Regulatory Transactions

Earlier today, U.S. Food and Drug Administration (FDA or the Agency) Commissioner Scott Gottlieb, M.D., announced FDA’s issuance of an advance notice of proposed rulemaking (ANPRM) to explore a product standard to lower nicotine in cigarettes to minimally or non-addictive levels (Nicotine ANPRM).  Gottlieb’s announcement comes nearly eight months after the Agency unveiled its planned tobacco regulatory policy shift to place nicotine, and the issue of addiction, at the center of FDA’s tobacco regulatory efforts, which we discussed here.

In addition to offering some of the details of the Nicotine ANPRM, Gottlieb also indicated today that FDA will soon issue two additional ANPRMs: one to seek comment on the role that flavors – including menthol – play in initiation, use, and cessation of tobacco products (Flavor ANPRM), and a second to solicit additional comments and data related to the regulation of premium cigars (Premium Cigar ANPRM).  As reported by Inside Health Policy on March 7, 2018, the White House Office of Management and Budget (OMB) has already cleared the Menthol ANPRM and the Premium Cigar ANPRM.