N-acetylcysteine (NAC) is a potent antioxidant that was approved as a drug in September 1963.first Since that time, it is used as a nutritional supplement that is not available in natural sources.2 NAC contains the amino acid cysteine, which is a precursor to glutathione, also known as the “major antioxidant.”3
Glutathione is made up of three amino acids – glutamic acid, glycine, and cysteine.4 However, NAC is only available in supplement form. NAC precursors can be found in foods high in cysteine, including pork, beef, chicken, eggs, dates, and sunflower seeds.5
NAC is used by prescription as an antidote to acetaminophen-induced liver toxicity.6 It is also a powerful mucosal degrading agent for use in upper respiratory conditions. Memorial Sloan-Kettering7 also lists uses in the treatment of depression, pre-cancer, HIV and AIDS, and for alleviating the side effects of cancer treatment.
In 2020, the NAC announced when the FDA decided to sell the over-the-counter compound, which at the time has been available for over 57 years, will require a prescription in the future. FDA has issued a warning letter8 to seven companies the agency says illegally sold hangover products. By May 2021, Amazon, which also owns Whole Foods, has decided to phase out any dietary supplements containing NAC.9
FDA requests more information about NAC
As reported by Natural Products Insider, the letters warned that NAC could not be “legally marketed in dietary supplements because it was first studied as a drug in 1963.”ten The Council on Responsible Nutrition (CRN) sent a letter in December 2020 to the FDA’s Office of Dietary Supplements Programs describing the position as “legally invalid”.11
CRN and the Natural Products Association (NPA) have filed separate citizen complaints with the FDA. The December 2020 CRN letter challenged the FDA’s determination that NAC should be excluded from supplement use.twelfth They then filed a citizenship petition on June 1, 2021, asking the FDA to reverse their position and state why this sudden policy change was “inappropriate.” legally binding on many grounds.”13
The NPA filed a separate citizen petition with the FDA14 asks the agency not to exclude NAC as a dietary supplement or, alternatively, the Department of Health and Human Services (HHS) to issue a regulation showing that NAC is legal in supplements. Although HHS has the right, it has not been used in the 27 years since the law giving HHS that right was enacted in 1994.
On November 24, 2021, the FDA announced that it is requesting more information about how NAC has been marketed as a dietary supplement.15 Natural Products Insider reports that this is encouraging to some in the industry because it signals the FDA is open to the idea of regulating NAC as a legal ingredient in dietary supplements.16 The FDA calls this:17
“… Expected response to both citizen petitions, requests for additional information from petitioners… and note that the agency needs more time to carefully and thoroughly review the allegations complex questions posed in these petitions.”
FDA18 also requires information and data about the date NAC was first marketed as a dietary supplement, reporting of adverse events, and details of how the product was marketed and sold. Data is requested by January 25, 2022. Steve Mister, president and chief executive officer of CRN said in a statement:19
“The provisions of the Dietary Supplement Health and Education Act of 1994 (DSHEA) may not be retroactively construed to exclude ingredients that were legally marketed in 1994 and have been has a long history of safe use since then. Delaying removing the NAC’s status by asking for more data and refusing to admit fault is against the law and disapproving of consumers who use NAC.
This is not a complicated determination for the FDA. The DSHEA makes it clear that ingredients used as dietary supplement ingredients prior to release will be widely available in the dietary supplement market. Therefore, pharmaceutical manufacturers cannot have any monopoly expectations in the years preceding the enactment of this provision of the law.
Given the long history of safe use of NAC, the FDA is currently unable to attempt to establish safety concerns to give the ingredient exclusively to drug manufacturers. ”
FDA uses rule to exclude legally questionable drugs for the first time
United States Code Title 21,20 specifically define what is a functional food and is not a functional food. The FDA’s actions in banning the sale of NAC as a “drug” are illegal under the law, according to experts. Attorney Stan Soper21 writes that pursuant to Title 21 §321 paragraph (ff) (3) (b) 10, FDA actions do not meet the Drug Exclusion Clause.
According to Soper,22 Exclusions are invoked only a few times, particularly when used to prevent red yeast rice, vitamin B6 and cannabidiol (CBD) from being sold as dietary supplements. In each of these cases, there is the potential for a pharmaceutical financial loss that results in a claim that the supplement is illegal.
In the case of red yeast rice, it contains a natural substance that has similar effects to Lovastatin, a statin drug.23 In 2005, drug manufacturer Biostratum filed an investigative new drug application (IND) with the FDA for the use of vitamin B6 in the treatment of diabetic kidney disease.
Their argument was that there was “no evidence that it was marketed as a dietary supplement or food prior to the IND and Phase II investigations”.24 In 2009, the FDA declared vitamin B6 not a dietary supplement, although it is documented that it was sold as such prior to the adoption of the IND.
