NMN (nicotinamide mononucleotide), one of the forms of vitamin B3, or niacin, has been shown to enhance the levels of nicotinamide adenine dinucleotide (NAD+) in the cells of the body.
In a letter from FDA to Rep. Duncan – shared with NutraIngredients-USA by the Natural Products Association (NPA) – the Agency stated that a public hearing was not necessary since stakeholders can use a Citizen Petition filed by NPA and the ANH (Alliance for Natural Health USA) to comment publicly.
“FDA has completely abdicated its duty to transparency and appropriate regulatory practice for dietary supplements, and this is the latest proof,” said Fabricant. “A public comment period and a public hearing are entirely different, and the agency knows that. FDA continues to hide behind the ‘Administrative Iron Curtain,’ citing our joint citizen’s petition with the Alliance for Natural Health as the rationale for not holding a public hearing on NMN.”
Speaking with us via video, Dr Fabricant said that FDA is on record as being upset with NMN, much like they were with NAC… “They [FDA] kind of said, ‘we’ll get back to you when we get back to you’. They kind of hid behind the Citizen Petition, which was unfortunate and didn’t really discuss things that could happen to stabilize the marketplace,” he said.
“It’s really similar to NAC, where we had to sue them to get them to the table, which, while successful, was resource intensive and could have been avoided.”
In its response to Rep Duncan, FDA also stated that it did not contact any ecommerce platforms about NMN. Notably, Amazon pulled NMN dietary supplements products from its virtual shelves earlier this year, citing FDA actions from late 2022.
Timeline
Despite issuing an acknowledgement without objection for a New Dietary Ingredient Notification (NDIN) in May 2022, FDA 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.
In its new letter to Rep. Duncan, the Agency stated that NMN is not approved as a new drug, and also stated that it has not determined when NMN was first available as a dietary supplement in the US.
All eyes are now back on the Citizen Petition, with about 40 days left of the original 180 day response time from initial submission of the Petition. The petition is requesting:
1. Determine nicotinamide mononucleotide (NMN) is not excluded from the definition of a dietary supplement under 21 U.S.C. §321(ff)(3)(B);
2. Commit to exercising enforcement discretion in connection with the marketing and selling of NMN in or as a dietary supplement; or
3. In the alternative, recommend the Secretary of Health and Human Services (HHS) issue a regulation after notice comment, finding NMN would be lawful.
“Given some of what they said to Congressman Duncan, it sounds like they [FDA] may be formulating responses [to the Citizen Petition] but that remains to be seen,” said Dr Fabricant.
“We can’t really lose this one. Someone’s going to have to stand up and fight on this, and the way that’s going it looks like that fight might be routed towards the courts.”
