Are We Being Set Up for Mass Depopulation?

How do you market and implement a financial system that nobody would want if they understood its full ramifications — a change so huge that it not only would mean the end of currency as we know it, but a total revision of sovereignty and individual rights? In the interview above, which is part of the full-length documentary “Planet Lockdown,”1 Michael Yeadon, Ph.D., a life science researcher and former vice-president and chief scientist of allergy and respiratory research at Pfizer, shares his views on the COVID-19 pandemic, fast-tracked COVID-19 “vaccines,” the issue of mutated virus variants and the need for booster shots, and how this manufactured crisis is being used to strip us of our civil liberties. Are You Putting the Pieces Together? Yeadon has a degree in biochemistry and toxicology and a research-based Ph.D. in respiratory pharmacology. He’s spent 32 years of his career working for large pharmaceutical companies, and 10 years in the biotechnology sector. “I'm in favor of all modes of new medical treatments, whether they're biologicals or vaccines, small molecules, creams, sprays, ointments, whatever, but I'm fervently against unsafe medicines or medicines used in an inappropriate context,” Yeadon says. “Some of the things I'm going to say are not favorable to the current crop of gene-based vaccines and it's [because] they're being inappropriately used. I don't think they have a sufficient safety profile to be used as a sort of wide-spectrum public health prophylactic … A few things have allowed me, I think, to spot what's going on in the world at the moment. One, I've loved biology since I was little. I've been continuing to learn and to apply biology broadly, whether it's pharmacology, biochemistry, molecular biology [or] toxicology. I've got a very broad grounding in all things to do with life science, in terms of health and disease. [Secondly], one of my former supervisors said that I had a remarkable facility that stood out above the sort of ordinary things you'd have to do to be a vice president or a CEO. He said I was able to spot patterns in sparse data earlier than my peers. So, when there's not enough data for most people to judge what was going on, I would often be able to see it. I could see a pattern forming when there wasn't quite enough information … On this occasion, it allowed me, quite quickly, to work out that what we were being told about this virus and what we needed to do in order to stay safe was simply not true.” A Massive Fraud Has Been Perpetrated Yeadon starts out by highlighting the “enormous changes” made in the U.K.’s attribution of causes of deaths. If you die within 28 days of testing positive for SARS-CoV-2, you are counted as a COVID-19 death, regardless of other underlying conditions. The same thing was done in the U.S. As noted by Yeadon: “We've never had anything as absurd as the rule that is now used. It's not just a matter of disagreeing professionally. It's just complete nonsense.” The shutdown of businesses and forcing healthy people to self-isolate also makes no sense. Yeadon points out that only people who are ill, who have discernible symptoms of a respiratory infection, pose any health risk to others: “To be a good, efficient source of infection, you have to have a lot of virus. And if you have a lot of viruses attacking you, you are fighting back. That process produces symptoms, inevitably, not just occasionally. It must always happen … And those people are not people who are walking around in the community, because if you're full of virus and symptomatic, you are also ill, and ill people tend to stay at home or in bed.” Asymptomatic spread, which has no sound basis, was used to justify lockdowns, which never had any basis in fact or science either. Lockdowns were implemented for entirely other reasons, namely to get you used to giving up your freedoms and your normal way of life, and to make you psychologically dependent on an outside source telling you when it’s OK to do what. It’s obedience training and a tool to get the population of the world to go along with the intentional decimation of the global economy and old way of life, thereby justifying the Great Reset, which is about transferring global wealth and ownership rights to the technocratic elite, and giving them the power to control the world’s nations. “Basically, everything your government has told you about this virus, everything you need to do to stay safe, is a lie,” Yeadon says. “Every part of it … None of the key themes that you hear talked about — from asymptomatic transmission to top-up vaccines [i.e., booster shots] — not one of those things is supported by the science. Every piece is cleverly chosen adjacently to something that probably is true, but is itself a lie, and has led people to where we are right now. I don't normally use phrases like this

Are We Being Set Up for Mass Depopulation?

How do you market and implement a financial system that nobody would want if they understood its full ramifications — a change so huge that it not only would mean the end of currency as we know it, but a total revision of sovereignty and individual rights?

In the interview above, which is part of the full-length documentary “Planet Lockdown,”1 Michael Yeadon, Ph.D., a life science researcher and former vice-president and chief scientist of allergy and respiratory research at Pfizer, shares his views on the COVID-19 pandemic, fast-tracked COVID-19 “vaccines,” the issue of mutated virus variants and the need for booster shots, and how this manufactured crisis is being used to strip us of our civil liberties.

