Regulatory Counsel

0910-AH90 201804 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Testing Standards for Batteries and Battery Management Systems in Electronic Nicotine Delivery Systems

This rule would propose to establish a product standard to require testing standards for batteries used in electronic nicotine delivery systems (ENDS) and require design protections through a battery management system for ENDS using batteries. This product standard would protect the safety of users of battery-powered tobacco products and will help to streamline the FDA premarket review process, ultimately reducing the burden on both manufacturers and the Agency. The proposed rule would be applicable to tobacco products that include a non-user replaceable battery as well as products that include a user replaceable battery.

]]> Economically Significant Previously Published in The Unified Agenda Proposed Rule Stage Yes No Regulatory Not Yet Determined 21 U.S.C. 301 et. seq. 21 U.S.C. 371 21 U.S.C. 387(b) 21 U.S.C. 387(g) 21 U.S.C. 387i No NPRM 12/00/2018 Yes Businesses None No Yes No Colleen Lee Regulatory Counsel 0910 Food and Drug Administration FDA 877 287-1373 ctpregulations@fda.hhs.gov 10903 New Hampshire Aveue, WO 71, Room G335, Silver Spring MD 20993