FDA Presses Forward on Anti-Aging Supplement Ban

In a letter recently made public on the federal docket, the FDA has restated the position it announced in October 2022 that NMN does not meet the definition of a dietary supplement because, in the agency’s view, it was studied as a drug before it was ever sold in or as a supplement. The FDA is clearly gearing up for a ban of this critical anti-aging supplement. We need a strong, sustained grassroots response from the natural health community to protect access to this supplement; we also need to support changes in this law that threatens many other natural compounds from being turned into drugs.

The letter, dated January 23, 2023 but made public on March 29, 2023, is in response to a “new dietary ingredient” notification filed by Effepharm, Ltd., in November 2022 with additional information submitted in January 2023. The letter reiterates the FDA’s position that NMN is not a legal supplement due to the back-channel at the FDA that we’ve described many times before.

For supplements that are considered “new” under the law—that is, they weren’t sold “in or as a supplement” before 1994—companies must submit a notification to the FDA with studies to prove that it is safe before that ingredient can be marketed—this is referred to as a “new dietary ingredient” (NDI) notification. But here’s the issue: if a drug company files an investigational new drug application (IND) and studies that ingredient before the FDA receives an NDI notification on it from a supplement company, it can no longer be sold as a supplement.

This back-channel is threatening the existence of a number of important supplements. The pyridoxamine version of vitamin B6 was banned through this mechanism; CBD and NAC are also in jeopardy due to this loophole. We’ve explained previously that this provision inherently favors drug companies. IND applications are confidential. A drug company can file an IND on an ingredient and sit on it for years. Meanwhile, an innovative supplement company could develop that nutrient into a great product, do the studies to comply with the FDA’s ridiculous notification process, and then create a market for that product—and then the drug company can swoop in with their IND, kick the supplements out of the market, and create a monopoly. 

Last month, ANH-USA filed a Citizen’s Petition with our allies, the Natural Products Association, calling for the FDA to issue a regulation stating that NMN is a lawful dietary supplement. You can read our previous coverage for more detail on the arguments contained in that submission.

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The EARN IT Act, an attack on encrypted communications, to be reintroduced next week

Those behind the Eliminating Abusive and Rampant Neglect of Interactive Technologies (EARN IT) Act must be hoping that third time’s a charm for this previously widely-opposed piece of legislation, that is set to be reintroduced next week.

The previous two attempts to make EARN IT into law failed amid outcry from opponents who said that while designed to protect children, the bill would fail to do that – but would still damage online privacy.

Now here’s the third, bipartisan attempt sponsored by Republican Lindsey Graham and Democrat Richard Blumenthal to bring changes to the Communication Decency Act (CDA) Section 230.

Critics say that the amendment as envisaged by EARN IT would harm internet users by removing legal protections Section 230 gives tech companies for third party content.

The consequence would be those companies protecting themselves by engaging in (even more) censorship, and “working” with the government to this end – even more than we are aware they already do.

At the core of EARN IT is to target platforms for violations related to child sexual abuse material (CSAM) rules that exist at the federal and state level.

But allegedly, these platforms are reluctant to “moderate” i.e., censor content in a heavy-handed manner, and for that reason oppose the legislation.

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HOW CALIFORNIA COPS EXPLOIT LEGAL GRAY AREAS TO CONTINUE THEIR WAR ON CANNABIS

Years after legalization, the state’s growers say police are taking a “seize first, ask questions later” mentality toward marijuana enforcement, sometimes with heavily militarized operations that allegedly violate their rights.

Zeke Flatten was driving southbound on Highway 101 in Northern California in December 2017 when he was pulled over by an unmarked SUV with flashing emergency lights.

Two officers clad in green, military-style garb and bulletproof vests approached Flatten’s vehicle but didn’t identify themselves. After asking Flatten if he knew how fast he was going, one of the men told him they suspected he was transporting cannabis, according to court documents. Flatten was immediately suspicious.

