By Mike Montemarano, Associate Editor10.20.23
The U.S. Food and Drug Administration has not yet reached a decision on how it will respond to a Citizen Petition filed by the Natural Products Association (NPA) and Alliance for Natural Health (ANH) requesting that the agency determine the regulatory status of beta-nicotinamide mononucleotide (NMN). Cara Welch, PhD, director of the Office of Dietary Supplement Programs at FDA, said the agency hasn’t reached a decision due to “competing priorities.”
NMN is one of many ingredients sold as dietary supplements which the agency called into question due to it being approved as an investigational new drug, apparently prior to its presence as a dietary ingredient. However, there has been uncertainty about whether NMN was approved as an investigational new drug prior to when NMN supplements first hit the market, as FDA hasn’t shared the IND approval timeline. The agency first took its position on NMN in November of last year, though NMN supplements had been on the market for several years prior.
FDA has been criticized for its lack of clarity in its decision on NMN by NPA and others, especially after it rejected a request to hold a public hearing on the matter.
“The FDA’s negligence has and will continue to cause severe economic damage to a growing sector of the dietary supplement industry. This decision to kick the can down the road after 6 months of deliberation will absolutely threaten the NMN sector, but also weakens the New Dietary Ingredient (NDI) process for manufacturers seeking to bring emerging and innovative ingredients for other dietary supplements to American consumers.”
As outlined in DSHEA, FDA has a 75-day deadline from the time it receives an NDIN to determine whether or not the given article is a dietary ingredient with adequate safety data backing it, NPA stated. “Even in the unlikely occurrence where they find a problem after that window, they have appropriate authorities for action. However, the FDA is avoiding that work here all in the name of rolling back DSHEA to protect the pharmaceutical industry’s intellectual property.”
Fabricant said the FDA’s number-one priority should be to reduce the regulatory ambiguity which plagues ingredients like NAC, CBD, and NMN.
“FDA has literally left the building when it comes to dietary supplements,” Fabricant said. “Instead of protecting Americans and working with stakeholders to bring more products to consumers safely and efficiently, it is wasting time, effort, and taxpayer money pushing a reorganization plan that is dead on arrival. But NPA is determined to devote whatever resources and means necessary to address this problem and hold this dysfunctional bureaucracy accountable.”
Despite the agency’s assurances, NPA noted its concern that the proposed reorganization will divert resources from supplement enforcement. Similarly, Senate Majority Whip Richard Durbin (D-IL) and Senator Richard Blumenthal (D-CT) said they were “concerned that these changes could divert resources, funding, and attention form the supplement market at a time when it is needed more than ever,” NPA reported.
"The ingredient—on the supplement market for years—has been in regulatory limbo after FDA declared it was first authorized as an IND."
“That’s a good thing when it’s applied appropriately,” Fabricant said. “The agency has the authority to resolve these conflicts with rulemaking that would grant an exception to the race to the market. But in a tale as old as time FDA has never exercised this authority and is unwilling to. When NPA filed a lawsuit against the agency for NAC it represented a significant step for the industry and our organization will continue to lead by example in holding the agency accountable when it has misapplied the law and caused the industry economic harm.”
When asked about how companies should proceed in this area of regulatory limbo, Fabricant said NPA has provided members with its analysis. “Ultimately, every business has different risk tolerances but if there are no safety concerns we believe companies should continue selling their products,” he said.
“There have been no safety issues with NMN, so the agency really needs to own up to why it has decided to put a B-vitamin derivative in the crosshairs.”
Unfortunately, despite declared intentions to become more transparent, FDA is falling short on too important an issue in its actions surrounding NMN, Fabricant added.
“The FDA took 180 days to let the industry know they failed to reach a decision on our NMN petition because it wasn’t a priority. It’s ironic, considering the agency recently held a webinar laying out its top priorities, which included strengthening new dietary ingredient regulation and informing decision-making through increased education, transparency, and communication. It’s laughable because the agency has fundamentally failed the industry in these phases of its so-called priorities,” Fabricant said.
“Unfortunately, there is no predicting what’s next for the agency, but this is why it’s so crucial that if you’re not involved with our organization, you need to start now. It’s insanity that the agency is pursuing reorganization that undermines the dietary supplement industry while they refuse to appropriately carry out the law.”
