Regulatory News In Brief
This article was originally published in The Tan Sheet
Proposals to change supplement regs tabled in Senate; Senate wants firm sunscreen rule compliance date; 2012 sees rise in tainted sexual enhancement supplements.
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Nine Democrats led by Senator Jack Reed ask FDA to resolve sunscreen issues that remain in regulatory limbo. FDA needs to clarify “misconceptions about misleadingly high SPF labels beyond 50, where the increase in UV protection is relatively small,” the senators suggest.
FDA softens disclaimer for green tea QHC; Formulife/Purus covers spectrum of violations; NAD refers Schick case to FTC; Genomma drops Prestige Brands board bid.
Reforms would end waiver caps for conflicts of interest, but whether they will solve the problems patient groups and others have with the advisory committee selection process is unclear. In a discussion draft, FDA could issue as many waivers of financial conflicts as it chose.