ANVISA, the National Health Surveillance Agency of the Brazilian Ministry of Health, has granted “safety and efficacy as a bioactive substance” pre-market approval, the culmination of a multi-year review of NEM’s safety and efficacy substantiation. The press release explains that NEM is a joint health ingredient supported by 16 research studies, including four randomized placebo-controlled trials and four open-label clinical trials.
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“Brazil marks the 3rdrigorous regulatory agency review of NEM’s safety and efficacy data, following Canadian and Australian approvals in recent years,” said Kevin J. Ruff, Ph.D., MBA, Sr. Director of Scientific & Regulatory Affairs for Stratum Nutrition, in the press release. “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.”Sandra de Anselmo, President of Ayalla, added: “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.”
