Tag: fda

FDA To Tighten Review Process for Food Additives

The Food and Drug Administration (FDA) is planning a major overhaul of the way food additives are reviewed for safety.

The move, announced on Thursday, will be a “major step to increase transparency and ensure the safety of chemicals in our food,” according to a statement made by Secretary of Health and Human Services Robert F. Kennedy Jr.

“No parent should ever worry about what’s in their child’s food,” Kennedy said in a statement.

“We’re taking decisive action and using every authority we have to clean up the food supply and protect American families.”

The new process will include a “modernized, evidence-based prioritization scheme” for existing chemicals, a “systematic post-market review process” for food chemicals that will be “shaped by stakeholder input,” and the development of an “updated list of chemicals under review.”

Chemicals subject to review include BHA and BHA, which are used as preservatives; ADA, a foaming agent added to sandwiches; phthalates; propylparaben, a preservative; and titanium dioxide. These chemicals have all been linked to chronic diseases, including reproductive harms and cancer.

The new review process will be rolled out over the coming months.

Health advocates have hailed the changes. Kendall Mackintosh, a member “MAHA Moms” movement, said they were “a long-overdue and necessary step in the right direction.”

“The announcement signals progress toward more transparency and accountability, and I’m hopeful this opens the door for deeper systemic reform,” Mackintosh added.

The FDA is also looking to eliminate its Generally Recognized as Safe loophole, which allows companies to self-regulate additives and use them in the food supply without independent testing.

In April, HHS announced it would phase out all petroleum-based synthetic dyes from U.S. foods and medications.

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The FDA Just Approved Another COVID Vaccine — But RFK Jr. Has Already Intervened

The Food and Drug Administration (FDA) on Friday approved the Novavax COVID-19 vaccine, but RFK Jr. is stepping in to limit its avaliability.

The latest Novavax vaccine will only be avaliable to the elderly and those over the age of 12 with an underlying medical condition.

The approval of the vaccine, named Nuvaxovid, is contingent on the company conducting studies to assess potential links to various heart conditions.

However, Some of these investigations can be carried out using existing data sources.

The New York Times has more details:

Scientific advisers to the Centers for Disease Control and Prevention, who typically make decisions on who should get approved shots and when, have been debating whether to recommend Covid shots only to the most vulnerable Americans.

The F.D.A.’s decision appeared to render at least part of their discussion moot.

The vaccine had previously been authorized under emergency use. Covid vaccines developed by Pfizer-BioNTech and Moderna, which are more widely used by Americans, were granted full approval in 2022. However, the companies are working on updated shots for the fall, and the new restrictions on the Novavax shot portend a more restrictive approach from the F.D.A.

The F.D.A.’s new restrictions also appeared to reflect the high degree of skepticism about vaccines from Robert F. Kennedy Jr., the health secretary, and the other leaders he has appointed at health agencies.

The jab is said to have fewer side effects than mRNA based vaccines because it is built on a more traditional vaccine platform.

Figures in the scientific establishment are already complaining about the restrictrions.

”This is incredibly disappointing,”said Dr. Camille Kotton, an infectious disease physician at Massachusetts General Hospital nd former adviser to the C.D.C.

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FDA Announces ‘Radical Framework’ for Overhauling Vaccine Approval Process

The U.S. Food and Drug Administration (FDA) is preparing to issue new guidance for vaccine manufacturers in the coming days as part of a new “radical framework.” The guidance will likely focus on the COVID-19 shots, The Washington Post reported Thursday, citing comments by FDA Commissioner Marty Makary earlier this week.

The Post published its story earlier Thursday, before The Wall Street Journal reported that unnamed sources at the U.S. Department of Health and Human Services (HHS) said HHS is expected to announce within days that it will no longer recommend COVID-19 shots for children, teens and pregnant women.

Speaking at the Food & Drug Law Institute’s conference in Washington, Makary gave few specifics about the upcoming new framework but said it will help ensure the pharmaceutical industry understands “exactly what we’re thinking,” Endpoints News reported.

According to the Post, this may entail “guidance to companies so that they know the agency’s approach to vaccine approvals.”

“We want to be very transparent, and we want to create a framework for vaccine makers that they can use so they have a predictable FDA where they don’t have to worry, ‘How is this going to be received?’” Makary said at the conference.

The announcement comes just a month before government regulators are set to review COVID-19 vaccines for the next cold and flu season.

James Lyon-Weiler, Ph.D., president and CEO of the Institute for Pure and Applied Knowledge and editor-in-chief of the journal Science, Public Health Policy & the Law, said the new framework is “long overdue” and “may represent an inflection point — if it goes beyond mere optics and addresses the core systemic failures that have plagued vaccine policy for decades.”

