Health
FDA Moves Forward With Last-Minute Push to Cut Nicotine Levels in Cigarettes
The Biden administration unveiled a proposal on Wednesday to cut the level of nicotine in cigarettes, a last-minute push on a plan that could meaningfully cut cancer rates nationwide and extend the lives of millions of cigarette smokers.
If finalized, the proposal would require cigarette makers to significantly reduce the levels of nicotine in their products in an effort to make smoking less addictive and less satisfying. Research has suggested that the move would result in fewer people taking up the habit and would help the nation’s roughly 30 million smokers quit or switch to less harmful alternatives like e-cigarettes.
The policy is a centerpiece of antismoking initiatives by Dr. Robert Califf, commissioner of the Food and Drug Administration, who has recounted treating cardiology patients ravaged by smoking during his medical career.
“It’s the biggest thing I’ve ever seen in terms of societal benefit, cost saving and lives saved, and strokes prevented and cancers prevented,” Dr. Califf said.
The policy’s companion effort to ban menthol cigarettes has been set aside indefinitely after vehement opposition from cigarette makers and other opponents, including convenience store retailers.
Whether the nicotine reduction plan would survive the incoming administration of President-elect Donald J. Trump is unclear. Mr. Trump has traditionally been industry friendly and opposed to heavily regulating businesses. In addition, he has had the support of tobacco companies, including Reynolds American, which contributed at least $8 million to Mr. Trump’s main super PAC during the presidential campaign. Reynolds has already expressed its opposition to the proposed requirement.
Mr. Trump’s campaign co-chair and incoming chief of staff, Susie Wiles, is a former lobbyist for Swisher, a company that makes cigars. The rule applies to cigarettes, roll-your-own tobacco, pipe tobacco and cigars (though not premium cigars).
Some public health advocates are holding out hope that the Trump administration will allow the proposal to move forward, given that a previous version was considered by the F.D.A. during his first term. At minimum, officials could continue to allow the public to comment on the initiative without killing it or putting it into effect.
The F.D.A.’s proposal includes projections that by 2100, the nicotine reduction measure would prevent an estimated 48 million young people from starting to smoke. By 2060, the agency also estimates that 1.8 million tobacco-related deaths would be prevented, and that $30 trillion in benefits would accrue over 40 years, mostly from the generation that would not begin smoking.
“We do have an extremely toxic and addictive product with cigarettes that remain on the marketplace, that still kills almost a half a million people a year,” said Dorothy Hatsukami, a tobacco researcher from the University of Minnesota who has studied low-nicotine cigarettes for about 15 years. “So it’s really kind of an unfortunate situation that we haven’t really done anything dramatically about it.”
In 2022, Dr. Califf released an updated proposal to lower nicotine levels, and opposition began to grow almost immediately.
Tobacco companies have viewed the initiative as a major threat to their business. Luis Pinto, a spokesman for Reynolds American, said the proposal would “effectively eliminate legal cigarettes and fuel an already massive illicit nicotine market.”
“These actions would also have a significant negative economic impact on farmers, retailers and others,” he added.
Convenience store retailers have also opposed earlier versions of the proposal, saying they would sustain substantial losses in revenue from a projected decline in cigarette sales.
Congressional Republicans have also tried to thwart restrictions on nicotine levels. In 2023, members of an influential House subcommittee passed a measure that would have prevented the F.D.A. from spending any money to advance limits on nicotine, with nearly all of the supporting votes by Republicans. The Senate did not include the provision in a final budget package.
Still, supporters of the plan point to signs that incoming public health officials may be receptive to it, including to the popularity of Robert F. Kennedy Jr.’s pledge to tackle chronic diseases and improve the health of Americans if he is confirmed to lead the nation’s top health agency. Mr. Trump himself has said that he is personally opposed to cigarette smoking.
“Given these enormous benefits, we urge the incoming Trump administration to move forward in finalizing and implementing this rule,” Yolonda C. Richardson, the president of Campaign for Tobacco-Free Kids, said in a statement. “Few actions would do more to fight chronic diseases such as cancer and cardiovascular disease that greatly undermine health in the United States, and that the incoming administration has indicated should be a priority to address.”
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Novo Nordisk to slash Wegovy, Ozempic list prices
Board certified rheumatologist Dr. Mahsa Tehrani discusses Novo Nordisk’s decision to dramatically cut the U.S. list prices for its popular diabetes and weight-loss drugs Ozempic and Wegovy on ‘America Reports.’
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The U.S. Food and Drug Administration announced on Thursday its approval of a new, higher-dose Wegovy (semaglutide) injection.
The 7.2 mg dosage, called Wegovy HD, is intended for weight loss and long-term weight loss maintenance for adult patients. It is triple the previous maximum dose of 2.4 mg.
This marks the fourth approval in the FDA’s National Priority Voucher pilot program, which “seeks to expedite approval of applications that address critical national health priorities,” according to FDA Commissioner Dr. Martin Makary.
NEW WEGOVY PILL OFFERS NEEDLE-FREE WEIGHT LOSS – BUT MAY NOT WORK FOR EVERYONE
“The new FDA is moving with unprecedented efficiency on products that advance national priorities,” he said in a press release. “Today’s approval is another demonstration of what the FDA can accomplish when we try bold new things.”
The U.S. Food and Drug Administration announced on Thursday its approval of a new, higher-dose Wegovy (semaglutide) injection. (Michael Siluk/UCG/Universal Images Group via Getty Images)
The higher-dose GLP-1 is indicated to “reduce excess body weight and maintain weight reduction long-term in adults with obesity, or overweight with at least one weight-related condition,” per the FDA’s statement.
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“The approval of a new higher dose will provide adult patients with an additional therapeutic option, offering the potential for greater weight loss,” the agency stated.
