FDA Announces Final Rule Establishing Current Good Manufacturing Practices for Dietary Supplements
June 22, 2007
The Food and Drug Administration (FDA) today announced its final rule establishing current good manufacturing practices (cGMPs) for dietary supplements.
In the Dietary Supplement Health and Education Act of 1994 (DSHEA), Congress gave the Secretary of Health and Human Services and, by delegation, FDA authority to issue regulations establishing cGMPs for dietary supplements. The cGMPs will require that dietary supplements are produced in a quality manner, are not adulterated with contaminants or impurities, and are accurately labeled to reflect the ingredients in the product. The cGMPs apply to all domestic and foreign companies that manufacture, package, or hold dietary supplements intended for sale in U.S. commerce, including those involved with the activities of testing, quality control, packaging, labeling, and distributing.
In a companion document, FDA is also announcing today an interim final rule (IFR) that outlines a petition process for manufacturers to request an exemption to the cGMP requirement for 100 percent identity testing of specific dietary ingredients. If the manufacturer can provide sufficient documentation that the supplier maintains appropriate in-process manufacturing controls and has consistently produced the dietary ingredient over a period of time, the manufacturer may be exempted from the testing requirement. FDA is soliciting comment from the public on the IFR. There will be a 90-day comment period. Written comments may be submitted to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852 or online at Dockets Open for Comment.
Additional information regarding the cGMPs is available through the CFSAN website at Dietary Supplements.