The FDA's War on Supplements

As a long-term user of N-Acetylcysteine, I started having a hard time finding it in stock around Spring 2021.  Assuming the shortage was COVID related, I never looked into it too much and figured it would sort itself out in time.  I take it daily in large amounts to (hopefully) offset acetaminophen-induced liver toxicity from the large doses of Tylenol I take every day.  So far it's working according to my liver enzyme tests.  It's not marketed for that use by the manufacturer to be clear, but that's how I use it.  And I've never had a single side effect from it.

So imagine my shock when I clicked on a random Youtube video about NAC the other day and found out that the reason for the shortage is that the FDA has begun a coordinated crackdown on the sale of it on Amazon that's likely to become a total ban of the manufacture and sale of NAC in the U.S!  This is a dietary supplement that's been on the market for over 30 years and has an incredible safety profile, with zero risk of abuse or addiction and no psychoactive properties whatsoever.  Not one person is using this to get "high" and it's killed no one.  

So why would they suddenly decide to ban its sale as a supplement?

The 'official' reason is that it was approved as a medication first, which is flimsy as there are many other supplements that are sold as both prescription drugs and supplements.  (See:  fish oil, Vitamin C prescribed as "Ascorb" & l-methylfolate prescribed as "Deplin" for depression).  More importantly, why is this only coming up NOW when NAC has been sold without issue for 30+ years on the supplement market?  

One popular theory is that studies have recently come out showing its effectiveness in improving outcomes in COVID patients.  I like this theory because it explains both the timing & the reasoning of the FDA, which is in line with some of their previous ban attempts.  To be more clear:  this cheap, effective supplement is competing with pharma's ability to create an expensive version of NAC that's available by prescription only.  They did this with cannabis by keeping it illegal for decades (see:  Marinol, Nabilone, Epidiolex) and undoubtedly want to do it with kratom.  No one's going to buy an expensive prescription version of NAC if it's available OTC for pennies per dose, so the only logical move is for the FDA to ban the supplement version.  

Implications of a Ban

From Brazilian study on Therapeutic uses of NAC (source)

NAC is vital for making the antioxidant glutathione, which neutralizes free radicals & fights cellular damage.  Not only is it not addictive, it might actually be beneficial for treating addictive behavior & mental illnesses like OCD & schizophrenia.  Its most well-known use is in hospitals to treat acetaminophen overdose, but it's also used clinically to treat serious lung diseases like COPD and cystic fibrosis due to its mucolytic effects.  Others use it to improve kidney, immune system & heart health.  As with kratom, one of the main benefits of NAC in its current form is that it's dirt cheap, meaning anyone can afford and access it, and the side effect profile is magnificent.  The most severe side effects tend to include nausea, diarrhea & allergic rash.  

If the FDA bans over-the-counter NAC, millions of people will lose access to this affordable & versatile supplement.  AND THERE'S NO RATIONAL REASON TO DO SO.  Americans should have the right to access vitamins, minerals, herbs & other supplements as long as they're not adulterated or promoted to treat/cure diseases they haven't been proven to cure.  And NAC isn't even one of the supplements that's been caught in an adulteration scandal like many of the various weight loss, sexual enhancement & detox supplements on the market.  The only reason I can fathom for this move is pharmaceutical companies' greed.  If a prescription COVID drug comes out that contains NAC or a derivative of it after this ban, there'd better be a lawsuit & mass protest at FDA headquarters.  The pharmaceutical industry should NOT have a monopoly on nutritional supplements & antioxidants. 

Furthermore, we shouldn't have to form lobbying groups like the American Kratom Association for every substance on the chopping block just to keep them legal.  This corporate fascism is getting way out of hand.   I'm not into conspiracy theories or demonizing "Big Pharma," but it's not hard to see why so many people are distrusting of corporations & government institutions when they do shit like this every few months.  There's a clear conflict of interest at the FDA when they pull stunts like this while rushing approval of drugs like Aduhelm which has practically zero proof of efficacy (and causes actual harm) in patients with Alzheimer's disease.  I've seen this movie before and the villain is often our own regulatory agencies, which are coincidentally run by a revolving door of ex-pharma fat cats & stock market profiteers like Scott Gottlieb, former Cephalon fentanyl procurer.  

(Yeah, I'm never letting that go.  Maybe I should do a copy/paste of the evidence on my own blog before it disappears down the memory hole forever).  

Now What?

Money talks at the FDA

What's next?  Is the FDA gonna ban Xylitol nasal spray because it's been shown to shorten COVID infection in clinical trials?  I'm all for innovation & ending this pandemic, but not at the expense of my right to access harmless supplements I've been taking for years.  And not when we still don't have affordable, accessible healthcare that would allow all people to obtain these supplements-cum-drugs should they be made prescription-only.  Nobody should have to pay to see a doctor & wait in line at the pharmacy for a supplement like NAC.

If you had any doubt that the FDA's kratom, CBD & Benzedrex ban attempts had NOTHING to do with keeping the public safe, here it is.  They're now trying to ban a supplement with a long & flawless safety record; a substance found in foods like eggs, cheese & turkey.  A frickin' antioxidant.  Whether you've ever used NAC or not, you should be very concerned about this development.  Write a letter to your representative or simply tag them @US_FDA on social media asking what their reasoning is for this ban.  This is a dark predictor of things to come & we can't allow it to go unchallenged.  

I'd love for an FDA representative to respond to this article & offer their reasoning for this suspiciously-timed ban of N-Acetylcysteine.  But I highly doubt that'll happen.  They answer to no one (except drug company CEOs and investors).  Here's your invitation anyway:  Please make this make sense.  

Update 1/12/22:  The makers of Xlear nasal spray have been sued by the FTC for citing a study which found that their product shortened the duration of COVID infection in subjects on their website.  They believe they were unfairly targeted and have responded to the lawsuit.  

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