H.R. 3250 would prohibit the sale of certain over-the-counter drug products containing dextromethorphan (DXM) to individuals under the age of 18 and would restrict the distribution of unfinished DXM. The bill would also authorize civil penalties if those restrictions are not followed. CBO estimates that the Food and Drug Administration’s (FDA’s) programs to enforce compliance with the bill’s prohibitions would cost $232 million over the 2017-2021 period, assuming appropriation of the necessary amounts. In addition, CBO estimates that the bill would increase revenues from civil penalties by less than $500,000 over the 2017-2026 period because we expect that retailers and other distributors will abide by the bill’s restrictions.
Pay-as-you-go procedures apply because enacting H.R. 3250 would affect revenues. CBO estimates that enacting H.R. 3250 would not increase net direct spending or on-budget deficits in any of the four consecutive 10-year periods beginning in 2027.
The bill would impose an intergovernmental and private-sector mandate as defined in the Unfunded Mandates Reform Act (UMRA) on retailers that sell over-the-counter drugs containing DXM. The bill would impose additional private-sector mandates on purchasers of over-the-counter drugs containing DXM and purchasers and sellers of unfinished DXM. Based on information from FDA and industry sources, CBO estimates that the cost of complying with the mandates would fall below the annual thresholds established in UMRA for intergovernmental and private-sector mandates ($77 million and $154 million in 2016, respectively, adjusted annually for inflation).