FDA ephedrine proposal
This article was originally published in The Tan Sheet
Executive Summary
Sens. Orrin Hatch (R-Utah) and Tom Harkin (D-Iowa) request staff briefing on dietary supplement issues, including FDA's proposed rule on ephedrine alkaloid-containing supplements, in Feb. 4 letter to agency. The letter says FDA's 1997 proposal to restrict serving sizes to 8 mg "appears to be based on 13 adverse event reports" and asks whether the number is "quantitatively sufficient, based on reasonable estimates of consumption for these products, to establish a causal relationship on which to base a serving limitation." The senators also ask whether the agency has "analyzed the trend in AERs to determine whether the number of scientifically reliable AERs" has changed since a 25 mg per serving, 100 mg per day standard was adopted by "major segments of the industry." They additionally seek updates on FDA regs on Good Manufacturing Practices for supplements and structure/function claims and request a briefing by Feb. 15
You may also be interested in...
Supplement GMP Warning Letters Make Modest Debut In 2010
Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC
In Brief
Combe sells most of its OTC brands
People In Brief
Perrigo promotes in pricing, planning