Latin America is becoming a land of opportunity for many emerging markets and Food Supplements are rapidly becoming more popular in the LATAM region. Factors that have contributed to food supplements popularity and growing market potential include a growing aging population, a more health conscience consumers, a growing middle class with disposable incomes, and COVID-19 pandemic has lead many people to look for immune boosting. This blog will overview Brazil, Mexico and Argentina Market potential for food supplements and relevant regulation specific to each region.
Article 215 of the General Health Law defines food supplements requiring the combination of vitamins and minerals with other ingredients. However, food supplements are governed specifically by the Regulation on Sanitary Control of Products and Services (RCSPS), which, among others, provides lists of categories of ingredients that can be used or not in food supplements; sets forth specific safety requirements for food supplements raw materials; addresses the defining lines between food supplements and medicinal products; indicates the food supplement product information required by the Ministry of Health, including general labeling and advertising provisions specific to food supplements; and sets the maximum amounts of vitamins and minerals as multiples of recommended daily allowance.
In the past, food supplements were regulated by different regulations in different product categories, which presented a significant challenge to them gaining access to the Brazilian market. That challenge was removed with the Resolution RDC No. 243, of 26 July 2018, a wide-ranging regulation that lays out the composition, quality, safety, and labeling requirements for the food supplement category.
In addition, a series of regulations for implementation include, among others: a list of authorized ingredients for use in food supplements, and the maximum levels of those ingredients; a list of authorized claims for use in food supplements; and the processes for updating both those lists. This has made the rules in Brazil far clearer for food supplement products entering the market.
In this regard, only food supplements containing enzymes or probiotics or with functional and/or health claims must go through an authorization procedure before marketing, that is, they must have prior approval.
The authorization process in Argentina is one of the most efficient in the region. Argentina’s ANMAT regulates food supplements under Chapter XVII of the Argentinean Food Code the broader category of foods for special dietary uses or dietetic foods. The chapter includes the definition of dietary supplements has been expanded, the minimum and maximum levels of vitamins and minerals have been revised, and the list of botanical ingredients that can be used in dietary supplements has been amended.
It is worth highlighting that a limited number of claims are allowed to be used in dietary supplements. However, there is a direct reference in the new definition to the nutritional or physiological effects of ingredients, which could contribute to a broader acceptance of the use of health claims in dietary supplements.
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Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations. To learn more, please contact us at firstname.lastname@example.org
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