Are You Putting the Pieces Together?

Yeadon has a degree in biochemistry and toxicology and a research-based Ph.D. in respiratory pharmacology. He’s spent 32 years of his career working for large pharmaceutical companies, and 10 years in the biotechnology sector.

“I'm in favor of all modes of new medical treatments, whether they're biologicals or vaccines, small molecules, creams, sprays, ointments, whatever, but I'm fervently against unsafe medicines or medicines used in an inappropriate context,” Yeadon says.

“Some of the things I'm going to say are not favorable to the current crop of gene-based vaccines and it's [because] they're being inappropriately used. I don't think they have a sufficient safety profile to be used as a sort of wide-spectrum public health prophylactic …

A few things have allowed me, I think, to spot what's going on in the world at the moment. One, I've loved biology since I was little. I've been continuing to learn and to apply biology broadly, whether it's pharmacology, biochemistry, molecular biology [or] toxicology. I've got a very broad grounding in all things to do with life science, in terms of health and disease.

[Secondly], one of my former supervisors said that I had a remarkable facility that stood out above the sort of ordinary things you'd have to do to be a vice president or a CEO. He said I was able to spot patterns in sparse data earlier than my peers. So, when there's not enough data for most people to judge what was going on, I would often be able to see it.

I could see a pattern forming when there wasn't quite enough information … On this occasion, it allowed me, quite quickly, to work out that what we were being told about this virus and what we needed to do in order to stay safe was simply not true.”

A Massive Fraud Has Been Perpetrated

Yeadon starts out by highlighting the “enormous changes” made in the U.K.’s attribution of causes of deaths. If you die within 28 days of testing positive for SARS-CoV-2, you are counted as a COVID-19 death, regardless of other underlying conditions. The same thing was done in the U.S. As noted by Yeadon:

“We've never had anything as absurd as the rule that is now used. It's not just a matter of disagreeing professionally. It's just complete nonsense.”

The shutdown of businesses and forcing healthy people to self-isolate also makes no sense. Yeadon points out that only people who are ill, who have discernible symptoms of a respiratory infection, pose any health risk to others:

“To be a good, efficient source of infection, you have to have a lot of virus. And if you have a lot of viruses attacking you, you are fighting back. That process produces symptoms, inevitably, not just occasionally. It must always happen …

And those people are not people who are walking around in the community, because if you're full of virus and symptomatic, you are also ill, and ill people tend to stay at home or in bed.”

Asymptomatic spread, which has no sound basis, was used to justify lockdowns, which never had any basis in fact or science either. Lockdowns were implemented for entirely other reasons, namely to get you used to giving up your freedoms and your normal way of life, and to make you psychologically dependent on an outside source telling you when it’s OK to do what.

It’s obedience training and a tool to get the population of the world to go along with the intentional decimation of the global economy and old way of life, thereby justifying the Great Reset, which is about transferring global wealth and ownership rights to the technocratic elite, and giving them the power to control the world’s nations.

“Basically, everything your government has told you about this virus, everything you need to do to stay safe, is a lie,” Yeadon says. “Every part of it … None of the key themes that you hear talked about — from asymptomatic transmission to top-up vaccines [i.e., booster shots] — not one of those things is supported by the science.

Every piece is cleverly chosen adjacently to something that probably is true, but is itself a lie, and has led people to where we are right now. I don't normally use phrases like this, but I think we are standing at the very gates of hell … It’s all about control …

The reason I'm commenting is because I believe it's not just about my life. More importantly, [it’s the lives] of my children and grandchildren that are being stolen … by a systematic process of fear and control that's going to culminate in, I think, some very horrible times, and I'm desperate to wake you up …

We're probably quite used to politicians occasionally telling white lies, and we kind of let them, but when they lie to you about something technical, something that you can check, and they do it [with] many, many elements of the whole event, then please, you've got to believe me, [they’re] not telling the truth.

And if they're not telling the truth, that means there's something else. And I'm here to tell you that there is something very, very bad happening. If you don't pay attention, you will soon lose any chance to do anything about it.”

Science Has Been Turned on Its Head

Yeadon rightly notes that everything we’ve known about virology and infectious disease has been turned upside down during this pandemic. None of the standard responses known to protect people from infectious disease was followed. Normally, you quarantine the sick to contain the infection.

Locking down entire societies has never been done and has no foundation in science or the history of epidemic control. Similarly, mass testing people without symptoms is without precedence. It simply isn’t done, and for good reason. It’s a waste of resources because as Yeadon explained earlier, we know how viruses spread. This isn’t our first rodeo. We’ve dealt with infectious epidemics before.

