FDA Issues Draft Guidances on Labeling of Dietary Supplements and Non-Prescription Human Drugs
The Food and Drug Administration has issued concurrent notices announcing the availability of separate 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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Comments on the draft guidances are due by March 3, 2008.
Guidance for Required Domestic Address/Phone Number Labeling Requirement
The FDA states that the draft guidances are intended to assist industry in complying with the labeling requirements of the Dietary Supplement and Nonprescription Drug Consumer Protection Act (DSNDCPA, Public Law 109-462) which requires that the labels of (1) dietary supplements being marketed in the U.S., and (2) nonprescription (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.
According to the FDA, if the label does not include the required domestic address or telephone number, the product is misbranded.
(See ITT's Online Archives or 11/16/07 news, 07111699 8, for BP summary of a FDA draft guidance on adverse event reporting and recordkeeping for dietary supplements as required by the DSNDCPA.)
| Vasilios Frankos (dietary supplements) | 301-436-2375 |
| Walter Ellenberg (non-prescription drugs) | 301-796-2090 |
FDA notice on the dietary supplements draft guidance (D/N 2007D-0491, FR Pub 01/02/08) available at http://a257.g.akamaitech.net/7/257/2422/01jan20081800/edocket.access.gpo.gov/2008/pdf/07-6266.pdf
FDA notice on the non-prescription drug draft guidance (D/N 2007D-0496, FR Pub 01/02/08) available at http://a257.g.akamaitech.net/7/257/2422/01jan20081800/edocket.access.gpo.gov/2008/pdf/07-6267.pdf
FDA draft guidance on dietary supplements entitled, "Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act" (dated December 2007) available at http://www.cfsan.fda.gov/dms/dsaergu2.html
FDA draft guidance on non-prescription drugs entitled, "Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved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" (dated December 2007) available at http://www.fda.gov/cder/guidance/Labelqanda_Cleared.pdf