Cigarette Nicotine Cuts Proposed in Last-Minute FDA Rule (3)

The FDA is pushing ahead with its plan to slash nicotine levels in cigarettes, a move aimed at reducing the addictiveness of the combustible products.

The proposed rule (RIN 0910-AI76) announced Wednesday by the Food and Drug Administration would establish new requirements by setting a maximum nicotine content level of 0.70 milligrams of nicotine per gram of total tobacco in certain products. It would lower youth use, addiction, and death from smoking cigarettes, according to the agency.

Nicotine yield is the amount of nicotine in smoke, or, the amount of nicotine to which a smoker potentially is exposed. The FDA gave a comparison, which said the average nicotine content in the top 100 cigarette brands for 2017 is 17.2 mg/g of total tobacco.

If finalized, the rule is expected to affect major tobacco companies including Altria Group Inc. and British American Tobacco PLC—leading cigarette manufacturers that fuel an industry worth billions.

Altria slid 1% as of 1:11 p.m. in New York Wednesday. London-listed British American Tobacco dropped 0.4% on the day.

“Multiple administrations have acknowledged the immense opportunity that a proposal of this kind offers to address the burden of tobacco-related disease,” FDA commissioner Robert M. Califf said in a statement. “This action, if finalized, could save many lives and dramatically reduce the burden of severe illness and disability, while also saving huge amounts of money.”

The incoming Trump administration will decide whether the nicotine proposal, which was floated under his first term, moves forward.

Trump’s Role

President-elect Donald Trump has vowed to “save vaping,” or the use of e-cigarettes. Many individuals use vapes because they deliver nicotine without some of the harmful effects of smoking combustible cigarettes.

“If there’s a goal to ‘Make America Healthy Again,’ I can’t imagine anything more important to get done than this,” Califf said in a press call Wednesday.

Over 480,000 people die prematurely from a smoking-related disease each year, making tobacco use the leading cause of preventable disease and death in the US, the FDA says. However, cigarette smoking among adults has declined over the past decades.

The rule would apply to cigarettes, cigarette tobacco, roll-your-own tobacco, most cigars, and pipe tobacco. It would exclude e-cigarettes, nicotine pouches, noncombusted cigarettes, waterpipe tobacco, or hookah, smokeless tobacco products, and premium cigars.

The Biden administration announced in 2022 its plans to issue the proposed rule. But even before that, the FDA introduced the agenda in March 2018 under then-FDA Commissioner Scott Gottlieb. The agency dropped the plans when Gottlieb left the agency in 2019.

The current proposal gained support from health groups including the American Lung Association, the Campaign for Tobacco-Free Kids, and the American Heart Association
“Establishing a nicotine standard has the potential to profoundly alter the trajectory of tobacco use in this country,” said Nancy Brown, CEO of the American Heart Association. “We hope the new presidential administration will prioritize efforts to reduce the use of all tobacco products with an early focus on combustible products.”

“The tobacco industry has long engineered and manipulated its poisonous products to enhance addictiveness,” Lisa Lacasse, president of the American Cancer Society Cancer Action Network, said in a statement. “The proposed rule, supported by strong, sound scientific research, would greatly accelerate progress in reducing tobacco-related disease and death.”

The current effort comes after the Biden administration delayed its attempt to ban menthol cigarettes and flavored cigars. The FDA was slated to finalize the ban last year, but halted plans to weigh “an immense amount of feedback.”

The proposed rule also comes the same week a federal court blocked the FDA’s authority to enforce its new labeling and advertising requirements for cigarette manufacturers that require health warnings and graphic depictions of health dangers.

A ‘Misguided’ Regulation

The proposal faces opposition from major tobacco companies as it’s predicted to lower the addictiveness of the nicotine in cigarettes that could lead to less product purchases.

“This proposed rule is unnecessary, lacks scientific support, is fundamentally flawed, and will fuel illicit markets in unregulated products,” David Sutton, director of corporate communications for Altria, said in a statement.

“Instead of prohibition, we urge the FDA to authorize smoke-free products, effectively regulate the marketplace by removing illegal disposable vapor products and encourage adult smokers to transition to a smoke-free future.”

The industry emphasized that smoking rates are at a historic low and argued that a nicotine reduction will not make the products less risky or improve public health.

“These actions 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,” said Luis Pinto, vice president of corporate communications at Reynolds American Inc.

“Instead of focusing on prohibitionist policies, FDA should focus its resources on authorizing potentially reduced risk products that exist today but continue to languish at the agency—many for more than four years.”

The National Association of Tobacco Outlets, a national retail trade association that represents more than 66,000 stores throughout the US, also finds the proposed regulation “misguided.”

“It will have a significant negative economic impact to regulated and licensed retailers which will include significant lost revenue, coupled with job losses across the country,” David Spross, executive director of the association, said in a statement. “This proposal will also increase criminal activity by creating a huge illicit market of traditional cigarettes.”