The approval follows a multi-year review by ANVISA of NEM’s safety and efficacy substantiation, which is required for foods or bioactive substances claims in Brazil
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 Stratum Nutrition’s NEM brand eggshell membrane.
NEM is a joint health ingredient, and is supported by 16 research studies, including 4 randomised placebo-controlled trials; 4 open label clinical trials; veterinary trials; and 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.
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.”
The approval marks the 3rd 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, Senior Director of Scientific & Regulatory Affairs for Stratum Nutrition.