“The ANPRM being issued today provides a wide-ranging review of the current scientific understanding about the role nicotine plays in creating or sustaining addiction to cigarettes and seeks comments on key areas, as well as additional research and data for public review, as we continue our consideration of developing a nicotine product standard. We’re interested in public input on critical questions such as: what potential maximum nicotine level would be appropriate for the protection of public health?” said Dr. Scott Gottlieb.
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Gottlieb started the press announcement by pointing out that following the tobacco plan announced last Summer, the FDA will be issuing an advance notice of proposed rulemaking (ANPRM) to explore a product standard with lowered nicotine levels in order to minimize the addictive aspect of tobacco. “This new regulatory step advances a comprehensive policy framework that we believe could help avoid millions of tobacco-related deaths across the country,” said Gottlieb.
Gottlieb added that cigarettes are still responsible for the deaths of over 480,000 Americans per year, and on top of this smoking costs nearly $300 billion a year in terms of health care and lost productivity. “In fact, cigarettes are the only legal consumer product that, when used as intended, will kill half of all long-term users,” said the FDA Commissioner.
Will decreasing nicotine in cigarettes, lead to a booming blackmarket?
Amidst the questions this ANPRM seeks to answer are the following, “Should a product standard be implemented all at once or gradually? What unintended consequences – such as the potential for illicit trade or for addicted smokers to compensate for lower nicotine by smoking more – might occur as a result?” The latter is a very important question, as public health experts keep pointing out that consumers’ response to their products of choice becoming unavailable tends to be turning to contraband versions.
Gottlieb referred to recent statistics that are being published in the New England Journal of Medicine, focusing on a specific policy scenario. This data indicates that if this policy is implemented it could lead to approximately 5 million smokers quitting. “And with this scenario, an even greater impact could be felt over time: by the year 2100, the analysis estimates that more than 33 million people – mostly youth and young adults – would have avoided becoming regular smokers,” added Gottlieb.
Read Full Press Announcement: US Food & Drug Administration