Effective Against COVID-19: FDA Wants to Ban Dietary Supplement NAC

NAC, short for N-acetylcysteine, is a dietary supplement that has been around for decades. People use it for various reasons, including enhancing athletic performance and treating chronic lung conditions. In 2004, the U.S. Food and Drug Administration (FDA) approved NAC to treat life-threatening liver side effects of acetaminophen overdose. In the fight against COVID-19, the supplement has been shown to have excellent potential as an effective treatment. With that in mind, though not the final word, the FDA recently reversed its longstanding position on NAC, postulating that it is a “medication,” therefore, it can not legally be marketed as a dietary supplement and should be removed from public sale.

For many years, NAC, which is turned into glutathione by the body when consumed, has been widely used as a standalone product in whole dietary supplements. The FDA’s Office of Dietary Supplement Program (ODSP), maintained by the National Institutes of Health (NIH), currently shows almost 1,500 products containing NAC. 

Currently, NAC is being studied as a treatment for COVID-19 in several actively recruiting clinical trials across the country. With the FDA alleging it first approved NAC as a drug on Sept. 14, 1963, the FDA is again going after NAC, claiming it does not qualify as a legal dietary supplement. The agency sent warning letters in July 2020 to seven companies selling products containing NAC, arguing that NAC couldn’t legally be sold in a dietary supplement because the ingredient was first approved as a drug (in 1963). Back in September, Dr. Anthony Fauci, skeptical about recommending any supplements for treating COVID-19, admitted he took supplemental vitamin D and C, adding, but “any of the other concoctions and herbs I would not do.”

In reaction to the FDA’s warning letters, the Council for Responsible Nutrition (CRN) sent a detailed letter to the FDA on Dec. 4, 2020, pleading with the Agency to reverse its invoked Drug Exclusion Provision in U.S. code Title 21 to ban the sale of NAC, thus prohibiting manufacturers from marketing products containing NAC as dietary supplements. Noting that thousands of consumers have come to rely on these products as a vital source of nutrients, the letter also calls into question information the CRN obtained through the FOIA, showing what appears to be a handwritten approval date of “1963,” raising several questions about the reliability of the approval date. The letter asserts:

This policy—which represents a sudden and drastic departure from past Agency practice—is legally invalid. As such, FDA should revert to its longstanding policy of allowing manufacturers to market products containing NAC as dietary supplements.

For decades, manufacturers have safely marketed products containing NAC as dietary supplements in the United States. There are currently hundreds of dietary supplements containing NAC on the market, and thousands of consumers have come to rely on these products as a crucial source of nutrients. And, until recently, FDA has consistently and affirmatively permitted manufacturers to market these products. In fact, FDA has considered over 100 structure-function claim notifications regarding NAC and at least one qualified health claim petition for a dietary supplement containing NAC and has not objected to the presence of NAC in any of these products.

Last month, according to several industry sources, Amazon began removing dietary supplement products from its platform that contain NAC (which has a long list of therapeutic uses), and a quick search seems to show that very few if any products remain today. Neil Levin, senior nutrition education manager for NOW, a leading dietary supplement company, recently spoke about NAC in an email:

“NAC is one of the supplements that have dual-use as drug and supplement, as do fish oil, niacin, potassium, etc., that also have prescription forms. Just as not all niacin or fish oil products are sold by prescription, not all NAC is, either. And we don’t make drug claims that would warrant calling our products’ drugs.’”

The National Institutes of Health (NIH) published a study in January 2011 examining NAC’s role in treating addictive behavior. The study concluding that multi-purpose medical and dietary NAC—the supplemental form of L-cysteine, which is a semi-essential amino acid present in our bodies—plays a prominent metabolic role in the body’s overall antioxidant activities by controlling the glutamatergic system (i.e., the regulation of reward, reinforcement, and relapse). The research found NAC quite promising, concluding, “At present, NAC appears to be a compound worth watching—one that may, in the future, play a valuable role in both psychiatric and medical settings.” Labeling NAC as a “safely used supplement,” the decades-old study indicated:

In addition to prescription availability, NAC is commercially accessible as an over-the-counter product and has been safely used as a supplement in humans for years (NAC is relatively rare in food). Commercial NAC is available in 500-mg tablets and capsules, 600-mg tablets and capsules, 750-mg capsules, and 1000-mg tablets.

