Tag: fda

FDA targets Hims & Hers, posts more than 100 letters to drugmakers

The Trump administration is cracking down on pharmaceutical advertising and they are specifically targeting telehealth companies that promote unofficial versions of weight loss medications.

More than 100 letters were posted by the Food and Drug Administration to drugmakers and online prescribing companies. Hims & Hers built a multibillion-dollar business around weight loss interventions. The letters warned the companies, including Hims & Hers, to remove “false and misleading ” promotional statements and advertising from their website.

Your claims imply that your products are the same as an FDA-approved product when they are not,” states the warning letter, dated Sept. 9.

Hims said Tuesday that it “looks forward to engaging with the FDA.”

“Our website and our customer-facing materials note that compounded treatments are not approved or evaluated by the FDA,” the company said in a statement.

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Trump FDA to Present Data Linking COVID Jabs to Child Deaths at Upcoming CDC Meeting

The Food and Drug Administration (FDA) will present data linking COVID-19 vaccines to the deaths of dozens of children.

According to several media reports, the CDC’s Advisory Committee on Immunization Practices (ACIP) will meet Thursday and Friday to review and recommend several vaccines, including this fall’s updated Covid shots.

The FDA is basing its claim on data from the Vaccine Adverse Event Reporting System (VAERS), a public database run jointly by the FDA and CDC.

The reports come after FDA Commissioner Marty Makary told CNN last week that the agency is investigating reports of healthy children dying after receiving Covid vaccines.

“We’ve been looking into the VAERS database of self-reports that there have been children that have died from the Covid vaccine,” Makary said.

“We’re going to release a report in the coming few weeks and we’re going to let people know. We’re doing an intense investigation.”

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FDA Chief Says No Solid Evidence Supporting Hepatitis B Vaccine At Birth

The head of the Food and Drug Administration said on Sept. 8 that there is no strong evidence supporting the administration of a hepatitis B vaccine to infants.

“I personally don’t believe that the evidence is solid to say the Hep B shot needs to be given at birth,” Dr. Marty Makary, the FDA commissioner, said during an appearance on Fox News.

“It’s totally different from polio and measles, and some of these other shots that are tried and true and have been around for a long time.”

The FDA, which is part of the Department of Health and Human Services, has cleared hepatitis B vaccines to be administered at birth. The Centers for Disease Control and Prevention recommends that all infants receive a hepatitis B vaccine on the day they are born.

A debate among some doctors regarding the recommendation has been taking place in light of the CDC vaccine advisory panel’s scheduled discussion on the hepatitis B vaccination at its upcoming meeting.

“I predict that what they’re going to do is try to change the birth dose of hepatitis B vaccine so that kids don’t get it when they’re born,” Dr. Demetre Daskalakis, who recently resigned from the CDC, said during an appearance on ABC.

The panel makes recommendations on vaccines. The recommendations are usually adopted by the CDC.

Hepatitis B is a liver infection that can lead to liver failure and death, although some of those infected never experience symptoms. Hepatitis B is contracted through contact with the bodily fluids of an infected person. Babies who are born to infected women can also contract it.

The CDC first recommended the hepatitis B vaccine in 1982, the year after it was cleared, for people deemed to be at high risk, such as drug users, pregnant women, and infants born to mothers who had hepatitis B.

By 1992, the recommendation for infants shifted to the first day of life and was broadened to all newborns because of “the difficulty of vaccinating high-risk adults,” according to the CDC.

Three doses of the vaccine are on the CDC’s childhood immunization schedule, and nearly every state requires hepatitis B vaccination to attend school and/or childcare facilities.

The stated goal of the vaccination campaign was to eliminate transmission of hepatitis B, which has not happened.

“We’re giving about 11 million doses of hepatitis B a year, and pretty much all of them are for kids who we know don’t need it,” since their mothers have been screened, Dr. Monique Yohanan, a senior fellow at Independent Women’s Forum, told The Epoch Times in a recent interview.

