The FDA's War on Supplements: Beta-Nicotinamide Mononucleotide Banned!

It's happening again:  The FDA has sided with Big Pharma by ruling that a compound already on the supplement market is "not a supplement," thereby freeing pharmaceutical companies up to push it out of the supplement aisle where customers will no longer be able to obtain it for a reasonable price without a prescription.  They tried this with n-acetylcysteine recently & were met with such pushback they had to step off & leave it on shelves as a supplement... at least in the U.S.  It had already been there for 30 years without issue, yet because it's also used in emergency rooms for acetaminophen overdose & was found to have promise in both preventing & treating COVID infection, greedy pharma companies tried to gold rush it & get rich(er).  

The compound in question now is beta-nicotinamide mononucleotide (b-NMN), found naturally in shrimp, tomatoes, edamame, avocadoes & broccoli.  Its purported health benefits include anti-aging effects, increased aerobic performance & neuroprotection, though these benefits remain unproven.  b-NMN was already sold on Amazon by several companies including SyncoZymes Co. Ltd. & Inner Mongolia Kingdomway Pharmaceutical Ltd., both of which were selling the compound without issue until pharmaceutical giant Metro International Biotech sicced the FDA on them.  Because it occurs naturally in food AND was sold as a supplement first, that would seemingly make it a food/supplement, yet the FDA has fallen squarely on the side of pharmaceutical companies & ruled it a drug.  It's now been banned for sale as a supplement in the U.S.  Case closed.

Why Should We Care?

Next time you see b-NMN, it'll be in a prescription bottle.

This matters to consumers because it allows pharma companies to patent the substance, set the (always ridiculous) price, allow doctors/dermatologists/whoever to require in-person visits & written prescriptions for it, bill private insurance companies, send patients to the pharmacy & make us jump through other hoops to obtain it.  All when we could've just logged onto the internet & had it delivered to our door for a reasonable price before.  This is not okay & has far-reaching implications.  

The FDA exists to protect consumers from deadly foodborne disease outbreaks, toxins in pet food & cosmetics and to prevent things like, oh, I don't know... the Sacklers saying "OxyContin is not addictive" for 3 decades while America falls victim to the biggest drug addiction crisis in our nation's history.  Not to aid the upward transfer of wealth into the pockets of those very pharma companies.  

If you've ever wondered why seemingly benign drugs like psilocybin mushrooms, peyote, ibogaine, khat & cannabis (which is still federally illegal) are in Schedule I while "hard" drugs like fentanyl & meth are in lesser Schedules, this is one of the main reasons.  It's also why the FDA has waged an all-out war on kratom.  The goal is to patent the active compounds & market them back to us while banning the whole plant, making themselves filthy rich in the process.  Speciogynine, a kratom compound, is currently being synthesized & studied by researchers at Purdue University's College of Pharmacy to treat alcohol use disorder.  According to their very own Adjunct Associate Professor of Medicinal Chemistry and Molecular Pharmacology, Richard Van Rijn: 

“The U.S. Drug Enforcement Agency has not scheduled kratom as a substance of abuse,” he said. “More research is needed to properly establish this, but one hypothesis for their lower risk for abuse is related to their cellular pharmacology.”

No, Rich, they haven't.  But not for lack of trying.  And they haven't stopped trying, issuing constant warnings/import alerts, seizing kratom shipments at the border and refusing to accept it as a New Dietary Ingredient for no good reason.  This, after seeking a GLOBAL ban on it in 2021 (lol).  If the nation's top scientific researchers are saying kratom is safe & has legitimate medicinal uses, why is the FDA still hellbent on banning it?  

For the hard-of-learning who missed it the first 17 times:  Because the FDA's sole purpose is helping pharmaceutical companies profit from any substance with a perceived medicinal or cosmetic benefit.  Duh.  Maybe they started as a legit regulatory agency with good intentions but that's not what they are now.  Like so many other American institutions, the FDA is a benevolent people-centered agency in name only.   In reality it's a revolving door of ex-pharma execs & stockholders that's been corrupted by money.  Speaking of money, pharma companies can't make it off a patented pharmaceutical molecule if everyone can buy the same (arguably superior whole plant) for much cheaper without a doctor's prescription on the internet or at the local GNC.  That's why they want to ban every recreational or medicinal substance under the sun:  so pharma has a total monopoly.  

Nobody's saying supplement companies are faultless here.  In fact, many popular supplements are made by pharma companies & megacorporations themselves.  The supplement market has its own serious safety and purity issues to contend with.  But the FDA has opted not to regulate supplements at all (see: DSHEA of 1994), which, again, tells me they aren't all that interested in protecting the public like they claim.  Absolutely no scientific backing is required for dietary supplements to be sold, & the companies selling them are entirely responsible for monitoring their purity & quality.  Fox guarding the hen house much?   🙄

Yet these very shortcomings leave the pharmaceutical industry wide open to compete with supplement makers fairly on the basis of safety, effectiveness, purity & compiled scientific data of their products.  A side by side comparison of pharmaceutical and supplemental b-NMN, for instance, would likely reveal that the former contains exactly what the label states while the latter does not.  (Supplements are routinely contaminated, adulterated or contain the wrong dose of the active ingredient, if any).  Rather than spending the money to point these things out, Big Pharma would rather twist the FDA's arm & have these compounds removed from the market entirely so there's no competition, and the FDA is all too eager to comply.  

That's corrupt as hell & we're sick of it.  

If there aren't going to be any concrete criteria for what constitutes a food, drug or supplement, the whole system is meaningless & needs to be thrown out.  The deep pockets of pharmaceutical companies are calling all the shots which isn't fair to supplement makers or the public.  As Michael A. Willis, corporate counsel to Metro International Biotech recently whined to the FDA regarding b-NMN: 

“protect the right of companies that have spent significant time and research to develop drug products from competition from dietary supplements that are clearly new dietary ingredients that have never filed a new dietary ingredient notification prior to the institution of substantial clinical trials.”

...and money, Mikey.  Time, research and money.  That's the key actor in this pay-to-play political drama where lobbyists make legislators & regulators jump like manic flaccid puppets while the rest of us go broke & die.