FDA Takes on Nicotine Addiction; Plus, Will Delays Dilute the Action?

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The U.S. Food and Drug Administration (FDA) recently issued three Advance Notices of Proposed Rulemaking (ANPRMs) as part of its agency-wide initiative to address tobacco and nicotine regulations. The intention of the comprehensive initiative is to place addiction at the center of its approach, encouraging innovative developments to render delivery mechanisms less harmful to users and ensuring that the FDA has the proper scientific and regulatory foundation to efficiently and effectively implement the Family Smoking Prevention and Tobacco Control Act.

The first ANPRM, issued March 16, focused on the development of a standard for the maximum level of nicotine permitted in cigarettes. With tobacco-related disease and mortality largely the result of nicotine addiction, the FDA’s proposed action aims to reduce the level of nicotine currently allowed in tobacco products to a minimally addictive or nonaddictive level. The FDA plans to use the best available science to determine the appropriate nicotine level to protect public health, with the goal of easing the cessation process for addicted tobacco users and preventing experimenters from initiating regular use. In conjunction with this ANPRM, the Agency also released a draft concept paper titled, Illicit Trade in Tobacco Products after Implementation of an FDA Product Standard, to start a dialogue around the emergence of possible illicit trade following potential future rulemaking.

The second ANPRM, issued March 21, focused on the inclusion of flavors, including menthol, in efforts to address the use of tobacco products and smoking cessation. The Agency is seeking information on how flavors attract youth to tobacco use, as well as how certain flavors could potentially transition adult smokers away from more harmful products. Regulatory actions may include standards and restrictions on the sale and distribution of flavored tobacco products.

The third ANPRM in the series, issued March 26, seeks to obtain stakeholder feedback and scientific data on the public health impacts and appropriate regulatory status of premium cigars. In 2016, the FDA published a final rule deeming a range of tobacco products, including premium cigars, under the Agency’s regulatory authority. While the FDA initially considered exempting premium cigars from certain regulations, no appropriate public health justification was determined. Rather, the Agency noted that while some premium cigar smokers may smoke infrequently or do not fully inhale when smoking, the behaviors do not fully negate the adverse effects of tobacco smoke or related secondhand smoke.

“The ACC has been a long-time advocate for policies that reduce the negative impact of tobacco use and nicotine addiction. It is encouraging to see the FDA soliciting and incorporating stakeholder feedback and comprehensive public health data as the Agency develops regulations to lessen the burden of cardiovascular disease,” says Thad Waites, MD, MACC, chair of ACC’s Health Affairs Committee. “However, we are troubled by the delayed deadlines implemented at the start of this initiative. While the College looks forward to working with the FDA to develop effective tobacco and nicotine regulations, in the interest of the health of our patient populations and Americans at large, we urge the Agency to act swiftly to strictly enforce provisions pertaining to these products. In addition to our efforts to reduce nicotine addiction, we must also address the increased risk of death and disease associated with prolonged exposure to these products as they currently exist.”

ACC Advocacy staff are actively reviewing all three released ANPRMs with the intention to provide comments. Stay tuned to ACC.org/Advocacy and the ACC Advocate e-newsletter for updates.

Will Delays Dilute Action?

Though premium cigars and e-cigarettes are now both included under FDA purview, the Agency delayed the deadline for filing applications for cigars and other newly-regulated combustible products until August 2021 and August 2022 for e-cigarettes. Additionally, the FDA declared that these products will remain on the market throughout the review process with no set deadline for when the review must be completed.

As a result, seven health care organizations, including the Campaign for Tobacco-Free Kids, have filed a federal suit against the FDA, claiming the Agency neglected its responsibility to regulate tobacco products by pushing back these review deadlines. The groups filing suit claim that these regulatory delays will unnecessarily expose children and teens to flavored and other kid-friendly tobacco products for years to come. The groups also charge that the FDA violated the Administrative Procedure Act by not providing an opportunity for public comment on the delayed deadlines. Click here to learn more about the lawsuit.

Clinical Topics: Congenital Heart Disease and Pediatric Cardiology, Prevention, CHD and Pediatrics and Prevention, Smoking

Keywords: ACC Publications, Cardiology Magazine, Adolescent, Tobacco Use, Tobacco, Smoking, Smoking Cessation, Public Health, United States Food and Drug Administration, Tobacco Products, Cardiovascular Diseases, Nicotine, Behavior, Addictive


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