FDA Proposes Nicotine Limit for Cigarettes and Other Tobacco

The FDA today announced a formal proposal to reduce nicotine in cigarettes and other combustible tobacco products below addictive levels. Under the rule, if it is finalized, 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.

In addition to cigarettes, the rule would apply to cigarette tobacco, roll-your-own tobacco, most cigars, and pipe tobacco. It would not apply to expensive, hand-rolled (“premium”) cigars or hookah tobacco (shisha).

The rule would also not apply to non-combustible products like vapes, nicotine pouches, heated tobacco products, 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 nearly three years to implement, and probably longer. And lawsuits by the tobacco industry could put the rule on hold—potentially for many years.

In its press release issued today, the FDA said it will accept public comment on the proposal beginning tomorrow, Jan. 16, until Sept. 15. After the public comment period, the agency would review comments and then create a final rule. After the final rule is published, there would be a two-year period before enforcement begins.

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

The FDA proposal would limit nicotine content in the affected products to 0.7 milligrams per gram, which is about four percent of the average 17.2 mg/g content in the top 100 cigarette brands.

Each standard American cigarette contains between 7.5 and 13.4 milligrams of nicotine. The amount of nicotine in a VLN cigarette 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, or quit nicotine entirely.

In theory, cigarette users would quickly turn to less-risky nicotine products, like vapes, nicotine pouches, smokeless tobacco, or nicotine gum. Of course, that theory assumes that an illegal market wouldn’t immediately pop up to provide smokers the standard cigarettes they’re accustomed to. 

The new prohibition will bring a new black market

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 created by the Prohibition in the 1920s. Such an outcome would be an enforcement nightmare, and could create new organized crime groups and strengthen existing ones. 

The FDA doesn’t believe that an illicit market would be “significant enough to outweigh the benefits of the product standard,” and is counting on federal, state and local police authorities to enforce against a black market anyway. However, cigarettes are produced around the world, and police have never proven able to stop committed smugglers and sellers of alcohol or illegal drugs in the past. The FDA’s response is, essentially, “not our problem.”

The FDA will not punish individuals who possess or use illegal standard cigarettes, but local authorities will make their own laws that may apply to individuals who, for example, possess certain quantities or give them to friends.

Smaller illicit markets for products like pipe tobacco are likely to arise too.. Will the entire hobbyist pipe economy—pipe shops, hand-carved pipes, locally blended and imported tobaccos—instantly crumble, or will this small segment of the tobacco market simply be ignored by the FDA and local authorities?

Will there be a market for very low nicotine cigarettes? 

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. 

(Note: 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. However, the FDA now refers to VLN cigarettes as “VLNC” (very low nicotine content) cigarettes, presumably to distinguish between all VLN cigarettes and the 22nd Century VLN brand.)

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. 

It's not known if the major tobacco companies will produce VLN versions of their popular brands. If they don't believe smokers will adopt them, they may focus their future on non-combustible alternatives while fighting the FDA in court (which could go on for many years). If they do, each new cigarette will require a PMTA submission.

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. Trump and his advisors have not commented on the proposal, and their positions on tobacco regulation aren't known. Trump himself has historically opposed smoking, but it's not clear if his distaste for cigarettes would mean support for restrictive laws.

Part of the reason for proposing the rule with less than a week left in Biden’s term may be Democrats' desire to embarrass the new President by forcing him to jettison a rule that would benefit public health and punish Big Tobacco. R.J. Reynolds, the manufacturer of Newport and Camel cigarettes (and Vuse vapes), was Trump’s single largest 2024 corporate campaign donor, according to Forbes. Protecting the tobacco industry by dumping the nicotine standard would certainly provide Democrats with fodder to criticize Trump.