The FDA has released revised draft guidance entitled “Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Revision 1.” This guidance is intended to assist industry in complying with the labeling requirements for nonprescription (over-the-counter (OTC)) human drugs marketed without an approved application established by the Dietary Supplement and Nonprescription Drug Consumer Protection Act. In an earlier version of the guidance issued January 2, 2008, the FDA stated that it intended to begin enforcing the labeling requirements for OTC drug products marketed without an approved application that are labeled on or after January 1, 2009; because the agency is still finalizing the guidance, the revised draft extends the enforcement date until January 1, 2010. Separate guidance regarding compliance with the labeling requirements for dietary supplements also has been released.