The U.S. Food and Drug Administration (FDA) has announced new tobacco and nicotine regulations with a goal of “better protecting children and significantly reducing tobacco-related disease and death.”
The approach places levels of nicotine, and the issue of addiction, at the center of the agency’s tobacco regulation efforts. The goal is to 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 FDA also plans to begin a public dialogue about lowering nicotine levels in combustible cigarettes to non-addictive levels through product standards.
The agency intends to extend timelines to submit tobacco product review applications for newly regulated tobacco products that were on the market as of Aug. 8, 2016. For example, the FDA intends to develop product standards to protect against known public health risks, such as electronic nicotine delivery systems, battery issues and concerns about children’s exposure to liquid nicotine.
The FDA says it will provide manufacturers additional time to develop higher quality, more complete applications informed by additional guidance from the agency. Under expected revised timelines, applications for newly-regulated combustible products, such as cigars, pipe tobacco and hookah tobacco, would be submitted by Aug. 8, 2021, and applications for non-combustible products like e-cigarettes would be submitted by Aug. 8, 2022.
Additionally, the FDA expects that manufacturers would continue to market products while the agency reviews product applications.
The anticipated new enforcement policy will not affect any current requirements for cigarettes and smokeless tobacco, only the newly-regulated tobacco products like cigars and e-cigarettes. This approach also will not apply to provisions of the final rule for which compliance deadlines already have passed, such as mandatory age and photo ID checks to prevent illegal sales to minors.
The agency also will seek input from the public on a variety of significant topics, including approaches to regulating youth appealing flavors in e-cigarettes and cigars.