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Untitled Letters & Advisory Actions

What is an untitled letter?​

An untitled letter (sometimes called a "notice of violation" or "advisory letter") is an FDA communication — less severe than a warning letter — that notifies a company of a violation that does not meet the threshold for a warning letter. Untitled letters are commonly used for:

  • Promotional violations — labelling or advertising that makes false or misleading claims, but where the violation is less egregious
  • Minor regulatory violations — technical non-compliance that does not present a direct safety risk
  • First-time or inadvertent violations — where FDA prefers to alert the company rather than escalate

Untitled letter vs warning letter​

The '15 business days' response deadline applies to Warning Letters, not Untitled Letters. The table should read: 'Formal response required? / Untitled Letter: Usually — but less formal / Warning Letter: Yes — within 15 business days' to make clear which response timeframe applies to each letter type. Alternatively, revise the Untitled Letter row to: 'Typically expected, but FDA is more flexible on timing.'

Advisory actions​

Beyond untitled letters, FDA has a range of informal advisory tools:

  • Meeting with FDA — FDA may request a meeting to discuss compliance issues before taking formal action
  • Regulatory meeting letter — documents the outcome of a compliance meeting
  • Compliance letter — similar to untitled letter; acknowledges an identified problem and requests correction
  • Courtesy letter — informs a company of a potential issue proactively, without asserting a violation

Responding to an untitled letter​

Even though less formal than a warning letter, an untitled letter should be taken seriously:

  1. Review the identified violation carefully
  2. Assess whether the violation is accurate — if not, document your disagreement professionally
  3. Implement corrections — stop the violating activity (e.g., withdraw promotional material)
  4. Respond in writing within a reasonable time (typically 30 days) describing your corrective actions
  5. Document the response — failure to respond can escalate to a warning letter

Official resources​