Educational only. Not medical or legal advice. This site summarizes public U.S. government statements as of October 22, 2026. It does not sell, recommend or endorse any product, and it does not give dosing information. Talk to a licensed clinician about any medicine, and check the linked FDA pages for the latest version.
- What it is: FDA's notice that it believes there are significant violations of federal requirements, such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use. [FDA]
- What it asks: a response within a set timeframe, such as a correction plan, or the recipient's reasoning if it disagrees. [FDA]
- Status can change: later communications and actions may change the regulatory status of the issues in the letter. [FDA]
- "Cyber" letters: sent electronically to websites offering to sell online prescription drugs that may be illegal. [FDA]
- Close-out letters: issued only after FDA has verified the corrective actions, usually by follow-up inspection, and not based on promises alone. No close-out letter issues for violations that cannot be corrected. [FDA]
- Redactions: some posted letters are redacted or edited to remove confidential information. [FDA]
Questions to ask while reading
These are reading tips, not FDA statements: What product and claims are named? Which law is cited? What did FDA ask for, and by when? Has a close-out letter been posted since?