The advance notice of proposed rulemaking is part of the FDA’s comprehensive plan for tobacco and nicotine regulation released last summer to issue a framework to minimize the number of tobacco-related deaths nationwide.
Dr. Gottlieb said March 14 the FDA plans to issue two additional ANPRMs within the coming months: one to seek comment on the role flavors, including menthol, play in the initiation, use and cessation of tobacco products, and another to solicit additional comments and data related to the regulation of premium cigars.
The agency will also jump-start a project to re-evaluate and modernize the FDA’s approach to the development and manufacturing of safe and effective medicinal nicotine replacement products, and will issue a series of foundational rules and guidance documents to delineate key requirements of the regulatory process.
“As we explore this novel approach to reducing the death and disease from combustible cigarettes, it’s critical that our policies reflect the latest science and is informed by the input we receive from our meetings with stakeholders, comments to the open public docket and future opportunities for comment,” the statement reads. “We’re committed to making sure that we have transparent regulatory policies and best practices in place to maximize our public health impact.”
To access Dr. Gottlieb’s full statement, click here.
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