FDA Extends Enforcement to January 1, 2010 for Draft Guidances on Supplements/Non-Prescription Drugs
The Food and Drug Administration has revised its draft guidances on (1) the labeling of dietary supplements and (2) the labeling of non-prescription human drug products marketed without an approved application.
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The revised draft guidances extend the date on which FDA intends to begin enforcing these labeling requirements to January 1, 2010 (from January 1, 2009).
The FDA states that the revised draft guidances are intended to assist industry in complying with the labeling requirements of the 2006 Dietary Supplement and Non-prescription Drug Consumer Protection Act (DSNDCPA, Public Law 109-462) which require that the labels of (1) dietary supplements being marketed in the U.S., and (2) non-prescription (over-the-counter (OTC)) human drugs marketed without an approved application in the U.S. include a domestic address or telephone number through which the responsible person may receive a report of a serious adverse event with such products.
Draft Guidances are Unchanged Except for 1 Year Extension of Enforcement
Because FDA is still in the process of finalizing these guidances, it is issuing these revised drafts to notify industry that it intends to exercise enforcement discretion with regard to these labeling requirements for an additional 1-year period.
The revised draft guidances remain identical to the December 2007 draft guidances with respect to all topics except that they state that FDA intends to begin enforcing the labeling requirements on or after January 1, 2010.
(See ITT's Online Archives or 01/07/08 news, 08010730, for BP summary of FDA's December 2007 draft guidances.)
| Vasilios Frankos (dietary supplements) | 301-436-2375 |
| Walter Ellenberg (non-prescription drugs) | 301-796-2090 |
FDA notice of revised draft guidance on dietary supplements (FR Pub 12/11/08) available at http://edocket.access.gpo.gov/2008/pdf/E8-29303.pdf
FDA notice of revised draft guidance on non-prescription human drug products (FR Pub 12/11/08) available at http://edocket.access.gpo.gov/2008/pdf/E8-29301.pdf
"Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Non-prescription Drug Consumer Protection Act: Revision 1" (dated December 2008) available at http://www.cfsan.fda.gov/dms/dsaergu3.html
"Questions and Answers Regarding the Labeling of Non-prescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Revision 1" (dated December 2008) available at http://www.fda.gov/cder/guidance/8621rev.pdf