Top Supplement Stories 2013: POM Saga, Spiked Products, GMPs
This article was originally published in The Tan Sheet
Experts’ predictions for tighter GMP enforcement and the federal government shutdown’s effect on industries regulated by CFSAN joined the POM-FTC litigation and Pfizer’s work to identify bad actors making ED-spiked supplements as top supplement sector stories in “The Tan Sheet” during 2013.
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The federal shutdown interrupts FDA’s increasing enforcement against firms marketing violative supplement products in addition to slowing drug application evaluations and facility inspections. FDA would retain 8,180 staff members, about 55% of its total, mostly because they could be “paid from carryover funding.”
An amici curiae brief filed in the POM Wonderful case by CHPA and CRN criticizes FTC for relying “on its own ‘expertise’ to determine the meaning of ambiguous advertisements.” A separate brief by attorney Jonathan Emord says FTC is creating unreasonable barriers for food product research.
The nearly three-year battle between FTC and POM Wonderful moves to a federal appeals court, where the pomegranate juice and supplement firm asks the judges to nix the commission’s order that POM conduct two randomized controlled trials to support disease-related health claims.