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New York Health Dept Defies FDA: Hochul’s Emergency Order Pushes Off-Label COVID Shots For Kids As Young as 3

New York’s department of public health released a series of odd guidances to pharmacists and physicians on Friday to promote COVID vaccines to children and adults for “off label” use, meaning in conflict with FDA’s official label. Signed by Governor Kathy Hochul, New York’s executive order 52 declares a “disaster in the state of New York due to federal actions related to vaccine access.”

“A friend of mine said they’re contacting the nurse’s union,” a New York City nurse texted me, shortly after New York released their new COVID vaccine guidance. “They don’t know wtf to do with that!”

A New York physician sent me documents the state’s health department sent to physicians and pharmacists, called “providers” in healthcare lingo. She and the majority of her colleagues no longer get COVID boosters, and she’s worried that the new guidance for “off label” use makes no sense, does not fully inform patients, and might be illegal.

Pfizer pled guilty to criminal charges and paid a record $2.3 billion fine for illegal, off label promotion of multiple drugs in 2009. As previously reported here, Biden’s FDA Commissioner and CDC Director both promoted COVID vaccines for uses that the FDA admitted were off label. No evidence exists that pharmaceutical companies helped to shape New York’s off label policy, but CNBC reported in 2021 that Governor Hochul’s daughter-in-law is a top lobbyist at a pharma firm that has sought to influence NY lawmakers.

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FDA Official Pressures YouTube Into Removing a Channel For Posting His Own Vaccine Comments

Last week, a top official with the Food and Drug Administration (FDA) apparently filed a bogus copyright claim to get a critic’s YouTube account taken down. This is an inappropriate act of censorship that, not long ago, conservatives would rightly have stood against.

“Jonathan Howard, a neurologist and psychiatrist in New York City, received an email from YouTube on Friday night, which stated that Vinay Prasad, who is the FDA’s top vaccine regulator, had demanded the removal of six videos of himself from Howard’s YouTube channel,” The Guardian reported this week. “Howard’s entire channel has now been deleted by YouTube, which cited copyright infringement.”

On his channel, Howard hosted videos of public health officials—including Prasad, Department of Health and Human Services Secretary Robert F. Kennedy Jr., and National Institutes of Health Director Jay Bhattacharya—making statements during the COVID-19 pandemic that turned out to be untrue or overly myopic. “I had accumulated about 350 videos, almost all of which were short clips of famous doctors saying absurd things,” Howard wrote in a blog post, “that herd immunity had arrived in the spring of 2021 and that RFK Jr. was an honest broker about vaccines, for example.” Howard is also critical of Prasad’s stance on vaccines, which Prasad now has the authority to regulate.

According to an email Howard posted, YouTube “terminated” his channel after “multiple copyright strikes” against his videos, and the “removal request” came from Prasad.

“Publishing someone else’s videos without modification or commentary is a clear copyright violation,” an FDA spokesperson told The Guardian. “The mission of Johnathan Howard was not medical transparency, but personal profit by grifting and stealing someone else’s intellectual property.”

“My YouTube channel had 256 subscribers and its videos were typically seen by dozens of people,” Howard wrote. “I never promoted the channel and made no money from it.” Besides, U.S. law allows for fair use of copyrighted material, which means someone can use protected content for purposes such as “criticism, comment, news reporting,” or “research” without the creator’s permission.

Howard is the author of the book We Want Them Infected, which criticized doctors and public health officials who advocated a herd immunity strategy for dealing with COVID-19. Howard says such warnings fed into anti-vaccine conspiracy theories. His YouTube channel collected videos of people who are now in charge of public health institutions, making what he feels were irresponsible claims during the pandemic.

But whether you agree with Howard or not, it is wrong and hypocritical for Prasad to silence his critics in this way.

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FDA Revokes Emergency Authorization For COVID-19 Vaccines

The Department of Health and Human Services under Health Secretary Robert F. Kennedy Jr. revoked emergency authorization for COVID-19 vaccines.

“The emergency use authorizations for Covid vaccines, once used to justify broad mandates on the general public during the Biden administration, are now rescinded,” Kennedy posted to X on Wednesday.