An article out today by PRN, titled “The FDA, Shock Troops for the Pharmaceutical Industrial Complex,” calls into question the notion that individuals who have been fully vaccinated against COVID-19 are protected and touches on the multiple instances where the FDA has attempted to ban effective natural supplements, including curcumin, boswellia and aloe vera from pharmacologic compounding, and now they are striving to do the same to NAC.

While it is unclear if other offices or agencies within the FDA are involved in the evaluation process surrounding NAC (which has been researched by Dr. Fauci as a treatment for HIV) and its potential complete removal as a dietary supplement, on May 10, Cara Welch, Ph.D., Acting Director of the FDA’s ODSP, replied to CRN’s letter stating the Agency is “closely reviewing the information provided in your letter and will provide a more substantive response once our evaluation is complete.” 

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GOP Chair Elise Stefanik: Justice Department Is “Trying To Block” Maricopa County Audit

GOP Chair Elise Stefanik: Justice Department Is "Trying To Block" Maricopa County Audit

Authored by Jack Phillips via The Epoch Times,

Rep. Elise Stefanik (R-N.Y.), who was recently elected as the House Republican Conference chair, said the Department of Justice’s questions about the Maricopa County, Arizona, audit of the 2020 election may be unconstitutional.

On May 5, the Justice Department sent a letter to Arizona Senate leader Karen Fann, a Republican, inquiring about the custody of the ballots under review by a group of private contractors, alleging that the group’s other processes—including the canvassing of addresses—could be considered “voter intimidation.”

“I support that audit,” Stefanik said after being asked about it in a Fox Business interview on May 16.

Transparency is good for the American people. And again, this should be a nonpartisan issue, whether you are Republican, Democrat, independent, or conservative, transparency is important, and the audit was passed by the Arizona state Senate.”

Stefanik later said that the “Biden Department of Justice is trying to block that audit,” which, she said, “is unconstitutional from my perspective.”

“Our states, constitutionally, are responsible for writing states’ constitution law,” she said.

Pamela Karlan, principal deputy assistant attorney general with the Justice Department’s Civil Rights Division, wrote to Fann that “the proposed work of the audit raises concerns regarding potential intimidation of voters.”

Fann replied that the plan by election auditors to verify the validity of certain voters had been placed on hold.

“If and to the extent the Senate subsequently decides that canvassing is necessary to the successful completion of the audit, its vendor will implement detailed requirements to ensure that the canvassing is conducted in a manner that complies fully with the commands of the United States Constitution and federal and state civil rights laws,” Fann wrote earlier this month.

Stefanik’s comments on May 16 came just days after Dominion Voting Systems and Maricopa County officials said they wouldn’t provide passwords for election machines in Maricopa County. Dominion said it would comply with the audit, but that Cyber Ninjas – the company hired by the Arizona state Senate – isn’t accredited by the U.S. Election Assistance Commission.

The Department of Justice didn’t respond to a request for comment by press time.

Stefanik was approved last week in a vote by House Republicans to become the Republican Conference chair—the party’s No. 3 position in the House. She took over after GOP lawmakers voted to remove Rep. Liz Cheney (R-Wyo.), a frequent critic of former President Donald Trump, from the position.

Stefanik received support from Trump as well as other House GOP leaders.

Tyler Durden
Mon, 05/17/2021 – 18:50

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BREAKING EXCLUSIVE: TGP Reporter Confronts Soros-Backed Maricopa County Sheriff After His Meltdown Over Router Request (VIDEO)

TGP Contributor Jordan Conradson is live in Phoenix, Arizona

The Sheriff of Maricopa County, Paul Penzone (D), has been in the news lately for going ballistic when the auditors from the 2020 Election in the County asked for access to the County’s routers.  TGP contributor Jordan Conradson asked him about this and more today.

