In this guidance, FDA sets out its 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: (1) modifications to battery-operated tobacco products solely to comply with UL 8139; and (2) 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 compliance policy provides that FDA does not intend to enforce violations of the premarket review requirements against such modified products on the basis of the modifications described in this guidance. In light of their potential safety risks, FDA strongly encourages manufacturers to remove the currently marketed unmodified tobacco products from the market prior to introducing the modified tobacco products to the market.      

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities.  Instead, guidances describe FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  The use of the word should in FDA’s guidances means that something is suggested or recommended, but not required.

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