Summary

GAO reviewed the Department of Health and Human Services, Food and Drug Administration's (FDA) new rule on current good manufacturing practice in manufacturing, packaging, labeling, or holding operations for dietary supplements. GAO found that (1) the final rule establishes the minimum current good manufacturing practice necessary for activities related to manufacturing, packaging, labeling, or holding dietary supplements to ensure the quality of the dietary supplements; and (2) FDA complied with applicable requirements in promulgating the rule.