Sibyl Swift, Ph.D., NPA’s Senior Vice President for Scientific & Regulatory Affairs, said in the release: “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.”
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Consumers and healthcare professionals are encouraged to report adverse events to manufacturers or FDA through thesafety report portal. This is the same system as MedWatch, FDA’s reporting program for FDA-regulated products. When necessary, information sent in from the public informs safety alerts.In the letter, Dr. Swift wrote: “If you believe that one of your patients has experienced an adverse event related to a dietary supplement, please encourage them to report the event to the FDA through the safety report portal. Alternatively, please consider completing the report for them to ensure that the issue is brought to the Agency’s attention.”
The 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