We know how viruses work in the body. When you have an active infection, you develop symptoms as your body mounts its defense. Without symptoms, your viral load is too low to pose a threat, either to yourself or others. The myth about asymptomatic spread has been a fear tactic.

T-Cell Immunity Is Far More Important Than Antibodies

Yeadon goes on to review how we’ve been misled about immunity and how your body fights off viruses. You’ve probably heard that the thing that gives you immunity against SARS-CoV-2 is SARS-CoV-2-specific antibodies.

The entire vaccination campaign is built around the premise that by injecting a synthetic piece of viral RNA into your cells, your body will start producing the SARS-CoV-2 spike protein, in response to which your body will produce specific antibodies that recognize that protein. This is also known as humoral immunity.

However, while antibodies are important, especially in bacterial infections, antibodies are not the only part of your immunity. More importantly, immunity against viruses — opposed to bacteria — actually does not depend on antibodies. Yeadon explains:

“Viruses are really tiny, and their business is to get as quickly as they can inside your cells. So, they bind to a receptor on the surface and inject themselves into your cell. So, they’re inside. Antibodies are big molecules and they're generally outside your cells.

So just think about that for a moment. Antibodies and viruses are in separate compartments. The virus is inside the cell, the antibodies outside the cell. I'm not saying antibodies have no role, but they're really not very important. This has been proven. There are some people in whom a natural experiment has occurred.

They have a defect and they actually don't make antibodies, but they're able to fight off COVID-19, the virus SARS-CoV-2, quite well. The way they do that is, they have T-cell immunity, cellular immunity. [T-cells] are cells that are trained to detect virus-infected cells and to kill those cells. That's how you defend yourself against a virus.

So, all of these mentions of antibody levels, it's just bunk. It is not a good measure of whether or not you're immune. It does give evidence that you've been infected, but their persistence is not important as to whether you've got immunity …

We've known this for decades. We've known about T-cells for decades. They were clearly in my undergraduate textbooks. And we've known about their importance in defending you against respiratory viruses since probably the 1970s, certainly the 1980s. So, don't believe anything where people suggest to you that their role is uncertain. We've known for a very long time that they are absolutely central.”

Antibodies Are Not the Answer to Variants

The central role of T-cell immunity, or cellular immunity, becomes particularly pertinent when discussing the threat of variants, mutated forms of SARS-CoV-2. As mentioned, your immune system is a multifaceted system that allows your body to mount defenses against all sorts of threats. Parasites, fungi, bacteria and viruses are the main threat categories.

Each of these invades and threatens you in completely different ways, and your immune system has ways of dealing with all of them, using a variety of mechanisms.

“You've got four or five different arms of the immune system: innate immunity, mucosal, antibody, T-cells and compliment[ary systems],” Yeadon says.

“There are all of these different wonderful systems that have integrated, one with another, because it needs to defend you against all sorts of different threats in the environment. What I'm telling you is that the emphasis on antibodies in respect of respiratory viral infections is wrong, and you can establish that quite easily by doing some searching.”

In essence, what Yeadon is saying is that whether you’re going to be susceptible to variants has very little to do with whether or not you have antibodies against SARS-CoV-2, because antibodies are not your primary defense against viruses. Your T-cells are the ones doing the heavy lifting.

What this means then, is that getting booster shots for different variants is not going to help you. It will not solve the problem, because these shots do not strengthen your T-cell immunity.

Carefully Rethink Need for Booster Shots

Of all the lies we’ve been told over the past year, the ones that worry and frighten Yeadon the most are the lies about virus variants and booster shots. In fact, he believes not buying into these lies may be key to your very survival, and here’s why:

“It's quite normal for RNA viruses like SARS-CoV-2, when it replicates, to make typographical errors. It’s got a very good error detection, error correction system so it doesn't make too many typos, but it does make some, and those are called ‘variants.’

It’s really important to know that if you find the variant that's most different from the sequence identified in Wuhan, that variance … is only 0.3% different from the original sequence.

I'll say it another way. If you find the most different variance, it's 99.7% identical to the original one, and I can assure you … that amount of difference is absolutely NOT possibly able to represent itself to you as a different virus.”

He explains how, earlier in the pandemic, scientists obtained blood from patients who had been sickened with the SARS virus 17 or 18 years ago. SARS-CoV-1, responsible for that SARS outbreak, is 80% similar to SARS-CoV-2.

