In a largely symbolic gesture, Representative Shelia Cherfilus-McCormick has introduced the “Disposable ENDS Product Enforcement Act of 2023.” The bill is characterized as closing “the Trump Administration’s loophole on disposable electronic nicotine delivery systems (ENDS),” but would practically accomplish nothing other than expressing Congress’ will that FDA enforce the law under its existing authority.
The bill finds its origin in FDA’s 2020 ENDS compliance policy, under which FDA indicated that it would prioritize enforcement against flavored ENDS (other than tobacco and menthol) lacking premarket authorization, but exempted disposable and open system ENDS from this policy. FDA’s compliance policy largely became a moot point after September 2020, when all ENDS manufacturers were required to submit premarket applications, and after 2021 and 2022, when FDA acted on and denied the vast majority of premarket applications for flavored ENDS. At this point, relatively few companies have pending, timely-filed applications for flavored ENDS. So very few flavored ENDS suppliers could find enforcement relief from FDA’s 2020 policy, either because their products were not sold in United States by FDA’s August 8, 2016 deadline for commercializing their products, because they did not meet FDA’s September 9, 2020 deadline for seeking marketing authorization for those products or because FDA has denied their applications.
Nevertheless, Representative Cherfilus-McCormick’s bill would direct FDA amend its 2020 compliance policy to prioritize enforcement against disposable ENDS, including disposable ENDS containing nicotine that is not derived from tobacco. With respect to this subset of products, FDA arguably already has clear direction from Congress by virtue of the 2022 amendment to the Family Smoking Prevention and Tobacco Control Act giving FDA jurisdiction over products containing nicotine that is not derived from tobacco. This law amounted to an effective ban on non-tobacco-derived nicotine products by conditioning those products’ lawful marketing on FDA authorization. To date, FDA has not authorized any of these products, and FDA has indicated that these products are among its highest enforcement priorities.
Although the bill is unlikely to pass, the bill is seen another effort to push FDA to enforce the law against countless unauthorized products on the market. The bill comes on the heels of a citizen petition filed by R.J. Reynolds, which also asks FDA to start enforcing the law against flavored ENDS.
