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Reporting Adverse Events From Therapies and Practitioners

What to do after a bad reaction to a supplement, herbal product, device or treatment, and which U.S. FDA reporting routes exist, plus how to complain about a practitioner.

Content last updated . This page has not been medically reviewed.

First, get care

If you or someone else has a serious reaction, get medical help first. In the United States, call 911 for an emergency, and Poison Help at 1-800-222-1222 if a product may have been swallowed (see poison help by country). Reporting comes after safety. Serious reactions the FDA lists for dietary supplements include hives or throat swelling, chest pain, fainting, severe vomiting, dark urine, abnormal bleeding, yellowing of the skin or eyes, and signs of stroke. [1]

Why reports matter

The FDA says consumers can play an important public health role by reporting adverse reactions or other problems with products it regulates. [2] For dietary supplements, the FDA does not approve them before they are sold to the public, so reports help it evaluate the marketplace and act on possibly unsafe products. [1]

Verified U.S. reporting routes

These routes come from the FDA's own pages. Which one applies depends on the product.
What happenedWhere the FDA sends you
Reaction to a dietary supplement or herbal productThe Safety Reporting Portal; the FDA says to stop using the product immediately and file a report [1]
Reaction to a medicine or a medical device (for example a device used in treatment)MedWatch, the FDA's reporting program for health professionals, patients and consumers [3]; the FDA lists an online voluntary form and a consumer form, Form FDA 3500B [2]
Reaction to a cosmetic, such as a hair dye or moisturizerMedWatch lists cosmetics among the products it receives reports about [3]
Misleading advertising for a supplementThe FDA says to contact the Federal Trade Commission [1]

Include as much information as you can; the FDA says even pieces of information can help identify dangerous products. [1] Acupuncture needles are regulated by the FDA as medical devices. [4] Remedies sold as homeopathic are also not evaluated by the FDA for safety or effectiveness. [5]

Complaints about a practitioner

We have not verified a single national complaint process. In the United States there is no standardized national credentialing system, and each state decides credentials and licensing. [6] To complain about a licensed practitioner, find the state licensing board that issued the license and use its complaint process; NCCIH names state regulatory agencies and licensing boards as the place to start for practitioner information. [7] In England, the NHS says chiropractors and osteopaths must be registered with the General Chiropractic Council or the General Osteopathic Council, and that other therapists should belong to an organisation accredited by the Professional Standards Authority. [8] For other countries, check your national health regulator. We do not provide complaint routes we have not read.

Also tell your clinician

Tell your regular health care provider what happened and what you were using, so your care stays coordinated. [9]

Related

See side effects, allergic reactions and reporting for supplement reactions, and acupuncture side effects and precautions.

Frequently asked questions

Do I need to be sure the product caused the problem before I report?

The FDA asks you to report if you think a supplement may have caused a serious reaction. [1]

Is reporting confidential?

We did not read a statement on this in the pages we used, so check the FDA's reporting page before you submit.

Who do I call about a reaction right now?

For an emergency in the US, call 911. For poisoning, Poison Help is 1-800-222-1222.

Can I report from outside the United States?

We have not verified reporting routes outside the US. Contact your national medicines or health regulator.

How do I report a practitioner?

Contact the board or regulator that licenses that profession in your state or country. [7]

References

Education, not medical advice. This page is for general information. It does not diagnose or treat any condition and is not a substitute for care from a qualified health professional. Natural does not automatically mean safe. Ask a clinician or pharmacist before changing your care, especially if you take medication, are pregnant or breastfeeding, or have a health condition.