, and regulatory classification. The offer of substances requiring medical prescription without proper professional guidance was also identified. In addition, therapeutic claims potentially incompatible with the regulatory category of dietary supplements were observed. These findings demonstrated weaknesses in compliance with current health legislation and gaps in technical knowledge regarding the use of medicinal plants and dietary supplements. The study also highlighted the importance of strengthening regulation, intensifying health surveillance actions, and promoting appropriate guidance for both establishment owners and consumers, aiming to encourage the rational use and responsible commercialization of these products, which are often perceived as “natural” and therefore risk-free, although this perception does not always reflect reality.