FDA NMN Policy - 4/24/2023 Update
FDA NMN Update - April 24, 2023
Unfortunately, the FDA recently reaffirmed its position on NMN in their response to our Uthever NMN New Dietary Ingredient Notification. Even though the application included everything required to qualify for a supplement designation and was filed by our manufacturing partner prior to the unprecedented change in FDA policy last year, the FDA rejected the notification.
No safety or efficacy objection was mentioned by the FDA, and the notification was rejected purely on the basis of their designation of MIB-626 (Metro Biotech's highly refined form of NMN) as an Investigational New Drug.
Fortunately, there's something that each one of us can do about it.
NAC and CBD are both in the same regulatory state as NMN, and both are still widely available for sale in the US thanks to the FDA's discretion in enforcing their policy rulings. To a large degree, the reason they're both still available is the public outcry when the FDA announced the impending bans on NAC and CBD.
Like NAC and CBD, NMN is safe and effective, and millions of people rely on it for their health. When congress passed the law that governs how supplements are sold, they never intended for all forms of an ingredient like NMN to be pulled from the market because a single highly refined version of it is being investigated as a new drug.
So let's tell our representatives in Washington that we want access to safe and effective natural ingredients like NMN to be protected. Using the link below you can send a form letter to your representatives in DC in just a few seconds. These letters do matter. If we all take less than 1 minute out of our day to send one, we may change FDA enforcement policy.
Action Center (votervoice.net)
FDA NMN Update - March 12, 2023
Last week, two of the largest supplement and natural products trade organizations filed a citizen's petition with the FDA asking that they change their position on NMN. The Natural Products Association (NPA) and the Alliance for Natural Health (ANH) asked the FDA to:
- Determine nicotinamide mononucleotide (NMN) is not excluded from the definition of a dietary supplement under 21 U.S.C. §321(ff)(3)(B);
- Commit to exercising enforcement discretion in connection with the marketing and selling of NMN in or as a dietary supplement; or
- In the alternative, recommend the Secretary of Health and Human Services (HHS) issue a regulation after notice comment, finding NMN would be lawful.
During a meeting on Friday, Dan Fabricant, the head of the Natural Products Association (the NPA) explained that although everyone hopes the citizen's petition leads to an FDA policy reversal on NMN, the filing is meaningful regardless of the FDA's response because it will ultimately allow the trade organizations the right to sue the FDA. Now that the citizen's petition has been filed the FDA has 180 days to respond. Often, they don't respond to citizen's petitions, but in both the case of a denial of the petition or a non-response the NPA and ANH gain the legal right to sue.
In order to avoid litigation and to encourage the FDA to come to the table to negotiate, the NPA is now asking that everyone who's interested in keeping NMN on the market as a supplement write to their representatives in congress. They'll create form letters next week that we'll forward on to you, but you can always visit your representative's website and write to them now.
As a reminder, Amazon will be removing all NMN products from their US website starting Monday, so if you prefer to buy ProHealth NMN on Amazon, this weekend is your last chance. We'll continue to sell NMN on ProHealth.com for as long as we can, and are working around the clock to bring our next generation NAD+ boosters to market. Please reach out with any questions or comments. I love to hear from you!
FDA NMN Update - February 17, 2023
Thanks for all the thoughtful messages I received in response to our FDA Update message last week. I received lots of emails with follow up questions that I'd like to share with everyone.
I love hearing how NMN has improved your health and life and enjoy reading your inspiring stories! I hope I’m in the gym, going for a 200 lb bench press personal record at 84 like D.O. who I was emailing with over the weekend! Please reach out to me at firstname.lastname@example.org if you have additional questions or comments, or if you’d like to share your story.
Q: Why is NMN being pulled from the US market?
A: Until/unless the FDA contacts us or issues a public policy statement, we won’t know for sure what the situation is. Below is the story being shared within the supplement community.
Most people will probably be surprised to learn that the way the FDA determines if a new ingredient should be classified as a drug or as a supplement is simply based on who files the paperwork first. NMN has been sold as a supplement for about 10 years in the US. Over the years, a few supplement companies have sent the necessary paperwork to the FDA to have NMN classified as a supplement, but each time the submission was rejected for unknown reasons. Then, a pharmaceutical company submitted the paperwork to have a refined form of NMN classified as an investigational drug and it was approved. After that, several supplement companies submitted the paperwork to have NMN classified as a supplement and at least one was approved. However, the FDA later retracted that supplement approval and changed the earlier designation of the refined form of NMN as a drug to include all forms of NMN as a drug.
Hopefully the FDA ultimately limits the drug classification to the refined form of NMN, but we won’t know until the FDA takes any enforcement action.
Q: Will NMN be pulled from the US market for sure?
A: We don’t know yet. It’s highly likely that NMN will be pulled from the market by the FDA, but the FDA doesn’t always enforce their own policy decisions. In the case of the product NAC, the FDA issued a policy statement that designated NAC as a drug but also issued an official policy statement that they won’t enforce the policy. So NAC is still widely available in the US. The NMN situation is different from NAC though in a material way. No pharmaceutical company had a vested interest in making NAC only available as a drug, whereas there is a pharmaceutical company with a strong financial interest in making NMN only available as a drug.
