The world of dietary supplements and drugs is often entwined with complexity. It seems like every other week there's an ongoing battle between those who believe in the natural rights of consumers and the powers that be.
This time, as many of you might have heard, the skirmish and controversy is over the status of Nicotinamide Mononucleotide (NMN) – a form of Vitamin B3.
In this post, we'll provide an in-depth look at the ongoing situation regarding the FDA wanting to restrict NMN as a dietary supplement.
A Quick Refresher: What are NMN supplements?
NMN supplements enhance the levels of nicotinamide adenine dinucleotide (NAD+) in our body cells. This might sound complicated, but in simple terms: NMN is considered good for you. That’s why many outstanding companies have worked their hardest to make it available to you and to all consumers by providing the best NMN supplements, such as Black Forest NMN.
The Timeline of Controversy: From Recognition of NMN to Restriction
- May 2022: The FDA acknowledged NMN as a New Dietary Ingredient (NDI), allowing it to be marketed as a dietary supplement.
- November 2022: The FDA reversed its stance, stating that NMN is no longer considered a dietary supplement due to its prior investigation as a drug.
- Dec. 1, 2022: The Natural Products Association (NPA) alongside Black Forest requested a typical dietary supplement public comment period, which was rejected by the FDA.
- Dec. 3-7, 2022: Meetings were held between FDA, NMN manufacturers, and retailers. The FDA also directed manufacturers to stop production.
- Jan. 23, 2023: Black Forest and NPA requested to open a docket on NMN, but the FDA denied the request.
- Feb. 16, 2023: Amazon announced a ban on all NMN sales, effective March 13, 2023, citing the FDA's decision.
- July. 20th, 2023: FDA Says No Public Hearing on NMN in Response to Congressional Request
Is NMN banned?
The timeline paints a picture of regulatory twists and turns, but the real battle lies in the broader struggle to protect consumers from authoritative institutions taking decisions against their interests.
Allowing this to happen would create a precedent that could destroy the supplement industry as we know it… opening their radar to endless natural alternatives to target and virtually “monopolized”.
Why the NMN Controversy?
Here's where things get dicey. The FDA, America's food and drug watchdog, decided to backtrack on its previous acknowledgment that NMN was a 'dietary supplement' (7 Months after acknowledging it was indeed, a supplement). They have now categorized it similarly to a drug, which means it requires a whole different level of regulatory hoops to jump through.
South Carolina Congressman, Jeff Duncan, asked the FDA for a public hearing on the matter. Their response? A letter (which, frankly, read like a polite refusal) stating that a public hearing wasn't necessary since the general public could comment using a Citizen Petition. This move has upset many, calling it an evasion of duty and a lack of transparency.
The Natural Products Association’s Fight
The Natural Products Association or NPA, under the leadership of Dr. Daniel Fabricant, has vehemently opposed the FDA’s decisions regarding NMN. Calling the FDA's actions "inexcusable and downright shameful," the NPA has committed to using every resource to challenge the agency.
We, Black Forest Supplements, are NPA partners and have attended continuous meetings (including those in Capitol Hill) in order to unite forces against this unjust and ethically questionable FDA supremacy.
A Blast from the Past: NAC
This isn't the first time such a decision has been made by the FDA. They did the same with N-acetyl-L-cysteine (NAC) in July 2020, which led to several legal and public outcries. After a considerable battle, it was finally allowed to be sold in the U.S. once more.
What About Amazon’s Ban on NMN?
Amazon, never one to be left behind, took FDA's decision as a cue and banned NMN sales. This move mirrored their decision with NAC earlier, drawing parallels between the two incidents. However, while Whole Foods continued to sell NAC, Amazon chose to remove it from its online marketplace.
This is the reason why, unfortunately, we can only offer Black Forest NMN directly on our webpage… Still, we can guarantee that the best NMN supplement will stay available for sale until a final decision has been made (in case it doesn’t go our way).
NMN as a drug: The Other Side of the Argument
Metro International Biotech, the company advocating for the classification of NMN as a drug, has also been active in this scenario. They have requested the FDA to protect their rights in developing drug products from competition with dietary supplements.
They've written to the FDA stressing the importance of distinguishing between dietary supplements and drug products and It has become infinitely clear they see a potential commercial threat from dietary supplements like NMN.
MetroBiotech's letter to the FDA
Looking Forward What’s next on NMN Supplements
The story of NMN supplements is still unfolding. There's a lot of hope in the air that NMN might see the same fate as NAC and continue to be sold as a dietary supplement.
For now, Black Forest Supplements stands with the many voices asking for clarity, fairness, and the right for consumers to make informed choices. We'll be keeping a close eye on developments and will update the tribe as soon as we know more.
What you can know with certainty, is that we won't stop until we rightfully claim back what’s ours (all of ours), and we will protect our TRIBE with everything we’ve got.
Furthermore, we wanted to provide all of you LOYAL TRIBESMEN with a 10% discount code for our ENTIRE CATALOG of products at Black Forest Supplements. (And for you to Stock UP on NMN! considering the situation and the possibility of it being gone soon...)
Black Forest Supplements Discount Code
We value your loyalty and are glad to have you as part of our ever-growing Black Forest TRIBE.