Latin America market opportunities for food supplements: Navigating regulatory complexities

This article discusses the growth opportunities in Latin America for food supplement businesses. It provides guidance for companies eager to interpret current regulation, predict future direction, and plan successful commercial strategies. The author addresses the commercial advantages going along with increased regional and global harmonization and how to navigate current regulatory complexities to realize commercial opportunities and meeting the challenges and opportunities for making claims and bringing food supplement products to markets in the region.
 
Introduction
Latin America is one of the most dynamic and diverse regional markets in the world. With its increasing consumer demand, it offers many opportunities for food supplement businesses.
 
In addition, consumers are becoming more health conscious than ever as they deal with the effects of the COVID-19 pandemic. Consequently, Latin American consumer demand is expected to increase further for food supplements that could help individuals meet their optimum health goals. From boosting immunity and digestive health to weight-management supplement products, consumers are also looking to lead more sustainable lifestyles as they become more earth-aware and seek out products they perceive as green and clean.
 
Because of the higher demand among Latin American consumers, food supplements have, for some time, been at the top of the regulatory agenda, resulting in more regulation.
 
In this regard, Codex Alimentarius standards and guidelines,¹ the international reference point for food regulations, have contributed to shaping food supplement regulations across Latin America, particularly since the region’s adoption in 2005 of the Codex Guidelines for Vitamin and Mineral Food Supplements.² In addition, Codex Alimentarius standards and guidelines on food additives and food labeling have also been implemented at regional and national levels in Latin America.
 
As such, there are harmonized horizontal regulations (e.g., food additives and labeling) in some of the trade blocs in the region, but with limited application to food supplements. At the same time, there are ongoing regional initiatives for the harmonization of vertical regulation specific for food supplements.
 
Companies need to take into account that food supplement regulations have been developed mainly at national level, which has created complex and diverse regulations across the region’s markets that present some challenges along with the opportunities.
 
Codex influence
Discussions during the development of the Codex Guidelines for Vitamin and Mineral Food Supplements,² and its adoption in 2005, contributed to the transformation of, among others, how food supplements are viewed in the region in terms of their classification under food law; the recognition of their nutritional relevance; the acceptance of a greater variety of ingredients; the broader acceptance of the different forms of presentation; and the expansion of maximum levels of nutrients based on safety.
 
In addition, the Codex General Standard for Food Additives (GSFA)³ – the single-most influential Codex text – has been implemented in many Latin American countries, meaning that a greater number of food additives are allowed to be used in food supplements. However, provisions of the Codex General Standard for the Labeling of Prepackaged Foods⁴ and the Codex Guidelines on Nutrition Labeling⁵ have been implemented at regional and national levels, with variations in their application to food supplements.
 
Harmonization opportunities
Several trade blocs co-exist in Latin America and the Caribbean. They include:

• Southern Common Market (MERCOSUR),⁶ composed of Argentina, Brazil, Paraguay, and Uruguay, with Bolivia pending for full integration
• Pacific Alliance,⁷ composed of Chile, Colombia, Mexico, and Peru
• Andean Community (CAN),⁸ composed by Bolivia, Colombia, Ecuador, and Peru
• Central American Integration System (SICA),⁹ composed of Costa Rica, El Salvador, Guatemala, Honduras, Nicaragua, Panama, and Dominican Republic
• Caribbean Community (CARICOM,¹⁰ composed of Antigua and Barbuda, Bahamas, Barbados, Belize, Dominica, Grenada, Guyana, Haiti, Jamaica, Montserrat, Saint Lucia, St Kitts and Nevis, St Vincent and the Grenadines, Suriname, and Trinidad and Tobago.  

Food additives and labeling
Although all these blocs have harmonized regulation in certain sectors, some have yet to harmonize regulation for specific areas. For example, CAN still has to harmonize its regulation for foods and beverages. CARICOM has harmonized its food labeling regulation through the CARICOM Regional Standard Specification for labeling of prepackaged foods¹¹ and implemented provisions of the Codex texts on food and nutrition labeling. However, the implementation of CARICOM regional standards is voluntary for its member countries. Considering that this regional standard applies to foods in general, it is up to each member country whether it will also apply the standard to food supplements, depending on how they are classified.
 
