PharmaSe
This article was originally published in The Tan Sheet
Executive Summary
New dietary ingredient premarket notification for L-Se-methylselenocysteine (SeMC) "lacks evidence to support" conclusion that 100 mcg selenium supplement taken twice daily "will reasonably be expected to be safe," FDA says in letter recently made available. If adults in upper percentile for selenium consumption were to take ingredient as recommended, their total daily selenium intake "could range from 308 to 480 mcg," exceeding tolerable upper intake and minimal risk levels, FDA says. "This indicates that there is an insufficient margin of safety between the estimated exposure to selenium and the level of selenium at which chronic toxicity would reasonably be expected to appear for adults who are high percentile consumers of selenium in the diet," agency adds