FDA seeks to reduce nicotine levels in cigarettes

The Food and Drug Administration plans to require tobacco companies to reduce the amount of nicotine in traditional cigarettes to make them less addictive and reduce the toll that kills 480,000 people every year.

This proposal, which could take years to implement, would place the United States at the forefront of global anti-smoking efforts. Only one other country, New Zealand, has put forward such a plan.

The headwind is strong. Tobacco companies have already indicated that any plan to significantly cut nicotine would break the law. And some conservative lawmakers might see such policies as yet another example of an abuse of power, a weapon that could spill over into the midterms.

A few details were released on Tuesday, but According to a notice issued by the US government Web site, the proposed rule will be published in May 2023 for public comment on setting maximum levels of nicotine in cigarettes and other products. “Because tobacco-related harm primarily results from dependence on products that continually expose consumers to toxins, the FDA will take these actions to reduce dependence on certain tobacco products, thereby giving consumers more options to quit,” it says. in the notification.

The FDA declined to provide further information. But in statement posted on website, Dr. Robert M. Califf, an agency commissioner, said: “Reducing nicotine levels to minimally addictive or non-addictive levels will reduce the likelihood that future generations of young people will become addicted to cigarettes and will help more addicted smokers quit. “.

Similar plans have been mooted to reduce Americans’ addiction to tobacco products, which coat the lungs in tar, release 7,000 chemicals, and lead to cancer, heart and lung disease. Nicotine is also available in e-cigarettes, gummies, patches and lozenges, but these products will not be affected by this offer.

“This single rule could have the biggest public health impact in the history of public health,” said Mitch Zeller, the recently retired director of the FDA Tobacco Center. “That’s the scale and scope that we’re talking about here because tobacco use remains the leading cause of preventable disease and death.”

About 1,300 people die prematurely each day from smoking-related causes, according to the Centers for Disease Control and Prevention.

However, the obstacles to such a plan are formidable and could take years to overcome. Some plans that have been made public call for a 95 percent reduction in the amount of nicotine in cigarettes. Experts say this could send approximately 30 million U.S. smokers into a state of nicotine withdrawal, which includes arousal, difficulty concentrating and irritability, and cause others to seek alternatives such as e-cigarettes. They deliver nicotine without most of the chemicals found in combustible cigarettes.

Experts say determined smokers may try to buy high-nicotine cigarettes from illegal markets or overseas in Mexico and Canada.

The FDA will likely have to overcome resistance from the tobacco industry, which has already begun to provide reasons why the agency cannot turn the $80 billion market. Legal issues can take years to resolve, and an agency can give the industry five or more years to make changes.

Efforts to lower nicotine levels follow a proposed rule announced in April that would ban menthol-flavored cigarettes, which black smokers love. The proposal has also been hailed as a potentially significant public health achievement and has already attracted the attention of tens of thousands public comments. The FDA is required to review and resolve these comments before finalizing a rule.

Other major tobacco initiatives, set out in the landmark Tobacco Control Act of 2009, have been slow to take shape. The lawsuit set aside the requirement for tobacco companies to display pictorial warnings on cigarette packs. And the agency recently said it would take another year to make key decisions about which e-cigarettes could stay on the market.

Marlboro’s maker Altria, a tobacco company, said in a statement that provides a preview of the arguments that opponents are expected to make against any rule that drastically reduces nicotine levels. “The focus should not be so much on withdrawing products from adult smokers as on providing them with a credible market for FDA-approved, smoke-free, harm-reduced products,” the company said in a statement Tuesday. “Today marks the beginning of a long-term process that must be scientifically sound and take into account potentially serious unforeseen consequences.”

RAI Services, the parent company of RJ Reynolds, declined to comment on the statement, but said, “We believe tobacco harm reduction is the best way to reduce the health impact of smoking.”

“Both an explicit ban and a de facto ban would have the same effect—both would defeat Congress’ explicitly stated goal of “allowing the sale of tobacco products to adults,” RAI Services said in a 2018 letter to the FDA about the earlier proposal.

