Compliance Policy for Limited Modifications to Certain Marketed Tobacco Products; Guidance for Industry; Availability

摘要

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry entitled "Compliance Policy for Limited Modifications to Certain Marketed Tobacco Products." This guidance describes FDA's compliance policy for premarket review requirements for two types of limited modifications to new tobacco products that were on the market as of August 8, 2016, specifically, modifications to battery-operated tobacco products solely to comply with UL 8139 and modifications to liquid nicotine products solely to comply with the Child Nicotine Poisoning Prevention Act of 2015 (CNPPA) flow restrictor requirements for liquid nicotine containers. This guidance will enable tobacco manufacturers to upgrade their battery-operated tobacco products to UL 8139. It will also enable manufacturers to comply with the CNPPA requirements for flow restrictors for liquid nicotine containers. FDA is issuing this guidance to address battery safety concerns and youth exposure to liquid nicotine toxicity.