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VITAMINS & SUPPLEMENTS · GUIDE

FTC and FDA Actions on Brain and Memory Supplement Claims: What They Found

A dated, attributed list of US FTC, FDA and court actions on memory and brain supplement claims, what each found, and what a warning letter or an allegation does and does not mean.

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

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Quick answer
US agencies have acted on brain and memory supplements in several ways: warning letters about disease claims, warnings that certain ingredients do not qualify as supplement ingredients, a safety warning about pregnancy, and a court case about memory advertising. This page lists only the actions we read on agency or court pages, with the agency and date. It is not a full list, and for information only. The FDA's own ingredient directory says it is not a comprehensive list of its actions. [1]

How to read an action

  • A warning letter states the FDA's view and asks for corrections within a set time. It is not a court ruling. [2]
  • A complaint is an allegation. The FTC said in 2017 that a federal judge would decide its case. [3]
  • A court finding is different: a judge or jury decided the facts.
  • The FDA does not approve dietary supplements for safety and effectiveness before sale. [4] Its work mostly starts after products are on the market. [5]

Actions we read

DateBodyWhat it said or found
Nov 30, 2015FDAIssued warning letters to five companies whose products marketed as dietary supplements claim to contain picamilon. [2] FDA considers picamilon not to meet the definition of a dietary ingredient, so products declaring it are misbranded. It is not approved as a drug in the US. [6]
Jan 9, 2017FTC and New York Attorney GeneralCharged the marketers of a memory supplement with "false and unsubstantiated claims" that it improves memory and is "clinically shown" to work. The complaint alleged the cited study "failed to show" it worked better than a placebo on any measure of cognitive function. [3] (Allegations.)
Feb 5, 2019FDA, with FTC co-signingWarning letter to a nootropics retailer: claims on its website, for example that a product "prevents cognitive decline (such as senile dementia and Alzheimer's disease)", established the products were drugs. [7] The letter was also signed by an FTC Division of Advertising Practices official. [7] It said one product was not labeled as a supplement, so it did not address whether such products could be sold as supplements. [7]
Apr 10, 2019FDAIssued 12 warning letters in total; 3 went to companies whose products are labeled to contain phenibut. The FDA says products listing phenibut as a dietary ingredient are misbranded. [8]
Jun 3, 2019FDASafety warning on vinpocetine: data reviewed by the FDA associate it with adverse reproductive effects, including possible miscarriage or harm to fetal development. It advised pregnant women and women who could become pregnant not to take it. [9]
Jun 2, 2023US District Court (D. Mass.)Permanent injunction against a distributor of a beverage powder containing phenibut; the labeling claimed it was intended to treat conditions including insomnia, PTSD and anxiety disorder. [10]
May 8, 2024New York Attorney GeneralA federal judge in Manhattan accepted a jury's finding that a memory supplement's makers made fraudulent and deceptive statements; the jury concluded none of the claims had been substantiated with reliable scientific evidence. [11]
Nov to Dec 2024FTCThe FTC's case page lists a Memorandum and Judgment (Nov 18, 2024), an Order (Dec 6, 2024) and a statement (Dec 10, 2024). [12] The statement says seven years of litigation included a jury trial and that health claims need reliable scientific evidence. [13]

For the memory-supplement case in detail see the dedicated page. For more letters see FDA warning letters on brain supplements and phenibut, tianeptine and kratom.

What the actions have in common

  • Disease language. Claims to prevent or treat dementia, depression or anxiety turned supplements into drugs in the FDA's view. [7]
  • Ingredient eligibility. Some ingredients sold for focus were judged not to be dietary ingredients at all. [6][10]
  • Evidence behind the claim. The memory-supplement actions turned on whether claims were backed by reliable science. [11][13]

Claims the FDA has evaluated

The FDA ingredient directory lists qualified health claim letters about phosphatidylserine and cognitive function or dementia from 2003 and 2004. [1][14] A qualified health claim is supported by less scientific evidence than an authorized health claim and must carry a disclaimer explaining the level of evidence. [15] We did not read the claim wording, so we do not state it. The directory is the place to check what the FDA has said about an ingredient. [1]

Frequently asked questions

Does a warning letter mean a product is dangerous?

Not by itself. A warning letter states the FDA's view that a product breaks the law, for example through disease claims or an ineligible ingredient. [7][2] Safety concerns are stated separately, such as the vinpocetine pregnancy warning. [9]

Does the lack of an FDA or FTC action mean a brain supplement is safe or proven?