“He never mentioned anything else about the reason, probable cause, why he stopped me,” Flatten said in an interview with The Appeal.

The officers were correct, however: Flatten, a film producer and former undercover cop who’d temporarily relocated to Northern California, had three pounds of marijuana, including a few rolled joints, in the car—worth over $3,000 at the time. Flatten says he was working on a number of cannabis-related projects and was driving to a lab to test the weed, which he’d hoped to sell legally.

Just over a year before the stop, California had voted to legalize the personal cultivation and possession of up to an ounce of marijuana with the passage of Proposition 64. Under the measure, possession of larger amounts of cannabis was reduced from a felony offense to a misdemeanor, punishable by up to six months of incarceration and a maximum $500 fine.

But marijuana remains illegal at the federal level, classified as a Schedule 1 substance alongside drugs like heroin, LSD, and MDMA, known as Ecstasy. When the officers identified themselves as members of the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), a federal agency, Flatten said he started to realize something was off.

“There’s no patches, there’s no badges, there’s no name tags,” Flatten said.

Flatten says he offered to show the officers his medical marijuana card, which should have allowed him to have the cannabis. But they didn’t want to look at the card. He figured if the agents believed the marijuana was illegal, they’d take it and provide him a receipt for the seizure, which would give him a chance to argue his case in court, Flatten said.

Instead, they proceeded to confiscate the cannabis from the back of Flatten’s car without running his name for warrants, or issuing a traffic ticket, court summons, or even documentation of the seizure, Flatten said. The officers did tell him that he might be getting a letter from the federal government. But he never did.

Flatten said he felt like he’d been robbed. He started looking for a lawyer, and a few days later, went to the Mendocino County Sheriff’s Department to report the incident. The next week, after returning to his home state of Texas, he made an official report at the FBI field office in San Antonio.

He would soon find out that the officers who seized his marijuana weren’t actually ATF agents. Flatten alleges one was a member of the sheriff’s department. The other was from the Rohnert Park Police Department, and has since been indicted on federal charges including extortion and conspiracy in connection with cannabis seizures.

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Trump Advocates Mass Incarceration, ‘Tent Cities’ To Address Homelessness

On April 18, former President Donald Trump posted a video on his Truth Social account titled “Homelessness Plan.” In it, Trump alleged that “the homeless, the drug-addicted, and the violent and dangerously deranged” had ruined America’s cities, “turn[ing] every park and sidewalk into a place for them to squat and do drugs.” He promised, “When I’m back in the White House, we will use every tool, lever, and authority” to “end the scourge of homelessness and make our cities clean and safe and beautiful once again.”

How would he accomplish this? “Working with states, we will ban urban camping wherever possible…. We will then open up large parcels of inexpensive land; bring in doctors, psychiatrists, social workers, and drug rehab specialists; and create tent cities where the homeless can be relocated and their problems identified.”

Treatment would be catered to individual need: “For those who have addictions, substance abuse, and common mental health problems, we will get them into treatment. And for those who are severely mentally ill and deeply disturbed, we will bring them back to mental institutions where they belong, with the goal of reintegrating them back into society once they are well enough to manage.”

Trump’s plan may sound magnanimous, but it’s anything but. First off, there’s no telling what such a plan, or for that matter any plan, would cost. Advocates often say that the Department of Housing and Urban Development (HUD) estimates $20 billion as the cost of ending homelessness in America. But that number was an informal, unverified estimate of the annual cost in 2012. And as Nan Roman, president and CEO of the National Alliance to End Homelessness, told VERIFY in 2021, “It’s not so difficult to figure out what it would cost to end homelessness for everyone who is homeless tonight…. The problem is that more people BECOME homeless every day because they don’t earn enough to pay for housing – we’re 7 million housing units short to meet the needs of low-income people.”

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Police Lied About Death of ‘Cop City’ Protester They Shot 57 Times

Medical examiner rules police shooting a homicide. Police say they were forced to shoot Manuel Esteban Paez Terán after the 26-year-old environmental protester—who went by the nickname Tortugita—shot at them first. But no gunpowder residue was found on Terán’s hands, Georgia’s DeKalb County Medical Examiner reported.

