Tag: fda

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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FDA’s Own Study Finds DNA Contamination in Pfizer Vaccines

A peer-reviewed study performed at a U.S. Food and Drug Administration (FDA) laboratory by high school students has confirmed the presence of a high level of DNA contamination in Pfizer’s mRNA COVID-19 vaccine.

The study, published Dec. 29, 2024, in the Journal of High School Science, was authored by three students at Centreville High School in Clifton, Virginia, and performed under the supervision of FDA scientists.

Maryanne Demasi, Ph.D., an investigative medical reporter, was the first to report on the study.

The research, performed at the FDA’s White Oak Campus in Maryland, found that levels of residual DNA in the Pfizer COVID-19 vaccine were 6 to 470 times higher than regulatory safety limits. The students tested two lots of the vaccine, finding they contained “residual DNA to a level that exceeds 10 ng [nanograms] per dose.”

“The potential health risk posed by residual small DNA fragments is currently unknown,” the study stated. However, the authors also said that DNA contamination may result in insertional mutagenesis — or DNA mutations — that can cause cancer.

Speaking last month on “The Defender In-Depth,” Kevin McKernan, who first identified DNA contamination in the shots in 2023, said DNA in vaccines can pose health risks because the DNA “could integrate into the genome and cause disruption of the genome … or it could disrupt other genes that are related to cancer.”

The FDA did not respond to multiple requests for comment on the study.

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FDA pushes RSV vaccines for kids despite halted Moderna trials

Advisers to the FDA recently met to discuss the future of respiratory syncytial virus (RSV) vaccines for children. This followed Moderna’s forced halt of its mRNA RSV vaccine trials after alarming data showed higher rates of severe RSV in vaccinated infants compared to those given a placebo. Clinical trial data revealed 12.5% of vaccinated children developed severe RSV disease, compared to just 5% in the placebo group.

These outcomes raised alarms due to past experiences with RSV vaccines. In the 1960s, trials of a formalin-inactivated RSV vaccine led to vaccine-associated enhanced respiratory disease (VAERD), where vaccination worsened illness instead of preventing it. That trial resulted in two toddler deaths and hospitalization for 80% of the vaccinated participants. Despite decades of research, the risks tied to VAERD remain unresolved.

FDA advisers emphasized the “unmet need” for pediatric RSV vaccines, framing RSV as a leading cause of infant hospitalizations in the US annually. Vaccine makers, spurred by a projected $13.59 billion global RSV vaccine market by 2030, are developing 26 RSV vaccines or monoclonal antibodies for all age groups.

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FDA Updates Recall On Blood Pressure Medication Due To Possible Carcinogen

A third blood pressure medication was recalled across the United States in the past several weeks, according to a notice updated on the U.S. Food and Drug Administration’s (FDA) website on Dec. 16.

The notice said that New Jersey-based Aurobindo Pharma USA Inc. is recalling Nebivolol tablets in 2.5 milligram doses in 30-count bottles, which are only available by prescription. Nebivolol, a type of beta blocker, is used to treat high blood pressure.

The reason for the recall is because of the “presence of nitrosamine drug substance related impurity,” adding that discovered N-nitroso nebivolol levels are above the “acceptable intake limit,” it said. N-nitroso nebivolol is a nitrosamine and is considered mutagenic.

It was first initiated by Aurobindo earlier this month. The FDA classified the recall as Class II on Dec. 16, which occurs when there is a low chance of injury or death, and a possibility of “adverse events” that may have irreversible effects. They are issued if the product can cause medically reversible or temporary health problems—or if there is a small chance of serious health consequences.

The lot numbers being recalled are: NB0224001A and NB0224001B. It has an expiration date of April 2027 and a National Drug Code, or NDC, of 59651-137-30, according to the FDA.

Nitrosamines are compounds that can increase the risk of cancer in individuals if exposed to them above levels established by the FDA, or for long periods of time, the agency says on its website.

“A person taking a drug that contains nitrosamines at-or-below the acceptable daily intake limits every day for 70 years is not expected to have an increased risk of cancer,” the FDA adds.

People who are taking medications with possible “nitrosamine impurities should not stop taking their medications” and should instead speak with a health care professional.

Nitrosamines can be found in small levels in the environment and foods, including “meat, vegetables, and dairy products,” the FDA says.

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