FDA warning letter lookup is a free search that anyone can run on fda.gov. It shows whether the agency has sent a formal warning to a supplement, drug, device or other company. This guide shows the steps and how to read what you find.
What a warning letter is
FDA sends a warning letter when it believes a company has made a significant violation of federal rules. The letter names the problem. FDA says examples include poor manufacturing practices, problems with claims about what a product can do, and wrong directions for use.
The company is asked to reply within a set time. It can send a plan to fix the problem. It can also disagree and give its reasons. FDA then checks whether the fixes are enough.
A letter is not a court ruling. It is a formal notice that the agency has concerns. That still matters to a buyer, because it is a public record from a primary source.
Sources: FDA, "About Warning and Close-Out Letters," fda.gov (page content dated March 20, 2024).
Step by step: run the search
Go to the Warning Letters page on fda.gov. The page lists letters in a table. Newest letters sit at the top. Each row shows the posted date, the letter issue date, the company name, the issuing office, a subject, and an excerpt.
Use the search box for a company name or a website name. Many letters go to online sellers, so try the web address as well as the brand name. Try a short version of the name, too. A search for the full legal name can miss a letter filed under a trade name.
The filters help you narrow a long list. You can filter by issuing office, letter issue date, posted date, and year. You can also filter for letters that have a response or a close-out letter. There is a button to download the list as a spreadsheet, which is handy if you want to check many brands at once.
Sources: FDA, "Warning Letters," fda.gov (page content current as of March 11, 2025).
Read the table before you open the letter
Two dates appear in each row. The issue date is when FDA wrote the letter. The posted date is when it went on the website. On the March 2025 page, some letters were posted days or weeks after they were written. A brand with no letter today may still have one on the way.
Look at the issuing office. A letter from the drug center reads differently from one sent by the tobacco or veterinary center. Pick the ones that match what you buy.
Then read the subject line. Short labels such as "Unapproved New Drugs/Misbranded" or "Adulterated" tell you the kind of problem. Open the letter for the exact wording. It lists each violation and quotes the product claims or label text that FDA objected to.
Sources: FDA, "Warning Letters," fda.gov (page content current as of March 11, 2025).
Check for a response or a close-out letter
A warning letter is a snapshot. The company may have fixed the problem later. FDA states that later contact with the company may have changed the status of the issues in a letter.
FDA may issue a close-out letter after it reviews the company's corrective actions. This program covers letters issued on or after September 1, 2009. FDA says it will not issue one based on promises. The fixes must be made and checked, usually through a follow-up inspection. If a violation cannot be corrected by its nature, no close-out letter is issued.
So when you find a letter, check whether the row shows a response or a close-out letter. A close-out letter is a good sign. A letter with no close-out is not proof of a current problem. It means the public record does not show the issue as closed.
Sources: FDA, "About Warning and Close-Out Letters," fda.gov (page content dated March 20, 2024).
What a clean search does and does not tell you
No result is useful, but it is not a clean bill of health. FDA does not post every contact it has with a company. The agency also posts letters after a delay. A company can be small enough that it has never been inspected.
FDA says that for more information on a letter, you can contact the agency. It also says requests for agency records go to its Division of Freedom of Information, and the page explains how to file a FOIA request.
Use the lookup as one check among several. Pair it with a review of the product label, the claims on the seller's site, and the lab reports the seller shares. Write down the date you searched and what you saw, so you can compare if you check again later.
Sources: FDA, "Warning Letters," fda.gov (March 11, 2025); FDA, "Regulatory Procedures Manual," fda.gov (content current as of July 12, 2024).
Quick checklist
Search the brand name and the web address. Check the posted and issue dates. Note the issuing office and the subject line. Open the letter and read the violations. Look for a response or a close-out letter. Repeat the search before a big purchase, since new letters appear every week.
Sources: FDA, Warning Letters page and About Warning and Close-Out Letters page, fda.gov.