Speaking with NutraIngredients-USA, Dr Fabricant, president and CEO of the Natural Products Association (NPA), said that the estimated US market for NMN (nicotinamide mononucleotide) – one of the forms of vitamin B3, or niacin – in 2022 was approximately $280 million.
“This is not an insignificant ingredient. So, I think there’s money there to fight the fight,” he told us.
“We continue to tell our members to sell NMN because FDA has said this isn’t a final Agency action.”
NPA, which filed the Citizen Petition in March with the Alliance for Natural Health (ANH), is now considering its next moves, and that includes looking back at NAC (N-acetyl cysteine), which FDA declared in July 2020 was not a legal dietary ingredient because of its prior approval as a drug (NAC was first approved as an inhaled mucolytic drug in 1963). This despite NAC being used in supplements since the early 1990s.
Both NPA and the Council for Responsible Nutrition (CRN) filed Citizen Petitions in relation to NAC, and NPA subsequently filed a lawsuit against the FDA. The Agency ultimately issued guidance stating it would exercise enforcement discretion for NAC, basically turning a blind eye to the sale of NAC-containing dietary supplement products so long as products do not make non-compliant disease claims.
“We are exploring that playbook on NAC. It worked well,” said Dr Fabricant. “It’s now really incumbent on the brands. I think what we saw with NAC that was troubling was that you had a few brands really step up, but you had a lot more people in the background that really benefited from NAC coming back to the market.
“I think there’s always concern that the same thing may happen on NMN… we hope the brands out there are going to really step up and say, ‘we’re not going to get answers to this. FDA is going to keep hiding behind the administrative process… we’ve exhausted our administrative rights, now what?’”
Fabricant said that it was likely the situation would approach a convergence point and that’s “likely the courts”.
“Taking FDA to Federal Court is expensive, but in this case, I don’t see where there’s another option if folks want relief in a timely manner.”
Unsurprising FDA response?
Earlier this summer the FDA declined a request from South Carolina Congressman Jeff Duncan for a public hearing on NMN in dietary supplements. Rep. Duncan’s request was in response to an Agency reversal in the legality of the ingredient.
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 response to Rep. Duncan, FDA 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.
Given these statements, there was some optimism that the Citizen Petition may yield a substantial response from the Agency.
“We were thinking it was 50-50 that there would be a substantive response, really based off of NAC,” said Dr Fabricant. “They [FDA] wrote us a really long response on NAC, which seems to dovetail into everything they’ve said publicly on NMN. We were thinking they’d either lean that way, or they’d do exactly what they did, which is run the clock.”
“They [FDA] has shut down all communication on NMN,” he added. “What was interesting was that there was an NDI filed after our Citizen Petition on NMN, and they responded to that. Unless they owe you a response by statute, and even that response mentioned our Citizen Petition. They’re going to hide behind the Citizen Petition until they don’t have to anymore.”