FDA Will Announce Nicotine Limit for Cigarettes

According to multiple sources, the FDA is expected to announce this week that it will formally propose a rule mandating that cigarettes contain a nicotine level too low to sustain addiction. While details of the rule are unknown, it is expected that under the new FDA standards, the only legal combustible cigarettes would be so-called very low nicotine (VLN) cigarettes, which contain about five percent as much nicotine as standard cigarettes.

The rule is not expected to apply non-combustible products like vapes, nicotine pouches or smokeless tobacco. 

The rule passed review by the Biden White House’s Office of Management and Budget (OMB) earlier this month. Implementation of the final rule, however, would require buy-in from the incoming Trump administration, which could also quash the proposal. 

Under the Congressional Review Act, any administrative rule issued 60 working days (or sooner) before an outgoing administration turns over power can be returned to pre-rule status by congressional resolution. The new administration could then simply remove it from consideration.

Even if Trump allows the rule to go forward, it would take at least a year to implement, and probably longer. And lawsuits by the tobacco industry could put the rule on hold, potentially for many years.

How would a very low nicotine (VLN) cigarette rule work?

Each standard American cigarette contains between 7.5 and 13.4 milligrams of nicotine. VLN cigarettes contain just one-twentieth as much nicotine—about a half-milligram per cigarette. The amount is so small that users are unable to obtain enough nicotine to satisfy their cravings, no matter how much they smoke. Even constant puffing would not provide enough nicotine.

Research suggests that users quickly tire of trying to satisfy their nicotine urges by smoking more, and seek other sources of the drug.

In theory, cigarette users would quickly turn to other sources of nicotine—like vapes, nicotine pouches, smokeless tobacco, or nicotine gum—that are much less harmful than smoking, or quit entirely. Of course, that assumes that an illegal market for standard cigarettes wouldn’t immediately pop up to provide smokers the cigarettes they’re accustomed to.

Will there be a market for very low nicotine cigarettes?

It is expected by many experts that a very low nicotine mandate would result in a massive black market of standard cigarettes that could rival the black market for alcohol that resulted from Prohibition in the 1920s. Such an outcome would be an enforcement nightmare, and could create new organized crime groups and strengthen existing ones. 

There is just one company currently selling commercial VLN cigarettes:  22nd Century Group, which produces cigarettes under the VLN brand in both unflavored and menthol varieties. The company has struggled to stay afloat in recent years, as cigarette consumers have shown no interest in 22nd Century's products. (The term "VLN" has been used generically to describe all very low nicotine cigarettes for longer than 22nd Century has used VLN as a brand name.)

In 2019, 22nd Century received FDA authorization for its very low nicotine cigarettes (originally using the Moonlight brand) through the premarket tobacco application (PMTA) pathway, and in 2021 the agency granted the product a modified risk (MRTP) designation. 22nd Century began test-marketing the cigarettes, branded as VLN, in 2022. Since then the company has seen its stock value sink, and has been forced to engineer several gimmicky “reverse stock splits” (in which shares are combined to artificially raise the stock price) to remain listed on the NASDAQ stock exchange. 

Are VLN cigarettes safer than standard cigarettes?

In a press release issued Monday, 22nd Century crowed about its dedication to health and “nicotine harm reduction.” But the only way VLN cigarettes provide a public health dividend is if consumers don’t smoke them.

VLN cigarettes are no less harmful than any other cigarette—because the dangerous substance in cigarettes is not nicotine, but the smoke itself. It is the thousands of chemicals and gasses created by burning tobacco that cause the heart and lung disease and cancer that kills millions of people each year. 

Consuming nicotine without smoke poses very little risk for most people. By authorizing 22nd Century’s very low nicotine cigarettes and giving the company license to claim its deadly cigarettes pose less risk than others, the FDA has turned the concept of harm reduction on its head, and led to further demonization of non-combustible nicotine products.

The only benefit a VLN cigarette rule may arguably provide is the likelihood that future generations would not become addicted to smoking. However, in the United States, teenage smoking is practically extinct already.

History of the very low nicotine rule

The tobacco industry successfully lobbied Congress to prevent the FDA Center for Tobacco Products (CTP) from eliminating all nicotine in cigarettes. That’s why the Family Smoking Prevention and Tobacco Control Act (TCA) only allows the agency to reduce nicotine content and not to remove it. 

By the time the TCA passed in 2009, the idea of drastically lowering nicotine content in cigarettes had already been discussed in tobacco control circles for at least 15 years. It remained something of a tobacco control fantasy until the first Trump administration provided a powerful advocate.

Scott Gottlieb, Donald Trump’s first FDA Commissioner, made a VLN cigarette mandate a pillar of his “comprehensive approach” to nicotine and tobacco regulation, announced in June 2017. Another element of the plan was to ban menthol cigarettes and flavored cigars.

In Gottlieb’s scheme, the FDA would authorize a variety of nicotine vaping products that smokers could use to substitute for cigarettes, and he postponed the deadline for PMTA submissions for vapes to give the agency time to “make the product review process more efficient, predictable, and transparent for manufacturers.”

A year later, Gottlieb’s FDA published an advance notice of rulemaking for the very low nicotine standard. However, the commissioner soon became consumed by the Juul panic, and both the VLN standard and the plan to create reasonable vaping product standards (along with the menthol cigarette ban) were apparently abandoned. Gottlieb resigned from the agency in spring 2019 for "personal reasons."

But tobacco control hardliners in the FDA had not given up on the VLN mandate, and in April 2021 it was reported that the Biden administration would carry on with the plans to reduce nicotine in cigarettes and ban menthol cigarettes. In June 2022, the agency formally announced its plan to impose a very low nicotine standard. (The FDA had issued a draft rule banning menthol cigarettes and flavored cigars two months earlier.)

President Biden put both the VLN rule and the menthol ban on hold during the 2024 election year—despite pressure from FDA Commissioner Robert Califf—for fear of scaring away voters who smoke. But with Biden’s loss in November, and his almost-certain political retirement, the restrictive VLN rule has made a sudden, last-minute comeback (the menthol ban, however, has apparently been permanently abandoned).

Now it will be up to incoming president Donald Trump and his health team to decide whether to pursue the prohibitionist policy. Part of the reason for proposing the rule with a week left in Biden’s term may be to embarrass the new President by forcing him to jettison a rule that would punish Big Tobacco. 

Newport and Camel cigarette (and Vuse vape) manufacturer R.J. Reynolds was Trump’s single largest corporate campaign donor, according to Forbes. Protecting the tobacco industry by dumping the nicotine standard would certainly provide Democrats with fodder to criticize Trump.

We will update this story when details of the FDA rule become available.