We reported last week that the Cyber Ninjas asked for access to the County’s routers so they could identify any curious transmissions recorded on these routers during the 2020 election and counting process.  The County refused to comply with this request:

IT EXPERT: Maricopa County Officials Refuse to Provide Routers and Passwords to Senate Auditors – They Don’t Want Public to Know Where Data Was Sent and When It Was Sent

The County claimed that there was personal data that was maintained in these files (which was not true since routers do not record the content of what is being transferred but rather the times and transfer points of data transfers).

We noted in the response to the request from the auditors, the Sheriff of Maricopa County, Paul Penzone, was cc’d in the letter.  He is probably better known for the $2 million in support from George Soros in 2016 in the Deep State’s effort to see Sheriff Joe lose for the first time in seven elections. This was reported in Arizona at the time:

When Paul Penzone ran for Maricopa County sheriff in 2016, he famously received a $2 million contribution from billionaire George Soros — the liberal philanthropist’s single biggest investment in a local race that year.

Apparently, when notified of the auditors’ requests, the Sheriff had a meltdown:

Sheriff Paul Penzone (D) said in a statement that providing router information to a shadowy private company led by a conspiracy-embracing CEO would compromise sensitive and highly classified law enforcement data and equipment.

“The Senate Republican Caucus’ audit of the Maricopa County votes from last November’s election has no stopping point,” Penzone said. “Now, its most recent demands jeopardize the entire mission of the Maricopa County Sheriff’s Office.”

It’s difficult to see how the request for router access for review would ‘jeopardize the entire mission of the Maricopa County Sheriff’s Office.”  This sounds like an overreaction or the Sheriff’s Department has a mission that he doesn’t want in the open.

This is where Conradson comes in.  When he noticed the Sheriff departing the building he decided to ask him a few very good questions.

The Sheriff was not prepared for this and looked very weak walking away from the brave reporter.

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‘May God Help Us’: Ontario Christians Pray For Police As They Kick Them Out Of Church, Lock Doors

A group of Christians in Aylmer, Ontario, were forced to worship outside Sunday after police seized their building during a worship service, evicted them, and locked the doors last week.

Pastor Henry Hildebrandt of the Church of God in southwestern Ontario, most of whose congregants come from the Mennonite tradition, preached an open-air service after Ontario Superior Court Justice Bruce Thomas ordered their church facility locked until the provincial gathering limit for indoor church services increases to 30% capacity or more, according to CBC News.

Under Ontario’s shutdown order, both indoor and outdoor religious gatherings are capped at 10 people.

In addition to having their church shut down, Hildebrandt, assistant pastor Peter Wall, and the church face $117,000 in fines and legal fees.

Thomas alleged that the small congregation’s insistence at holding church services had destroyed the tranquility of the town. “This whole thing has turned one small community in Ontario into a cauldron of hostility, one that has pitted neighbour against neighbour. I am deeply concerned about the toxic environment in Aylmer,” Thomas said during a virtual court hearing last Thursday.

“This congregation and these people, although different than the mainstream population of southwestern Ontario, were living in peace and tranquility in this community in the past. Now, I see a splintered community, a fractious community,” he added.

WATCH:

According to video, police officers interrupted the church’s worship service last Friday while congregants sang hymns. As the armed officers entered the sanctuary to order them to vacate, Hildebrandt read from the third chapter of the Book of Daniel, which recounts how Daniel and two of his friends were thrown into a fiery furnace for refusing to worship the king of Babylon.

Hildebrandt and the congregation then prayed for the souls of the police, asking God to forgive them “for they know not what they are doing.”

“Very, very sad day in Canada, to see this actually happening,” Hildebrandt told the camera as congregants shuffled out. “But they’re telling me they have to do their job, so we will have to leave it at that at this point. But we know that God is in control. We know that God is on his throne and that God knows exactly what is happening. We’re looking to the Lord to help us as we faithfully serve him continually.”