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FDA Says It Plans to Remove Some Fluoride Drugs for Children From Market

The Food and Drug Administration (FDA) plans to remove ingestible prescription drugs for children that contain fluoride, the agency announced on May 13.

The ingestible products have been linked to issues such as a disrupted gut microbiome.

“The best way to prevent cavities in children is by avoiding excessive sugar intake and good dental hygiene, not by altering a child’s microbiome. For the same reason that fluoride may kill bacteria on teeth, it may also kill intestinal bacteria important for a child’s health,” Dr. Marty Makary, commissioner of the FDA, said in a statement.

Researchers reported in a review article in March that multiple studies have found that the gut microbiota was negatively impacted in people who ingested high amounts of fluoride, a disruption that can lead to problems such as cancer.

The FDA said it plans to complete a safety review by Oct. 31 before “taking appropriate action regarding removal of these products from the market.” At the same time, its parent agency, the Department of Health and Human Services, is planning to provide the public with guidance on strong dental hygiene for children that does not alter gut health.

“Ending the use of ingestible fluoride is long overdue,” Health Secretary Robert F. Kennedy Jr. said in a statement. “I’m grateful to Commissioner Makary for his leadership on this vital issue—one that directly safeguards the health and development of our children.”

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FDA warns seniors to avoid this vaccine after deadly complications

Older adults are being warned against receiving the chikungunya vaccine before traveling.

The Ixchiq vaccination, developed by Valneva to prevent the mosquito-borne chikungunya virus, was approved by the Food and Drug Administration (FDA) in November 2023 as the first of its kind.

The approval applies to anyone aged 18 and older who has a risk of being exposed to the virus.

But the FDA and the Centers for Disease Control and Prevention (CDC) released a safety notice on May 9 recommending that adults over 60 years old pause use of the vaccine due to fatal complications.

“FDA and CDC will continue the evaluation of post-marketing safety reports for Ixchiq,” the release reads.

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FDA To Deploy Artificial Intelligence Across Agency

The Food and Drug Administration (FDA) is planning to roll out artificial intelligence across the agency following a successful pilot program.

FDA Commissioner Dr. Marty Makary has directed all FDA centers to immediately start using artificial intelligence (AI) and fully integrate it by the end of June, the FDA said in a May 8 statement.

By June 30, all centers will use what the agency described as a “common, secure generative AI system integrated with FDA’s internal data platforms.”

“I was blown away by the success of our first AI-assisted scientific review pilot,“ Makary said in a statement. ”We need to value our scientists’ time and reduce the amount of non-productive busywork that has historically consumed much of the review process. The agency-wide deployment of these capabilities holds tremendous promise in accelerating the review time for new therapies.”

AI refers to computer systems that can carry out complex tasks typically performed by humans.

“AI can be generally described as a branch of computer science, statistics, and engineering that uses algorithms or models to perform tasks and exhibit behaviors such as learning, making decisions, and making predictions,” FDA officials said in 2023.

Makary said on Thursday that past years have featured discussions on utilizing AI and that it’s time to start using it to save time, with some tasks that once took days now taking mere minutes.

“We at the FDA now have to ask big questions that we’ve never asked before. Why does it take over 10 years for a new drug to come to market? Why are we not modernized with AI and other things? We’ve just completed our first AI-assisted scientific review for a product and that’s just the beginning,” he said earlier in the week on social media platform X.

The rollout across the FDA is being coordinated by Jeremy Walsh, Booz Allen Hamilton’s former chief technologist, who was recently appointed as the agency’s chief AI officer, and Sridhar Mantha, who previously led the Office of Business Informatics at the FDA’s Center for Drug Evaluation and Research.

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RFK Jr. just made his best hire yet (and that’s saying something)

Yesterday, the Food and Drug Administration named Dr. Vinay Prasad, a San Francisco oncologist, as its top regulator for vaccines and other complex drugs called biologics.

This is a YUGE move.

I know Prasad. He is deeply thoughtful about the value and cost of new medicines. He understands the games Big Pharma plays to win approvals for expensive new drugs that all-too-often have little benefit — and hidden risks.

Those games often rely around the design of clinical trials: keeping them short for a drug that may be used for years; including only the healthiest possible patients (for example, the Covid-19 mRNA vaccine trials included few people over 80, who should have been the focus of the trials); comparing them to other drugs that have serious side effects and are not the true “standard-of-care.”

They also include pressure campaigns to push regulators to quickly approve drugs for serious conditions like cancer on the basis of “surrogate endpoints.” Drug companies, and the desperate patients they work with and fund, argue any treatment is better than no treatment.

They’re wrong.

Even for people who are dying, they’re wrong — at least on the institutional level.

