WASHINGTON, DC – The Natural Products Association (NPA) today in a letter to leading medical societies makes 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.
“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. 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,” said Sibyl Swift, Ph.D., NPA’s Senior Vice President for Scientific & Regulatory Affairs.
Healthcare 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
Society for General Internal Medicine
American Heart Association
American Board of Preventive Medicine
American Board of Pediatrics
American Board of Internal Medicine
American Board of Family Medicine
# # #
Natural Products Association
The Natural Products Association (NPA) is the trade association representing the entire natural products industry. We advocate for our members who supply, manufacture and sell natural ingredients or products for consumers. The Natural Products Association promotes good manufacturing practices as part of the growth and success of the industry. Founded in 1936, NPA represents over 1,000 members accounting for more than 10,000 locations of retailers, manufacturers, wholesalers and distributors of natural products, including foods, dietary supplements, and health/beauty aids. Visit www.npanational.org.