“This is what happens when we let our freedoms slide,” he went on, urging Canadians to repent. “This is what happens when we are not vigilant. This is where, so fast, a country can slide down into what we’re seeing here today. But God help us that we would wake up quick.”

Hildebrandt also later preached to the media and police outside who had cut off the surrounding roads, urging them to do the right thing.

As CBC News reported:

Police gathered evidence that will be submitted to the court, [Aylmer Police Chief Zvonko] Horvat said, adding more charges are expected under the Reopening Ontario Act. 

“We’re doing everything that is within our power to shut [Hildebrandt] down,” he said.

“We are working with the Attorney General’s office on that particular topic and with their assistance and the court processes. That’s what our options are and that’s what we’re going to continue to pursue.”

“It’s not a simple matter of just going in and removing everybody,” Horvat added. 

Lisa Bildy, a lawyer with the Justice Centre for Constitutional Freedoms, which is a nonprofit law firm representing the church, said, “Locking the doors of churches in Canada is a poignant symbol of our democracy under threat. This was two weeks to flatten the curve and has become 60 weeks and counting. No outbreaks have been traced to the church… I don’t think we should be locking church doors in this country. Church is fundamental to these people.”

“Another sad day in Canadian history,” Hildebrandt tweeted after the incident. “This afternoon we (the congregation of the Church of God at Aylmer) were ordered to vacate the building where we have met for decades to worship our Lord. To God be the glory, He is worthy of all our praise.”

Canadian MP Derek Sloan, who has publicly supported other pastors in Canada who have been punished for holding church services, condemned the treatment of Hildebrandt’s church, writing, “Police have come to the Church of God in Aylmer, forced the congregants to leave, and seized the church. We are all less free because of this despicable abuse of power. As [Hildebrandt] says, this is a very sad day for Canada.”

Related: Can Religious Liberty Survive COVID-19?

Related: WATCH: Jailed Alberta Pastor Released On Bail; Recounts Harsh Imprisonment And Blasts ‘Evil’ Canadian Politicians

Related: ‘Nazi Cowards’: Calgary Police Arrest Polish Pastor Who Refused To Allow Police, Health Officials To Disrupt Service

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YouTube Removes Video of Legal Scholar Defending Israeli Airstrikes

An Israeli legal scholar’s argument about the legality of Israeli airstrikes was temporarily removed from YouTube on Monday for violating unspecified "content guidelines."

Eugene Kontorovich, a professor at George Mason University, appeared on RT to explain why Israel’s counterstrikes in Gaza are protected by international law. YouTube removed a video of his appearance because it violated the company’s terms of service. It later reversed the decision and restored the video without an explanation for why the initial action was taken. Kontorovich believes the video was down for 24 hours.

The move continues a pattern of capricious moderation of content related to Israel from social media platforms. In April, the Chinese-owned platform TikTok hosted a series of viral videos of Arabs assaulting Orthodox Jews.

Although it was unclear at press time what rule YouTube cited in removing the video, the company says it removes "content promoting violence or hatred" against a number of groups, including "victims of a major violent event and their kin."

Kontorovich told the Washington Free Beacon he was surprised that YouTube would delete what he believed was "a completely calm, professional, academic discussion of international law."

A YouTube spokeswoman said, "After review by our teams, we determined the video does not violate our Community Guidelines and it’s now available on YouTube." YouTube did not respond to requests for comment on why the video had been taken down.

According to Kontorovich, restoring the video was not enough to combat what he sees as a battle for public opinion of Israel amid this ongoing conflict. Kontorovich told the Free Beacon that there’s "a major campaign to portray" Israeli defense efforts "as illegal and in violation of the laws of war," and that silencing arguments like his are "constraining Israel’s ability to defend itself from Hamas."

