FDA Looks Back on Year One of New Tobacco Roadmap

SILVER SPRING, Md. — One year after unveiling its new approach to tobacco regulation, the Food and Drug Administration (FDA) detailed the progress it has made in putting a bigger focus on nicotine.

As Convenience Store News previously reported, FDA Commissioner Scott Gottlieb revealed the agency's new tobacco roadmap on July 28, 2017. The Comprehensive Plan for Tobacco and Nicotine Regulation places nicotine, and the issue of addiction, at the center of the agency's tobacco regulation efforts.

A key piece of the approach is looking at the different levels of risk associated with nicotine. The plan focuses on the one product — the cigarette — that is the most harmful given its combination of toxicity, addictiveness, prevalence, use patterns, and effect on non-users, according to the FDA.

Now, looking back on the past 12 months, the FDA noted it delivered on several pieces of action:

• Publishing an advance notice of proposed rulemaking (ANPRM) on a potential product standard for nicotine levels in combusted cigarettes;
• Publishing an ANPRM on the regulation of flavors in tobacco products;
• Publishing an ANPRM on the regulation of premium cigars; and
• Updating the agency's process for reviewing Provisional Substantial Equivalence applications.

Taking the plan a step further, in April the FDA unveiled the Youth Tobacco Prevention Plan. Under this plan, the agency undertook several actions aimed at protecting youth use of — and access to — electronic cigarettes and other tobacco products. These efforts included:

• Sending warning letters to companies for selling e-liquids resembling juice boxes, candies and cookies;
• Sending warning letters to retailers for selling JUUL e-cigarettes to underage youth; and
• Creating the FDA's first e-cigarette public education ad.

"Many important steps were taken in the last year, but much work remains. The comment periods for all three ANPRMs have now ended, and FDA will begin reviewing the comments and considering appropriate next steps," the agency said.