Tag: fda

Thiel-Linked HHS Nominee Threatens MAHA Ambitions with Biotech Stance

Late last November, President Donald Trump announced Jim O’Neill as his nominee for deputy secretary of Health and Human Services (HHS), where he would work under Robert F. Kennedy Jr., Trump’s pick for HHS secretary upon confirmation. As deputy secretary, O’Neill would essentially function as the Chief Operating Officer of the department, overseeing “the day-to-day operations of all sub-agencies” as well as leading “public health emergency preparedness,” i.e. the government’s policy responses to bio-terror events, pandemics, etc. In addition, O’Neill would “oversee the development and clearance of HHS regulations” and ostensibly be the main implementer of the “Make America Healthy Again” (MAHA) policy agenda.

Built on a promise to eliminate industry capture of public health regulatory agencies and curb the influence of Big Pharma and Big Food, Robert F. Kennedy Jr.’s MAHA movement played a crucial role in funneling would-be Kennedy voters into the Trump camp. MAHA, in essence, granted the Trump campaign a tinge of populist legitimacy among Covid era dissidents, which grew out of the shuttering of RFK Jr.’s independent presidential run.

However, O’Neill’s business connections, both past and present, as well as his previous statements on public health policy, strongly suggest that he is not only unlikely to implement the policies that MAHA-centric voters are expecting, but that he may in fact pursue an agenda that stands in direct conflict with the main tenets of the MAHA movement. Specifically, he advocates reforming the FDA to deregulate and accelerate the pathway from drug development to legalization. This would notably aid the biotech industry, which has long struggled to get its products approved outside of an “emergency”-based deregulatory paradigm.

When considering the investments and board positions that O’Neill himself has made and held in biotechnology companies, this would likely include mRNA products that Kennedy and other MAHA influencers have spent years criticizing since the Covid-19 pandemic — a clear contradiction between O’Neill’s views on public health, and those which the MAGA base were sold on the campaign trail.

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ICAN Acquires Critical FDA Safety Reports Concerning COVID-19 Vaccines After Years of Litigation

ICAN just got a 153 page document detailing COVID vaccine safety surveillance info collected by the FDA. Here’s the press release.

In a nutshell, the documents show that the FDA and CDC’s safety monitoring is inept. It generated no signals of adverse events of any significance. Not death, not myocarditis, not anything.

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J&J’s ketamine-derived nasal spray approved by FDA to treat depression

The Food and Drug Administration (FDA) approved Johnson & Johnson’s ketamine-derived nasal spray to help millions of U.S. patients suffering from severe depression.

Spravato, approved as a standalone treatment, is “the first and only monotherapy for adults living with major depressive disorder who have had an inadequate response to at least two oral antidepressants,” the pharmaceutical giant said Tuesday. 

An estimated 21 million adults in the U.S. are living with major depressive disorder, one of the most common psychiatric disorders, but one-third of them will not respond to oral antidepressants alone, hindering their quality of life, according to Johnson & Johnson. 

“Treatment-resistant depression can be very complicated, especially for patients who do not respond to oral antidepressants or cannot tolerate them. For too long, healthcare providers have had few options to offer patients much-needed symptom improvement,” Bill Martin, global therapeutic area head of Neuroscience at Johnson & Johnson Innovative Medicine, said in a statement. 

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The FDA Proposes a De Facto Cigarette Ban, Which Would Expand the Disastrous War on Drugs

On its way out the door, the Biden administration has proposed a rule that would effectively ban cigarettes by requiring a drastic reduction in nicotine content. The Food and Drug Administration (FDA), which unveiled the proposed rule on Wednesday, says the aim is to make cigarettes unappealing by eliminating their “psychoactive and reinforcing effects.”

In addition to cigarettes, the FDA’s proposed rule covers cigarette tobacco, pipe tobacco (except shisha for waterpipes), and cigars (except for “premium” cigars). All of those products would be limited to 0.7 milligrams of nicotine per gram of tobacco. That cap technically complies with a federal law that bars the FDA from banning tobacco products or “requiring the reduction of nicotine yields of a tobacco product to zero.” But the negligible amount of nicotine allowed under the rule would amount to both in practice.

