Regulatory policy

FDA policy on cigarettes, menthol and vaping is contradictory

The Food and Drug Administration wants to prevent smoking-related deaths by making cigarettes less appealing. To that end, the FDA plans to ban menthol cigarettes and limit nicotine content to “reduce cigarette addiction.”

Meanwhile, the FDA seems determined to make vaping products, the most promising alternative to cigarettes, less appealing to smokers. The perverse combination of these two regulatory strategies would undermine public health in the name of its promotion.

The ban on menthol cigarettes, proposed by the FDA in April, is not based on evidence that they are particularly dangerous. Instead, the agency argues that menthol cigarettes are more addictive, especially for black smokers, who overwhelmingly prefer them.

The evidence for this is flimsy, as is the patronizing assumption that African Americans are powerless to resist the minty freshness of menthol or the marketing that touts it. Worse, the proposed ban would promote illegal production and distribution, inviting a law enforcement response that would disproportionately harm the people the agency claims to be trying to help — a point the FDA implicitly concedes by making alluding to the “racial and social justice implications” of the policy. ”

Imposing a reduction in nicotine content to “minimally” addictive or “non-addictive” levels, which the FDA says it will propose, also raises obvious issues. This policy would also stimulate black market activity and encourage current consumers to smoke. Afterwhich seems inconsistent with the stated objectives of the agency.

The same could be said of the FDA’s refusal to approve vaping products in flavors other than tobacco. Although the agency considers tobacco-free flavors dangerously appealing to teens, surveys indicate that the vast majority of ex-smokers who vape prefer them.

A 2019 analysis of data from the Tobacco and Health Population Assessment Study found that three-quarters of adult vapers last month, 93% of whom were current or former smokers, preferred flavors other than the tobacco. Furthermore, “ex-smokers who [had] completely switched to an e-cigarette” were particularly likely to have “switched from a tobacco-flavoured product to a non-tobacco-flavoured product”.

So far, the FDA has issued “marketing approval orders” for just four brands of vaping products, all of which taste like tobacco. Last month, the agency issued “market denial orders” to Juul, a major vaping company that had sought approval for menthol as well as tobacco pods.

The FDA said the rejection of Juul’s applications was based on inadequate toxicology data, a claim the company disputes. Juul obtained a temporary court order that prohibits the FDA from stopping sales of its products while the case is pending.

Beyond this specific controversy, the FDA has rejected millions of applications for vaping products without tobacco flavors, including menthol. Yet his cost-benefit analysis of the proposed ban on menthol cigarettes assumes the availability of alternatives to e-cigarettes.

As Michelle Minton, a senior researcher at the Competitive Enterprise Institute, points out, the FDA relies on a study in which “the substitution of high-risk combustible menthol cigarettes with low-risk menthol-flavored nicotine vapor products. .. accounts for about half of the benefits”. How are menthol smokers supposed to make this change if the FDA refuses to allow the sale of menthol flavored e-cigarettes?

More generally, the FDA’s bias against flavor variety is difficult to reconcile with its concession that vaping has great potential to reduce smoking-related illness and death. An arbitrary ban on flavors that adult consumers demonstrably prefer will encourage some people to start smoking again and discourage current smokers from switching.

Like a ban on menthol cigarettes and a nicotine limit, such flavor restrictions would also drive consumers to black market vendors, who are completely unconstrained by supposedly enlightened FDA regulations. The FDA apparently learned nothing from the country’s unfortunate experience with the war on drugs.

As with other drugs, the most sensible approach to nicotine is harm reduction, which seeks to minimize both the harm caused by psychoactive substances and the harm caused by governments’ misguided responses to them. The FDA seems oblivious to the latter.