The Consumer Healthcare Products Association (CHPA) released the following statement today from Jay Sirois, Ph.D., CHPA Sr. Director of Regulatory and Scientific Affairs in response to the Food and Drug Administration’s (FDA) inclusion of the publication of a revised version of the New Dietary Ingredient (NDI) Draft Guidance within its priorities for 2022.
“By including an updated NDI Draft Guidance within its 2022 priorities, FDA is signaling their openness to regulatory updates that will ultimately benefit dietary supplement consumers. NDI Notifications (NDINs) are key to ensuring dietary supplement products entering the market only include legal and safe ingredients. It’s been 10 years since NDI Draft Guidance was first published. We welcome this update as the demand for dietary supplements continues to grow as empowered consumers prioritize personal healthcare and adopt self-care approaches.
“While an updated NDI Draft Guidance is a step forward, we encourage FDA to also implement a master file system to support companies filing NDINs and prevent other manufacturers from copying and launching the same ingredient without their own safety information. This system will encourage companies to increase investments in science and clinical research to demonstrate the safety of ingredients.”
“We look forward to our continued work with FDA on regulatory solutions that prioritize public safety and facilitate growth of responsible dietary supplement manufacturers.”