On September 28, a string of mainstream public health organizations including the American Lung Association and the American Heart Association, together with the Campaign for Tobacco-Free Kids (CTFK), sent a letter to Janet Woodcock, acting commissioner of the Food and Drug Administration (FDA). Aside from its actual substance—a predictable demand that all flavored vaping products, including menthol, be removed from the market—the letter hit some rare notes of agreement with tobacco harm reductionists: urging the agency to expedite its long-awaited review process and panning the accompanying lack of transparency.
Because of a lawsuit filed and won by most of the signatories, the FDA had until September 9 to authorize or deny the marketing applications that vape manufacturers had to submit a year prior. Many of those premarket tobacco product application (PMTA) submissions have already received marketing denial orders (MDOs) from the agency, meaning those products can no longer be sold. But the largest companies, most of which make pod-based e-cigarettes, remain in a regulatory limbo.
The FDA has stated it needs more time to go over the corresponding science, an excuse that has been met with vitriol from all sides: Small- and medium-sized vape producers have essentially concluded that the industry will transform into an oligopoly of well-financed brands; prohibitionists aren’t thrilled that the agency has yet to target the most influential players.
The FDA’s opacity has left everyone guessing its next move, fueling rumors and turning manufacturers, consumers and activists of all stripes into pseudo-detectives.
In the meantime, speculation has been mounting that the anti-vaping organizations will grow impatient and return to court. In the letter, they chastise the FDA for its delay, arguing that it’s allowing the major companies to perpetuate a youth vaping “epidemic.” They also ridicule the agency for failing “to be transparent about the products for which it has issued MDOs.”
“To ensure against the continued availability of e-cigarette products that FDA has found unable to satisfy the statutory public health standard, and to enable the public to assess FDA’s enforcement against those products, FDA should disclose the products, and their flavors, for which MDOs have been issued and should continue to publicly identify those products going forward,” they write.
That sentiment, ironically enough, has been a recent refrain of tobacco harm reduction (THR) proponents. Amid a lack of information, they have worried that the FDA could be creating a de facto policy of banning all flavors (which many adult vapers find critical to switching from smoking) without admitting it. The FDA’s opacity has left everyone in the position of guessing its next move, fueling rumors and turning manufacturers, consumers and activists of all stripes into pseudo-detectives.
Is the FDA bracing for another lawsuit? Is it inviting one? Does it have a secret policy of rejecting all products with flavors other than tobacco or menthol? Speaking at the industry-sponsored Global Tobacco and Nicotine Forum (GTNF) in London last week, Todd Cecil, the deputy director of science at the FDA’s Center for Tobacco Products denied this last suggestion, while studiously giving away as little as possible.
Still, both of the two polarized camps in tobacco control—those who embrace safer nicotine alternatives for adults and those who would prefer to somehow legislate the substance out of existence—find themselves agreeing that the FDA has done a bad job from the start.
“The FDA didn’t have to do any of this,” Amanda Wheeler, the president of the American Vapor Manufacturers Association, said in a keynote address at GTNF. “FDA could have approached this by allowing companies that have always been registered with them and inspected by them to continue serving their customers while approaching the broader issue on a basis of sound science and true public health.”
She also scoffed at Cecil’s claim that MDOs have been issued on the basis of individualized assessments of flavored products, noting that many of her organization’s members received rejection letters that were basically identical.
“The whole process has been unclear from the very beginning,” Wheeler told Filter. “Where we are now shouldn’t be a surprise.”
In the past month, the FDA has been issuing MDOs to hundreds of companies for millions of products because they did not complete certain scientific and behavioral studies, all of them arduous and prohibitively costly to all but the biggest companies—and some of which the agency did not make clear were necessary until after the PMTA submission deadline had passed.
“The FDA needs to be transparent, not just about its approach to specific low-risk alternatives to lethal cigarettes, but about the overall direction of the agency.”
To put it mildly, this has led to a situation of abject anger and confusion. Many producers are now switching to synthetic nicotine, perceived as a legal gray area potentially outside the FDA’s jurisdiction; others are outright disputing the FDA’s decisions, saying the agency erroneously denied particular products. At least one major company, Turning Point Brands, has petitioned a US Court of Appeals.
“The FDA needs to be transparent, not just about its approach to specific low-risk alternatives to lethal cigarettes, but about the overall direction of the agency,” David Sweanor, a tobacco industry expert and an adjunct professor of law at the University of Ottawa, told Filter.
“The abstinence-only people are acting just like the groups that vigorously opposed pure food laws and science-based pharmaceutical regulations,” he continued. “For them, moralism trumps science. Such people perpetuate the very problems the FDA is set up to address, and the agency needs to be clear about the direction it plans to pursue.”