How to report a dietary supplement problem to FDA

To report a dietary supplement problem, get urgent medical or poison help first when needed, stop using the product if you suspect a serious reaction, preserve the package and product details, then use FDA’s Safety Reporting Portal or SmartHub. Consumers may submit voluntarily even when they are not certain the supplement caused the problem.

Quick read: Reporting is not a substitute for care. For a possible poisoning in the United States, call Poison Control at 1-800-222-1222 or use webPOISONCONTROL; call emergency services for an emergency. Keep the bottle, label, lot number, date, purchase record, remaining product, and a clear timeline. FDA says incomplete reports can still help.

Get help before filling out a report

If symptoms are severe or immediate, use emergency services. For a possible poisoning in the United States, Poison Control provides free, confidential help online and at 1-800-222-1222, 24 hours a day. Outside the United States, use local poison-center or emergency procedures.

FDA tells consumers who think a supplement may have caused a serious reaction or illness to stop using the product and submit a safety report. FDA’s broader consumer guidance also says to seek medical care or advice.

Do not delay care to find every package detail. A report can follow after immediate needs are addressed.

Know what kinds of problems can be reported

FDA accepts dietary supplement reports about suspected adverse events and product problems. Examples include:

a reaction, side effect, illness, hospitalization, or other harmful event;
unexpected changes after using the product;
a foreign object or apparent quality defect;
damaged, contaminated, or suspicious packaging;
a possible mismatch between the label and product; and
another safety or labeling concern.

A report does not need to prove causation. FDA asks for reports even when the reporter is unsure the product caused the problem.

For problematic supplement advertising, FDA directs consumers to the Federal Trade Commission. Health-fraud claims may also use FDA’s health-fraud reporting paths. Choose the route that matches the concern.

Preserve the exact product identity

Keep the original container when it is safe to do so. Photograph all sides before discarding anything.

Record:

brand and full product name;
flavor, strength, size, and format;
Supplement Facts and Other Ingredients;
lot, batch, or manufacturing code;
expiration or best-by date;
UPC or other identifying code;
manufacturer, packer, or distributor;
purchase date, seller, order number, and receipt; and
remaining product and packaging condition.

Do not combine remaining product with another bottle. Do not mail or surrender it unless a clinician, poison specialist, company, or regulator gives instructions.

The Supplement Facts and Other Ingredients guide explains where label details appear.

Write a timeline while details are fresh

Include dates and times when possible:

when the product was first and last used;
labeled serving and amount actually used;
when symptoms or the product problem began;
how symptoms changed;
care received and outcome;
other supplements, foods, medicines, or products used around the same time; and
whether another person used the same lot.

Use observable facts rather than guessing at a diagnosis. “Rash began about two hours later” is more useful than declaring a mechanism you cannot verify.

Do not restart a product to see whether the event happens again. Ask a clinician or poison specialist about next steps.

Submit through the FDA reporting route

FDA’s current consumer instructions point to the Safety Reporting Portal. A person can log in or report as a guest, start a new report, and select the voluntary private-citizen, business, or veterinary-provider option.

FDA’s SmartHub can route people to the appropriate form for different regulated products. The portal accepts reports involving human dietary supplements and can be used by consumers, health professionals, and industry.

Provide as much information as you reasonably can. FDA says complete reports are most helpful, but pieces of information can still help identify potentially dangerous products.

If you cannot use the online route, FDA says to contact its Human Foods Program assistance center. FDA 101 also lists 1-888-INFO-FDA as an alternative reporting contact when SmartHub cannot be used.

Contact the company without replacing the FDA report

Dietary supplement labels must provide a domestic address or phone number for serious adverse-event reports to the manufacturer, packer, or distributor named on the label.

You can report the event to that company and ask for:

a case or reference number;
confirmation of the exact lot and product;
instructions for preserving or returning the product; and
written follow-up contact information.

Reporting to the company does not prevent a voluntary report to FDA. FDA says supplement firms must report serious adverse events they receive to the agency within 15 days, but a consumer does not have to rely only on that process.

Know what happens after submission

A report becomes one signal FDA can evaluate with complaints, inspections, marketplace monitoring, and other adverse-event information. FDA may seek follow-up information. One report alone does not prove that a supplement caused an event.

Save:

submission confirmation;
report or case number;
copies of attachments;
company correspondence; and
any later medical or product information.

Update the relevant contact if material information changes. Do not post another person’s private medical information publicly.

Avoid common reporting mistakes

Do not delay urgent care for paperwork. Care and poison help come first.
Do not throw away the identifying package too soon. Lot and label details can matter.
Do not assume uncertainty makes a report useless. FDA accepts reports when causation is uncertain.
Do not restart the product as a test. Ask a qualified professional.
Do not report only the front label. Include Supplement Facts, Other Ingredients, codes, and seller details.
Do not confuse advertising complaints with adverse-event reports. Use the route matching the concern.
Do not invent precision. State what you know and label estimates as estimates.

This guide explains U.S. reporting routes. It does not diagnose a reaction, determine causation, or replace emergency, poison-control, medical, or legal advice.

Supplement reporting FAQ

How do I report a supplement side effect to FDA?

Use FDA’s Safety Reporting Portal or SmartHub after getting appropriate care. You can report as a guest and should include the product identity, lot, timeline, symptoms, and other relevant products or medicines.

Can I report if I am not sure the supplement caused it?

Yes. FDA asks people to report suspected harmful effects even when causation is uncertain. State the sequence of events without claiming more than you know.

What product details should I keep?

Keep the container, full label, lot or batch code, expiration date, UPC, receipt, seller, order information, and remaining product when safe.

Should I call the supplement company or FDA?

You can do both. The label provides company contact information for serious adverse-event reports, while consumers and health professionals can also report voluntarily to FDA.

When should I call Poison Control?

For a possible poisoning in the United States, contact Poison Control right away at 1-800-222-1222 or use webPOISONCONTROL. Use emergency services for an emergency.