Consultant David Pineda Ereño covered the region for many years for the EAS consultancy. He now operates his own shop under the shingle DPE consulting.
Pineda told Nutraingredients-USA that the regulation overhaul has been a long time coming. ANVISA (Agência Nacional de Vigilância Sanitária, or the National Health Surveillance Agency) the country’s regulatory body for foods and food ingredients, had first started to consider the overhaul in 2008. With such a long development time already come and gone, Pineda said he was loathe to speculate as to when the overhaul will finally go into effect, but said there is reason to believe it will be before the end of this year.
Lack of one category complicated matters
As matters have stood for many years, there has been no overarching definition of what constitutes a dietary supplement. Products that would be considered dietary supplements in North America or Europe and dealt with under a unified regulatory structure were seen as add-ons to food in Brazil. And the regulations that applied to them depended on the specifics of how the formulations went beyond what nutrients could be found in unfortified foods and what a company planned to say about these isolated and concentrated ingredients on product labels and in marketing materials.
It was a confusing system and one that was difficult to navigate. Much time and money could be spent and potentially wasted before a product came to market. It was challenging enough that in the past Pineda said he has recommended that companies seeking to build out a distribution footprint in Latin America steer clear of Brazil at first.
“A lot of the time they are looking at Brazil just because it is the biggest market. And it’s true the potential is huge,” Pineda said.
“But the regulation right now is very complicated. We advise a company to start in another market in South America, such as Colombia or Peru. There is not as big of a population but there is a higher likelihood that the product will get on the market in a reasonable amount of time,” he said.
Vitamin and mineral supplements have been the most straightforward products to get on the market in Brazil under the current regulations, Pineda said. But even then, adding an ingredient or two or upping the dosage of a constituent could push the product over the line into a different category requiring a different regulatory procedure. And making a claim for some health benefit on the product can reset the process yet again.
“It all depends on the formula and the claims. What ingredients you are putting into the products and what their concentration is. If you want to put more than 100% of an RDA [Recommended Dietary Allowance], that could be a different process to go through,” he said.
The new regulations will do away with this piecemeal structure and for the first time create a dietary supplement category within the country and finally do away with the patchwork quilt that has built up over the years, Pineda said.
Rather than in effect looking at each product category, each new concentration of an ingredient, or each new claim as a de novo addition to the food regulations, Pineda said the new structure will have product safety as its bedrock consideration. It will be a baseline that is akin in some ways to the DSHEA grandfather clause or the system of GRAS is the United States, i.e., start from an agreed upon basis of safe ingredients and safe levels and build from there in more of a unified fashion.
“There is no definition of supplement now. That is what is coming. There is a framework definition of supplements that is quite broad. It will benefit anything that goes beyond a vitamin or mineral supplement,” Pineda said.
“The new approach is one of safety that follows CODEX guidelines. The basis will rest on evidence from scientific studies and not rely so much on what the RDA for a nutrient is. It will do away with the maximum levels of vitamins and minerals,” he said.
Botanicals still impaired
The new regulatory structure, while more coeherent, will still be quite restrictive compared to others around the world. Botanical ingredients, for example, will still have a tough row to hoe and many will still have to consider going through a novel ingredient approval process.
“The use of botanical ingredients in supplements has been quite restricted and that won’t change. There is a discussion around allowable claims, and that will also be ongoing,” Pineda said.
“But now everything will fall under one category, and that is progress. That is actually a huge breakthrough,” he said. “The requirements for quality and safety will continue to be high. But there will be better speed to market. It’s going to make life easier for everybody.”