Natural Medicines. N-Acetyl Cysteine: Supplement, Drug, or Both?
N-acetyl cysteine (NAC) comes from the amino acid L-cysteine. It’s been available in dietary supplements for decades. But now the FDA is warning companies that it cannot be legally included in supplements. The tug of war between the industry and FDA is confusing, and highlights the great differences in supplement and drug regulations.
NAC was first approved by the FDA as a respiratory drug in 1963. It’s also used to prevent serious liver damage from acetaminophen poisoning. But it’s been available in dietary supplement products for decades – the ingredient itself is likely safe for most people. The FDA has pushed back on the use of NAC in supplements since 2010, but it’s ramped up significantly this year.
Some speculate this is due to new clinical investigations into the use of NAC for COVID-19. The FDA claims that there’s no evidence that NAC was used as a supplement prior to its use as a drug – so including NAC in a supplement makes the product an unapproved drug and thus illegal.
Most recently, several dietary supplement companies received warning letters for making hangover treatment claims about their products. The main purpose of these letters was to inform them that making these claims was a violation of the Dietary Supplement Health and Education Act (DSHEA). But in addition to this violation, the FDA also flagged several of these companies for including NAC in their products.
This renewed confusion over the legality of NAC places a spotlight on major holes in supplement regulations. For NAC, and other ingredients with confusing legality like CBD, nothing is black and white. Unlike drugs, there is NO approval process for dietary supplements. If a supplement contains dietary ingredients that were either already used in supplements before DSHEA (1994), or established as reasonably safe since then, it can be lawfully sold to consumers.
This is very different from drugs, which must go through an extensive approval process BEFORE entering the market. Those in the dietary supplement industry claim that there is no reason for the FDA to take retroactive steps to remove products that have been available for years with no clear safety issues. They are also concerned that this could open the door for the FDA to make the same determination about other products, such as fish oil and vitamin K. But the FDA stands by its current position. Stay tuned.
See more here: naturalmedicines.therapeuticresearch.com
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Mark Tapley
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While Big Pharma continues to kill and maim millions with its new food toxin chemo injections and prescription drugs and over the counter pain.pills are killing hundreds of thousands of people every year the FDA relentlessly pursues its war on natural remedies. Any thing can be abused by idiots and if there is fraud in the marketing of products it is the job of the court system to carry out legal recourse. It is also the job of the consumer to use common sense. It is not the government ts business to tell us what food to eat or what substances to use for any reason. This is just another scam to control people as with the so called “war on drugs. ” Get the government mafia off our backs and out of our pockets.
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Mark Tapley
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the word food in the first sentence was of course supposed to be blood.
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Tom O
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This only suggest to me that there is a drug company that wants to use this in a prescription to deal with some issue, thus the product can’t be available for self treatment.
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Scouse Billy
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I think that’s unlikely, Tom
NAC is a natural substance and cannot be patented, so has no profit potential.
However, it is a life saver…
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Tom O
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I didn’t say that they wanted to use it AS a medication, but potentially in a medication where it actually does the heavy lifting, if you will, thus it actually is the reason the medication works. If it wasn’t readily available , then you couldn’t just take the supplement to get the same effect. What non patent-able substances are in a proprietary blend may not be patented, but the blend can be I suspect.
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Mark Tapley
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Hi Billy:
It is a critical amino acid for the manufacture of Glutathione, the precursor anti oxidant. As you say it cannot be patented but anything that may be effective, accessible, and cheap compared to the allopathic snake oil, has to be regulated off the market by the FDA big Pharma mafia.
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Scouse Billy
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There’s a fair bit of cancer research involving NAC for that very reason – perhaps the oncologists feel threatened.
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Mark Tapley
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Hello Billy:
The medical racket depends on the profits from heart disease and cancer, both easily avoided and uncommon a century ago. To supplement for the current lossof profits from these cash cows the hospitals are receiving revenue from the fake covid19 payments in order to keep the scam going.
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Scouse Billy
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Spot on, Mark. I am well aware of the history going back to the Flexner brothers and their sponsors.
A very well written exposé on the suppression of safe non-toxic cures by “Official Medicine”, i.e., the FDA et al. is Politics in Healing: The Suppression and Manipulation of American Medicine by Daniel Haley. It’s out of print but there is a pdf available on ed2k (e-mule).
Meanwhile, our countries take on “odious debt” to the extent we are owned like never before…
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tom0mason
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“… acetaminophen poisoning …
In the UK it is known as paracetamol poisoning.
Acetaminophen/paracetamol is a liver destroying poison, the side effects is to provide some pain relief at lower doses. NAC (N-Acetyl Cysteine) effectively protects the liver from this poison. This is not to say NAC is without some side effects …
‘Anaphylactoid symptoms include airway obstruction (bronchospasm), angioedema, dyspnea, hypotension, shock, tachycardia, urticaria, and injection site reaction (including rash). These are most common either during, or at the end of the loading dose infusion, and may be dose related. Careful monitoring is recommended.’ Apparently these show more with injections than with the tablet form.
NATURE reports that NAC could be useful for the relief of osteoarthritis development (at lease in rats). See https://www.nature.com/articles/s41598-019-55297-2
As with just about all medication there are risks and benefits that have to be weighed up.
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Leonard Winokur
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https://www.veteranstoday.com/2020/08/21/most-controversial-document-in-internet-history-the-hidden-history-of-the-incredibly-evil-khazarian-mafia/
https://www.goodreads.com/en/book/show/18815919
https://go2.thetruthaboutcancer.com/final-chapter/episode-1/
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