ChromaDex Corp., Irvine, CA, has received New Dietary Ingredient (NDI) status from FDA for its patented and proprietary lead ingredient, NIAGEN nicotinamide riboside.
 
ChromaDex’s NIAGEN is the first and only commercially available form of nicotinamide riboside NR and is supported by five patents issued and several pending, with patents rights acquired from Dartmouth College, Cornell University, and Washington University.
 
The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that manufacturers and distributors who wish to market dietary supplements that contain “new dietary ingredients” notify the Food and Drug Administration about these ingredients. Generally, the notification must include information that is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing a new dietary ingredient will reasonably be expected to be safe under the conditions of use recommended or suggested in the labeling. (See Section 413(d) of the FD&C Act, 21 U.S.C. 350b(d)).
 
Frank Jaksch Jr., founder and CEO of ChromaDex, commented, “Receiving NDI status from the FDA validates the safety dossier we have compiled for NIAGEN.  Achieving NDI status is a significant milestone given that the FDA objected approximately 88% of NDI notifications in FY 2014. NDI status opens the door for the mainstream commercialization of NIAGEN in dietary supplements.”