Consumers to FDA: Keep NMN available as supplement
FDA has received more than 200 comments in response to a citizen petition that aims to preserve access to dietary supplements containing NMN, a healthy aging ingredient.Get more news about
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In March, the Natural Products Association (NPA) and Alliance for Natural Health USA filed a citizen petition with FDA regarding NMN. Among other things, the two groups requested FDA determine NMN (beta-nicotinamide mononucleotide) is not excluded from the definition of a dietary supplement.
FDA must respond to the citizen petition within 180 days, though it has discretion to delay a substantive response due to, for example, other agency priorities or a need for additional information.
Last year, the agency essentially determined the study of NMN as an investigational new drug precludes its use in supplements. FDA concluded NMN was authorized for investigation as a new drug (before being lawfully marketed in supplements) and was the subject of substantial clinical investigations that were instituted and made public.
That determination didn’t sit well with industry trade associations. They observed FDA had not raised the “drug preclusion” issue in its review of several NMN ingredient notifications prior to the fall of 2022.
In the docket that FDA opened in response to the citizen petition, consumers are requesting FDA keep NMN available as a supplement.
“I am pleading for nicotinamide mononucleotide (NMN) be allowed to be sold as it has in the past,” Mark Blickenstaff wrote to FDA. “I have used this product for the past 5 years and have found it to be very helpful for my health! It has been a major contributor to my overall wellbeing and find [it] difficult to believe it will no longer be available.”
Many comments to FDA included the same—or virtually the same—language, likely based on a standard form circulating among NMN advocates.
“The FDA has said that NMN, an important supplement that is on the cutting edge of lifespan and health span research, can no longer be sold as a supplement because it is being studied as a drug,” Tamara Cain stated in comments that FDA posted May 2. “If this decision stands, consumers lose, and drug company monopolists win. NMN has a number of documented benefits because it is a precursor to NAD, another crucial nutrient that is found in every cell in the body and is essential to life.
“There is a back channel at the FDA that allows Big Pharma to claim a monopoly on natural ingredients,” Cain added. “For supplements that are considered ‘new dietary ingredients,’ companies must submit a notification to the FDA with studies to prove that it is safe. But if a drug company files an investigational new drug application on an ingredient before the FDA receives an NDI notification on it, it can no longer be sold as a supplement. Please allow NMN to continue to be sold as a dietary supplement.”
Consumers to FDA: Keep NMN available as supplement
