January 08, 2019 04:04 pm News Staff – With use of electronic nicotine delivery system (ENDS) devices among U.S. teens now declared an epidemic -- one that firms the pathway to cigarette smoking -- the AAFP has called on the FDA to prioritize youth cessation research.
In a Dec. 22 letter to FDA Commissioner Scott Gottlieb, M.D., the Academy warned that swift and ample funding for research into pharmacological cessation methods is crucial to combat a new generation's addiction to nicotine and tobacco products.
The Academy emphasized, however, that current research doesn't validate the use of ENDS as an evidence-based cessation method on par with OTC or prescription nicotine replacement therapy, pharmacological options and counseling in adult populations.
"The AAFP does not support the use of ENDS in any form as a formal cessation option or therapeutic nicotine product," said the letter, which was signed by Board Chair Michael Munger, M.D., of Overland Park, Kan.
Rather, ENDS devices now present their own hazards and exert unprecedented market force. In 2018, the FDA reported a 77 percent increase in ENDS use among high school students over a 12-month period -- growth that the Academy's letter called "extremely alarming" and said requires quick action.
"The AAFP urges that the same rules regulating traditional tobacco products must be applied to ENDS as soon as possible, including regulations regarding flavors and nicotine content," the letter said. And to push back against rising ENDS addiction, it added, "There must be robust and ethical research with a corresponding body of evidence to determine if nicotine replacement or other drug therapies are beneficial for youth cessation."
The letter was a response to a request for comments titled "Eliminating Youth Electronic Cigarette and Other Tobacco Product Use: The Role for Drug Therapies" that was published in the Nov. 5 Federal Register.
The AAFP also asked the FDA to work with CMS to clarify policy regarding Section 2713 of the Public Health Service Act to increase family physicians' options for counseling patients about tobacco cessation. The policy, the Academy advised, "should include both counseling and pharmacotherapy, as described in the 2008 Public Health Services guideline."
The U.S. Preventive Services Task Force (USPSTF) has advised that physicians should ask all adults about tobacco use, advise them to stop using tobacco, and provide behavioral interventions and assistance using appropriate cessation aids. The AAFP supports the USPSTF recommendation.
The Academy has also said that it agrees with the USPSTF's clinical recommendation on tobacco use in children and adolescents, which states: "The USPSTF recommends that primary care clinicians provide interventions, including education or brief counseling, to prevent initiation of tobacco use among school-aged children and adolescents." The task force is currently in the process of updating this 2013 recommendation statement.
Counseling and pharmacotherapy, the AAFP told the FDA last April,(3 page PDF) are not uniformly covered by insurance companies and health plans even though they are more effective in tandem.
"Increasing opportunities for family physicians and other clinicians to counsel patients about tobacco cessation will be beneficial in addressing youth ENDS use," the December letter said.
Noting the scientific and clinical barriers complicating research into adolescent cessation, since smoking-cessation medications are approved only for adults, the letter restated the AAFP's call(2 page PDF) for new ICD-10 codes that "allow physicians to accurately record ENDS use in youth and adult populations."
Such codes would prime physicians to talk to their patients -- including youth -- about the dangers of nicotine and ENDS and discuss cessation methods.
"Empowering youth and adolescents to engage in their health and health decisions may also impact societal and clinical barriers, further encouraging research," the letter said.
Related AAFP News Coverage
ENDS Not Effective as Tobacco Cessation Method, Says Study