Stratum Nutrition, (a business of ESM Technologies), along with its Indian partner, Zenova Bionutrition, have announced the FSSAI, the Food Safety Standards Authority of India, has granted pre-market approval of the NEM brand of partially hydrolysed chicken eggshell membrane powder. Approval was the culmination of a multi-year review by the standards authority of NEM’s safety and quality, which is required for foods with a medical purpose, novel foods, health 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, Director of Scientific & Regulatory Affairs for Stratum Nutrition.
NEM is supported by a portfolio of 16 research studies, including four randomised placebo-controlled trials, four open label clinical trials; veterinary trials, including one canine RCT; and a 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.
Chris Haynes, Senior Director of Global Sales for Stratum Nutrition, said: “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. 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.”