Big Tobacco companies and other drug manufacturers have been investigated and some products banned over the past month, as the Food and Drug Administration and executive branch prioritize regulating tobacco and tobacco ingredients as part of President Joe Biden’s cancer-fighting initiative.
Earlier this year, Biden and his staff coordinated with the FDA to propose a new rule regarding the nicotine content of cigarettes, vape pens and similar tobacco products. Drug manufacturers were told to adhere to the new maximum levels of nicotine permitted or their products would be pulled from the market and they could face legal action.
The rule is part of Biden’s “Cancer Moonshot Initiative,” a collection of policies to drastically reduce cancer deaths in the United States. While it was originally announced in 2016 during Biden’s time as vice president, the initiative was revived in February, with the aim to reduce cancer deaths by at least 50% over the next 25 years.
Aligned efforts by agencies including the FDA, the Centers for Disease Control and Prevention, and the National Institutes of Health began with a proposed ban of menthol-flavored tobacco and cigarettes. According to the FDA, there are 18.5 million menthol cigarette smokers ages 12 and older in the United States. Removing these menthol-flavored tobacco products from the market could eliminate up to 654,000 deaths over the next 40 years, health officials said.
E-cigarettes, vape pens and other electronic nicotine delivery system products are included in the nicotine restriction. Officials say products like e-cigarettes that deliver nicotine electronically are especially appealing to adolescents and young adults.
Under the rule, e-cigarette manufacturers would have to show that their products serve some kind of positive purpose, such as helping someone addicted to smoking stop.
Youthful appeal
E-cigarettes are the most commonly used tobacco product among adolescents, according to the CDC, with more than 2 million students reporting recent usage in 2021.
Like other products involving nicotine, they can be dangerous, said Dr. Emily Beck, a University of Utah pulmonologist.
“Nicotine is a very addictive substance. We know that if people are exposed to nicotine at younger ages before their brains are done developing, they tend to have more of a physiological dependence and addiction because their neural pathways are still forming,” she said.
But research into the long-term effects of vaping is not as clear as other nicotine research, Beck said.
“There’s a lot of research in the mouse model — seeing how mice react when exposed to vape particulates. These studies are showing that there are changes in the lungs of mice that are exposed to vape cigarettes, and changes in behavior on a cellular level. I just don’t know that we’re far enough along to say what impacts those have, in terms of translating to clinical outcomes or medical diagnoses,” she said.
Braden Ainsworth, program manager of the Tobacco Prevention and Control Program at the Utah Department of Health, spoke with the Deseret News about the effect e-cigarettes and their marketing have had on adolescents.
“Initially when these products came out and we were seeing a big increase in youth use, we were aware that a large part of why they were using these was because of the flavors,” he said.
Ainsworth added, “Then there were other things, like the marketing of e-cigarettes. Early on, their social marketing appealed a lot to youth. They would have influencers (promoting) the content where available. The products became more sleek, small and easier to conceal.”
Flavored addiction
The nicotine in cigarettes is addictive due to its chemical effect — more specifically, its effect on the dopamine receptors in the brain. Over time, people start to consciously and subconsciously return to the high that cigarettes give, according to the Baylor College of Medicine.
Health experts say that part of the danger that comes from menthol cigarettes is in how the body receives and processes the nicotine. The CDC reports that menthol “creates a cooling sensation in the throat and airways, making the smoke feel less harsh and easier to inhale.” That reduces the negative association with smoking for users, furthering the nicotine’s effectiveness. In short, menthol in cigarettes creates a far more appealing, and therefore addictive, drug.
According to Medical News Today, e-cigarettes deliver nicotine by a slightly different method than combustible cigarettes as the “atomizer” heats and vaporizes the e-cigarette solution. That creates vapor instead of smoke but has an effect similar to combustible cigarettes. How nicotine enters the lungs is not the only difference. The CDC reported that a single e-cigarette pod could contain the same amount of nicotine as a pack of combustible cigarettes, making the product extremely addictive.
Additionally, e-cigarettes and other products that deliver nicotine electronically may come with flavors ranging from mango to mint. While these flavors were banned due to safety concerns and their appeal to school-age children, e-cigarette manufacturers, including the popular Juul Labs, still sell menthol-flavored solutions.
Conflict over Juul
In June, the Biden administration and the FDA ordered the removal of Juul products from the market. STAT news reported that this followed failure of the manufacturer, Juul Labs, to comply with new regulations concerning nicotine and menthol in their products.
Juul Labs countered that their products were crucial to weaning smokers off of combustible cigarettes, as well as preventing a new generation of smokers.
“In our applications, which we submitted over two years ago, we believe that we appropriately characterized the toxicological profile of Juul products, including comparisons to combustible cigarettes and other vapor products,” Juul Labs said in a statement on the company website. “(We) believe this data, along with the totality of the evidence, meets the statutory standard of being ‘appropriate for the protection of the public health.’”
Some health experts don’t agree with Juul Labs’ claims, however.
