Recently, the FDA issued its advance notice of proposed rulemaking (ANPRM) on the topic, stating it’s intent to significantly cut the levels of nicotine in cigarettes. This is part of the FDA’s shift in focus since Scott Gottlieb assumed the position of FDA Commissioner, who has stated that such a move could reduce the amounts of tobacco-related deaths across the U.S.
“We believe this unprecedented approach to nicotine and tobacco regulation not only makes sense, but also offers us the best opportunity for achieving significant, meaningful public health gain,” said Gottlieb. “This new regulatory step advances a comprehensive policy framework that we believe could help avoid millions of tobacco-related deaths across the country.”
With the ANPRM now published in the Federal Register, the FDA is now seeking public input on a range of topics including if a product standard should be rolled out and enforced all at once or gradually, the unintended consequences of such regulations including a rise in smoking or illicit trade increasing, and what would be the reasonable amount of nicotine for tobacco products.
The FDA also hopes to modernize its approach to and regulation of nicotine replacement products–including e-cigarettes and other electronic nicotine delivery devices–which have seen a boost in recent years as regulations on traditional e-cigarettes has increased.