FDA Director Presents at Smoker Friendly Tobacco Conference
On Aug. 25, 2023, the U.S. Food and Drug Administration (FDA) Center for Tobacco Products (CTP) Director Dr. Brian King spoke to the attendees at the Smoker Friendly Tobacco Conference and Festival in Broomfield, CO. Director King’s presentation focused on current FDA tobacco regulations and possible upcoming regulations.
The following were several key takeaways from Director King’s presentation at the Smoker Friendly Tobacco Conference:
• While the FDA has previously announced publicly that the agency planned to issue sometime this August the final regulations prohibiting menthol in cigarettes and characterizing flavors in cigars, Director King stated that the final regulations should be issued by the end of 2023.
• The FDA has also previously announced publicly that the agency plans to publish by the end of 2023 for public comment new proposed regulations to set a maximum cap of nicotine in cigarettes and possibly in other combustible tobacco products. However, Director King indicated that the nicotine cap regulations would be published sometime after the menthol cigarette and flavored cigar final regulations are issued by the FDA later this year.
• The FDA will continue to conduct compliance check inspections on retailers to determine if retail stores are selling tobacco and vapor products which have been denied marketing authorization by the agency or are under FDA pre-market review, but for which no final order to deny or authorize the sale of the product has yet been issued by the agency.
The FDA has only authorized the sale of 45 tobacco products, which were introduced into the market after February 15, 2007. These authorized products include 23 electronic cigarette/vapor products or devices. A list of those products accompanies this bulletin.
Director King reiterated previous FDA statements that if a tobacco product or vapor product was introduced into the marketplace after February 15, 2007 and has not received a marketing authorization order from the agency, then the product is unlawful to sell. The director also stated that retailers and wholesalers selling unauthorized products risk enforcement actions by the FDA including inspections, warning letters, product seizures and fines. However, the FDA is also prioritizing enforcement by focusing its enforcement resources on products which were not the subject of a Pre-Market Tobacco Application submitted by a manufacturer, products for which the FDA issued a Marketing Denial Order, flavored cartridge type e-cigarettes (except tobacco or menthol flavors), e-cigarette manufacturers not preventing youth access and e-cigarettes targeted to youth.