Tag: fda

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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Babies put at risk, even killed, in ‘reputable’ studies over the years

Public health officials and other medical professionals have helped untold millions over the years. But the hard truth is that some have hurt many.

This was a difficult lesson I learned many times when I was assigned to investigate FDA, CDC, NIH and pharmaceutical industry scandals at CBS News.

One of the most heartbreaking early stories I investigated in 2000 was the death of a baby who was given an experimental heartburn drug called Propulsid as part of a study. His death had been ruled a mysterious SIDS (Sudden Infant Death Syndrome) death.

Little Gage Stevens’ parents didn’t know that the drug he took, Propulsid, had been linked to dozens of deaths, including at least one other baby, before Gage even got his first dose. Shortly after Gage died, Propulsid was pulled from the market — linked to more than 300 deaths.

Read the death certificate on Gage.

My investigation revealed that the study consent form falsely stated Propulsid, made by Johnson and Johnson, was “approved by the FDA” for children. In fact, the Food and Drug Administration had repeatedly rejected it for pediatric use.

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FDA Says Ivermectin Doesn’t Work Against COVID-19 But Points To Studies That Show It Does

The U.S. Food and Drug Administration (FDA) says a drug called ivermectin does not work against COVID-19 but links to studies that show it does, an Epoch Times review has found.

The FDA’s website states, “Currently available data do not show ivermectin is effective against COVID-19.”

But half of the studies to which the FDA points support using ivermectin against COVID-19, according to the review.

The papers cut against the drug agency’s repeated exhortations for people not to take ivermectin for COVID-19. In Twitter posts, public statements, and emails, FDA officials have repeatedly warned against ivermectin. Some of those statements triggered a lawsuit from doctors who say the agency’s role is to approve drugs, not to issue recommendations. The suit was dismissed this week.

Dr. Pierre Kory, who frequently prescribes ivermectin for COVID-19 and co-authored a meta-analysis that concluded the drug is effective against the illness, told The Epoch Times that the government’s position on ivermectin “is one of the most glaring examples of the corruption of modern evidence based medicine.”

“There’s one message they want everyone to understand. And that message is that ivermectin doesn’t work,” Kory said. “That’s not a scientific conclusion, that’s theirs. That’s their perverted and distorted interpretation of the data.”

The FDA’s media office did not respond to a request for comment.

Dr. Janet Woodcock, a top official at the agency who was its commissioner from January 2021 to February 2022, told The Epoch Times via email that “ivermectin has been shown to be ineffective against COVID in large randomized trials.”

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FDA approves unpopular bivalent Covid shot for BABIES and ‘encourages parents to get their child vaccinated before the holidays’

US health officials today approved Pfizer and Moderna‘s bivalent Covid vaccines for babies, in a move bound to draw criticism.

The Food and Drug Administration (FDA) has green-lit plans for the updated shots to be given as part of a three-dose course for children aged six months to four years.

Agency officials said they ‘encourage parents and caregivers’ to get their child vaccinated ‘especially as we head into the holidays and winter months’.

It comes after a study found the bivalent vaccines are significantly weaker against a rising Covid variant expected to become dominant in the US in months.

Pre-school-aged children were already allowed to receive three extra-small doses of Pfizer’s original Covid vaccine, instead of the standard two-dose regimen for adults.

The move will see them given the Omicron-specific booster – made by either Pfizer of Moderna – as their third and final shot.

Officials recommend the children to receive the bivalent shot from the same brand they received their first two vaccine shots from.

So a child who receive the Pfizer vaccine for their first two doses should get the Pfizer bivalent shot as well. 

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FDA social media posts on COVID under legal, medical scrutiny for misleading claims

The FDA’s Twitter habits are getting scrutiny in court and from medical professionals as the feds seesaw between walking back their once-confident COVID-19 assertions and making sweeping new claims without providing evidence.

Having long ago conceded that COVID vaccines can’t stop viral transmission and that assertions to the contrary by President Biden among others were based on “hope” rather than science, the feds are now downplaying the influence of their social media to escape liability for allegedly violating statutory limits by interfering in medical judgments.

At the same time, over the past two months, FDA Commissioner Robert Califf has gone on a spree of evidence-free tweets about bivalent boosters and oral antivirals, such as Pfizer’s rebound infection-prone Paxlovid, prompting exasperation from leading doctors.

The FDA’s “social media statements … are what bother me the most,” U.S. District Judge Jeffrey Brown said in a hearing this month on the government’s motion to dismiss a lawsuit by three doctors who claim the agency’s false portrayals of ivermectin have harmed their ability to treat patients and threatened their licenses.

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