FDA plan to limit nicotine garners praise, criticism

Medical professionals had mixed reviews for the FDA’s recent announcement to pursue lower levels of nicotine in cigarettes, a multiyear strategy that the agency said is intended to better protect children and substantially lower the number of illnesses and deaths attributed to tobacco.

This is not the first time the FDA has made such proposals, but the doctors Healio Family Medicine spoke to had differing opinions on the agency’s latest attempt to potentially regulate certain tobacco products.

“I don’t think [the announcement] is lip service,” Eric Donny, PhD, professor of psychology, University of Pittsburgh and behavioral health oncology program at the University of Pittsburgh Medical Center, told Healio Family Medicine in an interview. “A comprehensive approach that includes reducing nicotine in cigarettes has been discussed by Center for Tobacco Products Director [Mitch] Zeller before.”

“We have ... seen fallacies of low tar and nicotine cigarettes ... Smokers simply smoked more of them to get the nicotine they needed to feed their addiction,” Harold J. Farber, MD, MSPH, pediatric pulmonologist at Texas Children’s Hospital, said in an interview. “Further, although the proposal is to reduce nicotine in cigarettes, the FDA is leaving plenty of nicotine in other very harmful tobacco products, such as cigars, cigarillos, hookahs, etc.”

Donny characterized the FDA strategy as one geared toward easing cessation strategies.

“Reducing nicotine in cigarettes should minimize the chance of youth becoming lifelong addicted smokers, so I am not sure how that is failing youth,” he said. “NIH/FDA has also discussed the product standards that reduce appeal, addictiveness, and toxicity are high priorities. I would predict [the FDA’s plan] would make cessation easier for young smokers because use of low nicotine cigarettes for an extended period of time reduces dependence.”

In March, several groups, including the AAP, asked the FDA to ban all flavored tobacco products, asserting that these products are undermining national efforts to reduce youth tobacco use and placing children at health risks from tobacco use and nicotine addiction.

Part of the FDA plan announced last month calls for obtaining public comment on the role that flavors, including menthol, in tobacco products plays in drawing in youth and may play in helping some smokers switch to potentially less harmful forms of nicotine delivery.

“This announcement indicates the FDA's failure to protect our youth. If the FDA wanted to protect our youth they would start with a ban on characterizing flavors — which make the tobacco products essentially highly addictive candy,” Farber said. “The real story is that the FDA is shirking the responsibility to regulate e-cigarettes and cigars — many of which come in fruit and candy flavors and are addicting our young people. Delaying regulation of these products puts our youth at risk.”

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Another part of the FDA’s strategy calls for noncombustible product applications, such as those on electronic nicotine delivery systems (or ENDS) and e-cigarettes, to be submitted by Aug. 8, 2022.

“The delay for the noncombusted seems like a reasonable approach that allows for additional information to be assessed on products that provide smokers with alternative sources of nicotine,” Donny said.

Farber contended that the FDA’s strategy caters to businesses, not people.

“[FDA Commissioner Scott Gottlieb, MD] appears to be willing to concede future generations of youth nicotine addicts to the tobacco industry, just so long as ‘Big Tobacco’ hooks kids on e-cigarettes and other noncigarette tobacco products,” he said. “By going easy on the ‘Big Tobacco’ (ie, granting the 4-year extension of submitting product information, taking no immediate action on flavored tobacco products, giving industry another 4 years to continue to market to youth, and exempting cigars from youth-protecting regulation), Gottlieb is effectively giving the green light for ‘Big Tobacco’ to continue to peddle addiction to youth.”

Other parts of the FDA’s proposal call for enhancing the use and availability of FDA-approved medicinal nicotine products; working with stakeholders to come up with a strategy that’s within the efficacy and safety standards but can also assist smokers who want to quit; and establishing rules that make the product review process more efficient, predictable and transparent for manufacturers, but still remain true to FDA’s mission.

“Unless we change course, 5.6 million young people alive today will die prematurely later in life from tobacco use. Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts — and we believe it’s vital that we pursue this common ground,” Gottlieb said in a press release announcing the plan. – by Janel Miller

Further reading : FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death. Accessed Aug. 14, 2017.

Disclosure: Farber is chair of the American Thoracic Society Tobacco Action Committee and associate medical director for Texas Children’s Health Plan. Healio Family Medicine was unable to determine Donny’s relevant financial disclosures prior to publication.