FDA’s Focus on Nicotine Levels Wavering?

‘Unified Agenda’ omission causes speculation over future of plan to lower levels in cigarettes
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WASHINGTON — Could the U.S. Food and Drug Administration (FDA) be wavering on its announced plan to target nicotine levels in cigarettes?

An update of an agency website caused a stir in recent weeks when it failed to include the goal to evaluate lowering nicotine levels in cigarettes, according to officials with a tobacco-retailing association.

Twice a year, federal government agencies update and publish the Unified Agenda, which is a list of regulations that they plan to work on within the next year. The FDA’s newly updated Unified Agenda does not include a regulation to reduce or cap nicotine levels in cigarettes, a plan former FDA Commissioner Scott Gottlieb announced in July 2017, according to Lakeville, Minn.-based NATO.

The FDA included a potential regulation for limiting or capping nicotine in cigarettes in its spring 2019 Unified Agenda, but the potential regulation was not included in the newly updated fall list of possible regulations, NATO officials said. In fact, the FDA issued an advance notice of proposed rulemaking (ANPRM) in March 2018 and asked the industry and the public to submit comments about a potential regulation that could reduce nicotine levels in cigarettes substantially. NATO submitted comments to the FDA’s ANPRM in July 2018.

According to an FDA official, the agency focuses on regulations that reflect its “most immediate priorities” as listed in its Unified Agenda this fall. “However, it is important to note that just because previously identified regulations were removed from the Unified Agenda, that does not mean the agency does not consider them a priority or will not continue to work on their development,” said Michael Felberbaum, an FDA spokesman, in an emailed response to CSP Daily News. “The FDA is focused on implementing a science-based, comprehensive approach to tobacco and nicotine regulation. As part of this effort, FDA continues to gather evidence and data on an ongoing basis regarding all tobacco products.”

Felberbaum said the FDA is reviewing all comments submitted in response to the ANPRM related to nicotine levels in combustible cigarettes from last year.

The debate over nicotine levels reemerges at a time when initiatives over flavored tobacco products, especially as they relate to e-cigarettes and vaping, are coming up at the federal, state and local levels.

[Editor’s Note: CSP is accepting nominations for its Category Manager of the Year awards, which includes the tobacco and other tobacco products (OTP) categories, as well as the new category of cannabidiol, or CBD, products. The nomination period ends Friday, Dec. 13. Winners will be announced at CSP’s Convenience Retailing University 2020 conference to be held Feb. 18-19, 2020, in New Orleans. To submit a nomination, click here.]

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