MERCOSUR has harmonized its food additives¹² and general food and nutrition labeling¹³ regulations for foods and beverages. All these regulations are currently under review. MERCOSUR countries are required to implement the bloc’s regulations at the national level. But, here again, there are some differences in how food supplements are classified in each member country. Therefore, MERCOSUR countries sometimes apply different approaches in the application of the MERCOSUR harmonized regulations to food supplements.
 
Similarly, SICA has harmonized its food additives and general food and nutrition labeling regulations for foods and beverages. The difference here is that the Central American Technical Regulation (RTCA)on Food Additives¹⁴ implements the Codex GSFA to the letter, including provisions directly applicable to food supplements. However, the RTCA on general food and nutrition labeling¹⁵ applies to food supplements in those jurisdictions in which supplements are regulated as foods. It is worth pointing out that the RTCA on nutrition labeling includes a list of nutrition and health claims with conditions of use in foods and beverages. In addition, claims allowed in markets of reference, such as the EU, are also accepted.
 
Food supplements
In addition to the above examples of horizontal regulations that have an impact on food supplements, there are ongoing initiatives for harmonizing vertical regulation specific to food supplements.
 
For example, a proposal has been presented to the Central American Economic Integration Secretariat¹⁶ for harmonization of vertical regulation of food supplements. However, the proposal is pending, and can only be formally incorporated into the agenda of the Central American Economic Integration Subsystem through the sponsorship of a member country.
 
In another example, the Pacific Alliance is currently undertaking the harmonization of food supplement regulations. During the process of harmonization, the alliance has taken into consideration the Codex Guidelines on Vitamin and Mineral Food Supplements, as well as the Codex labeling standards and guidelines. Consequently, the Pacific Alliance model, among others:

• classifies food supplements under food law
• recognizes the nutritional or physiological effect of food supplements
• includes a broad reference to the use of vitamins, minerals, and other ingredients
• establishes maximum levels of vitamins and minerals based on safety
• accepts the use of nutrition and health claims in food supplements
• harmonizes the market entry requirements.  

This is particularly relevant when maximum levels of vitamins and minerals in some of the Pacific Alliance countries are still based on recommended daily allowance values, health claims are not allowed, or different requirements and procedures are needed for the market entry of food supplement products. Therefore, the Pacific Alliance harmonization process is an example of the many opportunities that may be coming along with regional harmonization.
 
Key national developments
These harmonization opportunities require implementation at national level, which can sometimes take time. It is important to bear that in mind when navigating existing regulatory complexities across the region’s different markets and diverse requirements. However, with more regulation and the Codex influence, there are examples where regulation has improved conditions for marketing food supplements, thus presenting opportunities for food supplement companies.
 
In addition, it is worth pointing out that, in some cases, Latin American regulatory authorities have looked not only at the Codex Alimentarius, but also to US and EU food supplement regulations and policies as references for developing and reviewing their regional and national regulations.
 
The five countries below are examples of important regulatory developments in select Latin American markets and highlight the opportunities that can come with changes in regulation.
 
Argentina
Chapter XVII of the Argentinean Food Code¹⁷ regulates dietary supplements under the broader category of foods for special dietary uses or dietetic foods. The chapter is under review and includes the following notable changes: 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.
 
Dietary supplements have to be authorized before they can be marketed in Argentina, but the administrative procedures for receiving authorization are not being amended at present. However, the authorization process in Argentina is one of the most efficient in the region.
 
Brazil
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.¹⁸ 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.
 
While these new rules are already in place, the Brazilian regulatory authorities of the National Health Surveillance Agency¹⁹ continue to work on improving the regulations. In March, a new draft regulation with updates on the lists of authorized ingredients, their limits of use, the list of authorized claims, and the labeling requirements for food supplements was released for public commentary.
 
