NMN Sales Continue After FDA Refuses Public Hearing

Highlights:

• The FDA denied a congressman’s request for a public hearing concerning the FDA’s actions regarding NMN on grounds of public interest.
• NMN could be sold as a food additive because it has generally recognized as safe (GRAS) status.
• Because NMN is already considered safe and effective, the FDA is hurting consumers by not allowing for the sale of NMN as a dietary supplement.

In November of 2022, the Federal Drug Administration (FDA) reversed its decision to allow nicotinamide mononucleotide (NMN) to be marketed as a dietary supplement because it is being investigated as a new drug. However, consumer watchdogs the Natural Products Association (NPA) and Alliance for Natural Health USA (ANH-USA) petitioned against this reversal, stating the FDA “misconstrued and misapplied” the pertinent laws. 

FDA Denies Public Hearing

On July 17^th of 2023, in a letter to U.S. House Representative Jeff Duncan, it was stated that the FDA is still reviewing the petition. The letter was in response to a request by Representative Duncan for a public hearing concerning the FDA’s actions on NMN. The FDA denied Duncan’s request on the grounds of public interest. The letter says, 

“When deciding whether a [public] hearing would be in the public interest, the [FDA] Commissioner typically considers, among other factors, whether interested persons have other opportunities to present information and views on the topic in question.”  

The letter goes on to say that the NPA and ANH-USA’s petition was open to receive public comment and continues, 

“In light of this opportunity for the public to provide information and views that FDA will consider as part of our work in reviewing and responding to the citizen petition, we do not believe that it is in the public interest to hold a public hearing on this matter.”

Notably, the letter also states that the FDA has taken no enforcement actions on NMN. This means that platforms like Amazon removed NMN products from their electronic shelves on their own accord. Still, even if the legalities of NMN being taken off the shelves as a dietary supplement are fully realized, can NMN be sold in food products?

Can NMN Legally be Sold in Food Products?

Back in December of 2018, the president of Nutraland USA Inc. — a vitamin and supplement company — announced on LinkedIn that NMN has self-affirmed GRAS (Generally Recognized As Safe) status. In the post, the president said, 

“The GRAS affirmation will allow the inclusion of NMN from Nutraland in a wide range of food, beverage and supplement products.”

According to the founder and CEO of PricePlow, Mike Roberto, NMN is permitted in foods because of the GRAS self-affirmation. He says, 

“A company selling an “NMN supplement” could simply turn it into a food product and change the supplement facts panel to a nutrition facts panel — and the product would be legal! It’d take as little as adding some table salt or a vitamin to make that happen. They would also have to follow the good manufacturing practices for foods.”

 With a similar conclusion, the CIRS group said, 

“What should be highlighted is that the prohibition is valid only for NMN dietary supplement products manufactured and marketed within the US. It will not affect the manufacture and sale of NMN in other countries, nor shall it affect the GRAS declaration for NMN in common food.”

The FDA has not had a lot to say on the matter, at least as it pertains to the legality of selling NMN as a food additive. Their main focus has been on justifying their removal of NMN as a dietary supplement. However, the law states that if a product is marketed as a food additive before being investigated as a new drug, the FDA cannot remove its dietary supplement status. So, in a letter to the CEO of the NPA, the FDA stated, 

“A December 21, 2018, announcement by Nutraland USA that their NMN was determined to be generally recognized as safe (GRAS) by an independent review panel. GRAS evaluations concern safety, not marketing, and the date of a GRAS evaluation is not evidence of when an ingredient was first marketed as food.”

Essentially, the statement says NMNs GRAS status is not evidence of NMN being marketed as a food additive. The letter goes on to say that there is no evidence of NMN being marketed as a food additive before being investigated as a new drug. Still, there were instances where NMN was marketed as a food additive after the FDA received NMN’s new drug application. 

For example, Doctor’s Best Instant Whey Protein Concentrate Plus NMN “was marketed as a conventional food as early as September 2021.” However, the letter says that September 2021 is after the date of the new drug application for NMN. Remarkably, the FDA has still not yet released the date of the new drug application for NMN. 

Besides, the letter makes no mention of Doctor’s Best Instant Whey Protein Concentrate Plus NMN being marketed illegally. Therefore, it’s possible that since NMN has GRAS status, it can legally be included as an ingredient in food products.

The FDA is Not Benefiting Consumers

By removing NMN’s designation as a dietary supplement, the FDA is taking away a product that can potentially benefit the health of consumers. Because NMN was previously acknowledged as a dietary supplement, it is known to be safe and effective. Indeed, the current data demonstrates that NMN can mitigate the detrimental effects of aging by boosting NAD+ levels, promoting overall health.

Since the FDA has reversed NMN’s status due to Metro Biotech’s investigation of NMN as a new drug, it would seem that the FDA is at the whims of the interest of pharmaceutical companies. The government agencies mission statement is as follows:

“FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.”

Considering the already established safety and effectiveness of NMN, it would seem that the FDA is failing its mission.