ANVISA: Regulation must catch up to booming South American supplements market

ANVISA's Antônia Maria de Aquino: “The huge advertising appeal (of dietary supplements and functional food) is characterized by the variety of benefits broadcast on promotional materials without the need for scientific evidence.”

Just ahead of the 2014 Vitafoods Conference in São Paulo, Brazil, a spokesperson for the Brazilian Health Surveillance Agency (ANVISA) caught up with NutraIngredients-USA to discuss the exploding market for dietary supplements and functional foods and beverages that is albeit rife with regulatory uncertainty.

“There is no doubt that supplements and functional foods and drinks market has increased in recent years, as much in Brazil as other countries,” Antônia Maria de Aquino, nutritionist and special products manager for ANVISA’s General Management Food division,told NutraIngredients-USA. Research from other countries shows that consumers use these products for many reasons, such as health promotion, sports performance and disease treatment. However, most people who have balanced nutrition do not need to use supplements or functional food, because their food should be able to provide all needed nutrients, beyond other substances that promote a healthy life.”

Indeed, the Brazilian Nutrition Guide—which provides recommendations for nutrition habits for health from the Ministério da Saúde—contains no recommendations for dietary supplements or functional foods. Instead, the guide emphasizes the importance of “reintroducing traditional habits” to promote good nutrition, de Aquino said, adding that the growing demand for supplements and functional food in South America is largely a product of advertising and easier access through the online marketplace.

“The huge advertising appeal is characterized by the variety of benefits broadcast on promotional materials without the need for scientific evidence,” de Aquino said. “Beyond that, access to these kinds of products has become easier, with e-commerce and the possibility to buy without medical prescription, plus the growth of the population with healthcare also contributes to the popularity of these products.”

What’s a supplement and what’s a functional food? 

Brazil has yet to implement any formal legislation with regard to supplements and functional foods, which ANVISA is currently working to revise. “Because in many countries supplements are introduced on the market without any prior evaluation by the public health authorities, many producers find difficulties selling their products here, because they do not have the necessary information to prove that their products are safe and meet the claimed benefits,” she said.

In part, this process involves clarifying what constitutes a supplement versus a functional food. “In Brazil, these products can be considered food or medicine depending on their composition characteristics and reason for use,” de Aquino said. “The foods with functional aspects and most products that should be presented as a supplement must be registered and have their safety and scientific efficacy proven.”

De Aquino pointed to challenges in the US and Europe markets when it comes to regulating the supplements market, noting that the US’ Dietary Supplement Health and Education Act of 1994, which tried to restrict the regulatory capacity of the FDA, tends to empower the supplement industry at the risk of public health and safety, as evidenced by the “innumerous” warning letters issued by the FDA, she said.

On the other hand, the EU’s Diretiva 2002/46/CE (which tried to harmonize the definitions and criteria for supplements, though it’s limited to vitamin and mineral compounds) underscores the complexity of controlling properly the market of these products, which is characterized by products with a variety of ingredients, constant innovation and a huge advertisement appeal,” she said.

ANVISA regulation specialist Fátima Machado Braga will present opening remarks on the regulatory outlook for functional food to kick off the 2014 Vitafoods Conference on April 8. For more information on the conference, click here.

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