Chile
Title XXIX of the Chilean Food Sanitary Regulation²⁰ regulates the category of food supplements under the broader category of foods for special dietary uses. The title is under review, with the following key changes: the definition of food supplements has been expanded; the category of “supplemented foods” has been added; a list of authorized ingredients for use in food supplements and supplements foods has also been expanded and includes their maximum levels; lists of authorized nutrition and health claims for use in food supplements have been developed; and additional labeling and advertising requirements have been established for food supplements.
 
It is worth highlighting that food supplements are currently restricted from using health claims. However, the definition of food supplements has been amended in line with the Pacific Alliance definition, which recognizes the nutritional and physiological effects of food supplements. In that sense, the proposed list of authorized nutrition and health claims for use in food supplements is also a result of the harmonization work of the Pacific Alliance allowing their use.
 
In the meantime, food supplements need to be notified without having to go through a registration procedure, that is, authorization.
 
Colombia
In Colombia, dietary supplements are defined independently from foods and drugs. Maximum levels for vitamins and minerals are set based on their safety.²¹ The use of botanical ingredients is based on the demonstration of their nutritional effects. In addition, applicants have to substantiate, case-by-case, the scientific basis for the listed health claims in dietary supplements.²² Dietary supplements have to be authorized before they reach the market, and their advertising material has to be authorized before they are promoted.
 
Given the harmonization work of the Pacific Alliance, it could be expected that the alliance’s criteria for authorization of botanical ingredients will facilitate their acceptance in food supplements in Colombia. It is also hoped that the authorized claims will be used directly in food supplements, without having to go through a case-by-case substantiation process, as is currently the case.
 
Mexico
Article 215 of the General Health Law (LGS)²³ 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),²⁴ 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.
 
Although there is no specific mention of claims in the RCSPS, in practice, only certain nutrition claims may be allowed on advertising for some active components of food supplements. Health claims are not allowed for food supplement products, although the regulation does not clearly specify that. However, although imported food supplements must be notified in Mexico and do not have to go through a registration process, as in Colombia, food supplements require prior authorization of their advertising material.
 
Given the harmonization work of the Pacific Alliance and the example of Chile, it remains to be seen when, or whether, Mexico will begin the process of proposing regulation amendments, particularly on claims, at national level. A bill in the Mexican Congress proposes amending the definition of food supplements in the LGS in line with the Pacific Alliance definition, which recognizes the nutritional and physiological effects of food supplements. Such a process would be highly positive for the marketing of food supplements in Mexico.
 
Conclusion
The increased global and regional harmonization in Latin America is contributing to improvements in the regulations at the national level. However, companies still have to navigate the diverse regulatory frameworks to evaluate and identify important developments and business opportunities.
 
It is important for companies to identify market opportunities in Latin American countries that have favorable regulatory conditions for the food supplement products they are planning to launch, rather than looking only at the country’s market or population size. However, that does not mean there is no merit in looking closely at population profiles and characteristics, such as social change and evolution of lifestyle. Being aware of such elements can help identify trends in rising and stable incomes and locate the consumers of today and tomorrow.
 
A key element in developing a successful strategy for launching food supplement products in Latin America is to recognize and evaluate the regulatory challenges and opportunities before entering the market. It is essential to have a clear understanding of the diverse regulations across the different markets, including the regulatory entry requirements and procedures.
 
Abbreviations
CAN, Andean Community; CARICOM, Caribbean Community; GSFA, General Standard for Food Additives; LGS, General Health Law; MERCOSUR, Southern Common Market; RCSPS, Regulation on Sanitary Control of Products and Services; RDA, recommended daily allowance; RTCA, Central American Technical Regulation; SICA, Central American Integration System; SIECA, Central American Economic Integration Secretariat.
 
