Draft Guidance for Industry: Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Revision 1; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance document entitled "Draft Guidance for Industry: Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Revision 1." This revised draft guidance is intended to assist the industry in complying with the labeling requirements prescribed for dietary supplement manufacturers, packers, and distributors by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (the DSNDCPA). The revised draft guidance changes the date on which FDA intends to begin enforcing these labeling requirements. Separate guidance, issued by the Center for Drug Evaluation and Research on labeling requirements for nonprescription (over-the-counter) human drugs marketed without an approved application, is announced elsewhere in this issue of the Federal Register.