Disposable ENDS Product Enforcement Act of 2023
This bill requires the Food and Drug Administration (FDA) to update its enforcement guidance regarding Electronic Nicotine Delivery System (ENDS) products to include certain disposable ENDS products.
In April 2020, the FDA published revised guidance on how it intends to prioritize enforcement resources with respect to ENDS products that do not have premarket authorization (i.e., that have not received FDA approval). The guidance specifies that the FDA intends to prioritize enforcement against (1) flavored, cartridge-based ENDS products (except for tobacco or menthol flavored products); (2) other ENDS products for which the manufacturer has not taken adequate measures to prevent access to minors; (3) any ENDS products that are targeted or promoted towards minors; and (4) any ENDS products for which the manufacturer has not submitted an application for market approval or did not receive approval.
For purposes of this guidance, cartridge-based ENDS products do not include disposable products that are completely self-contained. The bill requires the FDA to incorporate these products, including nicotine products that are not derived from tobacco, into its enforcement priorities. The bill additionally specifies that the FDA may prioritize enforcement against these products in advance of updating the guidance. The FDA must also annually report on its enforcement actions with respect to these products.
Disposable ENDS Product Enforcement Act of 2023
This bill requires the Food and Drug Administration (FDA) to update its enforcement guidance regarding Electronic Nicotine Delivery System (ENDS) products to include certain disposable ENDS products.
In April 2020, the FDA published revised guidance on how it intends to prioritize enforcement resources with respect to ENDS products that do not have premarket authorization (i.e., that have not received FDA approval). The guidance specifies that the FDA intends to prioritize enforcement against (1) flavored, cartridge-based ENDS products (except for tobacco or menthol flavored products); (2) other ENDS products for which the manufacturer has not taken adequate measures to prevent access to minors; (3) any ENDS products that are targeted or promoted towards minors; and (4) any ENDS products for which the manufacturer has not submitted an application for market approval or did not receive approval.
For purposes of this guidance, cartridge-based ENDS products do not include disposable products that are completely self-contained. The bill requires the FDA to incorporate these products, including nicotine products that are not derived from tobacco, into its enforcement priorities. The bill additionally specifies that the FDA may prioritize enforcement against these products in advance of updating the guidance. The FDA must also annually report on its enforcement actions with respect to these products.
Disposable ENDS Product Enforcement Act of 2023
This bill requires the Food and Drug Administration (FDA) to update its enforcement guidance regarding Electronic Nicotine Delivery System (ENDS) products to include certain disposable...
In April 2020, the FDA published revised guidance on how it intends to prioritize enforcement resources with respect to ENDS products that do not have premarket authorization (i.e., that have not received FDA approval). The guidance specifies that the FDA intends to prioritize enforcement against (1) flavored, cartridge-based ENDS products (except for tobacco or menthol flavored products); (2) other ENDS products for which the manufacturer has not taken adequate measures to prevent access to minors; (3) any ENDS products that are targeted or promoted towards minors; and (4) any ENDS products for which the manufacturer has not submitted an application for market approval or did not receive approval.
For purposes of this guidance, cartridge-based ENDS products do not include disposable products that are completely self-contained. The bill requires the FDA to incorporate these products, including nicotine products that are not derived from tobacco, into its enforcement priorities. The bill additionally specifies that the FDA may prioritize enforcement against these products in advance of updating the guidance. The FDA must also annually report on its enforcement actions with respect to these products.