The news comes as the FDA, which is part of HHS, announced the approval of the Pfizer-BioNTech COVID-19 vaccine for older adults and children as young as 5-years-old who have at least one condition that puts them at higher risk of severe COVID-19 outcomes, Pfizer said in a Wednesday statement.  

Regulators have issued similar approvals for COVID-19 jabs from Novavax and Moderna. 

HHS revoking emergency approval means that FDA clearance is no longer in place for some 240 million Americans, however “These vaccines are available for all patients who choose them after consulting with their doctors,” Kennedy sai. 

As the Epoch Times notes further, per federal law, the FDA approves products it determines are “safe, pure, and potent.” Emergency authorizations, in contrast, can only be offered under certain circumstances, such as during a public health emergency, and are for products that officials believe “may be effective” in treating or preventing a life-threatening disease or condition.

Updated Approvals

Dr. Marty Makary, the FDA’s commissioner, and Dr. Vinay Prasad, its top vaccine official at the time, signaled the change in May, when they said that the FDA would stop approving COVID-19 vaccines for many Americans absent clinical trial data.

“The FDA can only approve products if it concludes, based on scientific evidence, that the benefit-to-harm balance is favorable. And we simply need more data to have that confidence for younger individuals at low-risk of severe disease,” Prasad said at the time.

In the United States, regulators in recent years have been authorizing updated COVID-19 vaccines annually in a bid to counter waning effectiveness and better match circulating variants. The model is based on the historical approach to influenza vaccines.

Regulators in 2024 cleared updated shots from Moderna, Pfizer, and Novavax without human data, citing animal tests and data from trials for previous versions.

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FDA Suspends License For Chikungunya Vaccine After ‘Serious Adverse Events’

Federal regulators on Aug. 25 said they’ve suspended approval for a vaccine against chikungunya, a mosquito-borne virus.

Due to reports of serious adverse events following administration of the vaccine, the Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) “believes this vaccine is not safe and that continued administration to the public would pose a danger to health,” the FDA said in a statement.

France-based Valneva makes the vaccine, known as Ixchiq.

“As we determine potential next steps, and as the clear threat of chikungunya continues to escalate globally, Valneva remains fully committed to maintaining access to our vaccine as a global health tool for addressing and preventing outbreaks of this devastating illness,” Thomas Lingelbach, Valneva’s CEO, said in a statement.

Zachart Stieber reports for The Epoch Times that the FDA originally approved Ixchiq in 2023 to prevent disease caused by the chikungunya virus in adults deemed to have an increased risk of exposure. The Centers for Disease Control and Prevention in 2024 recommended the vaccine for people traveling to certain countries.

Health officials said in an alert in May that they were advising a pause in administering the vaccine to elderly adults due to reports that some of those vaccinated had been experiencing serious adverse events (SAEs), including neurologic and cardiac problems.

This included 38 SAE reports for 32 unique cases (7 U.S., 25 foreign), including 21 hospitalizations and three deaths.

After CBER Director Dr. Vinay Prasad resigned, the FDA, in early August, ended the recommended suspension, stating that an updated assessment of risks and benefits for Ixchiq showed the benefits still outweighed the risks for some people.

In the new announcement, regulators said that is no longer the case.

The latest risk-benefit assessment includes four new foreign reports that came to light since the FDA lifted the recommended pause, including a report of problems following vaccination in a 55-year-old male.

Prasad said in a memorandum dated Aug. 22 that of the 32 cases, five tested positive for the vaccine strain of the virus, making it nearly certain that the vaccine caused the problem.

“There are reasonable grounds to believe the risks of the vaccine outweigh its benefits, and that it poses a danger to health. Therefore, CBER is suspending approval,” Prasad said.

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The Case of the Damning FDA Memos

On July 21, 2025, the Informed Consent Action Network (ICAN) announced that it had secured the release of over 600,000 pages of Emergency Use Authorization (EUA) data used by the US Food and Drug Administration (FDA) to authorize and approve Pfizer-BioNTech’s COVID-19 vaccine (BNT162b2), following a successful lawsuit, culminating in a late 2024 court ruling.

