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        Dietary Supplements

How to Report a Problem with Dietary Supplements Home
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          Dietary Supplements
          How to Report a Problem with Dietary SupplementsDietary Supplements How to Report a Problem with Dietary Supplements
  	
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    PrintDietary 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.

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 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

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 SRPSupport@fda.hhs.gov.

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).

                                                                                  Content current as of:
      05/06/2022
                  
                   
Regulated Product(s)
		 Dietary SupplementsHow to Report a Problem with Dietary Supplements
 
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