Anvisa approves unprecedented regulation for dietary supplements



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With a regulatory change, manufacturers will have to prove the effectiveness of the product

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Food supplements are products that may contain in their composition different nutrients, bioactive substances, enzymes and probiotics (iStock / Getty Images) Getty Images National Health Surveillance Agency (Anvisa) on Tuesday approved the unprecedented regulation of dietary supplements products that may contain different nutrients, bioactive substances, enzymes, and probiotics. , which will be published shortly in Journal of the Union (DOU) will define the general requirements for health, including rules of composition, quality, safety and labeling .

the new regulation will reduce the amount of disruptive information on the market, particularly e n regarding the submission of applications without scientific evidence, thus enabling consumers to access safe and quality products.

19659011] The agency will also issue a normative instruction with the list of permitted ingredients and approved claims. The text will be updated periodically and will set minimum and maximum limits for each substance, depending on the population group – children, pregnant and lactating women, for example.

Will also be on the Regulatory List Additives and Technological Additives (19459007) (live micro-organisms that, when administered in appropriate amounts, provide health benefits) and all the probiotics as well as information on the studies required to prove the safety and efficacy of the other substances used in the production of food supplements.

To date, as there was no legislation in the category of "food supplements", these products were clbadified as drugs or foods. From now on, they should bring the word "supplement" on the label. Companies will have five years to meet the new standard for products that are already on the market. According to the Brazilian Association of Food Industry for Special and Congenial Purposes (Abiad), research on consumption habits

Decision Based Research

supplements have shown that in more than 50% of households in Brazil there is at least one person who consumes dietary supplements. According to the survey, the consumer of supplements is aware in the search for a healthy and balanced diet and dietary supplements can contribute to the maintenance of health.

These results were presented to Anvisa in 2016 and contributed to the development of the new measure. "ABIAD has defended in recent years the development of a robust regulation, able to deal with the specificities of this market, with the main objective to protect the health of consumers without hindering the development of the productive sector, ensuring 39; access to safe and high quality products. […] It should be noted that the new regulation will provide clear information to the consumer since it provides for the use of functional and health claims, including fully recognized functions such as vitamins and minerals […] Due to the low health risk, dietary supplements are notified (with the exception of enzymes and probiotics), facilitating access and ensuring agility and innovation, generating regulatory convergence over existing practices in other markets. tion.

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