Regulatory framework for dietary supplements and the public health challenge

Abstract

OBJECTIVE 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.METHODS 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.RESULTS 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.CONCLUSIONS 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.

Exploration of facilitators and barriers to the regulatory frameworks of dietary and herbal supplements: a scoping review

“…Therefore, the National Health Surveillance Agency of Brazil (ANVISA), which oversees the licensing and health surveillance of HM products, has recognized the importance of knowledge mobilization and active collaboration between the HM researchers and regulators, and thus has engaged in various cooperative initiatives. Most notably, the International Pharmaceutical Regulators Forum encourages coordination between countries such as the United States, Canada, and India for the exchange of information gathered from research investigations, which may help to strengthen existing research on HM regulations in other countries [ 33 ]. ANVISA has even proposed organizing regular meetings with the Food and Drug Administration (FDA) to share information on regulatory policies regularly [ 33 , 34 ].…”

The knowledge and attitudes of pharmacists related to the use of dietary supplements: An observational study in northeastern Italy

“…This belief seems to be confirmed in their attitudes and practices, particularly with regard to counseling patients about natural sources of vitamin intake and healthy lifestyles, including diet, drinking, alcohol consumption, and smoking, whose importance in maintaining health and well-being and preventing noncommunicable diseases is undisputed. Although dietary supplements are an important complementary source of essential nutrients ( Epicentro, 2022 , FederSalus, 2018 ), their widespread and inadequately regulated use raises concerns about potential adverse effects ( ISS, 2020 ), which may be exacerbated by the incomplete or falsified information available on the Internet and social media ( Al Khaja et al, 2018 , Molin et al, 2019 , Adams et al, 2020 ) and by the ease of purchasing dietary supplements available over-the-counter.…”

Trajetória da regulação sanitária para utilização da enzima lactase em produtos alimentícios no Brasil

“…A RDC ANVISA nº 243/2018 estabeleceu os requisitos sanitários para suplementos alimentares, incluindo uma listagem de nutrientes, substâncias bioativas, probióticos e enzimas (Resolução n. 243, 2018). Esta legislação surgiu como uma proposta regulatória com menos entraves para os fabricantes visando a oferta de suplementos alimentares no Brasil com garantia de qualidade para o consumidor (Molin et al, 2019). De acordo com a Instrução Normativa ANVISA nº 28/2018 os produtos contendo lactase são classificados como suplementos alimentares, tendo origem do fungo Aspergillus oryzae e devem fornecer no mínimo 4.500 U.FCC (Instrução Normativa n. 28, 2018).…”