Reposted from Washington Post (11/30/17)

The Food and Drug Administration said Wednesday it is taking new steps to encourage the development of innovative nicotine-replacement therapies to wean smokers off conventional cigarettes.

In a blog post on the agency’s website, three top officials said they want to ensure the FDA has the right policies to advance new products to help smokers. “Our goal is to enable greater use of safe and effective options to help those who are addicted to nicotine get the help they need to quit combustible cigarettes altogether,” said the post, which was signed by FDA Commissioner Scott Gottlieb, Center for Drug Evaluation and Research Director Janet Woodcock and Center for Tobacco Products Director Mitchell Zeller.

The post said a new Nicotine Steering Committee made up of senior FDA officials will explore the agency’s handling of smoking-cessation products. It said the agency will hold a hearing on Jan. 26 to get public input.
Among the questions the committee will explore: Are there ways to improve on the current over-the-counter nicotine-replacement systems, or new strategies that might be more effective? And how should they be evaluated?

The effort is part of the agency’s new tobacco-regulatory regime announced by Gottlieb last summer.

About 480,000 people die of tobacco-related causes in the United States every year. While nicotine hooks people, it doesn’t kill them; the hazard is posed by thousands of other chemical substances in cigarettes, many of them carcinogenic.

Current FDA nicotine-replacement therapies include over-the counter gums, patches and lozenges, and prescription nasal sprays and inhalers. Most of those have been on the market for more than two decades. Some critics say the FDA has long been overly cautious in approving new smoking-cessation products, given the magnitude of the public health threat posed by smoking.

The blog post points out that studies suggest using such products can double the chance of success among those trying to quit smoking. The therapies are designed to supply controlled amounts of nicotine to reduce cravings.

The committee will consider which types of safety and efficacy studies should be required for nicotine-replacement therapies as well as other issues. Those could include “changes to the labeling and indications for existing products or a new product that might deliver nicotine at different rates, or through different delivery mechanisms,” the post said.

For example, some e-cigarettes or other types of electronic nicotine delivery systems might be candidates for regulation as over-the-counter nicotine-replacement therapies. But the FDA officials said they also see “additional opportunities” for new and improved OTC products that could help smokers quit.

Matthew Myers, president of the Campaign for Tobacco-Free Kids, praised the FDA’s move to support the development of more nicotine-replacement products. The new steering committee, he said, has the potential to bring about “fundamental change” by pursuing coordinated policy to reduce smoking. But he added that the panel also must regulate e-cigarettes in a way that ensures the devices are used to help smokers quit or switch to safer alternatives — and not for recreational use.

In July, Gottlieb unveiled a new framework for tobacco that was designed to put nicotine at the center of the agency’s regulatory effort. As part of the plan, he said, the FDA would require reductions in nicotine in conventional cigarettes to make them minimally addictive or nonaddictive.

He stressed at the time that people who are addicted to nicotine would need alternative ways to get the drug if they are to successfully give up regular cigarettes. To make sure e-cigarettes are readily accessible, he delayed for several years a requirement that e-cigarettes marketed after February 2007 submit to a stringent FDA review.

About 70 percent of adult smokers in the United States say they want to quit, according to the Centers for Disease Control and Prevention, and more than half try to do so each year.

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