Brazil's ANVISA Grants Novel Food Approval for NEM® brand eggshell membrane
CARTHAGE, Mo.: Stratum Nutrition®, along with our Brazilian partner Ayalla, are pleased to announce that ANVISA, the National Health Surveillance Agency of the Brazilian Ministry of Health, has granted "safety and efficacy as a bioactive substance" pre-market approval of NEM® brand eggshell membrane on January 14, 2021. This approval was 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.
Sandra de Anselmo, President of Ayalla, said, "NEM is an innovative science-based ingredient approved for the first time by ANVISA in Brazil. 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."
"Brazil marks the 3rd rigorous regulatory agency review of NEM's safety and efficacy data, following Canadian and Australian approvals in recent years. "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," said Kevin J. Ruff, Ph.D., MBA, Sr. Director of Scientific & Regulatory Affairs for Stratum Nutrition.
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: 4 randomized placebo-controlled trials (2 of which are healthy person trials); 4 open label clinical trials (3 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. In addition to subjective endpoints like joint pain and stiffness, recent clinical trials have included objective endpoints via the CTX-II cartilage degradation biomarker, giving the results additional credibility and substantiation.
Stratum is the global leader in eggshell membrane science and technology for joint health with products in over 20 countries.