Tag: fda

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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The FDA’s Own Experts Have No Idea Why It Approved Another COVID Booster Dose

The Food and Drug Administration (FDA) bypassed many of its own protocols to speed through the authorization of Pfizer’s second booster dose of the COVID-19 vaccine last week.

Multiple medical experts, including some who sit on the FDA’s top vaccine advisory committee, said they had no idea why the agency skipped over its normal approval process to authorize the fourth vaccine dose for Americans aged 50 and older. The authorization was even broader than the drug company requested, which was that it be greenlit for those aged 65 and older.

That FDA vaccine panel, the Vaccines and Related Biological Products Advisory Committee (VRBPAC), is meeting Wednesday, and part of the agenda will be to discuss the fourth vaccine dose and the Israeli studies which are being used to exhibit its effectiveness. Typically, the vaccine authorization process would involve a meeting and vote by VRBPAC on whether to recommend authorization, followed by the FDA head granting that authorization. Then, the Centers for Disease Control and Prevention’s (CDC) vaccine committee would vote on how to recommend the vaccine, which would then be determined by the CDC director.

Dr. Paul Offit, a co-inventor of the rotavirus vaccine and member of VRBPAC, said he couldn’t explain why the FDA didn’t present its data to the committee first before moving ahead with authorization: “The way it’s working here is that the government basically just declares that this is what they’re going to do.”

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Recently Unredacted Documents Prove Pfizer & FDA Knew Antibody-Dependent Enhancement Occurring in Vaccinated

The Food and Drug Administration (FDA) has released another batch of internal Pfizer documents under court order showing even more evidence that Pfizer and the FDA knew of the antibody dependent enhancement (ADE) phenomenon and tried to cover it up.

The trove of 11,000+ pages of documents, released on April 1, reveal both agencies knew that vaccine-induced ADE was occurring and worked to cover it up by claiming “no new safety issues have been raised.”

ADE occurs after the mRNA vaccine primes the immune system for a potentially deadly overreaction.

Numerous Vaccine-Associated Enhanced Disease (VAED) cases were outlined in Pfizer’s post-marketing experience report that’s just been unredacted.

From the Daily Exposé:

An investigation of official Government data has uncovered that fully vaccinated individuals are up to 3 times more likely to be infected with Covid-19, 2 times more likely to be hospitalised with Covid-19, and 3 times more likely to die of Covid-19 than unvaccinated individuals.

The question is, why?

One possibility is that as feared, the vaccinated are suffering Vaccine-Associated Enhanced Disease leading to conditions such as antibody-dependent enhancement, and cytokine storm. In effect, this means the Covid-19 injections cause a vaccinated person’s immune system to go into overdrive when they come into contact with the virus, causing harm to the person and worsening disease.

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Beef from gene-hacked ‘super cows’ can now be sold in the US

You could soon be eating genetically modified beef thanks to the US Food and Drug Administration.

The FDA claims that two gene-edited breeds of beef cattle produced by a major breeder are safe for human consumption.

The two breeds of cow in question have been edited so they grow short slick coats.

This change is not thought to be harmful to the meat or the cow.

Experts suggest this genetic modification is “low risk”.

That means Acceligen, the company which produces the breed, doesn’t need to seek approval to sell it.

This is said to be the first time that the FDA has made such an assessment.

The federal agency has never given a “low-risk” premarket approval before to a gene-edited animal food product.

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Just Released Documents by Pfizer Show BioNTech Paid FDA $2,875,842.00 “Drug User Fee” for COVID-19 Vaccine Approval

As the news cycle continues to focus on the Ukraine situation, the FDA complied with a court order to begin releasing 55,000 pages of Pfizer data per month that was used to authorize their COVID-19 vaccine produced with BioNTech, with the first batch quietly released yesterday, March 1st.

There are 150 documents that the public can now download here.

One of the documents released was the “Prescription Drug User Fee Payment” that BioNTech paid to the FDA on 4/20/2021 for the “COMIRNATY COVID-19 mRNA Vaccine” which the FDA subsequently approved in August of 2021.

That “Prescription Drug User Fee Payment” was $2,875,842.00. (Source.)

Another interesting document I found was the “EXTERNAL DATA MONITORING COMMITTEE” found here.

Here is the stated purpose of this “External Data Monitoring Committee”:

This External Data Monitoring Committee (E-DMC) (hereafter referred to as “the committee”) is a single, external,  independent, expert advisory group established to oversee safety and efficacy data from the BNT162 Vaccine Program. The  primary rationale for establishing the committee is to make certain that appropriate external safeguards are in place to help ensure the safety of subjects and to maintain scientific rigor and study integrity while the trial is on-going.

The committee will review accumulating safety data across all studies, as well as efficacy data in the Phase 2/3 portion of the C4591001 study. The committee will advise Pfizer regarding the safety of current participants and those yet to be recruited, as well as the continuing scientific validity of the trial. In addition to safety review by the committee, qualified Pfizer personnel will review safety data as specified in the safety surveillance review plan and will inform the committee of  significant findings. Efficacy data from the C4591001 study will be available to the committee when there is a planned  interim analysis of efficacy or if this is considered necessary to conduct a risk-benefit assessment.

And to make sure that this Committee is doing their job properly to ensure “the safety of subjects and to maintain scientific rigor,” who at the FDA is responsible to make sure this happens?

Well, that would be no one. Pfizer is the one who was responsible, and BioNTech funded it.

“Pfizer is responsible for conducting this study. BioNTech is the regulatory sponsor of this study.”

The committee members are to be free from “conflicts of interest.”

The committee members will complete a CT22-GSOP-RF01 Independent Oversight Committee Member Conflict of Interest Form. Committee members should be free of apparent significant conflicts of interest. Any potential conflict of interest that develops during a member’s tenure on the committee must be disclosed by the committee member.

And who at the FDA is responsible for assuring that this committee who is overseeing “safety and efficacy data” is free from conflicts of interest?

Well, that would be no one. Again, Pfizer is responsible for that.

“Pfizer will determine if any potential conflict requires termination of committee membership.”

The question that then begs to be answered here is, what role did the FDA play, if any, in the “external” monitoring of the data to ensure integrity and safety of a new vaccine about to be injected into hundreds of millions people in the U.S.?

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