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VITAMINS & SUPPLEMENTS · GUIDE

Reporting Side Effects of Brain Supplements and Where Adverse Events Go

How to report a bad reaction to a focus or memory supplement in the US and UK, which agency receives which report, and why FDA says reports matter.

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

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If you or someone else is unwell right now

Call 911 for an emergency. For possible poisoning, Poison Help is 1-800-222-1222 (US). The FDA's list of serious reactions to a supplement includes chest pain, fainting, irregular heartbeat, shortness of breath, abnormal bleeding, yellowing of the skin or eyes, marked mood or behavior changes, and thoughts of suicide. [1] If you are in the US and having thoughts of suicide, call or text 988. Reporting comes second; medical care comes first. Outside the US see Poison Help by country.

Why reports matter for brain supplements

The FDA says it does not approve dietary supplements before they are sold to the public, so reports from consumers and clinicians help it evaluate the marketplace. [1] It also says a single report can help identify a potentially dangerous product. [2] Focus and memory products are no exception, and some products sold as "nootropics" are not dietary ingredients under US law according to the FDA, such as phenibut and tianeptine. [3][4]

Where a report goes

This page describes official routes. Which one applies depends on the product type and country.
7 items reportedMost serious first. The colour shows how severe each report was.
  1. A US dietary supplement (capsule, powder, gummy, drink mix)

    Unclear

    The FDA Safety Reporting Portal: choose "A private citizen..." and give as much information as you can. [1] NCCIH also points to this portal. [5]

    Source: FDA, NCCIH

  2. A product containing tianeptine (US)

    Unclear

    The FDA asks consumers and professionals to report to MedWatch. [4]

    Source: FDA

  3. A medicine, device or other FDA-regulated product (US)

    Unclear

    MedWatch receives reports about FDA-regulated products such as medicines and medical devices. [6]

    Source: FDA

  4. The company that made the product

    Unclear

    Reports can also go to the maker or distributor using the address or phone number on the label. [2]

    Source: FDA

  5. Misleading advertising for a supplement

    Unclear

    The FDA says to contact the Federal Trade Commission (FTC). [1]

    Source: FDA

  6. UK

    Unclear

    The Yellow Card scheme, run by the MHRA, accepts reports from anyone about medicines, vaccines, devices and similar products. [7]

    Source: MHRA

  7. Canada, Australia, EU

    Unclear

    Not described in the sources we read. We tried the Health Canada reporting page and could not load it, so we state no route here.

    Source: Not verified

Whether the Yellow Card scheme takes reports about a particular herbal or food supplement is not stated on the page we read; use the site's search or ask a pharmacist.

What a useful report includes

The FDA says complete reports are the most helpful, but even pieces of information help. [1] Keep the product label and package. Note the product's listed ingredients, what else you take, when symptoms started and what happened. Your pharmacist can help with the details. See side effects and reporting.

What companies must do

The FDA says supplement firms must report serious adverse events they receive to the FDA within 15 days. [2] That does not replace your own report.

Stopping a product after a reaction

The FDA advises that if you experience an adverse event with a dietary supplement, you stop using it, seek medical care or advice, and report it. [2] NCCIH similarly says to contact your health care provider if you have side effects. [5] That applies to the supplement. Never stop a prescribed medicine on your own; ask the prescriber or a pharmacist. A clinician can also check for medicine interactions.

Limits of reporting

Reports are voluntary. Proper evidence not found: we read no source that gives how many supplement reactions go unreported, and we give no figure. A report is a signal for regulators, not proof that a product caused the problem. To understand quality questions, see quality testing and certifications and how nootropics are regulated.

Frequently asked questions

Can I report a reaction to a focus or memory supplement?

Yes. In the US, the FDA says consumers and health care professionals can use its Safety Reporting Portal. [1]

Is reporting only for serious reactions?

The FDA lists serious reactions to watch for and encourages reports of adverse events; it says even pieces of information can help. [1][2]

Who do I tell about a tianeptine product?

The FDA asks that adverse events related to tianeptine products be reported to MedWatch. [4]

Does the UK have a way to report?

The MHRA's Yellow Card scheme accepts reports from anyone about issues with medicines and some other products. [7]

Will the FDA recall the product if I report?

The FDA says one report can help identify a dangerous product and possibly remove it from the market, but the sources we read do not say what action follows any single report. [2]

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.