June 26, 2018 08:57 am News Staff – On June 20, the AAFP sent the FDA letters stating the Academy's position on three separate tobacco-related issues: the use of flavors in tobacco products, premium cigars and nicotine levels in cigarettes.
The letters came in response to advance notice of proposed rulemaking (ANPRM) requests for comments by the agency on these topics. Each letter was addressed to Leslie Kux, the FDA's associate commissioner for policy, and signed by AAFP Board Chair John Meigs, M.D., of Centreville, Ala.
Citing the Academy's comprehensive position paper on preventing and treating nicotine dependence and tobacco use, all three letters stated: "The AAFP believes the FDA should have the authority to regulate the manufacture, sale, labeling, distribution and marketing of all tobacco products, including cigars of all sizes and flavors, as well as electronic nicotine delivery systems (ENDS)."
In its letter regarding regulation of flavors in tobacco products,(3 page PDF) the Academy began by citing a robust, evidence-based study from the Campaign for Tobacco-free Kids that found flavored tobacco products of any kind appeal to youth and young adults.
"Eight out of 10 youth ages 12-17 began using tobacco with flavored tobacco products," the letter said, "and young adults ages 18-24 are significantly more likely to use flavored tobacco products than older tobacco users."
The AAFP said regulating flavors in all tobacco products could potentially decrease youth tobacco initiation rates significantly while improving health outcomes among vulnerable populations, preventing long-term addiction to tobacco products, reducing spending on tobacco-related illnesses and lowering the number of long-term tobacco users.
Noting that the Academy "supports the attainment of the highest level of health for all people," the letter urged the FDA to regulate flavored tobacco products and specifically include ENDS in these regulations.
"Finally, the AAFP calls on the FDA to closely examine the ENDS marketed under the JUUL brand," the letter added, referring to a specific type of device that utilizes a proprietary salt-based nicotine e-liquid formula and recharges via a USB port, according to the product's website. "These ENDS are touted as a way to quit smoking; however, … there is only anecdotal evidence supporting successful use of ENDS as cessation devices, and the stronger evidence suggests they are getting more people to start using nicotine than to stop.
"The AAFP strongly urges the FDA to regulate JUUL devices and pods, other ENDS, and tobacco flavors."
In its second letter to the FDA(2 page PDF), the AAFP strongly urged the agency to not revise the 2016 deeming rule that gave the FDA authority to regulate cigars.
Cigars of all sizes, including large cigars, cigarillos and little cigars, are associated with increased risk of negative health effects such as cancer, gum disease, tooth loss and lung disease, said the Academy. In some cases, cigars may contain 20 times more tobacco than traditional cigarettes.
Furthermore, the letter added, it's important for the FDA to continue to regulate cigars under the deeming rule because they are very popular among youth, particularly little cigars and cigarillos. This is in large part because the 2009 Family Smoking Prevention and Tobacco Control Act, which banned the use of all flavors except menthol in cigarettes, does not apply to cigars, which are still widely produced in various fruit and candy flavors.
"The AAFP believes there is no public health benefit or justification to exclude any tobacco products from the 2016 deeming rule," the letter stated. "The FDA should continue to prioritize addressing the leading cause of preventable death by regulating cigars of all sizes and flavors."
Finally, in the third letter to the FDA,(3 page PDF) the AAFP applauded the agency for investigating how to best implement regulations to reduce nicotine levels in cigarettes, and then followed up by calling on FDA officials "to create a nonaddictive nicotine level standard for all tobacco products, not just cigarettes."
The AAFP pointed to a study published online May 3 in the New England Journal of Medicine that estimated about 5 million people could quit smoking within one year and 13 million within five years if a final rule from the FDA requiring nonaddictive levels of nicotine in tobacco products were promulgated immediately.
"Comprehensive and specific regulations are necessary to prevent new products that may circumvent the nicotine level requirement," the letter stated. "The FDA must require independent mandatory testing to ensure the nicotine content is indeed nonaddictive, and this testing must be conducted in addition to or outside of manufacturer testing."
The letter also pointed out that the AAFP had joined more than 35 other health and public health organizations last month to call on the agency(4 page PDF) to issue a proposed rule within six months of its ANPRM and the final rule within one year.
"Implementation of the final rule should occur no later than March 2020," the June 20 letter concluded. "Swift action regulating nicotine content will prevent millions of Americans from dying prematurely due to tobacco use."
Related AAFP News Coverage
AAFP Joins Support for Less Nicotine in Cigarettes
FDA Proposal Calls for Nonaddictive or Minimally Addictive Levels
(5/25/2018)
FDA Proposes Reducing Nicotine in Combustible Cigarettes
(3/21/2018)