Revised FDA Draft Guidance Documents Provide Companies an Additional Year to Comply with the Labeling Requirements of the Dietary Supplement and Nonprescription Drug Consumer Protection Act; “Domestic Address” Interpretation Remains the Same

December 10, 2008

By Cassandra A. Soltis

FDA has posted on its web site two revised draft guidance documents (here and here) concerning the labeling requirements of dietary supplements and over-the-counter (OTC) drugs under the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006.  That Act requires the labels of dietary supplements and OTC drugs other than those approved through the NDA process to bear the domestic phone number or domestic address of the “responsible person” so that consumers can report serious adverse events. 

In its draft guidance documents issued in December 2007, FDA indicated that by “domestic address,” Congress meant the full address, which includes the street address or P.O. box.  However, Hyman, Phelps & McNamara, P.C. and industry trade associations disputed this narrow interpretation of “domestic address” in comments on the guidance documents, arguing that FDA’s current “place of business” requirement for the labels of dietary supplements and OTC drugs satisfies the “domestic address” requirement of the new law, provided that the place of business is domestic, not foreign.  FDA also stated in its December 2007 guidance that it would not begin enforcing the labeling requirements until January 1, 2009.

In notices to be issued in the Federal Register on December 11, 2008, FDA announces that the December 2008 revised draft guidance documents change the enforcement date to January 1, 2010, “[b]ecause the agency is still in the process of finalizing the guidance” documents.  Nevertheless, even if the final guidance documents continue to interpret “domestic address” as including either the street address or P.O. box, FDA’s interpretation is not binding on either FDA or industry.  As FDA’s own regulation makes clear, “[g]uidance documents do not establish legally enforceable rights or responsibilities” and “do not legally bind the public or FDA.”  21 C.F.R. § 10.115(d)(1)