09.06.19
Xylooligosaccharide (XOS) supplier AIDP, Inc. (Advanced Ingredients for Dietary Products), has gained regulatory approval for prebiotic claims for its PreticX brand with help from Canadian contract research organization Nutrasource Pharmaceutical and Nutraceutical Services.
In the evolving prebiotic and probiotic market, companies are looking for strategies to differentiate themselves. In addition to the FDA Generally Recognized As Safe (GRAS) and New Dietary Ingredient (NDI) notification in the U.S., AIDP is looking to extend the international regulatory approvals for its branded ingredient, PreticX XOS. AIDP worked with Nutrasource to develop a strategic regulatory pathway for the ingredient in Canada.
PreticX XOS’s chain composition creates a unique and robust prebiotic effect, according to AIDP. Other XOS materials, produced via different processes, result in distinct compositions, benefits and dosage. Claims can only be made from human clinical studies completed on a specific XOS and cannot be borrowed from literature. PreticX XOS has over 12 published human studies.
“AIDP is committed to investing in unique products like PreticX. Only PreticX XOS can make the desired claims, which separates this unique product from other XOS prebiotics on the market,” said Jennifer Gu, vice president of research and development for AIDP. “Working with the Nutrasource team was a collaborative effort achieved by joining their regulatory expertise with our science.”
“The Nutrasource team thrives in providing novel and unique regulatory solutions for its clients,” said William Rowe, president and CEO of Nutrasource, “We are honored to have secured these favorable regulatory results on behalf of AIDP for Canadian market access.”
Nutrasource has secured a Product License for PreticX XOS that has meaningful claims regarding prebiotic fiber and digestive health.
In the evolving prebiotic and probiotic market, companies are looking for strategies to differentiate themselves. In addition to the FDA Generally Recognized As Safe (GRAS) and New Dietary Ingredient (NDI) notification in the U.S., AIDP is looking to extend the international regulatory approvals for its branded ingredient, PreticX XOS. AIDP worked with Nutrasource to develop a strategic regulatory pathway for the ingredient in Canada.
PreticX XOS’s chain composition creates a unique and robust prebiotic effect, according to AIDP. Other XOS materials, produced via different processes, result in distinct compositions, benefits and dosage. Claims can only be made from human clinical studies completed on a specific XOS and cannot be borrowed from literature. PreticX XOS has over 12 published human studies.
“AIDP is committed to investing in unique products like PreticX. Only PreticX XOS can make the desired claims, which separates this unique product from other XOS prebiotics on the market,” said Jennifer Gu, vice president of research and development for AIDP. “Working with the Nutrasource team was a collaborative effort achieved by joining their regulatory expertise with our science.”
“The Nutrasource team thrives in providing novel and unique regulatory solutions for its clients,” said William Rowe, president and CEO of Nutrasource, “We are honored to have secured these favorable regulatory results on behalf of AIDP for Canadian market access.”
Nutrasource has secured a Product License for PreticX XOS that has meaningful claims regarding prebiotic fiber and digestive health.
