Biden ‘Nanny State’ Comes For The Smokers

One day after the Biden administration said it would develop a rule requiring tobacco companies to reduce nicotine levels in cigarettes, a new report via WSJ said the Food and Drug Administration (FDA) is preparing to order Juul Labs Inc. to take its e-cigarettes off the U.S. market.

WSJ cites people familiar with the matter who said the FDA decision could come as soon as today. 

The marketing denial order would follow a nearly two-year review of data presented by the vaping company, which sought authorization for its tobacco- and menthol-flavored products to stay on the U.S. market,” WSJ notes. 

Juul has spent the last several years attempting to regain the trust of the FDA and the public. The company limited marketing and stopped selling fruity flavors in 2019 — since then, sales have tumbled. 

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Bombshell Oxford Study: Less than 6% of “Approved” Medical Drugs Are Backed by “High-Quality Evidence” to Support Their Benefits – “Harms” are Significantly Underreported Across the Board

According to a newly released study by the University of Oxford, a jaw-dropping 94% of recently approved medications are not supported by high-quality evidence that demonstrates their benefits. What’s more, just like with the experimental Covid-19 ‘vaccines,’ side effects and adverse reactions to these drugs are being severely underreported across the board.

When looking at medical drugs that have been approved since 2008 under the Cochrane reviews – a “leading” international journal and database that is endorsed by over 100 organizations worldwide, including the US Food and Drug Administration (FDA) -researchers determined that just 87 of the 1,567 medications (6%) had clinical data that met the “high-quality” standard.

From the Oxford study:

“Of 1567 eligible interventions, 87 (5.6%) had high quality evidence on first-listed primary outcomes, positive, statistically significant results and were rated by review authors as beneficial.”

Unbelievably, the majority of these drugs could not even pass the ‘moderate-quality’ review, with over 50% failing to meet the reduced threshold. And yet, consumers have access to these drugs, which are causing unknown and underreported side effects – something that should amount to medical malpractice at the very least. That is – if we lived in a sane, well-functioning society.

One of the study’s authors, Dr. Jeremy Howick, certainly thinks so. Writing about the findings, Dr. Howick deemed the issue worrisome and stressed that, with this happening, ‘informed choice’ about medical treatments is essentially impossible.

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FDA Flags Heart Inflammation Risk Over Novavax COVID-19 Vaccine

Staff with the U.S. Food and Drug Administration (FDA) on Friday flagged the risk of heart inflammation following the administration of the Novavax COVID-19 vaccine, although they concluded the shot reduces the risk of mild-to-severe COVID-19.

In the company’s nearly 30,000 patient trial, conducted between December 2020 and September 2021, there were four cases of myocarditis, a type of heart inflammation also associated with mRNA vaccines, detected within 20 days post-vaccination. One patient in the trial reported myocarditis after receiving a placebo.

“These events raise the concern for a causal association with this vaccine, similar to the association documented with mRNA COVID19 vaccines,” FDA staff wrote in briefing documents that were released on Friday.

They continued: “Data from passive surveillance during post-authorization use in other countries also indicate a higher than expected rate of myocarditis and pericarditis (mainly pericarditis) associated with the vaccine. However, interpretation of these passive surveillance data is not straightforward, and further evaluation is needed to inform the risk of myocarditis and pericarditis associated with this vaccine, and their outcomes, as additional data emerge over time.”

The agency said it has asked Novavax to flag the risk of myocarditis and pericarditis, another type of inflammation of the heart, as an identified risk in its documentation. Data from Novavax’s trial was acquired before the Omicron and Delta variants spread across the world.

“Based on the efficacy estimate in the clinical trial of this vaccine,” the FDA staff wrote, “it is more likely than not that the vaccine will provide some meaningful level of protection against COVID-19 due to Omicron, in particular against more severe disease.”

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FDA Says CRISPR Gene-Edited Cattle Safe for Human Consumption

The U.S. Food and Drug Administration (FDA) has determined that short-haired cattle produced through CRISPR gene-editing technology are safe for human consumption. The cattle, known as PRLR-SLICK, were the first to receive an FDA “low-risk determination for enforcement discretion” after the agency determined the intentional genomic alteration (IGA) of the two genome-edited cattle does not raise any safety concerns.

Produced by Acciligen with climate change in mind, the cows have a genetic trait that gives them a short, sleek coat which is said to help the animals cope with hot weather more effectively. The FDA’s low-risk determination means the agency does not expect Acciligen, a “precision breeding” company, to seek regulatory approval before marketing products from the cattle.

The FDA spent years reviewing the two other genetically altered animals approved for human consumption—a faster-growing salmon and a pig the agency determined was safe for consumption by people with meat allergies. However, the review process for the CRISPR beef cattle took less than a year because the FDA noted the gene-editing results in the same slick-hair trait seen in cattle that are found in conventional agriculture. Talking about the Mar. 7, 2022 approval, Steven Solomon, director of the FDA Center for Veterinary Medicine, said:

“We expect that our decision will encourage other developers to bring animal biotechnology products forward for the FDA’s risk determination in this rapidly developing field, paving the way for animals containing low-risk IGAs (intentional genomic alterations) to more efficiently reach the marketplace.”

Looking closer at Acceligen, the company website says that most of its workers have backgrounds in the farm industry. The company explains that “precision breeding” is different from conventional breeding or genetically modified organisms (GMO) in that it allows a “highly desired trait” that may typically take years to show up to be expressed in “just one breeding cycle.”  

