The approval, announced on January 14, 2021, is the culmination of a multi-year review by ANVISA of NEM’s safety and efficacy substantiation, which is required for foods or bioactive substances claims in Brazil.
“NEM is an innovative science-based ingredient approved for the first time by ANVISA in Brazil,” said Sandra de Anselmo, President of Ayalla. “We are very proud and excited to introduce such a robust ingredient to the Brazilian market and we are sure it will be a best-selling product in Brazil. We thank our partner, Stratum for the endless support they have given us through the approval process, and we hope to live up to their expectations just the same.”
The Brazilian approval is the third rigorous regulatory agency review of the ingredient’s safety and efficacy data after Canadian and Australian approvals in recent years, said Kevin Ruff, PhD, Sr. Director of Scientific & Regulatory Affairs for Stratum Nutrition.
“We are extremely gratified to receive approval from ANVISA, as this again validates the substantial scientific portfolio that supports NEM and its health claims. Brazil is a major market for joint health ingredients and we believe that an innovative, scientifically-backed ingredient like NEM will quickly establish itself as a category leader,” he said.
NEM is one of the few joint health ingredients, and the only eggshell membrane ingredient that is supported by a full portfolio of 16 research studies, including: Four randomized placebo-controlled trials (two of which are healthy person trials); four open label clinical trials (three of which were conducted independently); veterinary trials, including one canine RCT; and a wide range of supporting in vitro and in vivo mechanism of action studies.