References

1. Codex Alimentarius website. http://www.fao.org/fao-who-codexalimentarius/en/. Accessed on 15 June 2020.
2. Guidelines for Vitamin and Mineral Food Supplements. CAC/GL 55-2005. http://www.fao.org/input/download/standards/10206/cxg_055e.pdf. Accessed on 15 June 2020.
3. General Standard for Food Additives. CODEX STAN 192-1995. http://www.fao.org/fao-who-codexalimentarius/codex-texts/dbs/gsfa/en/. Adopted 1995; last revised 2019. Accessed on 15 June 2020.
4. General Standard for the Labelling of Prepackaged Foods. CODEX STAN-1985. http://www.fao.org/input/download/standards/32/CXS_001e.pdf. Adopted 1985; last revised 2018. Accessed on 15 June 2020.
5. Guidelines on Nutrition Labelling. CAC/GL 2-1985. http://www.fao.org/fao-who-codexalimentarius/sh-proxy/es/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXG%2B2-1985%252FCXG_002e.pdf. Adopted 1985. Accessed on 15 June 2020.
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8. Comunidad Andina (CAN). http://www.comunidadandina.org/. Accessed on 15 June 2020.
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10. Caribbean Community (CARICOM). https://caricom.org/. Accessed on 15 June 2020.
11. CARICOM Regional Standard. Specification for labelling of pre-packaged foods. CRS 5: 2010. https://website.crosq.org/. Accessed on 15 June 2020.
12. Resolución Nº 11/06 - Reglamento Técnico MERCOSUR sobre “Lista general armonizada de aditivos alimentarios y sus clases funcionales.” https://www.mercosur.int/documentos-y-normativa/normativa/. Accessed on 15 June 2020.
13. Resolución Nº 26/03 - Reglamento Técnico MERCOSUR para Rotulación de Alimentos Envasados. https://www.mercosur.int/documentos-y-normativa/normativa/. Accessed 15 June 2020. Resolución Nº 46/03 - Reglamento Técnico MERCOSUR sobre el Rotulado Nutricional de Alimentos Envasados. https://www.mercosur.int/documentos-y-normativa/normativa/. Accessed 15 June 2020.
14. Reglamento Técnico Centroamericano RTCA 67.04.54:10. Alimentos y Bebidas Procesadas. Aditivos Alimentarios.
15. Reglamento Técnico Centroamericano RTCA 67.01.02:10. Etiquetado General de los Alimentos Previamente Envasados (Preenvasados).
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17. Código Alimentario Argentino, Capítulo XVII, Artículos 1339 al 1390 – Alimentos de Régimen o Dietéticos. https://www.argentina.gob.ar/sites/default/files/anmat-capitulo_xvii_dieteticosactualiz_2018-12.pdf. Accessed on 15 June 2020.
18. Resolução da Diretoria Colegiada - RDC Nº 243, de 26 de julho de 2018. Dispõe sobre os requisitos sanitários dos suplementos alimentares. http://portal.anvisa.gov.br/documents/10181/3898888/RDC_243_2018_.pdf/0e39ed31-1da2-4456-8f4a-afb7a6340c15. Accessed on 15 June 2020.
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21. Decreto 3249 de 2006, modificado por el Decreto 3863 de 2008. https://www.minsalud.gov.co/Normatividad_Nuevo/DECRETO%203249%20DE%202006.pdf. Accessed on 15 June 2020.
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24. Reglamento de Control Sanitario de Productos y Servicios. http://www.salud.gob.mx/unidades/cdi/nom/compi/rcsps.html. Accessed on 15 June 2020.

About the author
David Pineda Ereño, LLM, is managing director of DPE International Consulting, an international consultancy firm that provides legal advice and strategic solutions on the policy, regulation, and trade of foods, beverages, food supplements, and other nutritional products. Pineda has more than 17 years of experience providing strategic and regulatory advice to companies, trade associations, and government bodies in the food, nutrition, and health arena at national, regional, and international levels in Asia, Europe, Latin America and the Caribbean, and the United States. He also has expertise in regulatory harmonization processes in international organizations, such as the Codex Alimentarius Commission; in the notification processes of regulations to the World Trade Organization; and in the development of international policies on health and nutrition, with organizations such as the World Health Organization and the Pan American Health Organization. Pineda has a law degree from the University of Deusto, Bilbao, Spain, and a master’s degree in comparative law and European law from the University of Maastricht, The Netherlands. He can be contacted at davidpineda@dpeic.com.

Citation Pineda Ereño D. Latin America market opportunities for food supplements: Navigating regulatory complexities. Regulatory Focus. June 2020. Regulatory Affairs Professionals Society.