Jeffrey A. Singer
Researchers at the University of California-Davis released a study last month on three popular, currently illegal disposable pod vapes: ELF Bar, Esco Bar, and Flum Pebble. They found that certain heavy metals, such as antimony, chromium, copper, lead, nickel, and zinc, were present in the aerosols, some of which can be toxic or carcinogenic and are at unsafe levels. These metals likely originated from the devices’ heating coils. The researchers also identified leaded bronze in the non-heating device parts that contact the liquid source. This practice has been illegal in the US since 2014. All three products are manufactured in China. Given the popularity of these vapes among teens, the researchers expressed understandable concern about their long-term health effects.
In 2009, Congress gave the FDA authority to regulate tobacco. In 2016, the FDA expanded that authority to include vapes and other nicotine products through its Deeming Rule. The FDA requires manufacturers to submit a premarket tobacco product application (PMTA). After review, the agency determines whether these products can be legally sold. To date, the FDA has approved only four disposable pod vapes, all of which are NJOY brand devices made by a division of Altria Corporation. The FDA examined NJOY for metals in its aerosol as part of the PMTA process.
Although it detected many of the same metals, it concluded, “the overall toxicological risk to the users of the new products is lower compared to combusted cigarette smoke due to significant reductions in aerosol harmful and potentially harmful constituents (HPHCs) from the new products compared to cigarettes.” It continued:
Importantly, the FDA considered the risks and benefits to the population as a whole, including users and non-users of tobacco products, including youth. This included review of available data on the likelihood of use of the product by young people. For the authorized products, the FDA determined that the potential benefit to adult cigarette smokers who switch completely or significantly reduce their cigarette use, would outweigh the risk to youth—provided that the company follows post-marketing requirements to reduce youth access and youth exposure to their marketing.
Some health professionals, driven by an aversion to nicotine in any form (which I call “nicotinophobia”), are using the recent study to advocate for stricter restrictions on nicotine replacement products. However, they should view the study in the proper context.
In 2019, Congress authorized the FDA to enforce “Tobacco 21,” which made it federally illegal for retailers to sell tobacco or tobacco products—including disposable vapes, e‑cigarettes, and nicotine pouches—to anyone under age 21.
None of the three products the UC-Davis researchers tested is FDA approved. If young people get them, they do so on the black market. Legal retailers enforce age restrictions. In a legal market, manufacturers are liable and responsible for any harm their products may cause to consumers, and they face competition from other manufacturers regarding product safety. This is another example of how prohibition only makes products more dangerous.
Ironically, efforts to crack down on youth vaping may have worsened the problem in the past. As Michelle Minton reported in a 2020 study, the moral panic over vaping caused Congress to expand the FDA’s authority over marketing these products. It led then-FDA Commissioner Scott Gottlieb to declare a “youth vaping epidemic” in 2018. This resulted in a surge in youth vaping after many years of waning interest in the activity—a “forbidden fruit” effect.
However, youth smoking and vaping have fallen sharply in recent years. The Centers for Disease Control and Prevention reported last fall that teen use of any vaping product in the past 30 days has hit a 10-year low, with less than 8 percent of all youth using one. An unpublished study from Tufts University, reported in Boston media, shows it has decreased even further. With both teen smoking and vaping down, there is no reason for the moral panic to persist.
And, as I wrote in Your Body, Your Health Care, “Laws should not prohibit adults from consuming substances or engaging in activities simply because they are dangerous or harmful if children do them.”
As more companies release e‑cigarettes and other nicotine delivery devices and as more people use them, we will eventually learn about their long-term harmful effects. As these effects gain attention, market forces and liability concerns will drive manufacturers to create safer products and provide warning labels.
Finally, regardless of safety concerns, autonomous adults have the right to self-medicate or use any product they choose, as long as they do not infringe on the rights of others. Adults will value information from studies like the UC-Davis report to help them make their decisions. Adults deserve the freedom to use nicotine products if they choose, armed with accurate information, not blocked by government bans