FDA Releases New Plan For Tobacco and Nicotine Regulations

On July 28, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, announced a new agency-wide initiative to address tobacco and nicotine regulation. The proposal aims to place nicotine addiction at the forefront of the Agency's tobacco regulation efforts, encourage innovative developments to render delivery mechanisms less harmful to users and ensure that the FDA has the proper scientific and regulatory foundation to efficiently and effectively implement the Family Smoking Prevention and Tobacco Control Act.

The Center for Tobacco Control (CTP) plans to issue several Advance Notices of Proposed Rulemaking to seek input on new initiatives, such as the role of flavors, including menthol, in tobacco products, product standards around electronic nicotine delivery system battery issues and children's exposure to liquid nicotine.

The FDA intends to extend submission timelines for tobacco product review applications for newly-regulated products on the market as of Aug. 8, 2016, allowing the Agency to further examine how existing regulatory science can encourage innovations with the potential to make a notable public health difference and inform policies and efforts to eliminate tobacco-related disease and death.

“The ACC is pleased the Commissioner is taking on such an active role in the regulation of tobacco and nicotine, and sincerely hopes that these actions will reduce the burden of cardiovascular disease. The College looks forward to working with the FDA to implement effective tobacco and nicotine regulations in the interest of public health. However, the College is concerned by the appearance that the Agency is considering a change in its approach to e-cigarettes and premium cigars and urges the FDA to act swiftly to strictly enforce the Deeming Rule provisions pertaining to these products. The public health community’s interest in limiting access to nicotine products is not solely focused on addition concerns; instead, we are concerned about the increased risk of disease and death associated with the use and exposure to these products.”

Clinical Topics: Prevention, Smoking

Keywords: Tobacco, Electronic Cigarettes, Nicotine, Smoking, Public Health, United States Food and Drug Administration, Tobacco Products, Tobacco Use Disorder, Cardiovascular Diseases


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