FDA’s takedown of NMN raises fairness, transparency concerns

The Agency made this determination after having been made aware of recent drug studies on the ingredient.  This came while doing due diligence on a recent New Dietary Ingredient Notification.

NMN, or nicotinamide mononucleotide, is one of the forms of vitamin B3, or niacin, that has been shown to enhance the levels of the coenzyme nicotinamide adenine dinucleotide (NAD+) in the cells of the body.  Boosting these levels has been shown to have some significant benefits in staving off cellular senescence.

Another well known ingredient along these lines is nicotinamide riboside, patented and marketed by ChromaDex under its brand Niagen, and its finished product brand, TruNiagen.  The ingredient is also marketed by supplement manufacture Elysium, whose supplements feature the same ingredient from another source. 

The anti aging supplement category has boomed of late, driven partly by high profile marketing conducted by Elysium as well as the extensive research collaborations developed by ChromaDex.  NMN, which works on a slightly different mechanism, sidesteps some of the patent issues connected with the use of nicotinamide riboside.

FDA: No history of NMN being on market lawfully prior to drug

As a result, many players have sought to crowd into the space, with dozens of products in the market and a number of New Dietary Ingredient Notifications being filed on NMN. In responding to an NDI filed by Chinese firm Kingdomway, FDA noted that the commercial history of NMN includes supplements that have come to market without NDI Notifications on file.  Some of these ingredients may have had self affirmed GRAS dossiers in place, which theoretically obviates the need for a NDIN, but it’s common knowledge in the industry that some new ingredients debut without either.


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