FDA Asks for Comments on Dietary Supplement Labeling Requirements

The Food and Drug Administration is asking for comments on the burden of its dietary supplement labeling requirements under the Dietary Supplement and Nonprescription Drug Consumer Protection Act. The Act requires the label of a dietary supplement marketed in the U.S. to include a domestic address or domestic telephone number through which the product’s manufacturer, packer or distributor may receive a report of a serious adverse event associated with the dietary supplement. FDA expects 1,460 respondents will prepare 3.8 new labels per year for a total of 5,560 new labels, which will require an average of 0.2 hours per label, for a total of 1,112 annual burden hours. Comments are due Sept. 21.