The FDA’s approval, granted to drugmaker Novo Nordisk, was supported by clinical data that found higher doses resulted in additional average weight reduction compared to previous dosing.
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Higher-dose patients with both obesity and type 2 diabetes saw similar lowering of blood sugar compared to the lower dose, the agency noted.
The safety profile is consistent with the known side effects of semaglutide, which commonly include gastrointestinal reactions like nausea, vomiting, diarrhea, constipation and abdominal pain.
Wegovy HD (7.2 mg) is triple the dosage compared to the previous maximum dose of 2.4 mg. (Steve Christo – Corbis/Corbis via Getty Images)
Skin sensitivity, pain or burning occurred more frequently with higher doses of Wegovy, but generally resolved on their own or with dose reduction, the FDA reported. The agency is investigating these adverse effects.
The FDA warned that Wegovy should not be used by patients with a personal or family history of medullary thyroid carcinoma (a type of thyroid cancer) or who have multiple endocrine neoplasia syndrome type 2 (a rare inherited genetic disorder that causes tumors to develop in certain hormone-producing glands). All patients should see a doctor for guidance on proper use.
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Jamey Millar, executive vice president of U.S. operations for Novo Nordisk, commented on this approval in a press release.
“We are excited to bring Wegovy HD injection to adults with obesity who are looking for powerful weight loss, as no other weight-loss medicine has been studied to show superiority to Wegovy HD,” he said.
Millar also noted that Wegovy has been shown to reduce the risk of events such as stroke, heart attack or cardiovascular death in those who also have known heart disease.
A weight-loss expert warned that Wegovy HD should be used only for obesity management. (iStock)
Dr. Peter Balazs, a hormone and weight-loss specialist practicing in New York and New Jersey, reflected on results of the STEP UP clinical trial, on which the drug’s approval was based.
Patients taking the higher dose experienced an average weight loss of 20.7% compared to about 16% on the standard dose, the doctor noted. About one-third lost 25% or more of their body weight.
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“For patients who start on 2.4 mg and then hit a frustrating plateau, or for those with a very high baseline BMI who may need a stronger metabolic push, this creates a legitimate, evidence-based escalation path rather than forcing an early switch to another drug class,” Balazs, who was not involved in the study, told Fox News Digital.
“That said, I think this is an interesting approval, but I do not expect it to dramatically reshape the GLP-1 landscape,” he went on. “It gives Novo Nordisk an opportunity to remain competitive on efficacy while it continues developing next-generation therapies.”
“This creates a legitimate, evidence-based escalation path.”
“Other drugs have already shown greater efficacy in prior studies, and the broader GLP-1 space is likely to see much more significant change as new molecules enter the market.”
Balazs called the higher dosage a “major jump,” noting that the incidences of stomach- and skin-related side effects at this higher dose are “meaningful.”
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“This approval is for obesity management, not diabetes treatment,” the expert emphasized. “For patients with type 2 diabetes, currently approved semaglutide dosing remains lower unless the primary treatment goal is weight loss under the obesity indication.”
Fox News Digital reached out to the FDA for comment.
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For some men, March Madness isn’t just about brackets — it’s also prime time for a vasectomy.
Previous research has shown that demand for the procedure tends to spike during the NCAA Division I men’s and women’s college basketball tournaments, which are held every spring.
Some surgeons have agreed that this is a real phenomenon, largely because the steady stream of games offers the perfect activity for men recovering on the couch.
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A vasectomy is a simple surgical procedure for men that blocks the vas deferens, the tube that transports sperm, serving as a permanent form of contraception.
Recovery typically takes a few days to a week, with doctors recommending rest for 48 hours and light activity soon after.
Previous research has shown that demand for vasectomies tends to spike during the NCAA Division I men’s and women’s college basketball tournaments, which are held every spring. (iStock)
David Gentile, MD, chief of the department of urology at Highland Hospital, recently spoke to the University of Rochester Medical Center about the uptick in vasectomies during March Madness.
“It’s a great excuse to watch without interruption.”
“We tell patients they should plan on going home and putting their feet up after a vasectomy, so timing the procedure to watch some games while you recover works well,” he said.
“And it’s a great excuse to watch without interruption, as you won’t be able to do physical labor around the house while you’re recovering.”
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Jim Dupree, MD, associate professor of urology at Michigan Medicine, has also spoken about the trend.
“Major sporting events are a popular time for men to schedule a vasectomy because we advise them to take it easy for two to three days after the procedure,” he said in a press release for Michigan Medicine.
A vasectomy is a simple surgical procedure for men that blocks the vas deferens, the tube that transports sperm, serving as a permanent form of contraception. (iStock)
“For most men, this means sitting on the couch in front of their television, and sporting events offer them something to watch while resting.”
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Yet another surgeon, Dr. Ali Dabaja, director of male reproductive and sexual medicine at the Vattikuti Urology Institute at Henry Ford Hospital in Detroit, Michigan, weighed in on the topic in 2024.
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“After a vasectomy, we ask men to rest, not to lift anything heavy, and to go back to light duties during that week. So, timing the procedure for watching some games while you recover works well, and it’s a great excuse to watch March Madness without interruption,” he told the Urology Care Foundation.
“Historically, we have usually seen a rise in vasectomy consultations and vasectomies during March Madness,” he went on. “Other urology offices have reported a rise in vasectomies between 20% to 40%.”
“After a vasectomy, we ask men to rest, not to lift anything heavy, and to go back to light duties during that week, a surgeon said. (iStock)
A 2018 study published in the journal Urology found that March was one of the higher-volume months for vasectomy procedures, but the highest peaks were actually later in the year, particularly November and December.
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There were some limitations to that study, primarily that the monthly variation was observational, and the data lacked context of patients’ behaviors and scheduling.
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