Food

Dietary Supplements - How to Report a Problem

Dietary supplements include vitamins, minerals, herbs, amino acids, whey protein, creatine, and weight loss pills. FDA does not approve dietary supplement products before they are sold to the public. Therefore, it is particularly important for consumers, health professionals, and industry members to report serious health-related reactions or illnesses (also known as adverse events) to FDA, so we can take action to protect the public from unsafe products.

Serious reactions or illnesses may include:

  • itching, rash, hives, throat/lip/tongue swelling, wheezing
  • low blood pressure, fainting, chest pain, shortness of breath, palpitations, irregular heart beat
  • severe, persistent nausea, vomiting, diarrhea, or abdominal pain
  • difficulty urinating, decreased urination
  • fatigue, appetite loss, yellowing skin/eyes, itching, dark urine
  • severe joint/muscle pain
  • slurred speech, one-sided weakness of face, arm, leg, vision (stroke)
  • abnormal bleeding from nose or gums
  • blood in urine, stool, vomit, or sputum
  • marked mood, cognitive, or behavioral changes, thoughts of suicide
  • visit to Emergency Room or hospitalization

For Consumers and Health 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 “Dietary Supplement Report (voluntary)…” 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.

For Industry:

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 FD&C Act.

After logging in or choosing to report as a guest, select the option “Start a new report” and choose “Dietary Supplement Report (mandatory)…”

If You Need Assistance:

If you have any questions about reporting on dietary supplements, please contact DSRSupport@fda.hhs.gov. For technical support with submitting a safety report, please contact Support.SRP@jbsinternational.com.

For information on how to report a problem with food, visit How to Report a Problem with Food.

Contact FDA

Office of Dietary Supplement Programs

 

Toll Free 1-888-SAFEFOOD, 1-888-723-3366
or 240-402-2375
ODSP@fda.hhs.gov

 

Food and Drug Administration

(HFS-810)
Office of Dietary Supplement Programs

5001 Campus Drive

College Park, MD 20740

Page Last Updated: 01/10/2017
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