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FDA to rethink NRTs

30 Nov 2017. The US Food and Drug Administration (FDA) will rethink its approach to regulating nicotine replacement therapy products (NRTs), according to a blog post on the agency's website which referenced ‘electronic nicotine delivery systems’.

The FDA will form a Nicotine Steering Committee to focus primarily on the “development and regulation” of NRTs for cessation of use of combustible tobacco products, according to the post which was signed by FDA chief Dr Scott Gottlieb, Dr Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, and Mitchell Zeller, director of the FDA’s Center for Tobacco Products.

The post made reference to new “novel” forms of nicotine delivery, such as electronic nicotine delivery systems. These new forms of nicotine delivery "may" be developed into FDA-approved NRTs, the blog post said.

“When it comes to the discussion around transitioning current smokers to safer alternatives for the delivery of nicotine, a lot of public debate, to date, has been placed on the potential for modified risk tobacco products like electronic nicotine delivery systems and e-cigarettes. FDA also sees compelling opportunities to explore additional opportunities for the development of new and improved products that can be sold as new drugs, typically as over-the-counter pharmaceuticals,” the post read.

“If there are new kinds of NRTs — with different characteristics or routes of delivery – that can offer additional opportunities for smokers to quit combustible tobacco, we want to explore what steps we can take using our own regulatory policies to enable these opportunities, while making sure these products are demonstrated to be safe and effective for their intended use.”

The FDA said in July 2017 it would change the way it regulates tobacco and nicotine in light of advancements in technology related to nicotine delivery, and developments in tobacco harm reduction.