On the heels of obtaining GRAS status for its PUREFLEX® Glucosamine ingredients, TSI Health Sciences, Inc., a leading developer, producer and marketer of functional ingredients servicing the dietary supplement, pharmaceutical, and food and beverage industries, has now announced it has obtained self-affirmed GRAS (Generally Regarded as Safe) status for the use of its PUREFLEX® Chondroitin Sulfate Sodium products in conventional foods and beverages. The announcement was made by Larry Kolb, president, US Operations, TSI Health Sciences, Inc. (TSI) in Missoula, MT.
The GRAS affirmation for Chondroitin was conducted by a panel of independent experts, which deemed PUREFLEX® Chondroitin Sulfate Sodium products derived from Bovine, Avian, Marine and Porcine sources produced by TSI, are safe when added in conventional foods and beverages. Their independent analysis was based on TSI’s establishment of the appropriate food-grade specifications with respect to CGMP manufacturing processes required to produce food-grade material as well as on the results of advanced human clinical and safety studies.
“There is tremendous momentum today within the Food and Drug Administration to regulate liquid dietary supplements as foods,” says Kolb. “This new ingredient status provides TSI customers valuable market protection in the event GRAS affirmed ingredients ultimately become a requirement for inclusion in liquid supplement products, “Kolb added.
PUREFLEX® Chondroitin products are manufactured in a TSI owned and operated CGMP certified manufacturing facility, ensuring that all levels of production are monitored meticulously from start to finish. TSI also houses a sophisticated analytical laboratory in which each lot of PUREFLEX® Chondroitin is rigorously tested to confirm quality. For more information about PUREFLEX® visit www.TSIInc.com or call toll-free 877.549.9123.
About TSI Health Sciences
TSI Health Sciences, www.TSIInc.com, is a leading developer, producer and marketer of functional ingredients used by the dietary supplement, pharmaceutical and food and beverage industries. With US operations based in Missoula, Montana, TSI was founded in 1996 and has sales and marketing offices worldwide, including a 60-acre, fully integrated manufacturing, research, quality assurance and quality control campus in Jiangyin, China. The company’s specialized product range includes performance-based branded ingredients that are derived from botanical and natural product extracts, fermentation, and highly purified synthesis. TSI manufactures its ingredients to the strictest global standards, including ICH Q7A international CGMP manufacturing guidelines.