Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced that the FDA was seeking to support the development of new nicotine replacement products, such as vaping, that are both safe and effective.
According to the FDA tobacco use, primarily smoking continues to be the leading preventable cause of death in the United States – causing nearly half a million (480,000) premature deaths each year.
Gottlieb stated in the announcement, “Most adult smokers want to quit, and nearly half try to do so every year. But nicotine, which a cigarette efficiently delivers through the lungs and to the brain in less than 10 seconds, draws many people back despite their desire to stop.”
Nicotine is the highly addictive substance that keeps smokers coming back for more, but the primary cause of disease and death are actually the tar and more than 7,000 toxic chemicals found in the cigarette itself. But not all nicotine delivery systems are created equal. From a health standpoint, smoking cigarettes present the most risk of disease and death, while nicotine replacement therapy (NRT) such as the nicotine patch, nicotine gum, and lozenges present a significantly lower risk.
According to Gottlieb, “NRT products, which are designed to safely reduce withdrawal symptoms, including the nicotine craving associated with quitting smoking, are generally considered to double the likelihood of a successful quit attempt.”
The FDA’s announcement clarified its desire to build on existing NRTs by approving new nicotine replacement products, such as e-cigarettes. A number of research studies have found vaping is the most effective method of quitting smoking, effectively doubling a smoker’s odds of quitting.
The announcement also clarified that e-cigarettes and other potential new nicotine replacement therapies “would need to be proven safe and effective for smoking cessation and regulated as a drug product. This would allow them to be marketed as a prescription or over-the-counter drug products with medical claims for smoking cessation or related indications – ultimately reducing the likelihood of someone continuing to suffer the clinical consequences of smoking. This is different from our regulation of e-cigarettes as tobacco products.”
At this time, the FDA seems to be taking two distinctly different tracks with regard to vaping and e-cigarettes, seeking greater regulation with regard to vape juice flavors in an effort to curb youth vaping; as well as seeking more flexible frameworks to speed the development and FDA approval of new products that have potential to be effective in helping smokers quit combustible (traditional) cigarettes.
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