Leniency for Safety Changes

The U.S. Food and Drug Administration (FDA) will not enforce violations of its premarket review requirements relating to limited safety modifications to tobacco products on the market as of Aug. 8, 2016, according to a new guidance issued by the agency.

Titled Compliance Policy for Limited Modifications to Certain Marketed Tobacco Products, the guidance pertains to battery-operated tobacco products modified to comply with the voluntary industry UL 8139 battery standard and nicotine e-liquids modified to comply with the restricted-flow requirements set out in the Child Nicotine Poisoning Prevention Act (CNPPA) of 2015.

The FDA, the U.S. Consumer Product Safety Commission and global certification company UL worked together to develop a voluntary industry standard, UL 8139, to help manufacturers mitigate potential battery-related risks associated with their battery-operated tobacco products.

The FDA said it recognizes that to comply with the battery standard and the CNPPA, manufacturers may need to change certain aspects of their products, which may render their products as new tobacco products.

The compliance policy provides that the FDA does not intend to enforce violations of the premarket review requirements of products that were modified to comply with the UL 8139 or the CNPPA.