The FDA’s demonization of ncotine harms consumers and people who want to quit smoking
- Lindsey Stroud
- Jun 29, 2022
- 3 min read
Lindsey Stroud

The U.S. Food and Drug Administration (FDA) continues to play whack-a-mole on tobacco policies. The leading regulatory agency that oversees everything from food staples to pharmaceuticals to tobacco products still can’t understand that smoking rates are at all-time lows and continues with prohibitionist policies it likes to call “product standards.”
Earlier this year, the FDA announced new “product standards” that seek to eliminate menthol in combustible cigarettes and flavors in cigars. Now, the agency is doubling down in the form of taking on nicotine, and in doing so, is sowing nothing but confusion to the population that continue to smoke without understanding that there are less harmful forms of nicotine.
On June 21, the Biden administration announced they would push the FDA to develop a new product standard requiring manufacturers to “reduce the addictiveness of cigarettes and certain other combusted tobacco products.”
FDA Commissioner Robert Califf stated that reducing nicotine in combusted tobacco products “would help save lives … [and] would decrease the likelihood that future generations of young people would become addicted to quit and help more currently addicted smokers to quit.”
While attempting to reduce the number of people who smoke is commendable, there is scant evidence that lower nicotine cigarettes will reduce the number of smokers.
While there are studies indicating the efficacy of nicotine reduction mandates, there are also studies finding no real-life difference in smoking patterns. There are also no studies that examine the effects of ridding the marketplace of current regulated products and the more-than-likely chance of unscrupulous actors.
But, most alarmingly about the proposal is the demonization of nicotine and this bit of irony from the agency that was given regulatory authority over tobacco products to stem the misinformation of reduced risk tobacco products.
In 2009, when Congress passed the Family Smoking Prevention and Tobacco Control Act, it was purported that “consumers have misinterpreted advertisements in which one product is claimed to be less harmful than a comparable product, even in the presence of disclosures.” By reducing nicotine in cigarettes – but not the toxic tar and harmful smoke – the FDA is misleading the public on the harm posed by nicotine.
While nicotine is addictive, it is not the ingredient in combustible cigarettes which cause the most harm. In fact, it is the burning of tobacco that is to blame for the disease and death caused by cigarettes. A single combustible cigarette contains nearly 700 ingredients and when ignited, create more than 7,000 chemicals. It is this smoke (and chemicals) which is directly responsible for cardiovascular and respiratory disease, numerous forms of cancer, and other health ills related to smoking. It is not nicotine. Nicotine does not cause cancer, nor does it contribute to the development of pulmonary disease or cardiovascular disease.
Despite this clear science, Americans are completely misinformed of the risks of nicotine. A 2017 national survey of adults found that 53 percent of participants believed that “nicotine causes most of the cancer related to smoking.” More alarmingly, a 2020 study of more than 1,000 U.S. physicians found that more than 80 percent believed that nicotine “directly contributes” to the development of cardiovascular disease, chronic obstructive pulmonary disease (COPD), and cancer.
The demonization of nicotine is troublesome and is harming adult consumers. The nation’s so-called leading health authority should examine cases around the world in which tobacco harm reduction products that contain nicotine are embraced, rather than demonized.
In fact, Japan is an excellent model in comparing the effects of low-nicotine cigarettes and the role of novel tobacco products in creating a cigarette-free society.
Studies as far back as 2001 have examined the effects of low-nicotine cigarettes, with one study finding that among Japanese users of regular and low-nicotine cigarettes, “actual levels of nicotine intake bore little relation to advertised nicotine yield levels.” Another 2004 study of Japanese smokers of both products found that nicotine levels “in heavily dependent smokers was consistently high regardless of the nicotine yield of brands.”
Japan has significantly reduced smoking rates in recent years and this is directly linked to the introduction of novel tobacco harm reduction products, including e-cigarettes and heated tobacco products. In fact, a 2020 study by the American Cancer Society remarked that heated tobacco products “likely reduced cigarette sales in Japan.”
Rather than creating more black markets with shoddy product standards that are thinly veiled prohibitionist policies, the FDA ought to work on accelerating marketing authorizations for tobacco harm reduction products which have already proven effective in reducing the harms of combustible cigarette use.
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