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New FDA draft guidance ‘could see e-cigarettes regulated as drugs’

The US Food and Drug Administration (FDA) has released the first of two new pieces of draft guidance that may eventually enable e-cigarette manufacturers to apply for regulated drug status for their products. 

FDA Commissioner Scott Gottlieb, MD, said there is “no greater impact we can have to improve the health of our nation than to significantly reduce the rate of tobacco-related disease and death”. Smoking combustible cigarettes is the leading cause of preventable death in the United States, accounting for around one in five deaths. According to the Centers for Disease Control and Prevention (CDC), an estimated 38 million adult Americans were smokers in 2016, with around 16 million people living with a smoking-related disease. 

Several nicotine replacement therapies (NRTs) are already approved and available in the United States, for example, nicotine patches, lozenges, and gum. A number of drugs to aid smoking cessation are also available, such as Chantix (varenicline), granted FDA approval in 2006, and Zyban (bupropion), both of which are used to curb cravings and control withdrawal symptoms. 

When finalized, the FDA’s new guidance, entitled “Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products”, will provide support the development and approval of orally inhaled nicotine-containing drug products, such as e-cigarettes, Gottlieb asserted. While much information is available regarding the toxicity of nicotine, less data is available for other compounds found in e-liquids, such as flavorings and heat-generated chemicals, so it is important to improve understanding of the potential risks associated with exposure to these products, he added.   

“We want to strike the right balance between enabling a viable, efficient path for these products to be regulated as drugs - where we have substantial tools to evaluate their safety and efficacy for their intended use as smoking cessation products.” 

However, Gottlieb also highlighted the importance of balancing the creation of pathways for new inhaled NRTs with ensuring sufficient information regarding the long-term effects of these inhaled products is gathered, particularly the effects on the lungs.  

Quitting smoking can yield numerous health benefits, including lowering the risk of lung cancer and many other forms of cancer; reduced risk of heart disease, stroke, and peripheral vascular disease; and a reduction in respiratory symptoms, notably chronic obstructive pulmonary disease (COPD), which was the third leading cause of death in the US in 2014.

The second piece of draft guidance, scheduled for release by the FDA in the fall, will lay out a framework for “new potential clinically relevant outcomes for smoking cessation products”. Examples of this may include reducing the likelihood ex-smokers will relapse and return to cigarette use in the long-term, or measuring improvements to cardiovascular health. It may also cover alternative treatment regimens, such as reduce-to-quit (a gradual reduction in nicotine use), or using two NRT drug products simultaneously. 

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