In a letter to leading medical societies, the Natural Products Association (NPA) is urging that health care professionals make recommendations for reporting adverse events for dietary supplements. Manufacturers of dietary supplements are required to submit all information pertaining to adverse events associated with their products to the FDA (U.S. Food and Drug Administration).
“Adverse events from supplements are extremely low given their widespread usage, and most of these are the result of three factors: accidents, people not consulting with their doctor, or misuse of a product combined with other health factors,” said Sibyl Swift, PhD, NPA’s senior vice president for scientific & regulatory affairs. “Despite the low rate of AERs for dietary supplements, it is important for health care professionals and consumers to report these incidents when they do occur. The laws that regulate supplements require official reporting of adverse events so that the regulators, the health care community and others can review the data and make informed public policy decisions.”
Health care professionals and consumers are encouraged to report adverse events to manufacturers or FDA through the safety report portal. This system, the Center for Food Safety and Applied Nutrition (CFSAN)-Adverse Event Reporting System (or, CAERS) is the same system as MedWatch, which is FDA’s reporting program for FDA-regulated products. MedWatch (and CAERS) receives information from the public; when necessary, this information will inform safety alerts.
NPA’s letter was sent to the following medical societies:
- American Medical Association
- American Academy of Family Physicians
- American College of Physicians
- American Academy of Pediatrics
- American College of Preventive Medicine
- American Heart Association
- American Board of Preventive Medicine
- American Board of Pediatrics
- American Board of Internal Medicine
- American Board of Family Medicine
- Society for General Internal Medicine
For more information, visit www.npanational.org.