FDA Found Lead in Vitamins; California Files Suit

By Wes Siegner & Ricardo Carvajal – 

Last August, FDA published data that the Agency had gathered on the content of lead in 324 vitamin products labeled for use by women or children. FDA made clear that its estimates of lead exposures for all of the products surveyed were below the safe/tolerable exposure levels for children, pregnant and lactating women, and adult women.  However, it appears that FDA’s estimates of lead exposures for some products fell above the safe harbor levels for lead established under California’s Proposition 65. 

Not surprisingly, California’s Attorney General, joined by a number of county district attorneys, has filed suit against dozens of dietary supplement manufacturers alleging that they marketed vitamin supplements containing lead “without first giving clear and reasonable warning,” as required under Proposition 65.  The complaint asks for civil penalties and injunctive relief, among other things.  It is easy to imagine that this scenario could repeat itself with other contaminants that are the focus of future FDA surveys or of FDA’s increased inspectional activities under the recently promulgated dietary supplement Current Good Manufacturing Practices regulation.