They wanted to know if the immune systems of these patients would be able to recognize SARS-CoV-2. They did. They still had memory T-cells against SARS-CoV-1, and those cells also recognized SARS-CoV-2, despite being only 80% similar. Now, if a 20% difference was not enough to circumvent the immune system of these patients, why should you be concerned with a variant that is at most 0.3% different from the original SARS-CoV-2? 

“When your government scientists tell you that a variant that's 0.3% different from SARS-CoV-2 could masquerade as a new virus and be a threat to your health, you should know, and I'm telling you, they are lying,” Yeadon says.

“If they're lying, and they are, why is the pharmaceutical industry making top-up [booster] vaccines? You should be terrified at this point, as I am, because there's absolutely no possible justification for their manufacture. And the world's medicines regulators have said, ‘Because they are quite similar to the original vaccines … we won't be asking them to do any clinical safety studies.’”

Are We Seeing a Mass Depopulation Agenda in Action?

Yeadon stresses that variants simply aren’t different enough to represent a threat, which is why you don’t now, and won’t in the future, need one or more booster shots. Yet they’re already being made, and regulators are giving them a free pass when it comes to safety and efficacy studies.

“I'm very frightened of that. There's no possible benign interpretation of this,” Yeadon says. “I believe they're going to be used to damage your health and possibly kill you. Seriously. I can see no sensible interpretation other than a serious attempt at mass depopulation.

This will provide the tools to do it, and plausible deniability. They'll create another story about some sort of biological threat and you'll line up and get your top-up vaccines, and a few months or a year or so later, you'll die of some peculiar inexplicable syndrome. And they won't be able to associate it with the vaccines.

That's my belief — that they're lying to you about variants so they can make damaging top-up vaccines that you don't need at all. I think they will be used for malign purposes … We know that the people [SARS-CoV-2] injures and kills are only people who are elderly and or ill, usually both, so we're talking about less than 0.1% [of the population] …

Given that this virus represents, at worst, a slightly bigger risk to the old and ill than influenza, and a smaller risk [than influenza] to almost everyone else … it was never necessary for us to have done anything. We didn't need to do anything. [We didn’t need] lockdowns, masks, mass testing, vaccines.

There are multiple therapeutic drugs that are at least as effective as the vaccines are. They're already available and cheap. Inhaled corticosteroids that are used in asthma reduced symptomatology by about 90%.

An off-patent drug called ivermectin, one of the most widely-used drugs in the world, is also able to reduce symptoms at any stage of the disease, including lethality by about 90%. So, you don't need vaccines and you don't need any of the measures that have been introduced at all.”

Key Safety Concerns of mRNA ‘Vaccines’

In December 2020, Yeadon filed a petition2 calling on the European Medicine Agency to halt Phase 3 clinical trials of the Pfizer mRNA vaccine until they’ve been restructured to address critical safety concerns. Of course, those trials were not halted. The four key safety concerns Yeadon specified in his petition3 were:

1. The potential for formation of non-neutralizing antibodies that can trigger an exaggerated immune reaction (referred to as paradoxical immune enhancement or antibody-dependent immune amplification) when the individual is exposed to the real “wild” virus post-vaccination.

Antibody-dependent amplification has been repeatedly demonstrated in coronavirus vaccine trials on animals.4 While the animals initially tolerated the vaccine well and had robust immune responses, they later became severely ill or died when infected with the wild virus. Put plainly, the vaccine increased their susceptibility to the virus and made them more likely to die from the infection.

2. Pfizer’s mRNA vaccine contains polyethylene glycol (PEG), and studies have shown 70% of people develop antibodies against this substance. This suggests PEG may trigger fatal allergic reactions in many who receive the vaccine.

Indeed, within days of the vaccine’s release, reports started coming in of people having life-threatening anaphylactic reactions,5 leading to warnings that people with known allergies should not take the Pfizer vaccine.6 Since then, anaphylactic reactions have been reported by recipients of the Moderna mRNA vaccine as well.7

3. The mRNA vaccine triggers your body to produce antibodies against the SARS-CoV-2 spike protein, and spike proteins in turn contain syncytin-homologous proteins that are essential for the formation of placenta. If a woman’s immune system starts reacting against syncytin-1, then there is the possibility she could become infertile.

This is an issue that none of the vaccine studies is looking at specifically. Mass vaccinating women of childbearing age against COVID-19 could potentially have the devastating consequence of causing mass infertility if the vaccine triggers an immune reaction against syncytin-1.

