FDA In Brief: FDA explains policy for manufacturers of battery-operated tobacco products and e-liquids who are considering making limited safety-related modifications to their products

FDA In Brief: FDA explains policy for manufacturers of battery-operated tobacco products and e-liquids who are considering making limited safety-related modifications to their products 

Today, the U.S. Food and Drug Administration issued a guidance, Compliance Policy for Limited Modifications to Certain Marketed Tobacco Products, which sets out the FDA’s compliance policy for limited safety modifications to tobacco products on the market as of Aug. 8, 2016: (1) battery-operated tobacco products modified solely and only to the extent necessary to comply with the voluntary industry UL 8139 battery standard; and (2) e-liquid products containing nicotine modified solely and only to the extent necessary to comply with the restricted-flow requirements for liquid nicotine containers set out in the Child Nicotine Poisoning Prevention Act of 2015 (CNPPA). This guidance explains that the FDA does not intend to enforce violations of the premarket review requirements against such modified products on the basis of these limited modifications. On Aug. 8, 2016, all e-cigarettes and other electronic nicotine delivery systems (ENDS) products became subject to...

Read More