These documents, now publicly available on ICAN’s website, are part of a broader release of over 1.6 million pages, including data from the vaccine’s licensure in August 2021 and the earlier EUA in December 2020.

This report builds on my prior investigative work analyzing thousands of FDA documents released following the Public Health and Medical Professionals for Transparency (PHMPT) lawsuit, which focused on the biological product file submitted by Pfizer for the full approval of its COVID-19 vaccine in August 2021.

I was one of the initial researchers to uncover and analyse the damning data hidden within Pfizer’s Pregnancy & Lactation Cumulative Review, Interim-Narrative-Sensitive document (3000+ pages), and Cumulative Analysis of Post-Authorization Adverse Event Reports document, among others.

Both ICAN and PHMPT’s lawsuits sought to make public the FDA’s data on the Pfizer-BioNTech’s COVID-19 shot, asserting that transparency is critical for public trust and independent analysis, given the global administration of billions of doses of this experimental gene-based product that was mandated in several countries.

My preliminary review of ICAN’s EUA data reveals several irregularities, outlined below with references to key documents and downloadable sources. This report focuses on four critical issues: manufacturing oversight gaps, missing Bell’s palsy data, clinical trial site deficiencies, and the exclusion of unconfirmed COVID-19 cases.

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FDA Warns About Potentially Radioactive Frozen Shrimp Sold at Walmart Stores

The U.S. Food and Drug Administration (FDA) on Tuesday issued a public warning against potentially radioactive frozen shrimp products sold at Walmart stores in several states.

The FDA alert urged the public not to consume, sell, or serve certain Great Value raw frozen shrimp due to possible contamination with Cesium-137, a radioactive isotope.

Impacted Shrimp Products

Walmart also shared the FDA’s warning on its website.

The impacted raw frozen shrimp products were sold under the Great Value brand at stores in Alabama, Arkansas, Florida, Georgia, Kentucky, Louisiana, Missouri, Mississippi, Ohio, Oklahoma, Pennsylvania, Texas, and West Virginia.

The impacted products have been stamped with lot codes 8005540-1, 8005538-1, and 8005539-1.

They also have Best by Dates of 3/15/2027.

What is Cesium-137?

Cesium-137, also referred to as Cs-137, is a radioactive isotope of cesium that is man-made through nuclear reactions, according to the FDA. The agency says because Cs-137 is “widespread worldwide,” trace amounts of the radioisotope can be found in soil, food, and the air.

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FDA Approves Therapy For Rare Disease Without Randomized Trial Data

The Food and Drug Administration on Aug. 14 approved a therapy for a rare disease called recurrent respiratory papillomatosis (RRP).

Regulators cleared Papzimeos, an immunotherapy made by Precigen, citing data from a single-arm, open-label trial that looked at how it performed in adults with RRP and who needed at least three surgeries a year.

Patients received four injections of the therapy over 12 weeks following surgical procedures.

About half of the participants needed no surgery in the year following treatment. The safety profile was also deemed favorable.

“Randomized trials are not always needed to approve medical products and this approval is proof of that philosophy,” Dr. Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.

“The FDA will always demand the correct clinical study for the specific medical product and disease. Our requirements for products given to tens of millions of healthy people will be different than products given to at most hundreds or thousands of patients with unique diseases.”

The approval is the first announcement from Prasad after he rejoined the FDA following his July resignation.

Prasad had received criticism for not approving enough new drugs and therapies, including from the editorial board of the Wall Street Journal, which said that Prasad “has long criticized such single-arm studies that have no placebo groups.”

Replimune’s treatment for advanced melanoma is among the drugs the FDA has rejected since Prasad became its top vaccine and biologics official.

Prasad said in May that he favors randomized clinical trials but that for some rare diseases, it would be difficult or even impossible to complete such trials. He said that the FDA would have a “flexible regulatory standard” that takes into account “the context of a disease.”

In June, in an article co-authored by FDA Commissioner Dr. Marty Makary, he said that for some products targeting rare diseases, “premarket randomized trials may not be feasible.”

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