Will the FDA’s proposed nicotine regulations end smoking in the United States?

Earlier this month, the US Food and Drug Administration proposed regulations that would set maximum nicotine levels for cigarettes and other tobacco products.

By requiring companies to reduce nicotine in cigarettes to non-addictive levels, the regulations would be one of the most significant efforts to reduce smoking in the United States in decades and would deal a major blow to the tobacco industry. of $95 billion.

“Nicotine is highly addictive,” FDA commissioner Robert Califf said in a statement. “Lowering nicotine levels to minimally addictive or non-addictive levels would reduce the likelihood of future generations of young people becoming addicted to cigarettes and would further help currently addicted smokers to quit.”

Left to right: Richard Daynard, distinguished Northeastern University law professor and president of the Public Health Advocacy Institute; and Miki Hong, adjunct adjunct professor of public health and health equity at Mills College. Photo by Alyssa Stone/Northeastern University and courtesy photo

The FDA has said it intends to publish the rule by May 2023, but the process of adopting a rule like this requires a years-long process of public comment and legal action. Prominent North East law professor Richard Daynard predicts the proposal will become law by 2027, but he says the tobacco industry will not collapse without a fight.

“They’re not going to like it,” Daynard says of cigarette manufacturers.

Cigarette companies, their initial response is, ‘Well, that’s not really a cigarette. Nobody’s gonna smoke those damn things,’ says Daynard, who has been engaged in tobacco litigation for years and is now president of Northeastern’s Public Health Advocacy Institute.” Well, that may be true, but the question is whether they have the right to sell a dangerous, deadly, and addictive product on the theory that if it is not dangerous, deadly and addictive, no one will use it? I don’t think that’s a good argument.

Although nicotine itself is not directly responsible for cancer or lung disease – these are the result of carcinogens released by the burning of the tobacco leaf – the highly addictive nature of nicotine encourages people to smoke. , increasing their risk of negative side effects. According to the FDA, smoking is the leading cause of preventable disease and death in the United States. Each year, 480,000 people die prematurely from a smoking-related disease, more than AIDS, alcohol, illegal drug use, homicide, suicide and traffic accidents combined. , according to the FDA.

“This is a truly groundbreaking proposal that would accelerate the decline in tobacco use and save millions of lives from cancer and other tobacco-related diseases,” said Matthew Myers, president of Campaign for Tobacco-Free Kids, in a statement. “But these gains will only be realized if the administration and the FDA demonstrate an unqualified commitment to finalizing and implementing this proposal.”

The number of smokers in the United States is falling, and by drastically reducing nicotine levels, the FDA hopes that number will drop even further – and it has good reason to believe it will work.

FDA-funded research found that smokers who used cigarettes with 95 percent less nicotine than a regular cigarette, which contains 10 to 15 milligrams of nicotine per gram of tobacco, smoked fewer cigarettes and became less addicted. They were also more likely to try to quit, which about 55% of adult smokers are currently trying to do, according to the FDA. Only 4 to 7% succeed. The FDA is not at the stage of announcing what the maximum nicotine level would be, but the World Health Organization has found that cigarettes containing 1-2 milligrams per gram of tobacco are minimally addictive.

“Cigarettes are the most addictive of all nicotine delivery systems,” says Miki Hong, adjunct assistant professor of public health and health equity at Mills College, which is set to merge with Northeastern on July 1. “It’s a big problem because if they limit the amount of nicotine, [cigarettes] won’t be as addictive. And if they’re not as addictive, then ultimately it comes down to profit, because it means less cigarettes smoked, [more] lives saved and ultimately less profit for the tobacco companies.

The research, which was published in the New England Journal of Medicine in 2018, predicted that by 2100, if the regulations were passed, more than 33 million people would avoid becoming regular smokers and that there would be around 8 million fewer tobacco-related deaths.

But reducing the nicotine levels in traditional cigarettes isn’t the only tactic the FDA needs to take to curb smoking. The tobacco industry has made an art of marketing, designing and selling cigarettes, Hong says, and companies have found ways to target every market imaginable.

“These products, these nicotine delivery systems, these cigarettes, they were specifically designed, engineered and marketed to ameliorate addiction,” Hong said. “They’ve kicked things into high gear by creating the perfect cigarette for every market they can think of for their profit. When you remove this nicotine from all markets, what will they be left with? »

The FDA is already considering an outright ban on menthol cigarettes, which account for more than a third of cigarette sales in the United States. Menthol cigarettes also accounted for 81% of cigarettes used by black smokers in 2020 and have been “culturally adapted” to black communities, Hong says. The minty taste, aroma and cooling sensation of menthol ease mouth and throat irritation, making them easier to smoke, especially for young people and novice smokers. The most recent report from the US Surgeon General found that 87% of adult smokers start smoking before the age of 18.

At the same time, the FDA is focusing on cracking down on e-cigarette use. Earlier this month, the FDA denied e-cigarette maker Juul’s request to sell its products and ordered the vaping company to pull its products from the US market. Juul appealed the FDA’s decision to a federal appeals court and won a temporary stay.

Daynard predicts that the tobacco industry will fight tooth and nail every step of the way to prevent the FDA from passing these regulations. He says companies will likely use some of the same arguments they’ve used for years: that such a drop in nicotine levels will force smokers to go cold turkey, preventing them from making the choice to quit. .

“Their defense in legal disputes is often, ‘The smoker made a choice [to smoke]”” says Daynard. “Well, okay, whoever still smokes their cigarettes [after this regulation is passed] will actually make choices. The idea that “Oh my god, you can’t take nicotine out because it gives smokers a choice” isn’t going to sound very good.

The FDA will have to contend with a billion-dollar industry that constantly pressures policymakers and cooks up new ways to sell to smokers, but Hong says the regulations are worth fighting for. Comparing it to the first statewide indoor smoking bans, Hong says the latest FDA regulations would have a seismic impact on the country’s public health.

“When they made this switch between exposure to second-hand smoke in the workplace and restaurants… at the time, it was a big deal to annoy smokers,” Hong says. “It’s the same idea. The fallout will be significant from this lowering of nicotine [policy].”

For media inquiriesplease contact Shannon Nargi at [email protected] or 617-373-5718.

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