The FDA, which first considered this policy under Scott Gottlieb during the first Trump administration, has abandoned the idea of gradually phasing in the nicotine reduction because that would initially result in “compensatory smoking.” That is, current smokers would be apt to inhale more deeply, take more or bigger puffs, or consume more cigarettes to get the nicotine dose to which they are accustomed, which would increase their exposure to the toxins and carcinogens in tobacco smoke. But avoiding that pitfall by mandating an immediate cut to a negligible nicotine level would magnify the black-market effects of de facto cigarette prohibition.

Given the disastrous results of the war on drugs, it is hard to fathom why a government agency in 2025 would think it is a good idea to expand that crusade to include products that are regularly consumed by nearly 30 million American adults. The proposed nicotine cap “would effectively outlaw almost all cigarettes currently being sold,” which would “benefit organized crime by igniting a robust illicit market for cigarettes and other tobacco products,” the Law Enforcement Action Partnership (LEAP) notes in an emailed press release.

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FDA Orders Pfizer to Add PARALYSIS WARNING to RSV Vaccine Labels

Last Wednesday, the FDA ordered Pfizer and GSK to add Guillain-Barre Syndrome (GBS) as a serious adverse event risk warning to both Pfizer’s Abrysvo and GSK’s Arexy Respiratory Syncytial Virus (RSV) vaccine labels.

RSV is the leading cause of respiratory infection in adults over the age of 60. Prior to 2023, the CDC has not published data on the incidence of RSV death in babies and children. In 2023, the CDC estimates that approximately 100 children under the age of 5 died from RSV. Despite these low numbers, the CDC recommends that pregnant women receive an RSV vaccine to ‘protect’ their baby from RSV.

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Full list of foods that have red dye 3 in them as FDA bans substance over cancer links

The FDA announced today it was banning the use of red 3 dye in foods in America, telling thousands of manufacturers to strip it from their products.

Food and drink makers have until January 2027 to reformulate their recipes or be forced out of the market.

The FDA agency said it was taking the action as a ‘matter of law’ because some studies have found that the dye caused cancer in lab rats. 

‘The FDA is taking action that will remove the authorization for the use of… Red No. 3 in food and ingested drugs,’ said Jim Jones, the FDA’s deputy commissioner for human foods. 

The dye has been used for decades to give candy, soda, and other foods and vibrant, cherry-red hue. It was banned from cosmetics by the FDA about three decades ago.  

There is no indication so far that food manufacturers will challenge the new rule, and they will have sufficient time to adjust their products to meet the new standards.

There is some concern that manufacturers may opt to use red 40, which, along with red 3, has been associated with various health concerns.

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US bans popular red dye from foods — 35 years after it was banned in cosmetics

The FDA today has issued an order today that will ban Red No. 3 from food products and ingested drugs.

The dye, which was approved for use in 1907, has been banned in cosmetics and topical drugs since 1990 over evidence that it can cause cancer. Its use in food is already banned or restricted in Australia, Japan, and countries in the EU.

Red No. 3. is commonly found in candy, gum and cookies, including Brach’s candy corn, Betty Crocker sprinkles and strawberry Ensure.

Food manufacturers will have until Jan. 15, 2027, to remove it from all products, while makers of ingested drugs will have until Jan. 18, 2028.

The new ban is based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, which was enacted in 1960.

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DNA Contamination Study — Conducted at FDA Lab by Students Supervised by FDA Scientists — ‘Doesn’t Belong to FDA’ Agency Says

The U.S. Food and Drug Administration (FDA) has responded to a peer-reviewed study conducted within its own laboratory, which uncovered excessively high levels of DNA contamination in Pfizer’s mRNA COVID-19 vaccine.

