Following the decision that NMN-containing products can no longer be marketed as dietary supplements, the U.S. Food and Drug Administration (FDA) did not attempt to contact all firms selling these products. However, the expert says that companies continuing to do so may be subject to fines.
On October 11, the FDA informed the company Inner Mongolia Kingdomway Pharmaceutical Limited that its dietary supplement containing nicotinamide mononucleotide (NMN) could not be marketed as a dietary supplement or food.
It was the FDA's response to the company's voluntarily submitted New Dietary Ingredient (NDI) application on July 25, 2022.
The agency said that NMN's status as an NDI was changed because "NMN has been authorized for investigation as a new drug."
According to the preclusion provision of Section 201(ff) of the Federal, Food, Drug, and Cosmetic Act, also known as the drug preclusion clause, ingredients cannot be sold as dietary supplements if they were first approved or clinically studied as drugs.
NMN is a molecule naturally occurring in all life forms. As an ingredient of dietary supplements, it is thought to raise levels of nicotinamide adenine dinucleotide (NAD+), a compound that repairs and protects DNA and mitochondria in the body. The levels of NAD+ steadily decline with age.
The FDA's ruling made the headlines stating that NMN-containing supplements were now banned in the U.S. Nonetheless, some companies continue selling their products.
In its newsletter released on December 9, Renue by Science wrote, "at this time, it does not look as though the FDA will inform retailers to stop selling NMN products." The company said that its NMN products were still in stock.
What does the FDA say?
In a statement for Healthnews, sent on December 17, the FDA said it communicated with various dietary supplement firms and groups in recent weeks regarding the conclusion that NMN is excluded from the definition of dietary supplement.
However, the agency says it did not attempt to identify and contact all firms that sell NMN or communicate with retail stores or websites where NMN supplements are sold. It contacted only those who have submitted a new dietary ingredient notification pertaining to NMN.
"Companies that sell NMN products as dietary supplements should reformulate them to remove NMN if they want to continue to sell the products as dietary supplements," the statement says.
The FDA notes that NMN is currently not approved as a drug in the U.S. To market the ingredient as a drug, it would need to be submitted for review under a New Drug Application and approved by FDA following an evaluation of the drug's safety and effectiveness.
Alternatively, companies seeking to market an NMN product as a nonprescription drug without an approved application can submit an Over-the-Counter Monograph Order Request (OMOR), according to the FDA.
What do experts say?
Dr. Maher Chaar, a pharmacist and board-certified medication therapy management specialist, says that companies should stop selling NMN-containing products, or they will be violating the FDA's ruling and probably might be subject to fines.
Since NMN was disallowed to be marketed as a dietary supplement, industry representatives hold meetings with the FDA.
Chaar, PharmD, says that industry pressures should not change the ruling without supporting evidence regarding the safety and effectiveness of the product.
"The FDA still needs to approve, too," he told Healthnews.