4. The studies are far too brief in duration to allow a realistic estimation of side effects. Depending on what those effects end up being, millions of people may be exposed to unacceptable risk in return for a very minor benefit. 

Health Freedom Undermined in the Name of ‘Emergency’

Even more fundamental than any particular safety concern is the fact that a vaccination campaign of this magnitude, using an entirely novel technology, sets a most dangerous public health precedent. By drumming up unnecessary panic, many are now willing to forgo all manner of freedom in the name of responding to a global health emergency.

One of these core freedoms is your right to refuse an experimental medical procedure. This freedom was acknowledged in the Nuremberg Code of 19478 and enshrined in the International Covenant on Civil and Political Rights, which states that “no one shall be subjected without his free consent to medical or scientific experimentation.”9

Yet despite that, and despite the fact that clinical vaccine trials are still two years out from being completed, governments around the world are talking about making these vaccinations mandatory, or blackmailing people to take them against their will by encouraging private businesses to restrict access to vaccinated-only.

As noted by Yeadon and many others, the implementation of vaccine passports has nothing to do with protecting public health and everything to do with setting into place a surveillance, tracking and control mechanism that can easily be expanded into all other areas of life, thereby controlling your every move.

“[Vaccine passports] are not required at all,” Yeadon says. “What they provide, though, is complete control over your movements to whoever controls the database that your vaccination status is connected to. I hope you grasp this because this is not optional.

This is what's going to take over your life in a way that George Orwell in ‘1984’ didn't even dream of. Imagine you've been vaccinated and you've been awarded a vaccine passport on an app. It's going to be the world's first database that contains your name, a unique digital ID in the same format as absolutely everybody else on the planet on the same database.

It'll have like an editable health-related flag that will say [whether] you've been vaccinated. If you haven't been, the algorithm that rules that works out what you can do … That's what's going to control the rest of your lives until you die.”

Vaccine Passport Is a Ticket to Tyranny, or Worse

Indeed, I’ve written several articles detailing how the tracking of vaccination status will usher in a surveillance apparatus greater than anything we’ve ever experienced before.

The precedent being set up right now is one that, in the future, will grant health authorities the “right” to force any number of experimental drugs, vaccines and technologies upon us in the name of public health. If the right to refuse an experimental medical procedure is not upheld now, the entire population of the earth will be available for experimentation without recourse. 

But that’s not all. This initial vaccine surveillance system will ultimately be tied into other digital systems, such as all other medical records, biometric ID and an all-digital banking system.

The implementation of a Google-based social credit system, similar to that implemented in China in 2018, is also highly likely. Under a social credit system, points are awarded or subtracted for certain types of behavior. When your score falls below a certain point, punishment is meted out in the form of travel restrictions or the inability to obtain a loan, for example.

“Don't allow their system to come into force,” Yeadon says. “It's going to be used to coerce you. I believe if you allow a vaccine passport to come into force, you'll be pinged one day and it'll advise you to go to the medical center to have your top-up vaccine.

If you choose not to get your vaccine, your passport validity will expire, which means you won't be able to enter a shop. You may not be able to use your bank card. All somebody needs to do is set a rule that says ‘After a given a date, before any bank card can be used, a vaccine passport has to be [validated] …

I'm absolutely terrified that the combination of vaccine passports and top-up vaccines is going to lead to mass depopulation, deliberate execution, potentially of billions of people.

You can stop it once you've heard what I'm saying. Even if you like the idea of vaccine passports, put the thing in place using written records or something … but do not allow it to be on an interoperable global fixed-format database, because that will be the end of human freedoms. And I just see no way of recovering from that.”

Source : Mercola More   

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NAC Banned From Amazon, FDA Says It's Medication

