The approval follows a multi-year review of NEM’s safety and quality substantiation, which is required in India for foods with a special medical purpose, novel foods, health supplements, and nutraceuticals.
Chris Haynes, Senior Director of Global Sales for Stratum Nutrition, said in the press release: “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, continue. 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.”
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NEM is supported by 16 research studies, including four randomized placebo-controlled trials, two of which are healthy person trials; four open-label clinical trials, three of which were conducted independently; veterinary trials, including a canine RCT; and a wide range of supportingin vitroandin vivomechanism-of-action studies. Recent clinical trials have included objective endpoints via the CTX-II cartilage degradation biomarker.“We are extremely gratified to receive approval from FSSAI, as this again validates the substantial scientific portfolio that supports NEM and its health claims,” said Kevin J. Ruff, Ph.D., MBA, Sr. Director of Scientific & Regulatory Affairs for Stratum Nutrition, in the press release. “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.”
