The FDA is working to adjust nicotine to “non-addictive levels”


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Since its founding in 1906, the function of the Food and Drug Administration (FDA) has been to protect and promote public health by ensuring that the products placed for sale on the market are safe for consumers. But with the passage of the Family Smoking Prevention and Tobacco Control Act (FSPTCA) in 2009, for the first time in its history, the agency was faced with regulating a product that–when used as intended–kills up to half of the people who use it: tobacco.

According to a 2004 Surgeon General’s Report, smoking harms nearly every organ of the body, causing a myriad of diseases and reducing the health of smokers in general. It is responsible for nearly one out of every five deaths each year in the US and disproportionately harms behavioral health patients, as nearly 50% of the people who die each year have a mental illness.

The cost, of course, is huge: smoking accounts for more than $75 billion in direct medical costs annually.

It’s no secret that smoking is bad for you.  The Surgeon General released the first report warning of its dangers of in 1964.  Yet today, 40 million Americans are still smoking.

“Forty years have passed since the first landmark Surgeon General’s report on smoking and health. Yet, smoking remains the leading preventable cause of death in this country. It continues to cost our society too many lives, too many dollars, and too many tears,” wrote Secretary of Health and Human Services Tommy G. Thompson in 2004.

Nicotine’s addictive power

For nonsmokers, it’s always surprising that so many people smoke when the dangers are so well-known. This behavior, we know, has to do with addiction.

Nicotine is addictive because it is quickly absorbed into the bloodstream. Within 10 seconds of entering the body, nicotine reaches the brain, causing the release of adrenaline. This creates a temporary “buzz” of pleasure and energy to the consumer.

As the body builds tolerance to nicotine, it requires more cigarettes in order to achieve this effect. The body will crave more nicotine and, as with other drugs, when a smoker does not have nicotine in his or her system, they experience withdrawal. This cycle repeats over and over again, furthering the addiction.

Thus, while the initial decision to smoke a cigarette is an individual’s choice, the addictive nature of nicotine often leads to continued smoking behavior despite serious adverse health effects.  And research published earlier this year showed that people with certain genetic profiles are more likely to become quickly addicted and have more difficulty quitting.

Each day, more than 3,600 people under 18 smoke their first cigarette, and more than 900 begin smoking on a daily basis.

FDA Regulation: Where did this come from?

The concept of the FDA regulating tobacco products is nothing new. In fact, in 1994, the agency wrote a letter to the Coalition on Smoking or Health announcing its intention to consider regulating cigarettes.

The letter’s premise was that the vast majority of tobacco users self-administer the product for the drug effects of nicotine and to sustain their addiction and that cigarette manufacturers control the levels of nicotine in cigarettes to maintain this addiction.

Therefore, the FDA argued, cigarettes could be regulated on the basis of their nicotine content to prevent addiction. Today, nearly 20 years later, this possibility has come to fruition.

FDA regulation: What does it mean?

When President Obama signed the FSPTCA into law, it seemed like a big offensive move in the fight against smoking.

With more than 40 million Americans addicted to nicotine, FDA regulations could potentially curb this public health crisis. Under the FSPTCA, the FDA is able to establish product standards, which includes imposing standards for the nicotine content of cigarettes.

The FDA now has the power to reduce nicotine to “non-addictive levels” in an effort to greatly lower the number of individuals who are currently addicted and prevent many others from becoming addicted in the future.

What is a “non-addictive level” of nicotine?


Nicotine reduction is an attempt to prevent addiction, not experimentation – Credit: James Alby

A study published by the American Journal of Public Health in February 2013 found that most American adults support reducing nicotine in cigarettes to prevent people, especially children, from becoming addicted to smoking.

Researchers surveyed 511 nonsmokers and 510 smokers aged 18 and older and found that, overall, two-thirds supported reducing nicotine levels in cigarettes to non-addictive levels.

In 1994, renowned tobacco researchers Neal Benowitz and Jack Henningfield published a letter in the New England Journal of Medicine explaining that the optimal nicotine yield is less than 0.2 milligrams because it is likely below the threshold for addiction. By contrast, an average American cigarette yields about one milligram of absorbed nicotine.

They write: “The rationale behind the strategy for regulating the nicotine content of cigarettes is to prevent the development of nicotine addiction in young people. To minimize the hardship to already addicted adult smokers, the level of nicotine in tobacco could be reduced gradually, with a goal of reaching a target nicotine level over perhaps 10 to 15 years.”

While cigarettes would still be sold, they argued, the number of addicted smokers would be greatly reduced.  The goal was not to prevent experimentation or occasional smoking, but to reduce nicotine dependence, causing a substantial reduction in the rates of tobacco-related illnesses.

“It is difficult to prevent adolescents from experimenting with cigarettes,” they write. “However…it may be possible to prevent the transition from experimental or occasional smoking to addiction.”  The entire letter is worth reading; it offers a good public health perspective on smoking.

What is the next step? More research

While data have shown that cigarettes with lowered nicotine content reduce carcinogen exposure, relieve withdrawal and curb cravings, the FDA will not change the entire tobacco market without further research.

Lawrence Deyton, the FDA’s former chief tobacco regulator, told the Washington Post that in order to take steps such as dialing back the amount of nicotine in tobacco products, the agency must undertake exhaustive scientific research demonstrating that its decisions are not “arbitrary and capricious.”

Thus, researchers are looking to further study the potential effects of reducing nicotine in cigarettes and other tobacco products. One such study is being conducted at the University of Pittsburgh.

The NIDA-funded Center for the Evaluation of Nicotine in Cigarettes at the University of Pittsburgh is working to assess the potential impact of regulated reduction of the nicotine content of cigarettes as a means of improving public health.

While the study has not yet begun, it will examine the effects of reduced nicotine cigarettes on smoking behavior, toxicant exposure, dependence and abstinence.

Other preliminary research supports the feasibility and safety of gradual reduction of the nicotine content in cigarettes.

A 2013 study showed that reduced nicotine cigarettes lower cravings as well as regular cigarette

A 2013 study showed that reduced nicotine cigarettes lower cravings as well as regular cigarettes

What does it mean for the future?

Mitch Zeller, current Director of the FDA's Center for Tobacco Products

Mitch Zeller, current Director of the FDA’s Center for Tobacco Products

Ideally, once all of the research is gathered, the FDA can move forward and lower the nicotine content in cigarettes, thereby improving public health.

And while the media has been outspoken about the FDA’s lack of progress in the last two years, the appointment of long-time tobacco industry critic Mitch Zeller as director of its Center for Tobacco Products in March means we may now see more aggressive efforts to regulate tobacco products.

Before tobacco products on the market can change, however, we need a larger body of research about exactly how they should be changed.


Recommended Resources

Data on tobacco:

Family Smoking Prevention and Tobacco Control Act

The State of Tobacco Control 2013

Selected research on nicotine levels and addiction:

Smoking behavior and exposure to tobacco toxicants during 6 months of smoking progressively reduced nicotine content cigarettes

Nicotine Reduction: Strategic Research Plan

Comparing the mood-altering effects of regular and reduced-nicotine cigarettes

Dose-Response Effects of Spectrum Research Cigarettes

Reduced nicotine content cigarettes: effects on toxicant exposure, dependence and cessation

News & info on tobacco:

Tobacco Critic to Join FDA

Cigarettes Are Enlisted to Test Ways of Quitting

FDA should do more with its authority over tobacco products

Deepak Chopra: 11 Ways to Manage Nicotine Withdrawl