The office has ruled the death of Terán (who used they/them pronouns) a homicide.

Terán was part of a group protesting the building of the Atlanta Public Safety Training Center, a 265-acre property that opponents have nicknamed “Cop City.” The protesters were camped out on the property in January when state troopers showed up.

According to law enforcement officials, Terán shot at a state trooper, prompting police to respond with a barrage of gunfire.

“The individual who fired upon law enforcement and shot the trooper was killed in an exchange of gunfire,” Georgia Bureau of Investigation (GBI) Director Mike Register told the media in January. A GBI press release said officers “located a man inside a tent in the woods” and “gave verbal commands to the man who did not comply and shot a Georgia State Patrol Trooper. Other law enforcement officers returned fire, hitting the man.” The GBI also said that a handgun and shell casings had been found.

But an official autopsy report viewed by ABC News said there was no gunpowder on Terán’s hands. The report also revealed that they had been shot at least 57 times, suffering gunshot wounds to the head, chest, arms, hands, pelvis, thigh, buttocks, and abdomen.

“Collectively, the gunshots resulted in [Terán’s] death and therefore the cause of death is designated as multiple gunshot wounds,” states the report. “However, the gunshot wound to the head would have been fatal by itself as would have some of the other gunshots.”

An independent autopsy ordered by Terán’s family found they had their hands up when they were shot. The Dekalb County report said “there are too many variables with respect to movement of the decedent and the shooters to draw definitive conclusions concerning Mr. Teran’s body position.”

At the time of Terán’s killing, the media largely ran with the narrative supplied by the GBI.

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Biden Policies Could Spell the End of Freelance Contractors, Republicans Say

Republican members of Congress say President Joe Biden’s administration is waging war on independent contractors. Democrats counter that they are trying to ensure workers are not exploited and businesses compete on a level playing field.

Kim Kavin, a freelance writer from New Jersey, said this is not a partisan issue.

“Our members have voted for everybody from Bernie Sanders to Donald Trump,” Kavin told the Subcommittee on Workforce Protection of the House Committee on Education and the Workforce.

“All of us are in agreement on this.”

Kavin is one of five witnesses called before the committee for a hearing entitled “Examining Biden’s War on Independent Contractors.”

The hearing was called because the Biden administration is pushing a policy to deny Americans a fundamental right, according to Subcommittee Chairman Rep. Kevin Kiley (R-Calif.).

“Today’s hearing is about the right to earn a living. In a free society, few rights are as fundamental,” he said.

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Speak Your Truth: Don’t Let the Government Criminalize Free Speech

“If freedom of speech is taken away, then dumb and silent we may be led, like sheep to the slaughter.”—George Washington

What the police state wants is a silent, compliant, oblivious citizenry.

What the First Amendment affirms is an engaged citizenry that speaks truth to power using whatever peaceful means are available to us.

Speaking one’s truth doesn’t have to be the same for each person, and that truth doesn’t have to be palatable or pleasant or even factual.

We can be loud.

We can be obnoxious.

We can be politically incorrect.

We can be conspiratorial or mean or offensive.

We can be all these things because the First Amendment takes a broad, classically liberal approach to the free speech rights of the citizenry: in a nutshell, the government may not encroach or limit the citizenry’s right to freedom of religion, speech, press, assembly and protest.

This is why the First Amendment is so critical.

It gives the citizenry the right to speak freely, protest peacefully, expose government wrongdoing, and criticize the government without fear of retaliation, arrest or incarceration.

Nowhere in the First Amendment does it permit the government to limit speech in order to avoid causing offense, hurting someone’s feelings, safeguarding government secrets, protecting government officials, discouraging bullying, penalizing hateful ideas and actions, eliminating terrorism, combatting prejudice and intolerance, and the like.

