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OTC Monograph User Fees Up To $34M Floated In Senate Discussion Draft

 
• By Malcolm Spicer

Bulk of user fees would be raised through facility fees, under Sens. Isakson and Casey’s discussion draft, but there's little time to add the changes to FDA user fee reauthorization bills already moving in Congress.

Capitol House

Total annual user fees of $22m to $34m from OTC manufacturers – primarily from facility registrations – are among the proposals in a discussion document circulated by Sens. Johnny Isakson, R-GA, and Bob Casey, D-PA.

Fees would also be raised when companies request changes via the monograph system. While the proposal does not detail the...

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Utah Delegation’s Support For Supplement Industry Key For Caucus Restart In Congress

 
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Dietary Supplement Caucus e-launched the 119th Congress with Utah Republican House member Mike Kennedy and Texas Democrat member Marc Veasey as co-chairs and with a total of nine senators and 20 House members spanning both parties.

Price To Resolve US Hemp Dilemma Too High In House Appropriators’ FY 2026 FDA Spending Bill

 
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House Appropriators’ $3.2Bn For FDA In FY 2026 Includes More Non-User Fee Funds Than Requested

 
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A US House bill would give the FDA $33.1m more in budget authority than requested by the Trump Administration for fiscal year 2026. The measure was sent to the full House Appropriations committee on a party-line vote.

CHPA Survey Shows Consumer Trust In Supplements Strong, Not So Much In Regulation

 
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Results of survey found a majority of representative sample of US voters nationwide agree “current regulations should be updated and strengthened to protect consumers,” CHPA says.

More from Policy & Regulation

Utah Delegation’s Support For Supplement Industry Key For Caucus Restart In Congress

 
• By Malcolm Spicer

Dietary Supplement Caucus e-launched the 119th Congress with Utah Republican House member Mike Kennedy and Texas Democrat member Marc Veasey as co-chairs and with a total of nine senators and 20 House members spanning both parties.

US Adverse Event Report Forms Replace ‘Gender’ Options With Male Or Female ‘Sex’ Question

Modifications to forms FDA 3500, for voluntary reporting by healthcare professionals, and 3500A, for mandatory reporting by manufacturers, marketers or facilities, include limiting changing gender question to sex and asking for only male or female answer.

EU Industry Wants EFSA Changes To Support Innovation

 
• By Tom Gallen

Prominent trade groups call on the European Commission to improve risk assessment of innovative food products by making changes to processes at the European Food Safety Authority.