The human body is incredibly complex. Efforts to modify disease and healing processes are even more complex. Medicine is rife with stories of treatments, from bloodletting to lobotomies, that did more than harm than good but that became accepted cures for decades or centuries.

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Secret recordings with ousted FDA vaccines chief suggest disinterest in documenting vax injury

The Food and Drug Administration’s top vaccine official until late-March met online several times with a COVID-19 vaccine injury group’s leader, who, opposing the vaccines in part, begged him to no avail to take severe adverse events such as paresthesia as a precursor to neuropathy seriously and to urge doctors to treat them as such rather than write them off as “anxiety,” secret recordings suggest.

The Informed Consent Action Network (ICAN) released the videos, compiled on “The Real Peter Marks“ website, with other documentary evidence from Marks’ leadership of the COVID response starting with Operation Warp Speed, at the National Press Club in Washington on Tuesday.

They also include a virtual meeting between San Francisco intensive care unit doctor Patricia Lee, Marks and other FDA officials, who asked no questions after Lee said a patient’s severe complications from vaccination at 22 weeks’ pregnancy and related death prompted a “nervous breakdown” among nurses on her shift, requiring a psychiatrist’s overnight visit.

ICAN CEO Del Bigtree shared pieces of Lee’s Oct. 22, 2021, conversation with FDA officials, who allegedly ignored her pleas for vaccine-injured patients until she brought “legal pressure,” on his show two weeks earlier with ICAN lawyer Aaron Siri and REACT19 founder Brianne Dressen, whose neurological injuries from the AstraZeneca vaccine trial were confirmed by the NIH. 

Organized as an animated vertical timeline that loads as it scrolls, the Marks website loaded slowly during Just the News’ review Wednesday. “They are receiving a ton of traffic and working on it,” a spokesperson said in the early afternoon.

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Not so fast on the FDA’s food dye ban — the Supreme Court has changed the rules 

Last week, the Food and Drug Administration announced long-awaited bans on certain food dyes and added new warnings about sugar in processed foods. Public health advocates cheered. Parents breathed a sigh of relief. But as someone who has spent years reporting on the intersection of federal science, health and regulation, I have a warning: In today’s legal climate, we are celebrating too soon. 

The Supreme Court’s recent reversal of the Chevron doctrine means every new regulation is now living on borrowed time — and the FDA’s food dye ban may be its first casualty. 

For 40 years, the “Chevron deference” gave federal agencies the benefit of the doubt in their interpretations of ambiguous laws within their areas of expertise. So when Congress writes broad rules, courts are to give agencies like the FDA, EPA and NOAA wide latitude to fill in the scientific and technical details.

But last year, in a move cheered by conservative legal activists, the Supreme Court struck down Chevron. Now, federal judges need not give such great deference to agencies as to what the law means, even on issues where the judges have no practical experience, such as food additives and clean air.

This is a landmark shift with potentially far-reaching consequences. While a regulation-friendly administration like Joe Biden’s can’t guarantee that new public health protections will survive the courts, Robert F. Kennedy Jr.’s FDA under the Trump administration should prepare to encounter similar hurdles.

The Chevron ruling presented us with a fitting preview of what happens when judges — as opposed to subject-matter experts at relevant agencies — determine the best way to interpret applicable regulatory frameworks within the law.

Justice Neil Gorsuch, in a concurring opinion overturning Chevron, referenced “nitrous oxide” as a pollutant from coal plants. Nitrous oxide — the compound best known for providing the temporary euphoria you may experience while a dentist fills a cavity — has nothing to do with the “nitrogen oxides” that actually come out of smokestacks and threaten respiratory health.  

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MAHA Rising: HHS, FDA Announce Phase-Out Of All Artificial Food Dyes

Health and Human Services Secretary Robert F. Kennedy Jr’s quest to “Make America Healthy Again” grew far more substantial on Tuesday, with the announcement that the federal government will eliminate all petroleum-based synthetic food dyes by the end of 2026. The announcement came at a Washington DC news conference, with RFK Jr joined by Food and Drug Administration (FDA) Commissioner Marty Makary and National Institutes of Health Director Jay Bhattacharya. The podium was flanked by “MAHA Moms” and their children; the moms are a coalition of outspoken advocates of the Trump administration’s health agenda.  

Kennedy framed the move against artificial, petroleum-based dyes using forceful language: 

“For too long, some food producers have been feeding Americans petroleum-based chemicals without their knowledge or consent. These poisonous compounds offer no nutritional benefit and pose real, measurable dangers to our children’s health and development. That era is coming to an end. We’re restoring gold-standard science, applying common sense, and beginning to earn back the public’s trust. And we’re doing it by working with industry to get these toxic dyes out of the foods our families eat every day.”

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