Advocates fear FDA blowing smoke on nicotine limits

Advocates fear FDA blowing smoke on nicotine limits

The Food and Drug Administration (FDA) is raising eyebrows with talk of cracking down on nicotine levels in cigarettes and flavored tobacco products, including menthol.

The agency on Friday said it’s planning to look at reducing nicotine in cigarettes to nonaddictive levels, a policy change that would likely have huge repercussions for the tobacco industry.


The FDA said it would issue a regulatory notice “to seek input on the potential public health benefits and any possible adverse effects of lowering nicotine in cigarettes.”

Health advocates who want tougher action against cigarettes aren’t celebrating the announcement; they say the process mapped out by the FDA could take years and express doubts the agency will ultimately follow through.

“We’re concerned about how long a product standard on reducing the addictiveness of cigarettes is going to take based on the process outlined on Friday,” said Erika Sward, a spokeswoman for the American Lung Association.

The FDA said it plans to file an Advance Notice of Proposed Rulemaking on the nicotine levels, which is the first step in a time-consuming regulatory process that must cross several hurdles, including White House approvals and public comment periods that can last for months.

The notice isn’t the FDA’s first foray into research on nicotine reduction or the effects of flavored tobacco products.

The FDA’s Center for Tobacco Products teamed up with the National Institutes of Health (NIH) in 2012 and has been funding research ever since to “better inform FDA’s regulatory authorities,” according to the NIH website.

That year, the FDA and NIH awarded a team of researchers from the University of Pittsburgh and the University of Minnesota $2.6 million in grant funding, according to NIH records, to evaluate nicotine standards for cigarettes.

Dorothy Hatsukami, a professor of psychiatry at the University of Minnesota and a member of the team, said the clinical trial’s results released in 2015 showed that a dose of 2.4 milligrams of nicotine per gram of tobacco leads people to smoke less compared to those who smoked cigarettes with normal nicotine contents of 15.8 milligrams of nicotine per gram of tobacco.

The trials further showed there were more attempts to quit smoking among the people who smoked cigarettes with 0.4 milligrams of nicotine per gram of tobacco. 

Hatsukami said the team is now looking at what approach should be taken if nicotine levels are reduced — a gradual approach or more of an immediate change where all cigarettes sold by a particular date would have to meet the new standard.

“The idea that FDA wants to have a public dialogue on existing science I think is a good one,” she said. “We should want to take a look at what the science shows in terms of public health benefits, but we also need to look at the potential adverse effects.” 

Still, Hatsukami said there are concerns that regulating nicotine could lead to a black market for traditional cigarettes.

But frustrations are growing among health groups.

Sward said the FDA has had the science and research to justify regulating menthol since 2011 but has failed to do so.

The Tobacco Products Scientific Advisory Committee, which was created by the 2009 Family Smoking Prevention and Tobacco Control Act, issued a report in 2011 recommending the FDA remove menthol cigarettes from the marketplace.

“Menthol cannot be considered merely a flavoring additive to tobacco,” the committee said in its report. “Its pharmacological actions reduce the harshness of smoke and the irritation from nicotine, and may increase the likelihood of nicotine addiction in adolescents and young adults who experiment with smoking.” 

In addition to menthol, the FDA said it plans to seek public comment on regulating flavors for cigars and e-cigarettes that critics claim are appealing to kids.

Sward said she’s glad new FDA Commissioner Scott Gottlieb is taking action, but said it needs to be done quickly to prevent a generation of children from smoking.

Gottlieb said Friday that he plans to “pursue efforts to reduce addiction to nicotine with the same vigor” as efforts to reduce addiction to opioids.

“I view our opportunity to confront addiction to nicotine with the same obligation,” he said.

Experts say any regulation, even down the road, is likely to be tied up for years in a legal fight with industry.

“The tobacco industry is going to prioritize the need to maximize shareholder value and will likely oppose anything that gets in the way of that,” said Gary Giovino, a professor and chairman of the Department of Community Health and Health Behavior at the University at Buffalo.

“If they can make more money in the new paradigm, they would support it, but personally I can’t be optimistic that will happen.”

Altria, the parent company of Philip Morris USA, which makes Marlboro, Parliament and Virginia Slims, issued a subtle warning to the FDA last week.

In a statement, the company said “any proposed rule such as a nicotine product standard must be based on science and evidence, must not lead to unintended consequences and must be technically achievable.”

“Establishing a standard of any sort is a deliberative process, with multiple opportunities for interested parties to provide perspectives,” the company said.

While the FDA’s plans for nicotine left anti-smoking groups hopeful, the agency’s delay — announced the same day — of product reviews for cigars and electronic cigarettes dampened their excitement.

The FDA said it’s giving e-cigarette manufacturers until 2022 to submit pre-market applications for products that were on the market before the new rules took effect on Aug. 8, 2016.  Manufacturers of newly regulated combustible products, including cigars, pipe tobacco and hookah tobacco, have until Aug. 8, 2021, to submit applications for market approval.

“FDA’s move today to lower nicotine levels and take a harder look at how flavored tobacco products attract the young is to be commended,” Nancy Brown, CEO of the American Heart Association, said in a statement Friday.

“However, the association is disappointed with the agency’s decision to delay certain e-cigarette and cigar compliance deadlines. Altering the deadline for FDA review of e-cigarettes and cigars is a troubling step and one that we will closely monitor.”