No. The FDA says it does not approve supplements for safety and effectiveness, and that its ingredient directory is not comprehensive. [4][1]

What is the difference between the FDA's and the FTC's role?

In the sources we read, the FDA reviews labels and labeling for claims that could make a product a drug. [5] NCCIH says the FTC regulates advertising and requires it to be truthful and not misleading. [16] The 2019 warning letter was signed by both. [7]

Was the memory supplement court case decided?

In New York, a federal judge accepted a jury finding in May 2024 that the claims were deceptive. [11] The FTC's case page lists a judgment and order in November and December 2024. [12] We did not read the court documents themselves, which the FTC page links as PDFs.

Where can I report a problem with a brain or memory supplement?

The FDA asks people to report serious reactions through its Safety Reporting Portal. [17] See side effects and reporting. In an emergency call 911.

More details: evidence, limits and cautions

The details behind this page: cautions, limits of the evidence and where sources disagree. Open any note to read it.

Limits and uncertainty
  • These are the actions we could read. Proper evidence not found for a complete count of brain-supplement actions; we did not locate one in the sources we read.
  • Actions in other countries are not covered here. The sources we read for this page do not describe them.
  • An action against one product says nothing about unrelated products. The absence of an action does not show a product is safe or effective.
Safety and who should ask a clinician
Do not use an action list to pick products. Ingredients named in these actions can affect pregnancy or interact with medicines. Talk to a clinician or pharmacist before using any brain product, especially if you are pregnant or breastfeeding, give products to children, take prescription medicines (see medication interactions), have liver or kidney conditions, or have surgery planned. If you have memory changes, see a clinician first.
References
  1. US Food and Drug Administration, Information on Select Dietary Supplement Ingredients and Other Substances (ingredient directory, content current May 2026). Read 2026-10-23.
  2. US Food and Drug Administration, Recent FDA Action on Dietary Supplements Labeled as Containing Picamilon (Constituent Update, November 30, 2015). Read 2026-10-23.
  3. US Federal Trade Commission, FTC, New York State Charge the Marketers of Prevagen With Making Deceptive Memory, Cognitive Improvement Claims (January 9, 2017). Read through a web-fetch tool. Read 2026-10-23.
  4. US Food and Drug Administration, Is It Really 'FDA Approved'? (content current May 2026). Read 2026-10-23.
  5. US Food and Drug Administration, FDA 101: Dietary Supplements (content current June 2022). Read 2026-10-23.
  6. US Food and Drug Administration, Picamilon in Dietary Supplements (content current November 2017). Read 2026-10-23.
  7. US Food and Drug Administration (signed also by the Federal Trade Commission), Warning letter to Pure Nootropics, LLC, 565425 (February 5, 2019). Read 2026-10-23.
  8. US Food and Drug Administration, FDA Acts on Dietary Supplements Containing DMHA and Phenibut (Constituent Update, April 16, 2019). Read 2026-10-23.
  9. US Food and Drug Administration, Vinpocetine in Dietary Supplements (content current February 2023). Read 2026-10-23.
  10. US Food and Drug Administration, Phenibut in Dietary Supplements (content current July 2023). Read 2026-10-23.
  11. New York State Attorney General, Attorney General James Wins Trial Against Quincy Bioscience for Deceptive and Fraudulent Advertising of "Memory Improvement" Supplement Prevagen (May 8, 2024). Read 2026-10-23.
  12. US Federal Trade Commission, Quincy Bioscience Holding Company (case page, FTC Matter 152 3206). Page read through a web-fetch tool; the court PDFs it links were not read. Read 2026-10-23.
  13. US Federal Trade Commission, Statement on FTC's Win in Lawsuit Against the Makers of Dietary Supplement Prevagen (December 10, 2024). Read through a web-fetch tool. Read 2026-10-23.
  14. US Food and Drug Administration, Qualified Health Claims: Letters of Enforcement Discretion. Page read through a web-fetch tool, which listed titles and dates only; claim wording not read. Read 2026-10-23.
  15. US Food and Drug Administration, Dietary Supplement Labeling Guide: Chapter VI. Claims (April 2005, nonbinding recommendations; page content current 2005). Read 2026-10-23.
  16. National Center for Complementary and Integrative Health, Using Dietary Supplements Wisely. Read 2026-10-23.
  17. US Food and Drug Administration, How to Report a Problem with Dietary Supplements. Read 2026-10-23.
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.