“We laud the U.S. FDA for the agency’s strong push for nicotine regulation which paves the way for the development of innovative and less harmful tobacco products. It is our hope that local policymakers and regulators would follow the lead of the U.S. FDA,” said Tom Pinlac, President of The Vapers Philippines.
Last month, the U.S. Food and Drug Administration (FDA) issued an advance notice of proposed rule making (ANPRM) where FDA Commissioner Dr. Scott Gottlieb sees nicotine reduction as “a historic opportunity” to convince smokers to switch from conventional cigarettes to products that provide nicotine without the serious health hazards posed by burning tobacco. “In order to successfully address cigarette addiction, we must make it possible for current adult smokers who still seek nicotine to get it from alternative and less harmful sources,” said Gottlieb. He adds, “the agency’s regulation of both novel nicotine delivery products such as e-cigarettes and traditional tobacco products will encourage the innovation of less harmful products”.
“This latest FDA move could be a game changer in public health and help save millions of lives. It will help more currently addicted smokers to quit or switch to potentially less harmful products such as e-cigarettes,” said Joey Dulay, President of the Philippine E-cigarette Industry Association (PECIA).
The FDA advance notice has been published in the Federal Registrar (the daily journal of the U.S. Government) and will be open for public comment until June 14, 2018 to obtain information for consideration in developing a tobacco product standard to set the maximum nicotine level for cigarettes. It includes new data from an analysis funded by the agency and published in the March 2018 issue of the New England Journal of Medicine. The study, which evaluated a possible policy scenario, found that lowering nicotine levels could reduce the U.S. smoking rate to 1.4 percent from the current 15 percent of adults potentially resulting in eight million fewer tobacco-related deaths through the end of the century. This is “an undeniable public health benefit,” Gottlieb said.
According to the FDA, tobacco use, largely cigarette smoking, kills more than 480,000 Americans every year and costs the U.S. nearly $300 billion a year in direct health care and lost productivity. “Cigarettes are the only legal consumer product that, when used as intended, will kill half of all long-term users. Given their combination of toxicity, addictiveness, prevalence and effect on non-users, it’s clear that to maximize the possible public health benefits of our regulation, we must focus our efforts on the death and disease caused by addiction to combustible cigarettes,” Gottlieb said. “We’re at a crossroads when it comes to addressing nicotine addiction and smoking in this country – with important new tools to address this devastating public health burden.”
In January 2018,the FDA released its Strategic Policy Roadmap, which declared that “nicotine…is not directly responsible for the cancer, lung disease, and heart disease that kill hundreds of thousands of Americans each year. It is the other chemical compounds in tobacco, and in the smoke created by setting tobacco on fire, that directly and primarily cause the illness and death – not the nicotine.” In line with its comprehensive new approach, the FDA expressed its commitment to “take a fresh look” at electronic nicotine delivery systems (ENDS), which include e-cigarettes, “that can deliver satisfying levels of nicotine to adults who want access to it without burning tobacco.”
According to the FDA chief, the agency’s estimates underscore the tremendous opportunity to save countless lives if all stakeholders come together and forge a new path forward to combat the overwhelming disease and death caused by cigarettes. “And this unprecedented public health opportunity, contrasted against the cost of doing nothing, weighs heavily on me.” Gottlieb described the advance notice as “a significant step” in the FDA’s efforts to confront nicotine addiction in combustible cigarettes. “This milestone places us squarely on the road toward achieving one of the biggest public health victories in modern history and saving millions of lives in the process.”