NEW ORLEANS -- Is the FDA's support for low-nicotine cigarettes a step forward or backward for public health?
Members of the American Academy of Family Physicians (AAFP) examined this and other questions at their Congress of Delegates meeting on Tuesday.
AAFP's Illinois chapter introduced a resolution calling on the Academy to withdraw its support for the FDA's decision to force cigarette companies to keep nicotine levels below a certain threshold, arguing that there is no safe level of nicotine.
In March, the FDA released a notice of proposed rulemaking focused on exploring ways to develop a requirement to lower nicotine levels in combustible cigarettes, and to review the science around nicotine's role in cigarette addiction.
FDA Commissioner Scott Gottlieb, MD, stated that the new policy framework could "help avoid millions of tobacco-related deaths across the country," citing a recent study from the .
In the article, researchers who simulated the impact of the hypothetical policy -- reducing nicotine to "minimally addictive levels" -- estimated that 5 million smokers would quit smoking a year after implementation, and that more than 33 million additional people would avoid becoming smokers by the year 2100.
On March 20, applauding the FDA's decision, calling it "an important step toward cutting the addictive power of cigarettes" and one that "holds the potential for helping smokers quit."
Some delegates now believe that the Academy acted prematurely and sent the wrong message with its endorsement of the FDA's new approach.
On first glance, this sounds like a good thing, said Asim Jaffer, MD, a delegate from Illinois, "but what we're worried about here is the unintended consequences."
Jaffer introduced a resolution calling on the Academy to revoke its support for the FDA's proposed action of limiting nicotine to "minimally or non-addictive levels," while it reviews the literature on the health effects of low-nicotine products on teens and adults.
In committee discussions on Monday, Jaffer argued that the agency's recommendations lack strong evidence that decreased levels of nicotine are safe, and that this harm reduction strategy conflicts with current AAFP policy to "work towards elimination of all tobacco products."
"There is no safe use of nicotine," Jaffer said, and he and others are concerned about the "spin" cigarette companies will place on the AAFP's letter.
"We don't want to be seen as being in bed with the tobacco industry," he added. "Sometime soon there could be a tobacco product that could be labeled as 'being recommended by a leading family physician [group]' and we don't want that."
"It is our belief that there is no safe use of nicotine. There is not a linear relationship between nicotine use and disease -- cardiovascular, cancer, or otherwise," said Emma Daisy, MD, of Evanston Illinois.
She too noted the tobacco industry's history of deception in reframing information to suit its needs, recalling ads from the 1940s proclaiming that 'more doctors smoke Camels than any other cigarette.'
Tom Houston, MD, past president of the Ohio chapter of the AAFP and co-author of a (originally presented at an American Medical Association House of Delegates meeting in 1998), opposed the idea of the academy reversing its position; he did, however, support the idea of conducting a report after investigating and reviewing studies on the impact of low-nicotine products on the health of teens and adults.
While everyone is concerned about the increasing use of products like Juul, he said, "requiring all tobacco products to meet the very low nicotine delivery threshold has the potential for reducing nicotine update by both current and youth smokers."
Currently available studies suggest that "very low nicotine content cigarettes" can limit nicotine exposure, decrease dependence, and reduce the number of cigarettes smoked each day, Houston said.
As a result of these proposed changes, new smokers "may be less likely to become dependent smokers," he stressed.
Under current law, the FDA can't reduce nicotine levels to zero, and the AAFP's current endorsement, alongside other medical specialty organizations, should be maintained, Houston argued
The board of directors recommended that the resolution be referred to the board, saying the FDA's actions seemed appropriate while awaiting more evidence-based research.
However, after floor discussions with the full congress on Tuesday -- in which several delegates repeatedly stressed that "there is no safe level of nicotine" and emphasized the optics of a medical group appearing to endorse any type of cigarette -- the resolution to reverse the agency's earlier stance was approved (61-50) by electronic vote.