Beck told the Deseret News that it is difficult to determine the proper course of action due to e-cigarettes’ malleable nature and the fact they’re relatively new compared to other tobacco products.
“There are all sorts of additives (and) different flavorings. People can modify their devices to have different heating intensities, which can change the chemical compositions,” she said. “It’s a difficult argument to make that e-cigarettes are a safe alternative to cigarettes …because it’s so new. It’s taken 50 years for us to understand all of the effects of traditionally smoked tobacco products.”
She said e-cigarettes haven’t been around long enough to know the long-term effects.
“These are such new routes of administering nicotine and there’s so much more to learn. I would be wary to recommend (e-cigarettes) as a good tobacco cessation without better research,” she said.
Ainsworth also addressed the Juul ban and the company’s claim.
“Historically, tobacco companies have pushed the idea of ‘harm reduction,’” he said. “The way that (tobacco companies) frame it is that ‘There are these other, less harmful products that our goal is to get (consumers) to switch to,’ when evidence is showing that these products still cause a level of harm.”
He noted “a little margin where somebody will switch to e-cigarettes and will parse down over time their nicotine amount, and then eventually be able to quit. But what usually happens, in our research, is that people will start using e-cigarettes and will also smoke. They’ll become what is called a ‘dual user.’”
Rule backlash
Juul Labs filed an emergency appeal in federal court immediately after the FDA banned the company’s product, claiming the ban was “extraordinary and unlawful action,” according to Drug Watch. The federal appeals court responded by placing a temporary hold on the Juul pods ban, giving the FDA until July 7 to respond to Juul Labs’ motion.
On July 5, the FDA announced a temporary stay — though not a reversal — of its ban on Juul products. The FDA tweeted, “The agency has determined that there are scientific issues unique to the Juul application that warrant additional review.”
Backlash to the Biden administration’s proposals has not come solely from drug manufacturers.
The Rev. Al Sharpton, founder and president of the National Action Network, warned of possible, unintentional consequences from the FDA’s menthol ban in a letter to Domestic Policy Council Director Susan Rice. He wrote that since 85% of menthol smokers are African American, a federal ban on menthol cigarettes would put many “at risk of racially discriminatory government action while leaving all other cigarette smokers to enjoy the product of their choice safe and at peace.”
The CDC confirms the Rev. Sharpton’s statistic in research that also shows that “approximately 40% of excess deaths due to menthol cigarette smoking in the U.S. between 1980-2018 were those of African Americans, despite African Americans making up only about 12% of the U.S. population.”
Big Tobacco has a history of marketing to Black communities, from traditional advertising in historically Black magazines, to distributing menthol cigarettes to Black influencers, according to NPR.
The Rev. Sharpton described discrimination that could occur as increased police patrolling in predominantly Black neighborhoods or arrests for possession on the basis of racial profiling. But he cited other safety risks, as well.
“The proposed rule to ban menthol would expand the illicit market for menthol cigarettes in African American communities throughout the country,” he wrote. “Specifically, there would be a number of economically challenged consumers that would not comply with the ban and instead increase engagement in less regulated (but dangerous) activities like tampering with cigarettes to create their own menthols and switching to unregulated herbal menthol cigarettes.”
Modern Prohibition?
Several Twitter users have drawn comparisons between the Biden administration’s efforts and another attempt by the federal government to restrict the consumption of a potentially addictive substance: the prohibition of alcohol in the early 1920s.
One Twitter user said, “The U.S. has just banned all Juul e-cigarettes — but why? Like all drug prohibition, this just will make life more miserable for normal Americans.”
Jack S. Blocker Jr., a retired University of Western Ontario professor and expert on Prohibition, weighed in on the ties between the 1920s and the present.
“Government restrictions … on possibly addictive substances can vary considerably according to historical conditions. That makes it hard to project patterns from one historical period to another,” he told the Deseret News.
In a 2006 study, “Did Prohibition Really Work? Alcohol Prohibition as a Public Health Innovation,” Blocker wrote that while Prohibition resulted in Americans finding alternative ways to obtain alcohol, statistics showed a significant decrease in alcohol consumption in the decades following the repeal.
“The lowered level of consumption during the quarter century following repeal, together with the large minority of abstainers, suggests that Prohibition did socialize or maintain a significant portion of the population in temperate or abstemious habits,” Blocker wrote.
Still, he added, “The possibility remains that in 1933, a less restrictive form of Prohibition could have satisfied the economic concerns that drove repeal while still controlling the use of alcohol in its most dangerous forms.”
He told the Deseret News that public opinion on a ban or restriction has greater influence on a movement than government action. During Prohibition, the popular perception of alcohol was generally negative. Had the government action been contrary to popular attitudes, “the situation could be quite different,” Blocker said.
“Any measure has to be looked at carefully in terms of the conditions present when it’s put into place, in order to be able to make any reliable estimate of the likelihood of its effectiveness,” he said.