November 25, 2019
“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, J.D., 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.”
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 the FDA’s tobacco authorities, including the premarket authorization requirements in the Federal Food, Drug, and Cosmetic Act.
The FDA, alongside the U.S. Consumer Product Safety Commission, external stakeholders, and UL (a global safety certification company formerly known as Underwriters Laboratories), 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 recognizes that, to comply with this voluntary industry standard (UL 8139 Standard for Safety for Electrical Systems of Electronic Cigarettes and Vaping Devices), manufacturers of battery-operated tobacco products may need to change certain aspects of their product, which may render their products as new tobacco products. This compliance policy provides that the FDA does not intend to enforce violations of the premarket review requirements against battery-operated tobacco products that were on the market as of Aug. 8, 2016 and that are then modified solely and only to the extent necessary to comply with UL 8139, on the basis of such modification.
Additionally, to help mitigate the potential risks of accidental exposure of children to liquid nicotine, Congress passed the CNPPA, which requires liquid nicotine containers to have, among other things, special packaging that makes it difficult for children to open. The FDA believes e-liquid containers that comply with the flow restrictor requirements will potentially mitigate the risk of children becoming accidentally exposed to toxic levels of nicotine from e-liquids. This compliance policy provides that the FDA does not intend to enforce violations of the premarket review requirements against liquid nicotine products on the market as of Aug. 8, 2016 and that are then modified solely and only to the extent necessary to comply with the CNPPA requirements for restricted flow, on the basis of such modification.
# # #
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.