12.01.21
Stratum Nutrition’s NEM, a branded eggshell membrane ingredient formulated for joint health, recently received pre-market approval from the Food Safety Standards Authority of India (FSSAI). The approval is required for the sale of medical foods, novel foods, dietary supplements, and nutraceuticals in India.
“We are extremely gratified to receive approval from FSSAI, as this again validates the substantial scientific portfolio that supports NEM and its health claims. NEM, being ovo-vegetarian, makes a great combination with curcumin-based ingredients for joint health, and this approval should allow NEM to establish its place as an innovative, science-backed ingredient in India’s consumer market,” said Kevin J. Ruff, PhD, MBA, senior director of scientific and regulatory affairs for Stratum Nutrition.
NEM is supported by a portfolio of 16 studies, including 4 randomized placebo-controlled trials, 4 open-label clinical trials, veterinary trials including one canine RCT, and a range of in vitro and in vivo mechanism of action studies. In addition to establishing subjective endpoints such as joint pain and stiffness, recent clinical trials on the ingredient have linked it to improved concentrations of the CTX-II cartilage degradation biomarker, an objective endpoint.
“The long-term scientific efforts by Stratum to increase global acceptance of NEM as a joint health ingredient, which is fundamental for the health and well-being of the global population, continues. NEM’s exponential success of country-by-country registration clearly demonstrates the scientific validation of its function and results,” Chris Haynes, senior director of global sales for Stratum Nutrition, said. “Governmental agencies require statistically significant science to grant approvals – NEM provides this and continues to gain regulatory acceptance everywhere it enters a market. India will be a solid and strategic market for Stratum moving forward.”
“We are extremely gratified to receive approval from FSSAI, as this again validates the substantial scientific portfolio that supports NEM and its health claims. NEM, being ovo-vegetarian, makes a great combination with curcumin-based ingredients for joint health, and this approval should allow NEM to establish its place as an innovative, science-backed ingredient in India’s consumer market,” said Kevin J. Ruff, PhD, MBA, senior director of scientific and regulatory affairs for Stratum Nutrition.
NEM is supported by a portfolio of 16 studies, including 4 randomized placebo-controlled trials, 4 open-label clinical trials, veterinary trials including one canine RCT, and a range of in vitro and in vivo mechanism of action studies. In addition to establishing subjective endpoints such as joint pain and stiffness, recent clinical trials on the ingredient have linked it to improved concentrations of the CTX-II cartilage degradation biomarker, an objective endpoint.
“The long-term scientific efforts by Stratum to increase global acceptance of NEM as a joint health ingredient, which is fundamental for the health and well-being of the global population, continues. NEM’s exponential success of country-by-country registration clearly demonstrates the scientific validation of its function and results,” Chris Haynes, senior director of global sales for Stratum Nutrition, said. “Governmental agencies require statistically significant science to grant approvals – NEM provides this and continues to gain regulatory acceptance everywhere it enters a market. India will be a solid and strategic market for Stratum moving forward.”
