The Food and Drug Administration’s evolving stance on smokeless tobacco products now includes creating a nicotine steering committee to “re-evaluate and modernize” its regulatory approach.
The committee is the latest symbol of how the agency plans to regulate innovative nicotine and tobacco products in terms of a continuum of usage risk.
FDA Commissioner Scott Gottlieb and other FDA senior managers said Wednesday the committee’s main focus will be on the development and regulation of nicotine replacement therapy (NRT) products.
Most of those products are sold over the counter as gum, patches and lozenges, including Zonnic, a gum made by Reynolds American Inc. subsidiary Niconovum.
“This (committee) reflects the need to critically examine the evolving science behind FDA’s evaluation of the safety and efficacy of nicotine-replacement therapies,” FDA officials said.
Congress gave the FDA regulatory authority over tobacco products in 2009, which led to the formation of the Center for Tobacco Products.
The center proved controversial under the Obama administration, as officials downplayed or dismissed the potential smoking-cessation role of innovation products, such as electronic cigarettes, snus and heat-not-burn traditional cigarettes.
However, the Trump administration’s influence on the FDA includes putting less emphasis on adding regulations and being more willing to consider the innovative products as potential reduced-risk options compared with traditional cigarettes.
On July 28, Gottlieb announced plans for a sweeping regulatory “road map” on tobacco and nicotine products.
The road map includes: lowering the nicotine level in traditional cigarettes to non-addictive levels; limiting or eliminating flavorings, such as menthol in traditional cigarettes and candy and fruits in e-cigs and vaporizers, that the agency says appeal to youths; and establishing rules to make the product review process more efficient, predictable and transparent for manufacturers, while upholding the agency’s public health mission.
The FDA officials said “key topics will be the types of safety and efficacy studies we require, and the way these products are used and labeled.”
“The aim is to make sure FDA has the right policies in place to enable the development of product innovations that have the potential to be more helpful in helping smokers quit combustible cigarettes and maintain abstinence.”
There have been several recent university research studies that have shown e-cigs and vaporizers are emerging as the top product preference for smokers trying to kick their habit.
Meanwhile, several studies, including one by the Royal College of Physicians, have claimed e-cigs and vaporizers are up to 95 percent less harmful than traditional cigarettes.
“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 officials said.
Gregory Conley, president of the American Vaping Association, said that while he “welcomes any move by the FDA to spur product development in the NRT market, we remain concerned that President Trump’s FDA has not paid the same attention to the need to lower regulatory barriers for those manufacturing vapor products.”
Scott Ballin, past chairman of Coalition of Science or Health, said he is concerned that the FDA “is creating a new layer of bureaucracy, which may in the end cause more confusion to manufacturers and consumers.”
Dr. John Spangler, professor of family and community medicine at Wake Forest Baptist Medical Center, said he viewed the committee as another “very positive step by the FDA.”
“It is essential that drugs be used only if they are safe and effective. This is especially true for nicotine replacement therapy products with novel delivery systems.”
Spangler cautioned that “there is always a tension between balancing sound science on usefulness, the need for innovation and return on investment.”
“We need new products, and I hope that regulation will not impede companies from being willing to innovate.”