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Supreme Court Unanimously Agrees: Police Illegally Seized A Man’s Firearms In Violation Of The 4th Amendment

The Supreme Court on Monday ruled unanimously that police illegally seized a Rhode Island man’s firearms in violation of his Fourth Amendment rights. The SCOTUS decision overturned a 1st Circuit Court ruling that said police officers in the case were well within their right to confiscate the man’s firearms.

Police responded to a domestic violence call in 2015, at which point Edward Caniglia’s wife believed he was suicidal. He brought out a handgun, put it on the table, and instructed his wife to “shoot [him] and get it over with.” She ended up leaving for the night but had police conduct a welfare check after she failed to reach him, court documents explain.

When police arrived, Caniglia was sitting on the porch. He agreed to undergo a psychiatric evaluation under the condition that his firearms would not be seized. He was taken to a nearby hospital for evaluation, at which point police entered his home and confiscated two of his firearms. Caniglia’s firearms were confiscated without a warrant because he was deemed a threat to himself and others, police said.

Caniglia sued saying his Fourth Amendment rights were violated. Both the federal court and the 1st Circuit Court of Appeals stated the police were well within their rights. They cited the “community caretaking exception,” which was established in the Cady v Dombrowski case. In that case, “an officer took a gun out of an impounded car without a warrant. The Supreme Court ruled at the time that police can conduct such warrantless searches if they are performing ‘community caretaking functions’ in a ‘reasonable’ manner,” TIME reported.

According to the Supreme Court, the Cady case is irrelevant to the Caniglia case and “is not an open-ended license to perform [the community caretaking functions] anywhere, as Justice Clarence Thomas explained the Court’s view in the opinion:

Neither the holding nor logic of Cady justifies such warrantless searches and seizures in the home. Cady held that a warrantless search of an impounded vehicle for an unsecured firearm did not violate the Fourth Amendment. In reaching this conclusion, the Court noted that the officers who patrol the “public highways” are often called to discharge noncriminal “community caretaking functions,” such as responding to disabled vehicles or investigating accidents. But searches of vehicles and homes are constitutionally different, as the Cady opinion repeatedly stressed. The very core of the Fourth Amendment’s guarantee is the right of a person to retreat into his or her home and “there be free from unreasonable governmental intrusion.”  A recognition of the existence of “community caretaking” tasks, like rendering aid to motorists in disabled vehicles, is not an open-ended license to perform them anywhere.

The American Civil Liberties Union (ALCU), the American Conservative Union (ACU), and the Cato Institute filed a joint amicus curiae brief in the case, arguing against the Cady application in the case.

“The Fourth Amendment does not permit such a freewheeling balancing inquiry when it comes to searches of homes,” the joint brief explained. “… Given the capacious array of activities that could be called “community caretaking,” it is hardly surprising that courts have relied on it to uphold warrantless entries based on a wide variety of police actions.”

Other organizations that filed amicus curiae briefs include the Institute for Justice, National Association of Criminal Defense Lawyers, Firearms Police Coalition, American Association of Suicidology, The Rutherford Institute, Gun Owners of America, Second Amendment Foundation, Pacific Legal Foundation, and the Constitutional Accountability Center.

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‘THIS IS NOT A DRILL’: Activists FREAK as SCOTUS Takes Case That Could Overturn Roe v. Wade

