Dietary supplements include vitamins, minerals, herbs, amino acids, whey protein, and creatine. FDA does not approve dietary supplements before they are sold to the public. Therefore, it is particularly important for consumers, healthcare professionals, and industry members to report health-related reactions or illnesses (also known as adverse events) to FDA, so we can evaluate the marketplace and take action to protect the public from possibly unsafe products.
Serious reactions or illnesses may include:
- Itching, rash, hives, throat/lip/tongue swelling, or wheezing
- Low blood pressure, fainting, chest pain, shortness of breath, palpitations, or irregular heartbeat
- Severe, persistent nausea, vomiting, diarrhea, or abdominal pain
- Difficulty urinating, decreased urination, or dark urine
- Blood in urine, stool, vomit, or sputum
- Abnormal bleeding from nose or gums
- Fatigue or appetite loss
- Yellowing of the skin or eyes
- Severe joint or muscle pain
- Marked mood (irritability, anxiety), cognitive, or behavioral changes, thoughts of suicide
- Stroke (slurred speech, one-sided weakness of face, arm, leg, or blurry/loss of vision)
Adverse reactions can even result in Emergency Room visits or hospitalization.
For Consumers and Healthcare Professionals
If you think that a dietary supplement may have caused you or someone you know to have a serious reaction or illness, immediately stop using the product and fill out a safety report through the Safety Reporting Portal to submit your complaint to FDA.
After logging in or choosing to report as a guest, select the option "Start a new report" and choose "A private citizen, business or veterinary provider submitting a voluntary report." Please supply as much information as you can. Complete reports are the most helpful, but even pieces of information can help FDA identify potentially dangerous products.
Members of the dietary supplement industry may now use the reporting form on the Safety Reporting Portal to meet the reporting requirements established in section 761 of the Federal Food, Drug, and & Cosmetic Act.
After logging in or choosing to report as a guest, select the option "Start a new report" and choose "A manufacturer, packer or distributor of a human dietary supplement."
If You Need Assistance
For information on how to report a problem with food, visit How to Report a Problem with Food.
For information on health fraud and how to report fraudulent products, visit Health Fraud Scams.
To report problematic advertising for a dietary supplement, contact the Federal Trade Commission (FTC).