Let's say you wanted to keep as many people smoking as possible. How would you do it? Your best move would be to restrict consumer access to the most popular and effective smoking cessation tool we know of. You could fund low-grade research attacking the product and deny you did so; you could enforce pointless regulations that effectively ban the most popular versions of the product while exempting combustible cigarettes from the same oversight.
When called to account for your blatant hypocrisy and crass disregard for public health, you could fall back on the classic prohibitionist defense: claim the product threatens children's health, even though the evidence doesn't support such an allegation.
What you've just read is a brief summary of the Food and Drug Administration's (FDA) regulatory actions against electronic cigarettes. Under pressure from busybodies in Congress and the tobacco control movement, the agency has thrown the book at the vaping industry. The FDA recently put a cherry on top of its campaign by issuing a marketing denial order (MDO) for the most popular brand of e-cigarettes, JUUL. According to the agency, this means that:
“the company must stop selling and distributing these products. In addition, those currently on the U.S. market must be removed, or risk enforcement action.”
The FDA included several justifications for its decision, each of which falls far short of convincing. Let's take a look at the specifics: FDA in quotes, followed by my analysis.
“...[T]he FDA determined that the applications lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health.”
In so many words, demonstrating “protection of public health” means showing that the product encourages smoking cessation without enticing children to take up vaping. We have plenty of data on both counts. Multiple well-designed clinical trials and epidemiological studies have shown that vaping is far less harmful than smoking and helps people curb their cigarette habit. We also know that very few teenagers vape; those who do tend to be current smokers. Looking specifically at JUUL, just 0.6% of US teens have used the company's products. [1]
“In particular, some of the company’s study findings raised concerns due to insufficient and conflicting data – including regarding genotoxicity [damage to DNA] and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods ...”
It's hard to comment on the specifics without looking at the data the FDA reviewed. But I'm skeptical of this assessment because the very next paragraph in the agency's press release acknowledged that “... the FDA has not received clinical information to suggest an immediate hazard associated with the use of the JUUL device or JUULpods.” Putting these two statements together, it sounds like the FDA pulled a product off the market without sufficient evidence that it causes harm.
Whatever the case, the FDA's concerns here are hypocritical. “There are more than 7,000 chemicals in cigarette smoke,” the agency has written elsewhere, “More than 70 of those chemicals are linked to cancer.” Surely we have to get every single cigarette off the market immediately if we're concerned about genotoxicity. That will never happen, of course.
Additionally, the FDA very recently funded a low-quality study alleging that vaping increases health care costs. The problem, as my colleague Dr. Chuck Dinerstein pointed out, is that e-cigarette use probably offsets the expense of treating sick smokers because it's much less harmful than smoking. The FDA's willingness to reject “insufficient” evidence is inconsistent at best.
“There is also no way to know the potential harms from using other authorized or unauthorized third-party e-liquid pods with the JUUL device or using JUULpods with a non-JUUL device.”
People kill themselves by mixing prescription drugs and alcohol. Should we therefore remove all alcoholic beverages from the market until we figure out how to prevent every single one of these deadly interactions? Most people see the folly in such thinking. Many chemicals, from cleaning products to pesticides, are dangerous if misused. We do our best to account for this, but we don't outlaw the sale of bleach because some crazy person may drink Clorox hoping it will treat his COVID-19.
“There are many resources to help smokers who want to quit. Quitting all tobacco products is the best possible path to good health.”
This is certainly true. But common sense forces me to ask a simple question: If the FDA wants smokers to quit, why has it tried to ban the most popular vaping products on the market? There is no reasonable answer to that question, which may be why a federal appeals court just granted JUUL a temporary stay of the FDA’s order. Whatever the legal fallout in this instance, the agency needs to rapidly reverse course and take a more sensible approach to e-cigarette regulation. People's lives are on the line.
[1] ACSH opposes all underage use of nicotine products.
Cameron English
Director of Bioscience
Cameron English is a writer, editor and co-host of the Science Facts and Fallacies Podcast. Before joining ACSH, he was managing editor at the Genetic Literacy Project.
