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With all the benefits of N-acetyl cysteine (NAC), why is the FDA descheduling it?

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yellow medicine tablets on a aqua backgroundThere is great research going on in many parts of the world to investigate, share and publicize the benefits of N-acetyl cysteine (NAC).  Unfortunately, there is also a bureaucratic nightmare that is putting up barriers for people trying to get access to NAC. In this short article, we will share some thoughts about the supply problems that might be looming, and more about why it’s something you should be concerned about, thanks to the wide range of health issues that NAC can help you with.

About NAC

NAC is a synthetic form of cysteine, an amino acid that’s important in many reactions in the body’s biochemistry. The cysteine in NAC is metabolized to glutathione, which is an essential antioxidant required in immune system functioning and detoxification, as well as tissue building and repair.

NAC’s accepted role in treating respiratory conditions comes from its effectiveness in reducing chronic obstructive pulmonary disease (COPD), asthma, and bronchitis symptoms. The primary benefits of N-acetyl cysteine (NAC) are how it works to reduce inflammation in the airways and break down mucus in the respiratory system, making it easier to clear out. 

Nearly sixty years ago, the drug was approved by the FDA for the treatment of obstructive lung disease. The drug was withdrawn from the market many years ago, and treatment of these lung conditions with NAC has only very recently resumed with the release of Reolin

In 1985, it was given FDA approval for the treatment of acetaminophen toxicity caused by paracetamol overdose.

What is the new research saying about the benefits of N-acetyl cysteine (NAC)?

In some cases, it is still early days, but the potential that NAC represents for radical new treatments in a wide variety of unrelated disorders makes it a significant area of research. Acetylcysteine is one of the few compounds that can reduce the negative effect of oxidative stress (which is what it does in the case of paracetamol overdose).

Some of the more exciting fields are:

In animal models of Duchenne’s muscular dystrophy, treatment with low doses of acetylcysteine via drinking water significantly reduced muscle damage and improved strength.

In conditions such as autism, it is suggested that some symptoms may result from reduced levels of cysteine and related sulfur amino acids. There are those of the opinion that cysteine deficiency can be corrected with doses of NAC.

NAC may protect the human cochlea from damage. It reduced age-related hearing loss in animal studies.

Recovering addicts who have used certain drugs like cocaine, heroin, alcohol, and nicotine may have an increased vulnerability to relapse after re-exposure to the addictive drug if they have a reduction in the expression of one excitatory amino acid transporter (EAAT). Drugs like NAC that help to normalize the expression of the EAAT could be proposed as a possible therapy for treating addiction.

In the field of psychiatry, NAC has been the focus of many studies for major psychiatric disorders, including bipolar disorder, major depressive disorder, and schizophrenia.

There is good evidence [see note 1] that treatment with NAC can be effective for anxiety disorder, attention deficit hyperactivity disorder (ADHD), some addictions, as well as obsessive-compulsive disorder (OCD) and mood disorders. One of the most encouraging research fields [see note 2] into the benefits of N-acetyl cysteine (NAC) is treating bipolar disorder (what used to be labeled manic depressive disorder). For bipolar disorder, NAC has been turned into a strategy for depressive episodes, thanks to its role in limiting inflammation that is a likely cause of mood disorders. So far, it has been established that NAC was more effective than a placebo in reducing depression.

Now for the bureaucratic problem.

We have to get into some legal jargon here, don’t panic, we’ll keep it short and use simple language. Under a section of the Dietary Supplement Health and Education Act, if an article like NAC has already been approved as a new drug under section 505 of the Act, then products containing that article are outside the definition of a dietary supplement. 

In other words, the FDA is now saying that because NAC was defined as a drug way back in 1963, it cannot be marketed any longer as a dietary supplement, even though it has been on the market in this form for decades. In July 2020, the FDA issued warning letters to companies that are marketing NAC, stating that these companies are selling a dietary supplement which is a pharmaceutical ingredient, which contravenes the Act.

How does this affect us? It usually takes many years before early research on the various potential benefits of NAC is turned into approved medications. In the meantime, access to the completely safe and effective dietary supplement could be turned off simply because of a bureaucratic decision deep inside the hierarchy of the FDA. We will keep a close watch on what’s happening. As well, we’ll continue to offer you access to the latest versions of NAC from our shelves. Rheunac and Reolin both bring you the benefits of NAC. They are great not only for the regular treatment of lung congestion but equally for the newer areas of treatment for depression, anxiety, OCD and ADHD.

Notes and References

  1. N-acetylcysteine in psychiatry: Current therapeutic evidence and potential mechanisms of action. Journal of Psychiatry & Neuroscience: JPN, 36(2), 78-86.
  2. N-Acetylcysteine (NAC) in Schizophrenia and Bipolar Disorder – Prof Michael Berk, Deakin Chair of Psychiatry at Deakin University and Barwon Health. Psychscene Hub
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