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FDA Chief Claims “Misinformation” is Leading Cause of Death in the United States

During an appearance on CNN, FDA chief Dr. Robert Califf asserted that the leading cause of death in the United States is online “misinformation.”

Yes, really.

Califf spoke about his remarks during an interview with CNN’s Pamela Brown, which were originally made at a health conference in Texas last month when he said online misinformation was “now our leading cause of death.”

After admitting that there was “no way to quantify this,” before mentioning heart disease and cancer (actual killers), Califf went on to bolster the claim anyway.

Claiming that there has been “an erosion of life expectancy,” Califf went on to say that Americans were living an average of 5 years shorter than people in other high income countries.

Califf said that anti-virals and vaccinations meant “almost no one in this country should be dying from COVID,” before going on to explain that there was also a “reduction in life expectancy from common diseases like heart disease.”

“But somehow … the reliable, truthful messages are not getting across,” he said, adding, “And it’s being washed down by a lot of misinformation, which is leading people to make bad choices that are unfortunate for their health.”

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FDA issues long-awaited proposal to ban menthol cigarettes

The Food and Drug Administration on Thursday issued a long-awaited proposal to ban menthol cigarettes and flavored cigars, a major victory for anti-smoking advocates but one that could dent sales at tobacco companies.

The proposal, which comes a year after the agency announced the plan, still needs to be finalized and can take years to implement as it is likely to face stiff opposition from the tobacco industry.

“The proposed rules would help prevent children from becoming the next generation of smokers and help adult smokers quit,” said Health and Human Services Secretary Xavier Becerra

For decades, menthol cigarettes have been in the crosshairs of anti-smoking groups who have argued that they contribute to disproportionate health burdens on Black communities and play a role in luring young people into smoking.

Menthol cigarettes, banned in many states including California and Massachusetts, account for more than a third of the industry’s overall market share in the United States, even as overall smoking rates have been declining in the country.

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FDA Takes Only Months to Approve Pfizer Jab Yet Cannabis Remains Schedule 1 Despite Centuries of Data

Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under the Food and Drug Administration’s Emergency Use Authorization in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021. On August 23, 2021, it was granted full approval by the FDA.

The Pfizer-BioNTech COVID-19 Vaccine now become the fastest created, deployed, and subsequently approved vaccination in history. Previously, the fastest vaccine to go from development to deployment was the mumps vaccine in the 1960s, which took about four years.

The swift approval of the vaccine illustrates just how fast the government can react if it wants to do so. On the contrary, however, there have been hundreds if not thousands of studies on the benefits of cannabis to safely treat multiple ailments and diseases, spanning the course of centuries, yet the FDA has failed to approve its use for anything.

To be clear, the FDA has approved patentable pharmaceutical synthetic compounds such as dronabinol. The pharmaceutical patented drugs Marinol and Syndros both use dronabinol which is nothing more than a chemical synthetic equivalent to delta-9- tetrahydrocannabinol (THC) — but the plant-based version you can grow in your own home remains off the list.

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FDA and Pfizer Knew COVID Shot Caused Immunosuppression

With another batch of 11,000 Pfizer documents, released April 1, 2022, old suspicions have gained fresh support. As reported by “Rising” cohost Kim Iversen (video above), the first bombshell revelation is that natural immunity works, and Pfizer has known it all along.

The clinical trial data showed there was no difference in outcomes between those with previous COVID infection and those who got the shot. Neither group experienced severe infection. Natural immunity was also statistically identical to the shot in terms of the risk of infection.

Younger Adults More Likely to Experience Side Effects

The second revelation is that side effects from the shots were more severe in younger people, aged 18 to 55, than those aged 55 and older. (The risk of side effects also increased with additional doses, so the risk was higher after the second dose than the first.)

As many of us have said all along, the risk of severe COVID is dramatically lower in younger people than those over 60, which makes an elevated risk of side effects unacceptable.

As noted by The Naked Emperor on Substack,[1] “with a vaccine that is producing more frequent and more severe reactions and adverse events in younger individuals, the vaccine should have been restricted to those who were actually at risk of severe COVID-19.”

Pfizer Documents Show High Rate of Myocarditis

Interestingly, Pfizer’s documentation also includes medical information that mainstream media and fact checkers have labeled as misinformation or disinformation. A pediatric consent form lists several possible side effects, including a myocarditis rate of 10 in 100,000 — far greater than the 1 in 50,000 (i.e., 2 in 100,000) rate previously reported.

We also know that myocarditis is far more frequent in young males, so for them, the risk is significantly higher than 10 in 100,000, as they make up the bulk of these injuries.

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Government of Canada data suggests the Triple Vaccinated are suffering Antibody Dependent Enhancement; and Pfizer & the FDA knew it would happen

Official Government data coming out of Canada shows that fully vaccinated individuals are now statistically over four times more likely to be infected with Covid-19, 1.5 times more likely to be hospitalised with Covid-19, and twice as likely to die of Covid-19 than not-vaccinated individuals.

The horrifying thing about these stats is that they do not take into account age or the length of time since a person was vaccinated, but still equate to an average that shows the Covid-19 injections are not just ineffective but actually seem to worsen the effects of Covid-19 infection.

These are the sort of figures you would expect to see if a vaccine was causing Vaccine-Associated Enhanced Disease and antibody-dependent enhancement, and it turns out the latest round of confidential Pfizer documents confirm that both Pfizer and the US Food & Drug Administration knew it was a possibility upon emergency approval of the mRNA jab.

Then they received evidence of it occurring, including several deaths, but decided to ignore it and claim “no new safety issues have been raised”.

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