The study revealed that residual DNA levels exceeded regulatory limits by six to 470 times, validating earlier studies from independent researchers that the FDA had previously disregarded.

Published by students in the Journal of High School Science, the study has garnered significant attention since the story broke, with its altimetric score rivaling those of major studies in leading medical journals.

Despite the study being conducted at the FDA’s White Oak campus in Maryland, the agency has sought to distance itself from the findings.

A spokesperson stated that the study “does not belong to the FDA” and is therefore not theirs to disclose.

“The FDA does not comment on individual studies,” the spokesperson added, declining to acknowledge the new scientific findings.

The agency also refused to address the involvement of three of its own scientists — Shuliang Liu, Ph.D., Tony Wang, M.D., and Prabhuanand Selvaraj, Ph.D. — who supervised the students conducting the study.

When questioned about potential regulatory actions, such as issuing a public alert, recalling affected vaccine batches, or notifying other agencies, the FDA stood firm in its defense of mRNA vaccine safety.

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Biden admin working to effectively ban cigarettes in 11th hour proposal a ‘gift’ to cartels, expert says

The Food and Drug Administration (FDA) is moving forward with a regulatory rule in the final days of the Biden administration that would effectively ban cigarettes currently on the market in favor of products with lower nicotine levels, which could end up boosting business for cartels operating on the black market, an expert tells Fox News Digital.

“Biden’s ban is a gift with a bow and balloons to organized crime cartels with it, whether it’s cartels, Chinese organized crime, or Russian mafia. It’s going to keep America smoking, and it’s going to make the streets more violent,” Rich Marianos, former assistant director of the U.S. Bureau of Alcohol, Tobacco, Firearms and Explosives and the current chair of the Tobacco Law Enforcement Network, told Fox News Digital of the proposal. 

The FDA confirmed to Fox Digital on Monday that as of Jan. 3, the Tobacco Product Standard for Nicotine Level of Certain Tobacco Products had completed a regulatory review, but that the proposed rule has not yet been finalized. 

“The proposed rule, ‘Tobacco Product Standard for Nicotine Level of Certain Tobacco Products,’ is displaying in the Office of Management and Budget’s (OMB) ROCIS system as having completed regulatory review on January 3,” an FDA spokesman told Fox Digital. “As the FDA has previously said, a proposed product standard to establish a maximum nicotine level to reduce the addictiveness of cigarettes and certain other combusted tobacco products, when finalized, is estimated to be among the most impactful population-level actions in the history of U.S. tobacco product regulation. At this time, the FDA cannot provide any further comment until it is published.”

Fox New Digital reached out to the White House regarding concerns over the proposal if it were to take effect but did not receive a response. 

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A Young Child Died During Moderna Covid Vaccine Clinical Trial — Did FDA Know?

A preschool-aged child died of cardio-respiratory arrest after getting a COVID-19 booster in a Moderna clinical trial. However, Moderna didn’t reveal the death to the public and only recently reported it on a European regulatory agency database, Alex Berenson reported.

The death occurred in late 2022 or early 2023, Berenson said, when children under 5 who had already received Moderna’s original mRNA-1273 COVID-19 vaccine in the trial’s main phase were offered the “1273.214” booster against an early Omicron variant.

Berenson, a former New York Times reporter who now reports on his Unreported Truths Substack, today said the U.S. Food and Drug Administration (FDA) has declined to tell him whether the U.S. agency knew that a child died during Moderna’s clinical trial.

The failure of the FDA to provide a straightforward answer about whether it knew that a young child in a Moderna clinical trial died from cardiac-respiratory arrest is “vitally important,” Berenson told The Defender.

“Of all the mistakes public health authorities made around COVID, their insistence on pressing mRNA vaccines on children was probably the worst,” Berenson said.

By the time the COVID-19 vaccines were available for kids, it was clear that children were at almost no risk of serious illness or death from COVID-19, he said. “The shots had significant side effects, so the only rationale for giving them shots — even theoretically — was to reduce transmission.”

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