US FDA announces guidance for limited changes to hardware devices, e-liquid packaging

The US Food and Drug Administration (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:

1. Battery-operated tobacco products modified solely and only to the extent necessary to comply with UL 8139;
   
2. 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.

“We recognize there are certain modifications manufacturers can make to their tobacco products to address a voluntary industry battery standard and to comply with requirements related to safe packaging of liquid nicotine products, known as flow restrictors. We encourage these limited safety-related modifications because they are intended to ensure the public is protected from risks such as battery explosions or accidental exposure to toxic levels of nicotine,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “Today’s guidance will provide clarity to manufacturers considering these limited safety-related modifications to their electronic nicotine delivery system products by outlining our compliance policy for premarket review requirements for such modifications. In addition to publishing today’s guidance, the FDA continues to take steps to address the growing and disturbing trend of youth vaping use, including enforcement actions and resources for educators and schools. We are committed to doing everything we can to prevent kids from using tobacco products and will continue to develop a policy approach that aligns with that concern.”

More information can be found here.