FDA Proposes Labeling and Manufacturing Standards for All Dietary Supplements

For the first time, the FDA is proposing a regulation that would require all supplement manufacturers to adhere to current good manufacturing practices (CGMPs) in the manufacturing, packaging, and holding of their products. The requirement is designed to ensure not only that dietary supplements have the actual amount of ingredient indicated on the label, but also that they are not adulterated with contaminants or impurities. Recent analyses of some dietary supplements by independent laboratories have indicated that labeling is not an accurate indication of amounts of ingredients claimed, and that products often contain undeclared and potentially harmful contaminants. According to HHS Secretary Tommy G. Thompson, "Millions of Americans use dietary supplements, and we owe it to them to ensure that they are getting the products they're paying for." The intended proposal would cover all types of dietary supplements, but to limit disruption for small businesses, the FDA is proposing a three-year phase-in of a final rule for small businesses. Presently, the FDA is currently soliciting comments on this proposed regulation. For more information or for the address to comment on the proposed regulation, the summary and links to the proposed rule can be accessed at http://www.fda.gov/bbs/topics/NEWS/2003/NEW00876.html. Food and Drug Administration, HHS March 7, 2003 Return to Top