If NMN is Safe, Why Don’t Regulators Approve It?

Much to my surprise, lots of people take NAD+ boosting supplement NMN (FAQs and Anecdotes). But as readers of this site know, I’m certainly not one of them. While I’m sold on the importance of boosting NAD+ levels, I defer to the regulatory authorities in charge of evaluating consumer safety to determine which NAD booster to take. And hands down, it’s Nicotinamide Riboside “NR” (FAQs) (Anecdotes). It’s not even close. NR has been deemed safe by the FDA (NDI), Health Canada, EFSA, Australian TGA, and achieved GRAS status — NMN has received none of these approvals. What about the general science community? Well, they’ve clearly made their choice, too. There are currently 67 human clinical trials at some stage testing NR as a treatment for various diseases — only 14 trials for NMN. This suggests that scientists overwhelming choose NR when testing NAD boosters on human subjects. As well, the scientists at Nestlé chose NR over NMN when launching new food and beverage products selling to the general population. But while NR appears the safe choice, it remains abundantly concerning that even with the lack of regulatory body safety recognition, there’s obviously so much consumer demand for NMN that there are MANY companies still selling it. And each of these companies is selling something different. So it’s virtually impossible to know what you’re actually ingesting when taking NMN. And yet NMN remains incredibly popular. It’s a marketing triumph of significant proportions that so many consumers have been convinced to put something in their bodies that has so many red flags in plain sight. And then comes this:

A few weeks ago, NAD expert Dr. Charles Brenner (who discovered supplement NR as an NAD precursor vitamin) was a guest on the Darin Olien (“the superfood hunter”) podcast.

Olien asked Brenner about NMN.

In Brenner’s response, we learned something particularly concerning that I — and likely many others — was unaware of (@ the 54:30 mark OR continue reading the transcript below):

Darin Olien: “…And number two, I want to just unpack the supplementation of NMN as well.

Dr. Charles Brenner: Great.

So NADP has 3 phosphates — can’t get into cells.

NAD has 2 phosphates — can’t get into cells.

NMN has a phosphate — can’t get into cells.

NR is the biggest piece of NAD that can get into cells.

Just like in glucose metabolism, the first thing that cells do with glucose is they put a phosphate on it so that the glucose can be metabolized.

The first thing that happens with any NAD precursor vitamin is a phosphate gets put on it. Or nicotinamide gets a ribose phosphate. And nicotinic acid gets a ribose phosphate. And NR already has a ribose. So NR gets a phosphate put on it.

If somebody thinks they’re clever and they say, “oh, I want you to take NMN”, basically a chemist went to the trouble of putting the phosphate on and then basically in your alimentary canal — which means in your mouth and in your digestive system — the phosphate is coming off.

So you’re basically getting NR.

You’re paying for NMN and you’re getting NR.

And you’re getting something for which there is not a safety dossier like there is for NR.

We’ve known how to make clean, pure NR for a long time.

And the FDA has made a ruling on it that it’s generally regarded as safe (GRAS).

Just in the last week or 2, the FDA made a ruling that rejected the idea that NMN should be generally regarded as safe.

They said there’s not sufficient evidence to say that.

I don’t think that people really know what they’re getting if they’re buying NMN — but they’re certainly not getting something with the safety dossier“

Darin Olien: So it’s a gamble. You don’t know what you’re getting…”

——–

What FDA ruling on NMN is Dr Brenner referring to?

Well, it appears Brenner is talking about a few recent NMN applications seeking NDI (New Dietary Ingredient) status that were rejected by the FDA due to safety concerns: HERE and HERE.

As far as human safety studies are concerned, what do NMN sellers cite to support their case that NMN is safe?

They often point to this.

Of course, the problem with this study is that it tests a grand total of one single dose of NMN — hardly sufficient evidence if you’re considering supplementation.

Any other human safety studies?

Well, this company produced a toxicology study in which it provided self-affirmation of the existence of GRAS (generally recognized as safe). Of course, “self-affirmation” is hardly enough. We’ll see what the FDA says once the company files a notification “in the coming months”. Of course, even if this company receives GRAS designation it wouldn’t imply safety for the seemingly endless number of other companies selling NMN. As said above, not all NMN products are the same.

Finally, while many consumers appear to take NMN because Dr David Sinclair says he does, most still don’t know where Sinclair gets his NMN from. And when you hear Dr Sinclair discuss his decision to take NMN, he hardly sounds convincing.

The bottom line for me is safety.

NR has many safety designations from regulatory authorities.

NMN does not.

And, if there were enough support for the safety of NMN, wouldn’t we expect to see even one regulatory approval somewhere? Anywhere?

Disclosures: None

Related:

• Why Does Dr David Sinclair Take NMN Over NR? (Link)
• How Much NMN Does Dr David Sinclair Take? What Dosage Does He Recommend for You? (Link)
• Why Doesn’t David Sinclair Endorse Any Specific NMN Brands? (Link)
• FAQs and Anecdotes on NMN (Link)
• FAQs on NR (Link) (Anecdotes)

FOLLOW us on Twitter @RaisingNAD