N-acetylcysteine (NAC) has made the news, not because scientists discovered a new health benefit, but because the U.S. Food and Drug Administration decided after 57 years of over-the-counter sales the compound is now a medication that requires a physician’s prescription. Like ibuprofen (Advil)1 and acetaminophen (Tylenol),2 NAC has been available both over the counter and in prescription form.3 Doctors prescribe ibuprofen, acetaminophen and NAC in the hospital for specific uses. Historically, people could purchase all three over the counter. Recently, the FDA decided that, unlike ibuprofen and acetaminophen, NAC should be removed from public sale. NAC is an antioxidant compound made up of three amino acids — glutamic acid, glycine and cysteine.4 However, N-acetylcysteine is available only in supplement form and cannot be found as such in foods. But the precursors to NAC can be found in foods high in cysteine, including pork, beef, chicken, eggs, swiss cheese and sunflower seeds.5 NAC is valued as a precursor to glutathione, also called the “master antioxidant.”6 NAC is useful in the treatment of acetaminophen poisoning, helping to lower the risk of mortality and liver damage. Despite a long history of concurrent use as an over-the-counter supplement and prescription medication in the hospital, the FDA has not been interested in removing the status as a dietary supplement — not, that is, until recently when NAC showed promise in the fight against COVID-19.7 FDA Invokes a Legally Questionable Drug Exclusion Provision The law defines dietary supplements specifically. In the U.S. code Title 21,8 the law uses specific definitions of what a dietary supplement is and is not. According to experts, the actions of the FDA in banning the sale of NAC and finding it a “medication” is illegal under the law. Attorney Dan Soper9 writes that under Title 21 §321 paragraph (ff)(3)(b)10 the actions of the FDA do not meet the Drug Exclusion Provision. In the code, it defines what a dietary supplement is not. Specifically, it says that a dietary supplement (article) does not include: An article approved as a new drug, certified as an antibiotic, or licensed as a biologic under specific sections of the title. An article authorized for investigation as a new drug, antibiotic or biologic for which there have been substantial clinical trials and for which the existence of all of these investigations has been made public. In addition, the article was not before approved, certified, licensed or authorized, marketed as a dietary supplement or as a food “unless the Secretary, in the Secretary’s discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under this chapter.” According to Soper,11 the exclusion provision has only been invoked a few times, specifically when used to keep red yeast rice, vitamin B6 and cannabidiol (CBD) from being sold as supplements. In each of these cases there was a potential pharmaceutical financial loss that triggered the assertion the supplement was illegal. In the case of red yeast rice, it contains a naturally occurring substance that acts in a similar manner to Lovastatin, a statin medication.12 In 2005, drug manufacturer Biostratum filed an investigational new drug (IND) application with the FDA to use vitamin B6 in the treatment of diabetic kidney disease. Their argument was there was “no evidence that it was marketed as a dietary supplement or food prior to its IND and Phase II investigations.”13 In 2009 the FDA declared vitamin B6 was not a dietary supplement despite documentation that it had been sold as such before the IND application. The FDA has also invoked the Drug Exclusion Provision against CBD, warning that it is not a legal dietary supplement since there was no meaningful evidence it was marketed as such before drug investigations were approved for Sativex and Epidiolex, which are drugs that contain CBD. After the 2018 Farm Bill was signed legalizing hemp, then-FDA secretary Scott Gottlieb made the statement that it was illegal to introduce CBD into the food supply or market it as a supplement.14 Soper postulates15 that the use of the Drug Exclusion Provision against CBD may have opened the door for the FDA to use it against NAC. Others Hold the FDA Is Using a ‘Legally Invalid’ Position In 1994, Congress enacted the Dietary Supplement Health and Education Act (DSHEA).16 This gave the FDA regulatory authority and enforcement tools to protect consumers. The Council for Responsible Nutrition (CRN) supports enforcement of the law,17 but the recent FDA move against NAC appears to step well beyond the letter and intent of the Act. December 4, 2020, the CRN wrote an open letter18 to Steve Tave, director of the FDA’s office of dietary supplement programs, and sent a copy to Douglas Stearn, deputy director for regulatory affairs. In the eight-page letter, the CRN outlined why they believe the positio

NAC Banned From Amazon, FDA Says It's Medication

N-acetylcysteine (NAC) has made the news, not because scientists discovered a new health benefit, but because the U.S. Food and Drug Administration decided after 57 years of over-the-counter sales the compound is now a medication that requires a physician’s prescription.

Like ibuprofen (Advil)1 and acetaminophen (Tylenol),2 NAC has been available both over the counter and in prescription form.3 Doctors prescribe ibuprofen, acetaminophen and NAC in the hospital for specific uses. Historically, people could purchase all three over the counter.

Recently, the FDA decided that, unlike ibuprofen and acetaminophen, NAC should be removed from public sale. NAC is an antioxidant compound made up of three amino acids — glutamic acid, glycine and cysteine.4

However, N-acetylcysteine is available only in supplement form and cannot be found as such in foods. But the precursors to NAC can be found in foods high in cysteine, including pork, beef, chicken, eggs, swiss cheese and sunflower seeds.5 NAC is valued as a precursor to glutathione, also called the “master antioxidant.”6

NAC is useful in the treatment of acetaminophen poisoning, helping to lower the risk of mortality and liver damage. Despite a long history of concurrent use as an over-the-counter supplement and prescription medication in the hospital, the FDA has not been interested in removing the status as a dietary supplement — not, that is, until recently when NAC showed promise in the fight against COVID-19.7

FDA Invokes a Legally Questionable Drug Exclusion Provision

The law defines dietary supplements specifically. In the U.S. code Title 21,8 the law uses specific definitions of what a dietary supplement is and is not. According to experts, the actions of the FDA in banning the sale of NAC and finding it a “medication” is illegal under the law.

