From our good friend in natural health, Dr. Murray, a very important email concerning NAC.
Dear Mark,
If you have been following my newsletters, you know that I have warned that the FDA may be taking the dietary supplement N-acetylcysteine (NAC) off the market.
That FDA decision will now happen before March 31, 2023 – so, basically any day now.
These are CRAZY times we are living in.
Keep in mind that NAC is a dietary supplement that in one study reduced the death rate of patients hospitalized with COVID-19 by 97%.
Let me explain the situation and why I encourage you to load up on NAC while it is still available.
NAC has been sold for decades as a dietary supplement and well before the Dietary Supplement Health and Education Act of 1994 (DSHEA).
DSHEA grandfathered in all existing dietary supplements on the market prior to 1994 and allowed them to continue to be sold.
NAC can increase the manufacturer of glutathione - a major antioxidant and detoxifying agent in the human body.
NAC also produces additional benefits against infection, such as acting to break down thickened mucus, enhancing white blood cell function, and exerting some direct antiviral activity.
It is both effective and very safe. Sixty years of use and hundreds of clinical studies support that safety and efficacy.
So, what is the problem?
Well, in 1963, NAC was approved as a drug to treat acetaminophen toxicity and also act as a mucolytic in helping keep the airways clear in cases of respiratory infection, asthma, or chronic obstructive pulmonary disease.
The dietary supplement industry has been selling NAC since 1994 under the belief that it is protected under DSHEA.
Then, all of a sudden in July 2020, the FDA issued warning letters to seven manufacturers stating in the FDA’s opinion, NAC is a drug and not a dietary supplement.
And those warning letters scared many retailers, including Amazon, away from selling NAC.
The timing was a bit odd given the tremendous potential benefits that NAC offered in the COVID-19 pandemic.
In my opinion, the FDA should not have been moving to take NAC off the market, they should have been encouraging its use. That might have saved many lives.
Afterall, NAC was shown to exert impressive effects in COVID-19, including reducing mortality by 97%.
That result was shown in a study of 82 hospitalized patients with moderate or severe COVID-19 pneumonia. These patients received standard care alone or 1,200 mg of NAC daily for 14 days. Taking NAC significantly lowered the rate of progression to severe respiratory failure and the need for mechanical ventilation.
And most importantly, NAC also significantly lowered mortality. Only 2 of 42 patients getting NAC died. In contrast, 12 of 40 of patients in the control group died.
These numbers translate to NAC supplementation producing a 97% reduction in mortality in patients hospitalized with COVID-19.
Are you kidding me? And the FDA is fighting to take it off the market?
Here is the current situation. In response to the threat of losing NAC in the marketplace, trade organizations like the Council of Responsible Nutrition (CRN) and Natural Products Association (NPA) took action.
The CRN helped execute a citizen’s petition in August 2021 and the NPA filed a lawsuit with the Department of Justice.
These actions have forced the FDA to make a final decision by March 31, 2022.
All we can do is hope that rational thinking prevails. But trusting the FDA to make the right decision is something I am not relying on.
So, what am I doing? What I have been encouraging all of you to do for nearly two years now. Load up on NAC while you can.
Be well,
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