FDA Releases Draft Guidance for OTC Labeling

Rockville, MD (Dec. 8)-The US Food and Drug Administration released a draft guidance document that contains questions and answers relating to new labeling requirements for over-the-counter drug (OTC) products that are marketed without an approved application under section 502(x) of the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006.

Specifically, the guidance document discusses the following:

• The meaning of “domestic address” as referenced in section 502(x)

• The agency’s recommendation for the use of an introductory statement before the domestic address or phone number that is required to appear on the product label according to section 502(x)

• The agency’s intent regarding enforcement of the labeling requirements under section 502(x).

FDA intends to begin enforcement of section 502(x) “on or after Jan. 1, 2010,” or more than two years after this section of the Act became effective, which was on December 22, 2007.