Attorney Dan Soper9 writes that under Title 21 §321 paragraph (ff)(3)(b)10 the actions of the FDA do not meet the Drug Exclusion Provision. In the code, it defines what a dietary supplement is not. Specifically, it says that a dietary supplement (article) does not include:

  • An article approved as a new drug, certified as an antibiotic, or licensed as a biologic under specific sections of the title.
  • An article authorized for investigation as a new drug, antibiotic or biologic for which there have been substantial clinical trials and for which the existence of all of these investigations has been made public.

In addition, the article was not before approved, certified, licensed or authorized, marketed as a dietary supplement or as a food “unless the Secretary, in the Secretary’s discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under this chapter.”

According to Soper,11 the exclusion provision has only been invoked a few times, specifically when used to keep red yeast rice, vitamin B6 and cannabidiol (CBD) from being sold as supplements. In each of these cases there was a potential pharmaceutical financial loss that triggered the assertion the supplement was illegal.

In the case of red yeast rice, it contains a naturally occurring substance that acts in a similar manner to Lovastatin, a statin medication.12 In 2005, drug manufacturer Biostratum filed an investigational new drug (IND) application with the FDA to use vitamin B6 in the treatment of diabetic kidney disease.

Their argument was there was “no evidence that it was marketed as a dietary supplement or food prior to its IND and Phase II investigations.”13 In 2009 the FDA declared vitamin B6 was not a dietary supplement despite documentation that it had been sold as such before the IND application.

The FDA has also invoked the Drug Exclusion Provision against CBD, warning that it is not a legal dietary supplement since there was no meaningful evidence it was marketed as such before drug investigations were approved for Sativex and Epidiolex, which are drugs that contain CBD.

After the 2018 Farm Bill was signed legalizing hemp, then-FDA secretary Scott Gottlieb made the statement that it was illegal to introduce CBD into the food supply or market it as a supplement.14 Soper postulates15 that the use of the Drug Exclusion Provision against CBD may have opened the door for the FDA to use it against NAC.

Others Hold the FDA Is Using a ‘Legally Invalid’ Position

In 1994, Congress enacted the Dietary Supplement Health and Education Act (DSHEA).16 This gave the FDA regulatory authority and enforcement tools to protect consumers. The Council for Responsible Nutrition (CRN) supports enforcement of the law,17 but the recent FDA move against NAC appears to step well beyond the letter and intent of the Act.

December 4, 2020, the CRN wrote an open letter18 to Steve Tave, director of the FDA’s office of dietary supplement programs, and sent a copy to Douglas Stearn, deputy director for regulatory affairs. In the eight-page letter, the CRN outlined why they believe the position the FDA has taken is “legally invalid.”19

In December 2020, a journalist from Natural Products Insider20 outlined the arguments CRN used in their letter to Tave, stating why the FDA’s actions were not legally defensible. The points the CRN made included:

Through a Freedom of Information Act request, CRN learned the FDA's claim that NAC had been approved as a drug in 1963 was nothing more than a handwritten notation. The CRN notes this raises questions about the reliability of the record, true approval date and who made the notation.

The 1963 handwritten notation was for an inhalation drug. However, the code clearly states the chemical cannot be called a dietary supplement if the "article" is the same as the drug. In this case, the FDA is asserting an inhaled drug is the same as an oral supplement. Steve Mister, president and CEO, and Megan Olsen, CRN associate general counsel, wrote:21

"Further, a dietary supplement, by definition, must be “a product that ... is intended for ingestion.” Because of this limitation, a dietary supplement would, by its very nature, differ significantly in the route of administration and dosage form from an inhaled drug.

Such significant differences, which will affect a substance’s impact on the human body, must preclude an inhaled ingredient from being considered the same “article” as an orally ingested ingredient."

