Tag: fda

FDA creates path for psychedelic drug trials

Federal regulators are laying out guidance for psychedelic drug trials for the first time, in a move that could encourage the mainstreaming of substances like magic mushrooms and LSD as behavioral health treatments.

Why it matters: Psychedelics are turning into a multi-billion industry and gaining widespread acceptance after decades of concerns about recreational use of the products — and the high risk for misuse. But research to date has largely been backed by private sponsors.

Driving the news: The Food and Drug Administration on Friday released first-ever draft guidance outlining considerations — including trial conduct, data collection and subject safety — for researchers looking into psychedelic treatments for a variety of conditions, including PTSD, depression and anxiety.

  • The agency filed the 14-page document two days after a bipartisan coalition in Congress led by Rep. Dan Crenshaw (R-Texas) introduced legislation directing the issuance of clinical trial guidelines.
  • It also came as 10,000 attendees and hundreds of exhibitors converged on Denver for what was billed as the “largest psychedelic conference in history,” with guests ranging from New York Jets quarterback Aaron Rodgers to National Institute of Mental Health director Joshua Gordon.

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FDA warns stores to stop selling Elf Bar, the top disposable e-cigarette in the US

The Food and Drug Administration on Thursday said it has sent warning letters to dozens of retailers selling fruit- and candy-flavored disposable e-cigarettes, including the current best-selling brand, Elf Bar.

It’s the latest attempt by regulators to crack down on illegal disposable vapes that have poured into U.S. stores in recent years.

Last month, the FDA issued orders allowing customs officials to seize shipments of Elf Bar, Esco Bar and two other brands at U.S. ports. None of the products have received FDA authorization and they come in flavors like cotton candy, which regulators say can appeal to teenagers.

In the latest action, the FDA said it issued warnings to 189 convenience stores, vape shops and other retailers.

“We’re not going to stand by as bad actors are profiting off the sale of illegal products that are addicting our nation’s youth,” Brian King, the FDA’s tobacco center director, said in an interview. “Today’s action is just part of our long-standing efforts to address those products, particularly flavored disposable products.”

The FDA has tried for years to regulate the multibillion-dollar vaping industry, but separate data released by government researchers Thursday shows unauthorized e-cigarettes continue to launch.

The Centers for Disease Control and Prevention analysis showed the number of e-cigarette brands in the U.S. grew from 184 in early 2020 to 269 by late 2022.

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Elon Musk’s Neuralink Gets FDA Approval to Study Brain Implants in Humans

Elon Musks’s neurotechnology company Neuralink announced on Thursday it has obtained approval from the U.S. Food and Drug Administration (FDA) to carry out a clinical study of brain implants in humans.

It marks the first in-human clinical study for the company.

“This is the result of incredible work by the Neuralink team in close collaboration with the FDA and represents an important first step that will one day allow our technology to help many people,” the company said in a statement.

“Recruitment is not yet open for our clinical trial. We’ll announce more information on this soon!” it added, without providing further details about the trial.

Musk, in response, wrote on Twitter: “Congratulations Neuralink team!”

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Miscarriages and Dead Infants Were Described in a Secret FDA Review but Hidden From The Public

A new document was released to ICAN this April, thanks to a FOIA legal action that compelled the government to provide Pfizer documents they tried to keep secret for 75 years. Indeed, they had a good reason to hide it.

That document is called “PREGNANCY AND LACTATION CUMULATIVE REVIEW.” Many findings in it validate several concerns of COVID vaccine skeptics.

Pfizer identified 458 pregnancies where mothers were vaccinated (with and without adverse events).

Of the 673 case reports identified in the search, 458 involved BNT162b2 exposure during pregnancy (mother/fetus) and 215 involved exposure during breast-feeding.

In 210 out of the 458 cases, maternal exposure … was reported either with no associated AEs or with AE off-label use/product use issue for either the mother or the baby.

What happened to those pregnancies?

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FDA Presses Forward on Anti-Aging Supplement Ban

In a letter recently made public on the federal docket, the FDA has restated the position it announced in October 2022 that NMN does not meet the definition of a dietary supplement because, in the agency’s view, it was studied as a drug before it was ever sold in or as a supplement. The FDA is clearly gearing up for a ban of this critical anti-aging supplement. We need a strong, sustained grassroots response from the natural health community to protect access to this supplement; we also need to support changes in this law that threatens many other natural compounds from being turned into drugs.

The letter, dated January 23, 2023 but made public on March 29, 2023, is in response to a “new dietary ingredient” notification filed by Effepharm, Ltd., in November 2022 with additional information submitted in January 2023. The letter reiterates the FDA’s position that NMN is not a legal supplement due to the back-channel at the FDA that we’ve described many times before.

For supplements that are considered “new” under the law—that is, they weren’t sold “in or as a supplement” before 1994—companies must submit a notification to the FDA with studies to prove that it is safe before that ingredient can be marketed—this is referred to as a “new dietary ingredient” (NDI) notification. But here’s the issue: if a drug company files an investigational new drug application (IND) and studies that ingredient before the FDA receives an NDI notification on it from a supplement company, it can no longer be sold as a supplement.

This back-channel is threatening the existence of a number of important supplements. The pyridoxamine version of vitamin B6 was banned through this mechanism; CBD and NAC are also in jeopardy due to this loophole. We’ve explained previously that this provision inherently favors drug companies. IND applications are confidential. A drug company can file an IND on an ingredient and sit on it for years. Meanwhile, an innovative supplement company could develop that nutrient into a great product, do the studies to comply with the FDA’s ridiculous notification process, and then create a market for that product—and then the drug company can swoop in with their IND, kick the supplements out of the market, and create a monopoly. 