When expressive activity crosses the line into violence, free speech protections end.

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Whistleblowers: Trying Hard Not to Adjust to a Sick Society

“It is no measure of health to be well adjusted to a profoundly sick society.” – Jiddu Krishnamurti, Asian Indian philosopher

Last weekend, I talked my two grandsons into joining me to watch The Fifth Estate, the new feature film about WikiLeaks and its founder Julian Assange. The movie is being marketed as an “action thriller” and is reportedly having a hard time competing, revenue-wise, with two current blockbuster movies, Gravity and Captain Phillips. (I don’t doubt that fact because, at the end of the Saturday afternoon screening, we were the only ones left in the theater; folks who had been in the audience at the beginning had bailed out, presumably for more mindless, more entertaining fare elsewhere in the multiplex theater.)

For those readers who are not fully aware of what WikiLeaks really is, here is a good definition from a supporter:

WikiLeaks is an international, online, non-profit organisation which publishes information submitted by courageous whistleblowers, people with conscience. Most whistleblowers prefer to remain anonymous for fear of reprisals. Google what happened to Bradley Manning and Edward Snowden. They are being hounded, hunted, criminalised, ostracized, ex-communicated by the very top people whose secret criminal deals and activities they have exposed.

The final sentence of that quote explains why tremendous courage is necessary to be a whistleblower and why most of us are too frightened to speak out when witnessing injustice. The last phrase summarizes what is a major component of what constitutes “a profoundly sick society”.

I brought my grandsons to see the WikiLeaks film because I thought it was important to expose them to a movie about a historically important movement that was trying to respond to Krishmamurti’s concerns (about the western society he had witnessed in the first half of the 20th century). My busy, “wired-in” grandsons, like most distracted, computer game savvy, over-entertained adolescent students their age, seem to be relatively oblivious to pertinent past history – and even current events. I see the eternal truth of George Santanana’s powerful truism about the mistakes made by sick societies who are historically illiterate: “Those who cannot remember the past are condemned to repeat it.” Whistleblowers, who are all motivated by their consciences, might be our only hope.

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FLASHBACK (2013): With Sounds of Praise and Acclamation

In the last month of 2011, the United States Senate voted in approval of the National Defense Authorization Act and President Obama expressed no concern about the law which would strip Americans of their Fifth and Sixth Amendment rights.   “Due Process of Law” and the “right to a speedy a public trial,” two bold facets of the American justice system, would be undermined by the ink from a pen and the clapping hands of American’s representatives.

And for the first time in American history, indefinite detention of any person suspected, without charge or trial, was placed into legal code.  The individual rights of the American against the dangers of tyranny were abolished.

How did the American people react?  They voted for the abolitionists in 2012.

What will become of such a provision?  And if utilized, will the American people leap to their feet in outrage?  That question has been answered.

With swarms of military-grade weaponry and tanks strong enough to attack the armies of the world, tyranny under the guise of security descended upon the American people in Boston.

Asked to come out with their hands over their heads, the citizenry of Boston and surrounding areas were driven out of their homes without warrant and without “necessary and proper cause.”  The people of the so-called “land of the free” were treated as criminals before being proven as such.  It is under the guise of securing the peace that tyranny enters a land.

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The Supreme Court Will Decide Whether You Have a Right to a Prompt Hearing After Cops Seize Your Property

Do you have a right to a prompt hearing after the government seizes your property? The U.S. Supreme Court will consider the question in its upcoming term.

The Supreme Court has agreed to hear Culley v. Attorney General of Alabama, two consolidated cases concerning whether property owners have a due process right to a hearing to determine if police had probable cause to seize their property.

The issue may seem esoteric, but it’s hugely important to people who have their property seized by police under civil asset forfeiture laws. Under civil asset forfeiture laws, police can take property suspected of being connected to criminal activity even if the owner hasn’t been charged with a crime. Property owners then often have the burden of going to court and proving their innocence, a process that can take months and sometimes years.

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