Q: Will I continue to be able to buy NMN supplements in the US anywhere after it’s pulled from the market?
A: If the FDA enforces their current position, then NMN won’t legally be sold by anyone other than pharmacies, and by prescription only. Even with a prescription, it’s unclear what diseases it would be prescribed for.
Q: Will NMN be available in other countries still?
A: We don’t know of any regulatory changes in any other countries that would cause NMN to be pulled from any foreign markets.
Q: What’s the difference between “normal” NMN & the investigational NMN drug?
A: We don’t know much about the investigational drug version of NMN. Natural NMN found in food is unstable and occurs in such small quantities that it would be impossible to sell an extract made of natural, unrefined NMN. We know that all supplement and drug forms of NMN are manufactured, refined, stabilized, etc… but we don’t know the differences.
Q: How much more effective is the investigational NMN drug than “normal” NMN?
A: We don’t know. Some researchers have indicated it’s much more effective, but we don’t know exactly what that entails: how much more effective, more effective compared to what baseline, or what it’s effective at doing.
Q: How much will your new NAD+ supplements cost compared to NMN?
A: We’re working with our suppliers to bring costs down, but at least initially many of the new NAD+ supplements will be more expensive than NMN. That said, they will also be more concentrated so less will be needed to accomplish the same outcome. The price of NMN dropped significantly over the last few years. We expect that with volume and manufacturing innovations costs and prices will come down on our new products too.
Q: Is there a petition that we can sign to help preserve our access to NMN?
A: We don’t know of any petition that people can sign yet, but as soon as there is one we’ll pass it along.
Q: What’s the shelf life of your NMN?
A: Our NMN is tested and guaranteed to be stable for at least 2 years. Heat and light don’t have much effect on our NMN, but moisture does. To maximize shelf-life, limit exposure of NMN to humidity. Refrigeration won’t extend shelf life because of the temperature, but a refrigerator is usually one of the lowest humidity options in a home.
Thanks for all of your questions, and thanks for choosing ProHealth!
FDA NMN Update - February 17, 2023
Dear ProHealth Customers,
As many of you probably already know, the FDA notified several NMN manufacturers late last year that they had classified NMN as a drug, which means that it can't be sold as a supplement. This type of initial FDA notice is often challenged and can take years to litigate before there's broad enforcement. Due to this we had advised our customers to wait until the ruling was final and enforced before taking action.
Yesterday, we received a notice from Amazon stating NMN sales will be discontinued starting March 13th, so it's possible that the FDA has begun to enforce their NMN ruling. We don't know if Amazon changed their NMN policy because they received an enforcement letter from the FDA or because of an internal review. Walmart.com also discontinued the sale of NMN, so it's likely that enforcement letters are going out and NMN will become unavailable as a supplement. ProHealth hasn't received any communication from the FDA, and we plan to continue to sell NMN until the FDA tells us that we have to stop. NMN is critical to many people's quality of life, so at this time we're advising customers to consider stocking up on NMN.
While we hope that NMN continues to be available in the US, we've been working feverishly behind the scenes for about a year to develop and test new NAD+ precursors and NAD+ boosters that don't rely on NMN. Because positive results are fundamentally dependent on quality, ProHealth only sells clinically proven, pharmaceutical grade UtheverⓇ NMN. Similarly, as we launch our next generation of NAD+ supplements we'll be using the highest quality, clinically proven ingredients so you'll get exactly the same material, from the same source as the product used in the clinical studies.
Even though the front of two supplement bottles may show the same named ingredient, they could have completely different effects on your body. Assuming that the ingredient isn't fake (which isn't always a safe assumption unfortunately), the same named ingredient can come in different forms, come from different sources, be made using different manufacturing methods, come in different levels of purity, have different levels of impurities, etc… So when it's possible, we buy from the same supplier as the clinical research test products.
I'm incredibly excited about the launch of our first non-NMN, NAD+ boosters that will be available in under 2 months and I'm confident that if NMN is pulled from the market you'll have other great options. I'm personally not concerned about losing NMN, but if you're happy with NMN and don't want to risk running out soon you should consider stocking up. Unfortunately, this recent news has caused a run on bulk NMN and our supplier informed us yesterday that they're back ordered for a month. We've been stocking to maintain an adequate, available supply, but with so many people stocking up right now some of our NMN products may be intermittently unavailable over the next few months.
I personally believe that the FDA's ruling is mistakenly overly broad. NMN is a naturally-occurring form of a vitamin that's essential to life and has been in the US food supply forever, so it perfectly fits the definition of a supplement. If a pharmaceutical company invests significant time and money to create new and novel improvements to naturally-occurring molecules, they should be rewarded for their efforts, and have the exclusive ability to sell those new and novel innovations.
The basis of the MIB626 drug patent is that it's a novel improvement over naturally occurring NMN, and if it's different and better than NMN then it's not NMN. The drug application should only cover that specific, highly-improved crystal polymorph form of NMN, not all NMN. Currently, we're working with the largest supplement industry groups to ask the government to reconsider their decision. Although I'm sure it will likely take a long time, I hope that eventually NMN is classified as a supplement and MIB626 as a drug.
Thank you for your loyalty over the last 3 decades, and please reach out if you have any questions or concerns.