NPA, along with the Alliance for Natural Health (ANH), recently filed a Citizen’s Petition with FDA requesting the Agency reevaluate the status of NMN (nicotinamide mononucleotide) or exercise Enforcement Discretion on Drug Exclusion Clause for the ingredient.
NMN is one of the forms of vitamin B3, or niacin, that has been shown to enhance the levels of nicotinamide adenine dinucleotide (NAD+) in the cells of the body. Boosting these levels has in turn demonstrated significant benefits in staving off cellular aging.
Despite issuing an acknowledgement without objection for a New Dietary Ingredient Notification (NDIN) in May 2022, the Agency announced in November 2022 that NMN is not allowed as a dietary ingredient because of its prior investigation as a drug. The agency reportedly made this determination after having been made aware of recent drug studies on the ingredient. For more information, please view NDIN 1247.
“I think what’s odd about the NMN case is that Agency gave companies an AKL, a good day letter on their NDI, and then took it away,” Dr Fabricant told NutraIngredients-USA. “There is nothing in the statute that gives FDA that ability: It’s a notification process. Second of all, they also failed to recognize a GRAS [self-affirmed Generally Recognized as Safe] that we believe pre-dates the IND filing on NMN.”
The goal of the new petition is specific relief, he said. “We want NMN back on all platforms, we want FDA to go, ‘it is a lawful dietary ingredient’ whether that’s by writing a regulation, which would be ideal, or enforcement discretion, or reversing course on their previous statements on NMN that it doesn’t fit the definition due to an IND filing.”
The approach is similar to the playbook that NPA employed for NAC (N-acetyl cysteine), which did result in the Agency announcing enforcement discretion.
“Seeing the example that NAC set, it did set a precedent, it’s one that should have been used before,” said Dr Fabricant.
“I think we live in a world now where a lot of natural components are going to walk in two worlds: At a higher dose they may be therapeutic, they may be pharmacological. At a smaller dose they may be physiological. I think that’s what we’re seeing more and more.
“NAC was an amino acid. NMN, by a lot of people’s science, is a better form of niacin, so I think it’s really time they [FDA] move in that direction.”
In the case of NAC, NPA ultimately filed a lawsuit against the FDA, and when asked if that was something that the association was keeping in its back pocket, Dr Fabricant admitted it is “certainly being considered.
“We hope the Agency is responsive to the Citizen’s Petition. We think it should be. The fact that we have to do this to get responsiveness, or possibly pursue other avenues to get responsiveness I think underscores a larger problem. We really hope everyone comes to the table in earnest as says, ‘OK, how do we make this work?’”
“Does FDA have a safety concern on this? We’ve heard no, similar to NAC,” said Dr Fabricant. “Why should access be restricted for something that is a form of a B vitamin?”
“These are oddities we haven’t dealt with before. The removal of the AKL alone – if they can do that to NMN, they can do that to anybody’s who got an AKL. So, I would hope folks are taking notice in the industry because that could affect everybody and in a potentially very bad way.”
Dr Fabricant also discussed the ongoing uncertainty around CBD, and the challenges ahead for that ingredient.