Concerns About New FDA Regulations
Federal and state regulators are facing a high stakes issue: How to protect the interests of adults who use e-cigarettes while also preventing minors from accessing these products. The FDA’s new e-cig regulations
represent an extreme approach. Is there a better approach that protects children without harming both the adults who use e-cigs and the convenience stores that sell them.
Iowa Attorney General Embraces Evidence and Harm Reduction
In a tautly reasoned letter to the FDA
, Iowa’s Attorney General (AG) Thomas Miller adopted a humane and rational stance: “Young people suffer significant harm when a parent or other significant people in their lives die or are incapacitated by smoking-related disease.”
The Iowa AG’s letter debunked a number of popular misconceptions about vaping, questioned the FDA’s approach and requested an in-person meeting to discuss the issue further. The concerns he raised about the new FDA regulations on e-cigarettes deserve serious consideration.
FDA Press Release Designed to Score Political Points
The first thing you will notice in Miller’s letter are the clarity and logic of his argument. Compare his tone to the rambling 4,000 word FDA press release
. The issues of harm reduction and youth nicotine addiction are too important to resort to buzzwords and transparent emotional appeals.
FDA director Scott Gottlieb’s press release was a profound disappointment to anyone who hoped for a nuanced and balanced approach to this complex subject. Instead, we were provided with a political document that was far removed from the science-based decision making that we deserve.
Iowa AG: New Regulations Could Cost Lives
The Iowa AG’s letter warned that a “disproportionate intervention” against electronic nicotine delivery systems (ENDs) could result in a national health catastrophe. As Miller pointed out, “A half million annual American deaths from cigarette smoking are an immediate, stark, and preventable tragedy that should be fully factored in to a rational risk-benefit analysis.”
Teenage vaping use has been defined as an epidemic due to a spike in use between 2017 and 2018. Vapor4Life agrees that nicotine products need to be kept out of the hands of minors and that e-cig companies need to rigorously age verify and avoid targeting children with their marketing campaigns.
FDA Failed to Make Their Case
An interesting point made by Miller was that the more alarming numbers released by the FDA do not distinguish between adolescent occasional use and regular or daily use. This is an important distinction. Without further clarification, it is nearly impossible to distinguish between an epidemic and a fad in just a single calendar year.
Another factor that was overlooked by the FDA, perhaps intentionally, was the role e-cigarettes may be playing in plummeting teen smoking rates. As Miller wrote, “The most intensive adolescent e-cigarette users are far more likely to also be smokers. They may potentially benefit from e-cigarette use. There is no ethical basis for ignoring public health harm reduction benefits to those under 18.”
Harm reduction is the core of his argument. Here is Miller’s response to concerns about e-cigarette use because of their relative newness on the market: “We know enough now to be confident that these products pose little direct risk to either adults or adolescents compared to smoking or to many common youth risk behaviors.”
New FDA Rules Could Have Unintended Consequences
The potential for unintended consequences must always be weighed when passing new and stringent regulations. This is a major concern of the Iowa Attorney General. There is scant evidence that vaping leads to smoking but nicotine dependence in youth is something that we want to avoid.
The reality is that there are children who are using ENDs and Miller is worried that, “the removal from the market of the products they are using could lead to unpredictable behavioral responses, including uptake or increase of smoking – the outcome that FDA and the public health community seeks to avoid.”
Earlier surveys into youth e-cigarette and tobacco use found that social channels are their primary method of obtaining nicotine products. This issue has been almost entirely ignored by the FDA. Children do not exist in a vacuum.
Flaws In the FDA's Argument
As discussed in our Quick Guide to the New FDA E-Cig Regulations
, there are two pillars that support the new FDA regulations and both are suspect. The first is that convenience stores are incapable of verifying the age of their customers. A 96.7 percent compliance rate during FDA sponsored checks this summer suggests that the vast majority of convenience store and gas station outlets are performing their due diligence.
Questions have also been raised about the legality of limiting these outlets to mint, tobacco and nicotine flavored e-juices. Many of these convenience stores are permitted to sell alcohol, lottery tickets, cigarettes and pornography.
The second pillar is that fruit/dessert flavored e-juices are manufactured because of their appeal to minors. The FDA’s own numbers undermine this argument. The majority of adult vapers use sweet flavored e-juices. “Even if FDA can identify causal connections between product characteristics, such as flavors, and uptake of youth vaping, there are further difficulties in establishing the effects of any intervention on youth behavior and whether this will cause net harms or net benefits.”
Net Harm or Net Benefit?
Net harm or net benefit. This is what matters. While the FDA’s concern about youth vaping is certainly valid, the distorting influence of ill-conceived regulations must be taken into account.
Iowa Attorney expressed hope that the “FDA will pause to reflect before taking further action in the vaping market” and was concerned that the FDA’s regulatory approach, “Is highly contingent on the availability of appealing and effective alternatives to smoking. A hasty response that does not consider the harm reduction potential for adults could render FDA’s broader strategy inoperable.”
Enforcing existing rules and identifying companies that fail to verify the ages of their customers is a much more reasonable next step. As shown by Chicago Mayor Rahm Emanuel’s lawsuit against 8 e-juice companies
that allegedly sold to minors, it is possible to identify businesses that break these rules and to allow the court of law to determine their guilt or innocence.