FDA Takes Aim at Flavors and Nicotine Addiction in Fall 2018 Unified Agenda

FDA Unified Agenda Flavor Ban

The U.S. Food and Drug Administration (FDA) has updated its regulatory roadmap known as the Unified Regulatory Agenda. This document outlines the regulatory priorities of the FDA and provides some sense of a timeline for the FDA and other federal agencies. Among the FDA’s priorities–reducing the burden of addiction crises, including nicotine and youth tobacco use.

Nicotine and youth prevention as it relates to tobacco use has been a major initiative of the FDA in 2018. So far this year, the FDA has issued three advanced notices of proposed rule making (ANPRMs) that relate to tobacco–nicotine levels, flavors, and the premium cigar category [read more here]. These ANPRMs were issued and comments were submitted by various manufacturers, trade associations, advocates and anti-tobacco groups on these topics and are currently being reviewed by the agency. The FDA has a comprehensive multi-year plan in place to address tobacco and nicotine regulation and is determined to help curb nicotine and tobacco addiction and significantly reduce tobacco use among America’s youth.

“We’ll continue to consider a product standard to lower nicotine in combustible cigarettes to minimally or non-addictive levels, and we’re proposing additional meaningful actions to advance our comprehensive approach to nicotine, combustible cigarettes and electronic nicotine delivery systems,” wrote FDA commissioner Scott Gottlieb in a recent press release.

One area of Gottlieb and the FDA’s comments that caught the attention of the tobacco industry was the agency’s Unified Agenda relating to flavors in tobacco products. The FDA is looking to establish a standard for flavors in tobacco products, establish requirements for tobacco product manufacturing practices, implementing product standards for testing battery safety and battery management systems of e-cigarettes, creating registration and product listings for tobacco products and administrative detention of tobacco products. Gottlieb also reaffirmed the FDA’s recent ramped up efforts to address what it views as an epidemic as it relates to youth use and access to e-cigarette and ENDS products.

“This comprehensive plan aims to stop youth use of, and access to, tobacco products—especially e-cigarettes. Significant regulatory and research efforts related to access, marketing are already underway and new steps are forthcoming,” Gottlieb said within the press release.

Scott Pearce, executive director of the International Premium Cigar & Pipe Retailer Association (IPCPR), responded to the updated Unified Regulatory Agenda by stressing the importance of persistent advocacy of premium cigars, a topic the FDA noted is still ongoing and under review.