Global Regulations: Uniting Latin America's Dietary Supplement Regulations

Within Latin America, food supplements are subject to diverse regulations. While in Europe there exists a harmonized approach towards food supplement regulation, and within the Association of Southeast Asian Nations (ASEAN) there is a harmonization process underway, the policies in Latin America vary from country to country, leading to various challenges in marketing food supplement products across the region.

One of the main challenges is the categorization of supplements under either the food or the medicine umbrella. In Brazil and Venezuela, for example, supplements fall within the food category when their levels do not exceed the Recommended Daily Allowance (RDA). If exceeded, these are then treated as medicines. In Colombia, dietary supplements are treated as a different category from food and drugs. In Argentina, Chile, and Mexico, they are regulated as food.

These different categorizations create diverse conditions and further implications for the marketing and sale of food supplements. For example, in Brazil, supplements are referred to as “vitamin and/or mineral supplements” and in Venezuela as “food supplements of vitamins and minerals.” Both countries only allow vitamin and mineral supplements. Other ingredients, such probiotics or herbs, are not allowed in supplements and might be regulated under specific standards in the food and/or medicine category.

In other countries in the region, the definition for supplements is broader, as in Argentina and Colombia where the term dietary supplement is used, or as in Chile and Mexico where these products are referred to as “food supplements.” Ingredients other than vitamins and minerals are permitted for use, but the types of permitted ingredients vary from country to country. Ginseng, for example, is permitted in Chile and Colombia but not in Mexico, where it is regarded as an ingredient with a pharmacological action and therefore falls under the medicine umbrella.

A second challenge relates to the different ingredient levels permitted in the Latin American countries, which in some cases requires different product formulas applied in order to comply with the regulations. For example, in Brazil and Venezuela, maximum levels are based on RDA amounts, whereas in others (e.g., Colombia) higher nutrient thresholds have been established. For example, maximum levels for vitamin C vary significantly, from Brazil (45 mg) to Chile or Colombia (1000 mg). This inconsistency between countries challenges the possibilities of product harmonization within the region.

Thirdly, there are also different rules for the use of health and/or functional claims. In Mexico and Venezuela, health claims are not permitted for supplements. In Argentina, the use of health claims is not yet regulated, but the authorities are already working on a future regulation. At present, the scientific substantiation required for the use of health claims is being discussed. And in Brazil, Chile, and Colombia, health claims are permitted:

• Brazil: a positive list of functional claims was approved in July 2008 for 18 nutrients/ingredients
• Chile: health claims are regulated by a technical standard that sets a list of 18 “health associations” (e.g., fat or dietary fiber and cancer) with conditions of use
• Colombia: there are three positive lists of health claims for: 1) an association of 11 nutrients with nutrient function claims; 2) an association of eight nutrients with disease risk–reduction claims; and 3) other functional claims for omega-3 and omega-6 fatty acids and probiotics

Finally, market access to food supplements also differs. In Brazil, Mexico, and Chile, supplements can be placed on the market through a notification process, while in Argentina, Colombia, and Venezuela, they are required to go through a registration process.

With so much disparity in food supplement policies across Latin America, some countries are currently reviewing their regulations. Authorities in Argentina, Brazil, and Venezuela, for example, are currently assessing how to broaden the definitions of supplements and their ingredients. There will likely be more developments along these lines in the region, which may eventually extend to the setting of maximum levels based on safety and a broader use of health claims for food supplement products.