FDA Announces Final Rule Establishing Current Good ManufacturingPractices forDietary Supplements

June 22, 2000

The Food and Drug Administration (FDA) today announced its final ruleestablishing current good manufacturing practices (cGMPs) for dietarysupplements.In the Dietary Supplement Health and Education Act of 1994 (DSHEA),Congressgave the Secretary of Health and Human Services and, by delegation, FDAauthority to issue regulations establishing cGMPs for dietarysupplements. The GMPs will require that dietary supplements are produced in a qualitymanner,are not adulterated with contaminants or impurities, and are accuratelylabeledto reflect the ingredients in the product. The cGMPs apply to alldomestic andforeign companies that manufacture, package, or hold dietary supplementsintended for sale in U.S. commerce, including those involved with theactivitiesof testing, quality control, packaging, labeling, and distributing.In a companion document, FDA is also announcing today an interim finalrule(IFR) that outlines a petition process for manufacturers to request anexemptionto the cGMP requirement for 100 percent identity testing of specificdietaryingredients. If the manufacturer can provide sufficient documentationthat thesupplier maintains appropriate in-process manufacturing controls and hasconsistently produced the dietary ingredient over a period of time, themanufacturer may be exempted from the testing requirement. FDA issolicitingcomment from the public on the IFR. There will be a 90-day commentperiod.Written comments may be submitted to the Dockets Management Branch(HFA-305),Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville,MD 20852or on line at:http://www.fda.gov/dockets/ecommentsAdditional information regarding the cGMPs is available through theCFSANwebsite athttp://www.cfsan.fda.gov/~dms/supplmnt.html.NOTE:* TO GET PAST ISSUES OF FDA-DSFL, go to Electronic InformationNetworks:http://www.cfsan.fda.gov/~dms/infonet.html.********************************FDA Web Page Addresses:* Dietary Supplements http://www.cfsan.fda.gov/~dms/supplmnt.html* Food Labeling and Nutrition http://www.cfsan.fda.gov/label.html* Infant Formula http://www.cfsan.fda.gov/~dms/inf-toc.html* Qualified Health Claims http://www.cfsan.fda.gov/~dms/lab-qhc.html* Center for Food Safety and Applied Nutrition http://www.cfsan.fda.gov/list.htmlOther Federal Government Links:* Federal Trade Commission http://www.ftc.gov/* Office of Dietary Supplements, NIH http://dietary-supplements.info.nih.gov/* US Department of Agriculture - Food Safety and Inspection Service http://www.fsis.usda.gov/ - Food and Nutrition Service http://www.fns.usda.gov/fns/Non-Federal Government Links:* National Academy of Sciences http://www.iom.edu/CMS/3788.aspx