NMN is one of many ingredients sold as dietary supplements which the agency called into question due to it being approved as an investigational new drug, apparently prior to its presence as a dietary ingredient. However, there has been uncertainty about whether NMN was approved as an investigational new drug prior to when NMN supplements first hit the market, as FDA hasn’t shared the IND approval timeline. The agency first took its position on NMN in November of last year, though NMN supplements had been on the market for several years prior.
FDA has been criticized for its lack of clarity in its decision on NMN by NPA and others, especially after it rejected a request to hold a public hearing on the matter.
Kicking the Can Down the Road
Daniel Fabricant, PhD, president and CEO of NPA, said the response to the NMN petition was “woefully inadequate.”“The FDA’s negligence has and will continue to cause severe economic damage to a growing sector of the dietary supplement industry. This decision to kick the can down the road after 6 months of deliberation will absolutely threaten the NMN sector, but also weakens the New Dietary Ingredient (NDI) process for manufacturers seeking to bring emerging and innovative ingredients for other dietary supplements to American consumers.”
As outlined in DSHEA, FDA has a 75-day deadline from the time it receives an NDIN to determine whether or not the given article is a dietary ingredient with adequate safety data backing it, NPA stated. “Even in the unlikely occurrence where they find a problem after that window, they have appropriate authorities for action. However, the FDA is avoiding that work here all in the name of rolling back DSHEA to protect the pharmaceutical industry’s intellectual property.”
Fabricant said the FDA’s number-one priority should be to reduce the regulatory ambiguity which plagues ingredients like NAC, CBD, and NMN.
“FDA has literally left the building when it comes to dietary supplements,” Fabricant said. “Instead of protecting Americans and working with stakeholders to bring more products to consumers safely and efficiently, it is wasting time, effort, and taxpayer money pushing a reorganization plan that is dead on arrival. But NPA is determined to devote whatever resources and means necessary to address this problem and hold this dysfunctional bureaucracy accountable.”
Despite the agency’s assurances, NPA noted its concern that the proposed reorganization will divert resources from supplement enforcement. Similarly, Senate Majority Whip Richard Durbin (D-IL) and Senator Richard Blumenthal (D-CT) said they were “concerned that these changes could divert resources, funding, and attention form the supplement market at a time when it is needed more than ever,” NPA reported.
"The ingredient—on the supplement market for years—has been in regulatory limbo after FDA declared it was first authorized as an IND."
—Daniel Fabricant, PhD, Natural Products Association
Fabricant: FDA Has Rulemaking Powers for a Reason
Fabricant noted that DSHEA recognized the eventuality that certain ingredients would fall within both the categories of drug and dietary supplement. FDA has the ability to engage in special rulemaking to make exceptions for ingredients like NMN, NAC, and CBD, which are subject to the race-to-market paradigm of DSHEA.“That’s a good thing when it’s applied appropriately,” Fabricant said. “The agency has the authority to resolve these conflicts with rulemaking that would grant an exception to the race to the market. But in a tale as old as time FDA has never exercised this authority and is unwilling to. When NPA filed a lawsuit against the agency for NAC it represented a significant step for the industry and our organization will continue to lead by example in holding the agency accountable when it has misapplied the law and caused the industry economic harm.”
When asked about how companies should proceed in this area of regulatory limbo, Fabricant said NPA has provided members with its analysis. “Ultimately, every business has different risk tolerances but if there are no safety concerns we believe companies should continue selling their products,” he said.
“There have been no safety issues with NMN, so the agency really needs to own up to why it has decided to put a B-vitamin derivative in the crosshairs.”
Unfortunately, despite declared intentions to become more transparent, FDA is falling short on too important an issue in its actions surrounding NMN, Fabricant added.
“The FDA took 180 days to let the industry know they failed to reach a decision on our NMN petition because it wasn’t a priority. It’s ironic, considering the agency recently held a webinar laying out its top priorities, which included strengthening new dietary ingredient regulation and informing decision-making through increased education, transparency, and communication. It’s laughable because the agency has fundamentally failed the industry in these phases of its so-called priorities,” Fabricant said.
“Unfortunately, there is no predicting what’s next for the agency, but this is why it’s so crucial that if you’re not involved with our organization, you need to start now. It’s insanity that the agency is pursuing reorganization that undermines the dietary supplement industry while they refuse to appropriately carry out the law.”
