FDA to Reduce Nicotine Levels in Cigarettes

FDA's Ambitious Plan to Reduce Tobacco-Related Disease

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In late July 2017, the FDA released a sweeping plan to regulate tobacco and nicotine products. According to the FDA, the plan “will serve as a multi-year roadmap to better protect kids and significantly reduce tobacco-related disease and death.”

Part of this plan is to reduce the nicotine concentrations in cigarettes to non-addictive levels.

Lowering Nicotine Levels in Cigarettes

The FDA has its sights trained on the much larger issue of nicotine addiction.

According to FDA Commissioner Scott Gottlieb, MD:

Because nicotine lives at the core of both the problem and the solution to the question of addiction, addressing the addictive levels of nicotine in combustible cigarettes must be part of the FDA’s strategy for addressing the devastating, addiction crisis that is threatening American families. Our approach to nicotine must be accompanied by a firm foundation of rules and standards for newly-regulated products. To be successful all of these steps must be done in concert and not in isolation.

Essentially, the FDA is trying to move people away from combustible tobacco products like cigarettes in favor of non-combustible alternatives like e-cigarettes. Although nicotine is addictive, cigarette smoke is full of disease-causing particles which lead to lung cancer, heart disease, COPD, and more. The calculus is that by lowering the nicotine levels in cigarettes, people who are dependent on nicotine won’t want to smoke cigarettes anymore and use e-cigarettes instead.

In reality, it could be years before the FDA actually lowers nicotine concentrations in cigarettes. Predictably, this move by the FDA will be met by strong resistance by the powerful tobacco lobbies. The FDA’s endgame to phase out cigarettes would serve as a major blow to beleaguered tobacco manufacturers.

Another part of the FDA’s plan is to develop a foundation “of rules and standards for newly-regulated products.” To do this, it’s delaying by either three or four years the regulation of e-cigarettes, cigars, cigarillos, and hookah (i.e., water pipe). Originally, the FDA was supposed to have already started regulating these products if not for a delay by the Trump administration.

This move to delay the regulation of e-cigarettes, cigars, cigarillos, and hookah has dismayed many public health experts. These products are made to appeal to kids and come in kid-friendly flavors, such as mint and apple, as well as kid-friendly packaging. Lots of underage kids who are new users purchase tobacco and nicotine products.

Other public health experts are excited that the FDA is linking its policies on e-cigarettes and cigarettes and is following through with the Family Smoking Prevention and Tobacco Control Act, or Tobacco Control Act, which grants the FDA the authority to regulate tobacco products. Specifically, the law finds that “nicotine is an addictive drug” and vests the FDA “with the authority to regulate the levels of tar, nicotine, and other harmful components of tobacco products.”

The Tobacco Control Act was signed into June 22, 2009 by Barack Obama.

The law mandates the FDA with the authority to regulate the manufacture, distribution, and marketing of tobacco products to protect public health. In May 2016, the provisions of this law were expanded to cover e-cigarettes and vape pens as well as cigars, pipe tobacco, gels, hookah tobacco, and future tobacco products.

Nicotine Levels in E-cigarettes

In order for the FDA’s plan to work, and for e-cigarettes to emerge as a safer alternative to cigarettes, the e-cigarettes themselves must be able to consistently deliver enough nicotine to sustain dependence. However, research shows that e-cigarettes vary widely in the amount of nicotine they deliver.

In a 2013 study titled “Nicotine Levels in Electronic Cigarettes,” Goniewicz and co-authors tested 16 popular electronic cigarette brands. They found that the amount of nicotine in vapor varies widely between 0.5 mg to 15.4 mg. (Cigarettes contain between 6 mg and 12 mg of nicotine.)

Furthermore, in electronic cigarettes tested, the amount of nicotine delivered in 15 puffs by an effective device—not all devices are effective—was less than that of a cigarette. Instead, it took between 150 and 180 puffs to deliver the nicotine using e-cigarettes. Keep in mind that it takes about 15 puffs to smoke a cigarette. In other words, it takes a lot of puffs to get the nicotine out of an e-cigarette.

Summing up

The FDA plans to lower the nicotine concentrations in cigarettes to phase cigarettes out in favor of e-cigarettes, which don’t involve disease-causing smoke particles. This move should substantially reduce tobacco-related disease and death.

However, this change could take several years and will likely be met by steep opposition from tobacco lobbies. Furthermore, in order to take enough time to set the foundation for this grand plan, the FDA is postponing regulation of e-cigarettes, cigars, cigarillos, and hookah. Many of these products appeal to kids and pose a threat to public health. Finally, current e-cigarettes don’t consistently deliver nicotine to users, which compromises their efficacy.

Sources:

FDA. Family Smoking Prevention And Tobacco Control Act.

FDA News Release. FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death.

Goniewicz, ML, et al. Nicotine Levels in Electronic Cigarettes. Nicotine & Tobacco Research. 2013; 15:158-166.

Office of the Federal Register. Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products. https://www.federalregister.gov.

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