The FDA also invoked the Drug Exclusion Clause against CBD, warning that it was not a legal dietary supplement because there was no meaningful evidence that it was marketed as such prior to the release of the drug. Approved drug investigation for Sativex and Epidiolex, which are CBD-containing medications.
After the 2018 Farm Bill was signed into law legalizing hemp, then-FDA secretary Dr. Scott Gottlieb stated that adding CBD to the food supply or marketing it as a supplement was illegal.25 Soper’s postulate26 that the use of the Drug Exclusion Clause against CBD may have opened the door for the FDA to use it against NAC.
Why Target NAC?
In the petition of citizens27 Sent to the FDA June 1, 2021, CRN argued that the FDA failed to fully account for this sudden change in NAC policy, thereby “making it arbitrary and capricious.” According to CRN, prior to seven warning letters in July 2020, it was “longstanding FDA policy to permit the marketing of dietary supplements containing NAC”.
Although the agency has reviewed more than 100 informed structure/function claims for supplements containing NAC over the years, it has never issued a drug exclusion clause. In a response to a qualified health claim application, the FDA even stated that NAC is considered a dietary supplement.
While the Drug Exclusion Clause for CBD may have opened the door, it still raises the question of why the FDA chose to target the NAC. In the past, redundancy was inappropriately used to protect the finances of pharmaceutical companies. That could also be the source of the motive for banning NAC as a supplement.
As pathologist Dr. Roger Seheult briefly explains in the MedCram video below, NAC is an important chemical compound required to reduce the oxidative stress associated with severe COVID-19 infection and therefore could significantly affect sales of antiviral drugs. And, as I and other medical professionals have pointed out before, is there really a need to get vaccinated if there’s no serious illness?
Glutathione Depletion COVID-19 Outcome Worse
Researchers have been studying NAC since it was discovered. In 2010,28 The researchers found that it was able to inhibit the expression of proinflammatory cytokines in cells infected with the highly virulent H5N1 influenza virus. These same pro-inflammatory cytokines play an important role in severe COVID-19.
Researchers have confirmed that in severe cases, cytokine levels are elevated, and once they reach excessive levels, it triggers a cytokine storm.29 This causes significant tissue damage that NAC can inhibit. In a 2020 paper,30 The authors describe a case of COVID-19 in a patient with glucose-6-phosphate dehydrogenase (G6PD) deficiency.
This is an inherited disorder that can lead to hemolytic anemiathirty first and deplete glutathione,32 increases the risk of human coronavirus infection like the common cold. NAC was given to the G6PD-deficient patient and 9 other COVID patients on ventilators. NAC “produced a clinically significant improvement and reduction in CRP in all patients.”33
Other documents that have been published since then have demonstrated that there is a possibility of using NAC in the treatment of COVID-19.34,35,36 A 2021 study37 compare consecutively hospitalized patients with moderate or severe COVID-19 pneumonia.
One group received standard care only and the other received 600 mg of NAC twice daily for 14 days. There were 42 people in the NAC group and 40 people in the control group. Treatment with NAC resulted in a significantly lower incidence of severe respiratory failure and mortality.
Early treatment at home is very important
NAC is just one of a number of proven successful treatments that are vilified by government agencies. Since the start of this pandemic, it seems that global and national health authorities have done everything in their power to encourage and prevent people from accessing treatments, such as ivermectin38,39,40 and hydroxychloroquine,41,42,43,44 compete with COVID jab.
The actions surrounding NAC appear to be another shameful attempt to prevent patients from helping themselves. By limiting access to nutritional supplements that have been shown to reduce the severity of infections, organs are essentially increasing the risk of infections progressing to more serious cases. .
If you are experiencing symptoms of COVID-19, early treatment is important. Not only can it significantly reduce the duration of illness, but early treatment will also minimize the risk of long-lasting syndrome,45 may include symptoms that last much longer than the initial infection.forty six This can include coughing, body aches, trouble sleeping, headaches, and brain fog.
There is also scientific evidence that NAC can improve a wide range of lung problems, including pneumonia and acute respiratory distress syndrome (ARDS), common features of COVID-19. Eg:
- Search47 published in 2018 showed that NAC reduced oxidative damage and inflammation in patients with community-acquired pneumonia.
- Another 2018 study48 NAC improves lung function after surgery in liver transplant recipients.
- A meta-analysis of 201749 found a significant reduction in ICU stay among ARDS patients treated with NAC.
- NAC is also a well-known mucolytic agent used to help clear mucus from the airways of cystic fibrosis patients.50 Some research also shows that NAC can help reduce symptoms of COPD and prevent it from getting worse.51