The CRN found records to suggest that NAC was not approved for drug use until 2016, "well after dietary supplement companies had been marketing NAC as a supplement."22

The FDA's interpretation of the law also conflicts with “the presumption against statutory retroactivity,” which Mister and Olsen go on to say, "Even if FDA records reliably demonstrated drug approval before 201(ff)(3)(B)(i) was enacted, it is a well-established canon of statutory interpretation that legislation shall not be read to have a retroactive effect on private rights unless Congress expresses a clear, unambiguous intent to the contrary."23

The CRN also argues that the FDA failed to explain the policy change before sending warning letters to several NAC manufacturers in July 2020. Mister and Olsen wrote:24

“In response to the extensive history of NAC being treated by FDA as a dietary supplement, manufacturers have invested substantial resources to develop hundreds of such products, and thousands of consumers have come to rely on such products to meet their daily nutritional needs.

Now, FDA has decided to not only change its decades-long policy, but to do so through the issuance of warning letters that fail to provide any reasonable explanation for this consequential policy shift.”

Lastly, the CRN maintains the FDA cannot enforce the policy because they exhibited a lack of diligence, writing:25

"First, FDA’s decades-long delay in bringing enforcement action against manufacturers of dietary supplements containing NAC indisputably resulted from a lack of diligence by FDA, rather than an unawareness that these products were on the market.

In fact, there is ample evidence that FDA has long been aware that these products are on the market, and that FDA has actively considered — and failed to object to — structure/function and qualified health claim petitions regarding products containing NAC. Thus, FDA’s long-delayed enforcement against these products resulted from the Agency’s own lack of diligence."

In an email to Natural Products Insider, Mister said:26

“CRN is firmly committed to protecting our members’ interest in this matter to sell a lawful ingredient. FDA’s warning letters on NAC issued earlier this year are not final agency actions, but rather should be viewed as the opening salvo, inviting those with sound legal arguments to respond and present an opposing point of view, which we are doing.

CRN is optimistic that FDA will closely consider the legal argumentation we have laid out and evaluate its initial position regarding NAC in light of these arguments.”

Why Is the FDA Taking Aim at NAC?

Using the Drug Exclusion Provision on CBD may have opened the door for the FDA to make similar claims against NAC, but there is still the question of timing. Why has the FDA chosen to target NAC now? In the past the provision was used inappropriately in three instances to protect the finances of pharmaceutical companies, and it is likely the motivation to ban NAC as a supplement has the same roots.

As pulmonologist Dr. Roger Seheult succinctly explains in this MedCram video, NAC is a crucial chemical compound necessary to reduce the oxidative stress associated with severe COVID-19 infections and thus may significantly impact the sales of antiviral drugs. And, without severe disease, is there truly a need for a vaccine?

Nine months after the FDA issued warning letters with their position that NAC supplements could not legally be sold, Amazon began removing products containing the supplement.27 In 2020, Amazon adopted polices to improve the quality of the supplements sold on their platform after knock-off dietary supplements were found28 and NOW Health Group identified inferior quality supplements from third-party lab tests.29

Amazon did not respond to Natural Products Insider30 to explain why the products were being removed from the platform. One long-time public relations professional in the industry postulated it may have been a result of significant turnover in Amazon's regulatory staff that prompted the move if the new staff believed selling NAC made the company vulnerable.

More Health Benefits of N-acetylcysteine

NAC supplements are well absorbed and can effectively increase levels of glutathione in the body.31Glutathione deficiency is a key contributor to oxidative stress.32 In turn, oxidative stress contributes to the pathogenesis of several diseases such as liver disease, Alzheimer's disease, Parkinson's disease, cancer, heart attack and diabetes.

NAC contributes cysteine, which one study33 found is inversely associated with the risk of stroke in women. Two papers34,35 concluded that NAC shows promise in the treatment of psychiatric conditions, including addiction, compulsive disorders, schizophrenia and bipolar disorder. The treatment may benefit those whose condition has not responded to drugs and medication.

One team of scientists36 presented a review on different applications NAC may have in a variety of health conditions. This includes reducing insulin resistance and providing a therapeutic approach in the treatment of polycystic ovary syndrome.

Based on evidence, they hypothesized that NAC may reduce the number of premature births and recurrent pregnancy losses by exerting an anti-inflammatory effect in women who have bacterial vaginosis, a risk factor of preterm delivery and low birth weight.

They found there were positive influences that NAC exerted in patients who have ulcerative colitis, including decreasing oxidative stress, lowering cell apoptosis and improving recovery in the colon. Lab studies and animal models have demonstrated NAC can protect normal cells from radiation therapy and chemotherapy but does not protect cancer cells.

NAC has preventive effects against airway hyperresponsiveness in animal studies using acute exacerbation of asthma. In their review, they found NAC was “safe and well tolerated” without considerable side effects.37

Source : Mercola More   

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