Dr. Brian King, director for the Center for Tobacco Products (CTP) at the United States Food and Drug Administration (FDA), acknowledged a major public health failure in recent commentary in the journal Addiction: Many adults who smoke are unaware of the relative safety of nicotine vapes and other tobacco harm reduction options compared with combustible cigarettes.
What he conspicuously failed to acknowledge was his own agency’s role in perpetuating misperceptions that cost lives.
Dr. King was commenting on a study published earlier this year by Dr. Olivia Wackowski et al., which found that just 18 percent of participating adults who smoked held the correct belief that “e-cigarettes contain fewer harmful chemicals than cigarettes”—a belief associated with higher chances of switching to vapes.
The research is valuable. Yet for years, a litany of other surveys and studies have found the US public to be disastrously misinformed on a comparison that is critical to public health. Only now does the head of the CTP pronounce that “opportunities exist to educate adult smokers about the relative risks of tobacco products, including e-cigarettes, using evidence-based approaches.”
Actions speak louder than words. The FDA is responsible for a mess of regulatory inaction and confusion.
Better late than never. But while King’s recommendation is encouraging—even if he immediately follows it with a warning on youth use, referencing the FDA’s notorious “Real Cost” campaign—actions speak louder than words.
So far, the FDA is responsible for a mess of regulatory inaction and confusion. Without drastic policy changes, mere lip service will do little for the millions of US adults who could benefit from safer alternatives to smoking.
The FDA has long acknowledged, if quietly, that “tobacco products” (as it terms all nicotine consumer products) exist on a “continuum of risk”—with combustible cigarettes being the most harmful and other alternatives presenting significantly fewer risks. Smoke, not nicotine, is the primary source of harm. Yet misconceptions about nicotine have become so entrenched that US doctors, never mind the general public, overwhelmingly believe that nicotine directly causes cancer.
In 2017, then-FDA Commissioner Scott Gottlieb unveiled an ambitious plan that aimed to strike “an appropriate balance between regulation and encouraging the development of innovative tobacco products that may be less dangerous than cigarettes.” In the accompanying statement, the FDA noted that a “key piece” of the agency’s “approach is demonstrating a greater awareness that nicotine—while highly addictive—is delivered through products that represent a continuum of risk and is most harmful when delivered through smoke particles in combustible cigarettes.”
In the years since, the agency has spectacularly failed to communicate this message.
It is the FDA’s own inaction that is causing the most damage, through a convoluted application process to bring new products to market.
Perhaps the misperception stems in part from the language in the Tobacco Control Act (TCA). Line 46 of the 2009 act prohibits the FDA from “approving” tobacco products. The TCA states that if a manufacturer is allowed to market their product as “approved or inspected by [the FDA] or complies with [FDA] standards,” then consumers—get this—“are likely to be confused and misled.”
As such, the FDA does not approve tobacco products, regardless of their relative safety, but authorizes them to be sold.
This allows certain public health groups—funded heavily by billionaire Michael Bloomberg—to imply that since the FDA has not approved any vaping products for smoking cessation, they are no safer than combustible cigarettes. These organizations are actively spreading misinformation, hampering the transformation of the US tobacco market into a sector with a wide variety of safer nicotine products.
But it is the FDA’s own inaction that is undoubtedly causing the most damage. This immobility is due to a convoluted application process to bring new products to market, regardless of the harm they may or may not pose.
Currently, there are two pathways to seek FDA authorization for tobacco products introduced after February 15, 2007 (the predicate date established in the TCA): substantial equivalence (SE) and premarket tobacco product applications (PMTAs).
The SE pathway demands that a product either has the same characteristics as a preexisting product, or raises no different public health questions from a preexisting product. In other words, it offers expedited authorization for products that maintain the marketplace status quo.
To date, FDA has issued hundreds of SE orders, including 421 marketing orders between 2019 and 2022. Of these, 127 were for combustible cigarettes; none of them were for safer alternatives to cigarettes.
Absurdly, this double standard makes it easier for new cigarettes to receive authorization than vapes.
The PMTA pathway, in contrast, demands that the FDA must determine a product to be “appropriate for the protection of public health” (APPH)—a far more onerous standard, requiring reams of scientific research that only the biggest companies can realistically generate.
Since 2015, the agency has rejected millions of PMTA applications. It has authorized just 45 different products under the PMTA pathway—of which only 23 were vaping products, made by only three different manufacturers.
Absurdly, this double standard makes it easier for new cigarettes to receive authorization than vapes.
It’s a curious reality for a federal agency with funding tied to combustible cigarette sales. The CTP is “solely funded by tobacco user fees,” which are applied to six different types of tobacco products including combustible cigarettes, cigars, chewing tobacco, pipe tobacco, roll-your-own, and snuff. The fee amount is determined by market share, with combustible cigarettes making up over 83 percent of tobacco user fees collected. Essentially, cigarettes (and the adults who smoke them) are funding CTP’s actions.
It’s fair to point out that the FDA remains mired in ambiguities and near-impossibilities spun by the underlying statute. The TCA states that APPH “shall be determined with respect to the risks and benefits to the population as a whole, including users and nonusers of the tobacco product,” and including the likelihood of either using the products. And while the TCA makes note of tobacco companies marketing to youth, it offers no concrete definition of what constitutes a youth-appealing product.
In this context, the FDA continues to use youth vaping as a pretext to deny marketing orders for all flavored tobacco harm reduction products—flavors with central importance to many adults who switch—using the APPH determination.
In 2021, in the first (of many) marketing denial orders for flavored e-liquid PMTAs, the FDA claimed that the “applicants lacked sufficient evidence that [the products] have a benefit to adult smokers sufficient to overcome the public health threat posed by the well-documented, alarming levels of youth use of such products.”
In May 2023, the FDA issued additional denial orders citing that the agency determines “whether the products in the applications showed an added benefit to adult smokers … that could outweigh the known and substantial risk of flavored e-liquid and e-cigarette products to youth.”
Youth and adults alike use flavored vaping products. Yet youth users are not widely citing flavors as a reason for vaping. In 2021 (the same year FDA issued massive denials for flavored products because of youth), nearly half (43.4 percent) of US middle and high school students currently vaping said they were self-medicating feelings of anxiety, depression and/or stress. Only 13.2 percent said they had used vapes because of flavors.
There is an obvious starting point for the FDA: acknowledging its own part in misleading the public and keeping people smoking.
If the FDA finally wishes to rectify public misunderstanding around tobacco harm reduction products, it faces an uphill battle.
The agency will need to overcome the challenges of language, definitions and determining exactly why youth use e-cigarettes—without inflating the harms. It will need to clarify and reform processes to relay accurate information to consumers. It will need to streamline its authorization pathway for a far wider range of products that are much safer than cigarettes.
We can hold out hope that the FDA will belatedly follow the science and the imperative to save lives. But if it wants to begin communicating clearly and honestly, there is an obvious starting point: acknowledging its own part in misleading the public and keeping people smoking.
Screenshot from the FDA’s “Real Cost” campaign via YouTube