thereby significantly compromising the agency’s ability to actively monitor dietary supplement safety.
Recommendation: Congress should amend DSHEA to require that manufacturers and distributors report to FDA, in a timely manner, any serious adverse event associated with use of its marketed product of which the manufacturer or distributor is aware. Given that a 15-calendar-day notification of any serious unexpected adverse event to FDA is the standard for medical products,2 this time frame seems reasonable. Dietary supplements, as for conventional foods, are not expected to be associated with any serious adverse events; therefore, all such events are considered unexpected and should be reported to FDA.
Recommendation: FDA should continue to work with the Poison Control Centers as a source of adverse event reports, and sufficient resources to support this activity should be provided.
Education of Consumers and Health Professionals about Reporting of Adverse Events Related to Dietary Supplement Ingredients
Finding: Consumers and health professionals are not adequately aware of the importance of reporting adverse events to FDA.
Recommendation: FDA should increase efforts to inform health care professionals and consumers that they should use the MedWatch adverse event reporting program to report adverse events associated with the use of dietary supplements. Additional outreach efforts should include:
Distribution of MedWatch forms with instructions for use for reporting adverse events relating to use of dietary supplements,
Education of health care professionals to include questions about dietary supplement use when taking diet and drug histories, and
Education of consumers that dietary supplements are not necessarily safe and adverse events should be reported to their healthcare professional or directly to FDA.
It is recognized that with the important exception of drugs that have undergone a switch from prescription status to over-the-counter (OTC) drug status, there is no such reporting requirement for OTC drugs. However, premarket approval following expert review is required for OTC drugs, with such assessments incorporating safety, labeling, purity, and manufacturing, but is not required for dietary supplements. Thus there is a required accumulation of evidence for OTC drug safety that is not required for dietary supplements. This difference in regulatory control results in the need for mandatory reporting of serious adverse events associated with the use of dietary supplement ingredients.