For more than a year, the U.S. Food and Drug Administration’s (FDA’s) daunting deeming regulations were seemingly set in stone, poised to strike a massive blow to the entire e-cigarette and vaping category.
Then in midsummer, the doors suddenly reopened.
Mitch Zeller, director of the FDA’s Center for Tobacco Products (CTP), seemed to have made his stance clear in a media briefing in May 2016, where he firmly spelled out specifics of the so-called deeming regulations that put electronic nicotine-delivery devices (ENDs), cigars and other non-cigarette tobacco products under his control within the larger FDA. He laid out, without waiver, the regulations’ most onerous and costly requirements.
At that press event, Zeller seemingly threw out “continuum of risk” or “reduced-risk” arguments that bolstered the value of e-cigarettes, dismissing supportive cience from the Royal College of Physicians and describing any cessation claims as “anecdotal.”
“A hypothetical pack-a-day smoker who was otherwise unable or unwilling to quit cigarettes—if that person were to completely switch to e-cigarettes, there’s no question that person would be significantly reducing his or her risk,” Zeller admitted. However, he also said, “We can’t make policy at a national and population level on the basis of hypothetical individuals or anecdotal reports of benefit.”
But today, Zeller is singing a different tune, harmonizing with the FDA’s new commissioner, Dr. Scott Gottlieb, on everything from reduced-risk options to the need for further public comment and science-based policy.
So what happened?
The FDA’s overall turnaround appears to come largely from its new commissioner. When Zeller spoke at a NATO seminar in August, he calmly reiterated what Gottlieb directed. When asked about the FDA’s change of heart—and policy—Zeller cited Gottlieb’s influence.
“We spent time briefing [Gottlieb] on every aspect of the CTP,” Zeller told the group of about 75 attendees at the seminar, sponsored by Minneapolis-based NATO. “He then pivoted to policy decisions … [to] reframe the debate, [moving] forward together with the new focus of nicotine addiction.”
Zeller and Gottlieb even published a joint article in August in the New England Journal of Medicine. In it, they announced the reopened discussion on a number of topics, including regulating nicotine levels in cigarettes, flavored tobacco (including menthol) and the value of persuading smokers to choose less harmful ways to inhale nicotine.
While the new policy they described introduced uncertainties over how the FDA would regulate nicotine levels and flavors, renewed talk of public input and evaluation periods based on scientific evidence reassured tobacco retailers.
At the August NATO seminar, Zeller said the agency would encourage public comment and thoroughly review all aspects before issuing any final standard. The FDA conducts a large amount of research and is vested in hard data, he said, citing one study that addressed the issue of unintended consequences. The study showed smokers in markets that banned flavored cigarettes simply switched to flavored cigars or cigarillos.
“It’s like a game of whack-a-mole,” he said, “where users find alternatives instead of quitting.”
The postponement of FDA deadlines for manufacturers to submit costly new-product applications was another olive branch. Deadlines of August 2018 moved to Aug. 8, 2021, for combustibles and Aug. 8, 2022, for noncombustibles.
“The debate for the last decade has been remarkably unproductive,” Zeller said at the August NATO seminar. “A harm-reduction dialogue [may offer] common ground.”
On some points, Zeller is still holding the industry to task. At the seminar, Zeller said the FDA would not change the predicate date of Feb. 15, 2007, for grandfathering in new products. Any tobacco products on the market before then were grandfathered into the FDA’s jurisdiction and spared the time-consuming, expensive FDA application process.
Congress set the predicate date and the FDA has no legal standing to change it, Zeller said, citing that the agency previously asked the public to provide legal arguments to consider but had not received any that would warrant a change.
Zeller’s change of heart did not come out of the blue. At an April 2016 NATO event, just prior to his May 2016 announcement of deeming regulation specifics, Zeller spoke in support of reduced-harm products and the “continuum of risk.”
And in April 2016, just as in August 2017, Zeller said pro- and anti-tobacco sides were “having the wrong debate.”
“The e-cig debate has been emotional, divisive and is not advancing common ground on harm reduction,” Zeller said. “Where and how can we apply the principle of harm reduction to this debate and find common ground? It’s been horribly ineffective to date.”
Whatever the cause of Zeller’s apparent change of heart, those following the industry felt upbeat about the new tone.
“In sum, we expect the FDA will be deliberately thoughtful in its approach … given its desire to avoid ‘unintended consequences’—for instance, compensatory smoking, smoker migration [and] illicit markets,” said Bonnie Herzog, managing director of consumer equity research for Wells Fargo Securities LLC, New York, in her newsletter. “Importantly, the debate is being reframed, and we are optimistic that a continuum-of-risk policy could have positive implications on encouraging innovation in noncombustible nicotine-delivery products.”
Daniel Trope, director of federal government affairs for the International Premium Cigar and Pipe Retailers Association (IPCPR), Washington, D.C., focused his thoughts on the new leadership at the FDA.
“Leadership today views cigars differently [than the past administration], just from the fact that they reopened the dialogue after saying it was a closed book,” he said.