The United States Supreme Court just announced that it will take up a Mississippi abortion case that could potentially affect the so-called right to abortion in the entire country and blue checks on Twitter are giving their doom and gloom responses.
SCOTUS announced on May 17 that it would provide a ruling on a controversial abortion ban from the state of Mississippi and hear the case next fall. The Mississippi law – passed in 2018 but blocked by lower courts – banned all abortions after 15 weeks of pregnancy.
LifeSiteNews summed up the threat to Roe, writing that SCOTUS is now set to hear the case “which challenges the ‘viability’ threshold of current legal precedent and therefore sets the stage for a decision that will either uphold, overturn, or modify Roe v. Wade.” The Fifth Circuit Court of Appeals ruled against the Mississippi ban (prompting the SCOTUS ruling), citing that the 15-week-ban violates legal precedent that abortions cannot be banned before the unborn baby is viable, which is around 22 to 24 weeks. That precedent, according to the circuit court, traces “an unbroken line dating to Roe v. Wade.” If SCOTUS sides with Mississippi’s ban, then Roe v. Wade would be in the crosshairs.
Again, the idea that a chunk could be taken out of the federal right to kill their preborn offspring put leftists on Twitter into a state of panic. Ilyse Hogue, the president of America’s largest abortion lobby, NARAL, tweeted that this was the culmination of devious GOP pro-life designs, something leftists were desperate about in their disgusting protest of Justice Brett Kavanaugh’s appointment. 
Hogue tweeted, “Never forget that McConnell and others mocked us and gaslit us through the Kavanaugh fight for claiming that legal abortion was in jeopardy. They knew. They lied. We knew. We fought. And we’re so far from done fighting.” Of course, we all knew why leftists went scorched earth in their defaming of Kavanaugh, to prevent a conservative SCOTUS from hearing a case like this. 
Breaking: #SCOTUS to hear direct challenge to Roe v. Wade. Never forget that McConnell and others mocked us and gaslit us through the Kavanaugh fight for claiming that legal abortion was in jeopardy. They knew. They lied. We knew. We fought. And we’re so far from done fighting.
— Ilyse Hogue (@ilyseh) May 17, 2021
The ACLU appeared panicked in response to the news. From its official Twitter account the far leftist activist organization tweeted, “this is the moment anti-abortion politicians have been waiting for since Roe v. Wade was decided: The Supreme Court just announced that it will hear a case that could decimate the constitutional right to abortion.” If pro-baby killers weren’t alarmed before that tweet, they are now. 
This is the moment anti-abortion politicians have been waiting for since Roe v. Wade was decided: The Supreme Court just announced that it will hear a case that could decimate the constitutional right to abortion. https://t.co/Ksmq2hPF6o
— ACLU (@ACLU) May 17, 2021
New York Times contributor and feminist author Amber Tamblyn spread fear on social media as well, tweeting, “This is not a drill. The path to overturning Roe Vs. Wade is this one. Support organizations like @NARAL today. Give your money, give your time, give your attention. Spread the damn word.”
This is not a drill. The path to overturning Roe Vs. Wade is this one. Support organizations like @NARAL today. Give your money, give your time, give your attention. Spread the damn word.
Donate now:https://t.co/466IJzWwIv https://t.co/HHUjTjgrdD
— Amber Tamblyn (@ambertamblyn) May 17, 2021
And far left gay actor George Takei tweeted, "Incredibly concerning. With the stacked Trump court, reproductive rights are under threat as never before."
Incredibly concerning. With the stacked Trump court, reproductive rights are under threat as never before.
My friends at @VoteChoice work tirelessly to elect pro-choice leaders, which is one way we can and must fight back. I hope you’ll join the fight by giving them a follow. https://t.co/ZAcqoxSE3M
— George Takei (@GeorgeTakei) May 17, 2021
Yeah, so are unborn babies, Mr. Takei, and, God willing. SCOTUS will think of them in the upcoming ruling.

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Mark Levin warns: Here’s why we can’t let Democrats cut off US aid to Israel

As Hamas ruthlessly targets Israel’s major population centers with a hailstorm of rockets, the world is witnessing a military miracle: Israel’s anti-missile system known as the Iron Dome.

On "LevinTV" this week, Mark Levin shared a little-known story of the Iron Dome’s development, from Ronald Reagan’s Strategic Defense Initiative to the Patriot Missile System.

Co-developed by Israel and the U.S., Israel has created a defensive masterpiece, but as Levin warned, there are those within the Democrat Party that seek to cut off the aid to Israel necessary to continue development of these defensive systems.

Watch the video below for more from Mark Levin:

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Supreme Court Unanimously Rules Against Cops Seizing Guns Without a Warrant

The Supreme Court secured a major victory for gun rights Monday as it unanimously ruled that seizing firearms while someone is being monitored for suicide is unconstitutional. The case centered […]

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