Last month, ANH-USA filed a Citizen’s Petition with our allies, the Natural Products Association, calling for the FDA to issue a regulation stating that NMN is a lawful dietary supplement. You can read our previous coverage for more detail on the arguments contained in that submission.

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FDA Commissioner Dr. Robert Califf says “regulation” is needed to target “misinformation”

In an interview with CNBC, FDA Commissioner Dr. Robert Califf said that online misinformation was harming the life expectancy of people, there is a need for “better regulation” on how to handle health misinformation and that “specific authorities at FDA, FTC, and other areas are going to be needed.”

“We know more and more about misinformation. It relates back to this life expectancy,” Califf said. Why aren’t we using knowledge of diet? It’s not that people don’t know about it. Why aren’t we using medical products as effectively and efficiently as our peer countries? A lot of it has to do with choices that people make because of the things that influence their thinking. The COVID vaccines and the antivirals give us an easy way to talk about it, but this is not limited to those areas. In heart disease, so many people don’t take their medicines, even though they’re now generic and very low-cost, often [they’re] deluded into taking things that are sold over the Internet that aren’t effective.”

According to the FDA commissioner, one of the solutions is telling the “truth is a louder volume.”

“In the good old days, when I was a practicing cardiologist, for the most part, people developed products, they got through the FDA, the label determined what was talked about, the Internet didn’t exist, you advertised in medical meetings and journals. There was sort of a hierarchy of information that went through the prescriber or the implanter in the case of devices to the patient. Of course, the problem in that system is it left a lot of people out. We now know about that. Now, everyone’s included because everyone’s connected to the Internet. But we can put out a statement about what we’ve determined based on the highest level of evidence, within ten minutes, someone who’s thought ten minutes about it can reach a billion people. And there’s nothing that restricts them from telling things that are not true. This has always existed. … But they couldn’t reach so many people,” he explained.

He added that there isn’t enough regulation on health information and that is “impacting our health in very detrimental ways.” As such, he thinks “there is a real need for better regulation of how to deal with this complex information.”

Califf noted that the FDA already has regulatory authority over advertisements content on tech platforms. But he feels the agency could do it better.

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CDC, FDA Respond to Florida Surgeon General’s COVID-19 Vaccine Safety Alert

U.S. health authorities have responded to the warning from Florida’s surgeon general about a spike in reports of adverse events following COVID-19 vaccination.

Drs. Rochelle Walensky and Robert Califf claimed in the response that Dr. Joseph Ladapo, the surgeon general, was misleading the public by focusing on the increase in adverse events reported to the Vaccine Adverse Event Reporting System (VAERS).

“The claim that the increase of VAERS reports of life-threatening conditions reported from Florida and elsewhere represents an increase of risk caused by the COVID-19 vaccines is incorrect, misleading, and could be harmful to the American public,” Walensky and Califf said in the missive.

Walensky heads the U.S. Centers for Disease Control and Prevention (CDC). Califf heads of the U.S. Food and Drug Administration (FDA). The CDC and FDA co-manage VAERS, which accepts reports from anybody but which is primarily used by healthcare workers.

The COVID-19 vaccines were given emergency authorization in late 2020. Under the emergency authorizations, vaccine companies and healthcare workers are required to report certain adverse events through VAERS, “so more reports should be expected,” Walensky and Califf said.

“Most reports do not represent adverse events caused by the vaccine and instead represent a preexisting condition that preceded vaccination or an underlying medical condition that precipitated the event,” they said.

They did not cite any studies or other research to support the claim.

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FDA Reveals Rare, Possibly Fatal Neurological Disorder Is A “Potential Risk” With New Pfizer Vaccine

People around the globe have suffered serious adverse reactions resulting from COVID vaccines, especially from the Pfizer shot.

Now the Food and Drug Administration (FDA) tells us another Pfizer vaccine can cause serious complications in recipients. After receiving Pfizer’s Respiratory Syncytial Virus (RSV) shot during a clinical trial, two older individuals contracted Guillain-Barré syndrome.

This was enough for the FDA to flag the disease as “an important potential risk” from the RSV shot. Yet Pfizer is still seeking approval for general public use.

According to the Mayo Clinic, Guillain-Barré syndrome is a rare disorder in which your body’s immune system attacks your nerves.

While most people recover from Guillain-Barre syndrome, some severe cases can be fatal. Other serious cases can result in paralysis.

There’s no known cure for Guillain-Barre syndrome.

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FDA Will No Longer Require Animal Tests Before Human Trials for All Drugs

Animal testing will no longer be a mandated part of the Food and Drug Administration’s approval process for all new drugs. Since 1938, pharmaceutical makers seeking FDA approval have had to successfully put their medications through multiple animals trials before proceeding to human tests.

Now, though, drug companies will have the option of either animal or non-animal tests—in a shift that animal rights groups and some pharma companies have long advocated for. Meanwhile, researchers’ reactions are mixed: Some say the move is unlikely to trigger immediate change, others are excited by the possibilities, while others still have safety concerns.

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FDA vaccine advisers ‘disappointed’ and ‘angry’ that early data about new Covid-19 booster shot wasn’t presented for review last year


Some vaccine advisers to the federal government say they’re “disappointed” and “angry” that government scientists and the pharmaceutical company Moderna didn’t present a set of infection data on the company’s new Covid-19 booster during meetings last year when the advisers discussed whether the shot should be authorized and made available to the public.

That data suggested the possibility that the updated booster might not be any more effective at preventing Covid-19 infections than the original shots.

The data was early and had many limitations, but several advisers told CNN that they were concerned about a lack of transparency.

US taxpayers spent nearly $5 billion on the new booster, which has been given to more than 48.2 million people in the US.

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