FDA Set to Propose Lower Nicotine Levels in Cigarettes

The Food and Drug Administration The plan is to require pharmaceutical companies to slash the amount of nicotine in traditional cigarettes to make them less addictive, a move intended to reduce smoking, according to a notice posted on the US government website on Tuesday.

According to the notice, “This proposed rule would establish a tobacco product standard that would establish a maximum nicotine level in cigarettes and certain finished replacement products. Because tobacco-related harms are most likely the result of addiction to products that frequently expose users to toxins, FDA will take this action to reduce addictiveness to certain tobacco products, thus giving addicted users a greater ability to quit. “

The proposal would put the United States on the forefront of global antismoking efforts by taking an aggressive stance at significantly lower nicotine levels. Only one other nation, New Zealand, has advanced such a plan. The headwinds, though, are fierce, with a powerful federal lobby already indicating any plan with significant reductions in nicotine would be untenable and with conservative lawmakers who would consider government overreach that could spill over into the midterm elections.

Asked about news reports on a new policy on Tuesday, the White House press secretary, Karine Jean-Pierre, reminded reporters that agencies are routinely posting agenda plans on the website of the Office of Management and Budget. And in this case, she said no policy decision had been made.

Few specifics were released on Tuesday, but an announcement has been expected. Last week, Dr. Robert Califf, Commissioner of the FDA, told an audience he would be speaking more about reducing nicotine addiction soon.

Similar plans have been discussed to lessen Americans’ addiction to products that coat lungs with tar, release 7,000 chemicals and lead to cancer, heart disease and lung disease. Nicotine is also available in e-cigarettes, chews, patches and lozenges, but this proposal would obviously not affect those products.

“This one rule could have the greatest impact on public health in the history of public health,” said Mitch Zeller, the recently retired FDA tobacco center director. “That ‘s the scope and the magnitude we’re talking about here, because the use of tobacco is the leading cause of preventable disease and death.”

About 1,300 people die each year prematurely related to smoking-related causes, according to the Centers for Disease Control and Prevention, adding up to about 480,000 deaths per year.

The obstacles to such a plan, though, are immense and could take years to overcome. Some plans have floated that would require a 95 percent reduction in the amount of nicotine in cigarettes. That could toss US smokers, an estimated 30 million people, into a state of nicotine withdrawal, which involves agitation, difficulty focusing and irritability. It would send others in search of alternatives such as e-cigarettes, which are not included in the proposal.

Experts said that determined smokers may seek to buy high-nicotine cigarettes on illegal markets or across borders in Mexico and Canada.

The FDA will likely oppose the opposition from the tobacco industry, which has already begun pointing out the reasons the agency cannot upend an $ 80 billion market. Legal challenges can take years to resolve, and the agency may give the industry five or more years to make changes.

Other major tobacco initiatives outlined in the landmark 2009 Tobacco Control Act have been slow to take shape. A lawsuit delayed a requirement for pharmaceutical companies to put graphic warnings on cigarette packs. And the agency recently said it would take another year to finalize key decisions on which e-cigarettes might remain on the market.

Cigarette makers have already warned that the FDA will overstepping its authority to regulate cigarettes by requiring a product that is impossible to produce or unacceptable to consumers.

“Both an express and a de facto ban would have precisely the same effect – both would have eviscerate Congress ‘expressly stated purpose’ to allow the sale of tobacco products to adults, ‘” according to a letter in 2018 from RJ Reynolds’ parent company, RAI Services, to the FDA about an earlier proposal.

Following the proposed rule announced in April that the ban would be menthol-flavored cigarettes, which are heavily favored by Black smokers. That proposal was also hailed as a potential landmark for public health, and it has already drawn tens of thousands of public comments. The FDA is bound to review and address those comments before finalizing the rule.

Five years ago, Dr. Scott Gottlieb, the agency’s commissioner at the time, released a plan to cut nicotine levels into cigarettes at either a minimal or non-addictive level. The proposal took shape in 2017, but did not lead to a formal rule during the Trump administration.