Five years ago Dr. Scott Gottlieb, the agency’s commissioner at the time, unveiled the plan to reduce nicotine levels in cigarettes to minimal or non-addictive levels. The proposal took shape in 2017 but did not result in a formal rule under the Trump administration.

Among 8000 Comments that resulted in this proposal, there was opposition from retailers, wholesalers and tobacco companies. Florida Wholesale Association, trade group, said it might lead into “new demand for black market products and lead to an increase in human trafficking, crime and other illegal activities”.

In 2018, RAI Services stated that the FDA had no evidence that a plan to lower nicotine levels would improve public health. The agency “will take decades for tobacco manufacturers to comply” and figured out how to consistently grow low-nicotine tobacco. RAI said letter to FDA, Tobacco Control Act of 2009 gave the FDA broad powers regulate tobacco products with standards “appropriate for the protection of public health”, although the law specifically outlawed the prohibition on cigarettes or reduced nicotine levels down to zero.

Low nicotine cigarettes are already available to consumers, albeit in limited quantities. This spring, New York-based biotech company 22nd Century Group began selling reduced-nicotine cigarettes that took 15 years and tens of millions of dollars to develop by genetically manipulating the tobacco plant. According to James Misch, the company’s chief executive, the company’s VLN brand contains 5% nicotine compared to conventional cigarettes.

“It’s not some distant technology,” he said.

In order to achieve FDA designation as a reduced-risk tobacco product, VLN has undergone numerous trials and clinical trials by regulatory agencies.

The company is currently selling VLNs at Circle K convenience stores in Chicago as part of a pilot program. mr. Misch described sales as “modest” – retail prices are similar to premium brands like Marlboro Gold – but he said the FDA proposal would likely speed up plans for a national rollout in the coming months.

Dr. Neil Benowitz, professor of medicine at the University of California, San Francisco, who studies tobacco use and smoking cessation, first came up with the idea quitting nicotine in cigarettes in 1994.

He said one of the main concerns was whether smokers would inhale harder, hold their smoke longer, or smoke more cigarettes to compensate for lower nicotine levels. After several studies, the researchers found that the cigarette that prevented this behavior was the lowest nicotine version, about 95 percent less of the addictive chemical.

Dorothy K. Hatsukami, professor of psychiatry at the University of Minnesota who studies the relationship between nicotine and smoking, says growing evidence suggests that rapidly and significantly reducing the nicotine content of cigarettes will provide greater public health benefits than the gradual approach that has been promoted some scientists.

2018 study led by Dr. Hatsukami, who followed the habits of 1,250 smokers, found that participants randomly assigned to ultra-low nicotine cigarettes smoked less and showed fewer signs of addiction than those given cigarettes with nicotine levels that gradually declined over 20 weeks. .

However, reducing nicotine in one fell swoop also had drawbacks: participants dropped out of the study more often than in the gradualist group, and they experienced more intense nicotine withdrawal. Some have secretly turned to their regular full nicotine brands.

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

However, a recent study offers a cautionary tale about the extent of the public health benefits that lawmakers can expect from tobacco control policies. While there is no other country to turn to for expertise on low nicotine cigarettes, there is a ban on menthol flavor.

Alex Lieber, Associate Professor of Oncology at Georgetown University School of Medicine who studies tobacco control policy, studied Poland’s experience with the 2020 menthol cigarette ban.

In the study, he others wrote found that the ban did not reduce overall cigarette sales. Lieber said it’s likely because tobacco companies have lowered the price of cigarettes and also started selling flavor cards (for about a quarter each) that users can put in a pack of cigarettes to bring back the flavor. (Some experts say any move to sell flavor cards in the US is likely to be illegal.)

“They know how to sell and make money, and they will make more and more as long as they have some wiggle room,” he said. “I just don’t expect anything less.”

Zolan Kanno-Youngs contributed a report from Washington.