Untitled Letters are like Warning Letters, listing alleged violations that FDA wants companies to fix. Except Untitled Letters deal with less serious violations and FDA allows for longer response times. Still, the most important factor in resolving an Untitled Letter is to respond decisively and expertly to FDA’s claims.

When the FDA finds violations of the law and regulations, they may issue Untitled Letters informing you and requesting that you “voluntarily” correct those violations. These violations are often allegations of adulteration and misbranding against your products based on an inspection. An adulteration allegation typically points to failures in safe and sanitary production. Misbranding charges involve mistaken or misleading labeling and advertising.

An Untitled Letter is similar to the more common FDA “Warning Letter” in that they both point to alleged violations. The difference is that Untitled Letters are issued for less serious violations and do not include a warning of enforcement action for failure to comply, as you would find in a Warning Letter.

These letters request a written response within a reasonable time explaining how the company will rectify the alleged violations. In some cases, a response will include our team educating FDA on how the company is not in violation – because FDA is not always right.

Unlike Warning Letters, FDA does not publish most Untitled Letters. FDA typically only publishes Untitled Letters on the FDA website when the Agency deems it necessary to protect the public, deter future violations, or to ease FDA’s Freedom of Information obligations. While there is no fixed period for its issuance, FDA “strives” to issue Untitled Letter within six months from the last day of inspection, sample analysis, or of evidence collection.

To quickly resolve an Untitled Letter, you must respond decisively and expertly to FDA’s claims. Delay can lead to escalation by FDA.

Untitled Letter – A private citation of violations with a request for correction and a written response within a reasonable time—typically 30 days

Adulterated – The product violates FDA law by being unsafe, unsanitary, contaminated, filthy, or otherwise improperly made.

Misbranded – The label or labeling violates FDA law because it has false or misleading statements, or otherwise lacks required label or labeling statements.

Enforcement action – Actions that the FDA may take when a cosmetic is adulterated, misbranded or for other FDCA violations. These include civil seizure, criminal charges, mandatory recall of products, access to records, and suspension of facility registration.