An attempt to ban NAC - Law over Ethics?

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Be the change you wish to see in the world

- Anonymous

I am a big believer of doing whatever you can to create a move in the right direction. Even if 99% of the situation you're in is someone else's fault, you have to focus on that 1% which you are responsible for because that's what you can control. However, it's important to notice the things others are responsible for so you understand who is on your side. This blog is about that 99% with an attempt to figure out who is on our side.

In July 2020, the FDA in US sent letters to some manufacturers of a supplement which can help with over 1000 health issues stating that it has been wrongly classified as a supplement, and should be considered as a drug/medicine which requires a doctor's prescription. Let's look at some facts and try to understand the entire situation.

Facts

N-Acetyl Cysteine is a precursor for the amino acid cysteine. Cysteine is required to produce one of the most effective antioxidants in the human body called Glutathione (abbreviated as GSH). Glutathione is made from 3 amino acids - cysteine, glutamate and glycine. Of these, cysteine is unique as it contains Sulphur. Due to this, cysteine becomes the most limiting amino acid for the production of GSH, which is a part of all 1st class protein sources and the supplement NAC.

GSH has the function as an antioxidant which is elimination of reactive oxygen species. To put it in simple words, all chemical reactions going on in our body result in oxidative stress. Oxidative stress is the damage caused to your body by a molecule known as reactive oxygen species (ROS for short). ROS is basically a molecule with very high reactivity. Look at it as feral dog who will run after you if you come close to it, and if you're unlucky, bite you. Similarly, the oxidative stress (the bite itself) is caused when a 'reactive oxygen species' (a feral dog) tries to react with (chase or run after) any other stable molecule which is in close vicinity (you). This damages the stable molecule and shows up as symptoms like -

1. Fatigue

2. Memory loss and/or brain fog

3. Muscle and/or joint pain

4. Wrinkles and grey hair

5. Decreased eye sight

6. Headaches and sensitivity to noise

7. Dry, damaged skin

8. Dry hair and hair fall

9. Liver issues

10. Nerve damage

11. Inflammation

12. Drop in immunity

13. Increased infections

14. Increased upper respiratory tract infection (also the 'rona)

GSH, the antioxidant quenches these reactive oxygen species. GSH molecule sacrifices itself and prevents ROS from reacting and damaging the healthy cells of our body. Using our analogy, if ROS is a feral dog, the people from animal shelter who responsibly deal with the feral dog is Glutathione(GSH). And the best way to have adequate GSH levels is to consume enough cysteine, glutamate and glycine, the amino acids (amino acids are smallest unit of any protein) that made GSH.

Another way to quickly improve GSH levels in your body is by supplementing the limiting amino acid Cysteine in the form of N-Acetyl Cysteine or NAC. Apart from that, NAC is also known to improve immunity and prevent viral infections. In fact, it has been the go to supplement in prevention of COVID. It is the most important supplement for someone recovering from COVID infection. The medicines, steroids, and mental and physical stress that body goes through reduces immunity and makes the person more susceptible to other infections, including Mucormycosis, a rare and serious infection caused by fungi/fungus.

It is known be effective on almost all lifestyle and metabolic disorders. It is known to have benefits on about 1000 health issues.

Then why would FDA, the Food and Drug Administration agency in the US send letters to manufactures saying it's illegal to sell it as a supplement and try to ban it's sales?

Reason for Ban

It has been one of the most important supplements for prevention of COVID. It's the supplement that is on top of the list for any COVID recovery program. The sales for NAC spiked up last year by 32% to a total of $5.68 million (as compared to $4.31 million in 2019).

Which has probably made the pharma companies paranoid. That resulted in the FDA, the Food and Drug Administration agency in the US to send letters to various supplement manufacturers claiming that NAC is a drug and can't be sold as a supplement. Amazon was quick to remove NAC containing dietary supplements from its website (amazon.com). "FDA had issued a raft of warning letters over hangover cures which make the case that recovering from having had too much to drink is essentially a disease condition. In addition, some of the letters raise a potentially thorny issue concerning an ingredient that was formerly positioned as a drug." said CRN, the Center for Responsible Nutrition who also sent their reply to FDA. The letter CRN sent to FDA as a protest to their claim is found here.

Imagine a supplement which cures majority or our health issues, also cures hangovers. Hangovers are a result of excess consumption of alcohol, which classifies it as a 'disease condition'. So the logic is that if something cures a disease condition, it will get classified as a drug (sold on prescription) and not a supplement (bought over the counter for improving health). NAC was first approved as a drug under section 505 of the Act [21 U.S.C. § 355] on September 14, 1963.

I read the act. Based on what I understood, NAC will be rightly classified as a drug. But here's the catch. For decades, manufacturers have been marketing and selling NAC and NAC containing supplements as a dietary supplement in the US. FDA has consistently permitted to market these products as such. FDA has considered many supplement claims until now and have approved NAC containing supplements for sales until now, without raising any safety issues.

So if NAC is so effective for various health issues, including COVID, the FDA has been approving it's sales as a supplement for decades, and if people are getting healthier by taking NAC, why try to ban it now? Why would an agency try to ban something that reduces our dependency on drugs and pharmaceutical companies? I'll leave it to you to answer that question. Reach out to me directly with your answers.

Impact

If NAC gets banned as a supplement, you cannot buy it from supplement stores. You would need a prescription to buy NAC. And the prescription will be for a specific drug like L-cysteine which is inferior to NAC when it comes to health benefits. We will lose all the health benefits we get from NAC, and we will be more and more dependent on drugs from pharma companies which obviously don't have the cure.

Just click on this PubMed link and you'll see thousands of benefits for chronic lifestyle as well as genetic conditions which can be treated and managed with NAC supplements.

Luckily India has not banned NAC in India yet, and I hope we don't follow the FDA in the future. At the time of writing this blog, NAC is still available on amazon.in, and I hope it stays this way.

The 99% in this case seems too strong and the situation it has created seems to go against public health. All that's possible now is to hope that our morals stay high. And lets focus on the 1% by working with what can do. Work on our own health and immunity with a diet with adequate in 1st class protein.

Reach out to me directly if you are recovering from COVID or know someone who is. I can guide you to a better health. COVID was bad and you deserve the best now. Click on the contact form below.

Like, share, comment and let me know your thoughts about this. Until then,

Eat Good, Stay Strong, Live Free

Cheers,

Sushil Dhokne