(WASHINGTON) – Today, FDA has issued a Federal Register notice announcing the availability of the “ Compliance Policy for Limited Modifications to Certain Marketed Tobacco Products” guidance for industry to address ENDS battery safety concerns and mitigate the risk of accidental exposures of children to liquid nicotine.
This guidance describes FDA’s compliance policy for premarket review requirements for two types of limited modifications to tobacco products that were on the market as of Aug. 8, 2016:
- Battery-operated tobacco products modified solely and only to the extent necessary to comply with UL 8139; and
- E-liquid products that contain nicotine modified solely and only to the extent necessary to comply with the Child Nicotine Poisoning Prevention Act of 2015 (CNPPA) restricted flow 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 the guidance.
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