US Interim Funding Bill Gets Biden’s Signature; Window Narrows For Cosmetics, Dietary Supplement Legislation
Passed by the US House and signed into law on 30 September, the Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023, avoids a partial government shutdown and furloughs in FDA user-fee programs. Policy riders stripped from the legislation, including for cosmetics and dietary supplement regulatory changes, could still find their way into a final FY 2023 spending omnibus.
Cosmetics modernization and dietary supplement mandatory product listing could have a final chance in the 117th US Congress if they can catch a ride on omnibus 2023 spending legislation that remains to be negotiated before year-end.
President Joe Biden on 30 September signed the Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023, hours before FDA user-fee agreements, and all 2022 federal spending programs, were set to expire.
The bill, which includes FDA user-fee reauthorizations for prescription drugs, generic drugs, biosimilars and medical devices, passed the US House the same day by a 230-201 vote. The Senate passed the amended legislation, H.R. 6833, one day earlier.
“This bipartisan legislation continues vital federal funding through December 16 and is a temporary measure to afford Congress sufficient time to complete the fiscal year 2023 omnibus,” the House Appropriations Committee explains in its announcement.
“There is still more work to be done, including providing FDA with the tools it needs to further improve its ability to regulate the rapidly growing dietary supplement industry." – CHPA
The stopgap measure does not contain the Modernization of Cosmetics Regulation Act, which was included in an FDA user-fee reauthorization bill proposed in the Senate before key committee leaders from both chambers, faced with the looming 30 September deadline, agreed to move forward with a “clean” version of the bill without MoCRA and other policy riders.
Personal Care Products Council leaders said this week they’re hopeful that MoCRA gets picked up in omnibus spending legislation before year-end. (Also see "PCPC Sees Opportunity For US Cosmetics Modernization After Congressional Mid-Terms" - HBW Insight, 29 Sep, 2022.)
Provisions to establish an FDA mandatory product listing (MPL) program for vitamin, mineral and supplement products also were left out of the continuing resolution enacted today. (Also see "US Budget Stopgap, FDA User Fee Reauthorization On Tap Minus Supplement MPL Program" - HBW Insight, 27 Sep, 2022.)
House Appropriations Committee chair Rosa DeLauro, D-CT, notes, “Passing this bill is just a temporary measure as Congress turns to enacting final 2023 funding bills before the end of the year. I look forward to bicameral, bipartisan negotiations with my counterparts to complete the fiscal year 2023 appropriations process as soon as possible.”
The Consumer Healthcare Products Association applauded the short-term spending package, while noting, “There is still more work to be done, including providing FDA with the tools it needs to further improve its ability to regulate the rapidly growing dietary supplement industry. CHPA has appreciated the robust dialogue surrounding the modernization of supplement regulations, and we look forward to continuing to work with stakeholders and Congress in support of comprehensive reform.”