FDA Recaps Year of Tobacco Initiatives

By 
Angel Abcede, Senior Editor/Tobacco, CSP

dr. scott gottlieb

SILVER SPRING, Md. -- In the year since unveiling a new roadmap for the regulation of tobacco products, the U.S. Food and Drug Administration (FDA) recapped its efforts in a recent newsletter, reviewing a range of activities that included public-comment periods on nicotine levels in cigarettes to a series of actions aimed at keeping youth from vaping and having access to e-cigarettes.

On July 28, 2017, Scott Gottlieb, commissioner of the FDA, unveiled the agency’s Comprehensive Plan for Tobacco and Nicotine Regulation, which placed nicotine and the issue of addiction at the center of its tobacco regulation efforts.

A key piece of the approach is demonstrating a greater awareness that nicotine, while highly addictive, is delivered through products with different levels of risk, FDA officials said in the newsletter.

The FDA recapped its series of accomplishments, which included the following …

Photo courtesy of the FDA. 

Public comment periods

stack of documents

Starting this past spring, the FDA held three major public-comment periods:

  • An Advance Notice of Public Rulemaking (ANPRM), or public-comment period, on a potential product standard for nicotine levels in combusted cigarettes.
  • An ANPRM on the regulation of flavors in tobacco products.
  • An ANPRM on the regulation of premium cigars.

Reviewing its processes

reviewing report in an office

The agency started updating its process for reviewing Substantial Equivalence applications and the ways it reviews and evaluates new tobacco products. 

A youth initiative

multi ethnic young friend group texting and reading

The FDA also unveiled an additional effort it called its Youth Tobacco Prevention Plan, taking actions on several fronts to discourage youth from using e-cigarettes and other tobacco products (OTP). 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.
  • Creating the agency’s first e-cigarette public education ad.

To mark the one-year anniversary of the agency’s announcement, FDA has updated its webpage for the Comprehensive Plan—including the addition of a new Youth Tobacco Prevention Plan webpage—to serve as a home for all of the latest updates.