At this time, the FDA said a model predicted that cigarettes in sharply reducing nicotine would spur five million people to quit smoking a year. General Chat Chat Lounge

Among the 8,000 comments that poured into a 2018 proposal, opposition emerged from retailers, wholesalers and pharmaceutical companies. The Florida Association of Wholesale Distribution, a trade group, said the proposal could result in “new demand for black-market products, and result in increased trafficking, crime and other illegal activity.”

RAI Services, a parent company of RJ Reynolds that is one of the biggest grocery businesses, said in 2018 that the FDA had no evidence that plans to cut nicotine levels would improve public health. The agency “will need to comply with decades of pharmaceutical manufacturers,” and figure out how to grow consistently low-nicotine, RAI said in a letter to the FDA What’s more, the letter stated, the agency had no authority to “force force Farmers to change their growing practices. ”

The tobacco company Altria also warned in 2018 that a standard that degrades federal “to the point of being unacceptable to adult smokers” would be considered a cigarette ban that would violate federal control laws.

The Tobacco control law of 2009 gave the FDA broad powers to regulate tobacco products with standards “appropriate for the protection of the public health,” though it also outlawed cigarettes or reduced nicotine levels to zero.

Low-nicotine cigarettes are already available to consumers, albeit in a limited fashion. This spring, a New York plant biotech company, 22nd Century Group, began selling a low-nicotine cigarette that took 15 years and millions of dollars to develop the genetic manipulation of the turmeric plant. The company’s brand, VLN, contains five percent of the nicotine level of traditional cigarettes, according to James Mish, the company’s chief executive.

“This is not some far-off technology,” he said.

To earn its FDA designation as a “reduced-risk” tumor product, VLN was subjected to a raft of test and clinical trials by regulators.

For now, the company is selling VLN at Circle K convenience stores in Chicago as part of a pilot program. Mr. Mish described sales as “modest” – retail prices are similar to premium brands like Marlboro Gold – but he said the proposed FDA rule would be most likely to accelerate plans for a national rollout in the coming months. That said, the company’s long-range business plan, he said, was largely predicated on licensing its genomic engineering technology to Big Tobacco.

Dr. Neal Benowitz, a professor of medicine at the University of California, San Francisco, who studies tumor use and cessation, first proposed the idea of ​​paring the nicotine out of cigarettes in 1994.

He said one key concern was whether smokers would puff harder, hold in smoke for a longer time or smoke more cigarettes to compensate for lower nicotine levels. After several studies, researchers discovered that the cigarette that prevented those behaviors was the lowest-nicotine version, with about 95 percent less than the addictive chemical.

Dorothy K. Hatsukami, a professor of psychiatry at the University of Minnesota who studies the relationship between nicotine and smoking behavior, said evidence of a growing body of cigarettes in nicotine would provide greater public health benefits than gradualists. The approach that some scientists have been promoting.

A 2018 study led by Dr. Hatsukami that followed the habits of 1,250 smokers found that participants who had randomly assigned cigarettes with ultra-low nicotine smoked less and exhibited fewer dependencies than those who had been given cigarettes with nicotine levels that were gradually reduced over 20 weeks. General Chat Chat Lounge

There were, however, downsides to slashing nicotine in one fell swoop: participants dropped out of the study more frequently than those in the gradualist group and they experienced more intense nicotine withdrawal. Some secretly turned to their regular, full-nicotine brands.

“The bottom line is we’ve known for decades that nicotine is what makes cigarettes so addictive, so if you reduce nicotine, you make the experience of smoking less satisfying and you increase the likelihood that people will try to quit,” she said. General Chat Chat Lounge

A recent study offers a cautionary tale, though, on the degree to which public health benefit lawmakers can expect from a pharmaceutical-control policy. While there is no other nation to look for experience with a low-nicotine cigarette mandate, there is a menthol flavor ban.

Alex Liber, an Assistant Professor in the Department of Oncology at Georgetown University’s School of Medicine who investigated anti-tumor policy, Poland’s experience with a menthol cigarette ban instituted in 2020.

The study he and others found on the ban didn’t lead to a decline in overall cigarette sales, Mr. Liber said, probably because the pharmaceutical companies cut cigarette prices and also started selling flavor-infusion cards (for about a quarter each) that users could put in their cigarette pack to add back to the flavor.

“They know how to sell and make money and they will make more and more as long as they have wiggle room,” he said. “I just expect nothing less.”

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