Do Not Claim Investigational Drug Is Safe or Effective in Promotional Context

AI-verifiedblockerBinding lawRaised as a question — a person decides

Rule

A sponsor, investigator, or anyone acting on their behalf may not state or imply, in a promotional communication, that an investigational new drug is safe or effective for the use under investigation.

Check

Scan promotional materials about an unapproved (investigational) drug or unapproved use for any express or implied safety/efficacy claim (e.g., 'proven effective', 'well tolerated', favorable efficacy statistics presented as established fact). Flag any such claim.

Escalate when

The material discusses trial results or data about the investigational drug and it is unclear whether the framing crosses from neutral scientific reporting into an implied safety/efficacy claim; escalate for human judgment on whether the piece is promotional in context.

Where this comes from

21 CFR 312.7(a). The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

… § 312.7 Promotion of investigational drugs. (a) Promotion of an investigational new drug. A sponsor or investigator, or any person acting on behalf of a sponsor or investigator, shall not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise promote the drug. This provision is not intended to restrict the full exchange of scientific information concerning the drug, including dissemination of scientific findings in scientific or lay media. Rather, its intent is to restrict promotional claims of safety or effectiveness of the drug for a use for which it is under investigation and to preclude commercialization of the drug before it is approved…

Open the original at these words on ecfr.gov ↗Read our full copy →

Document: 21 CFR 312.7
Version: 2026-09-16 — the link above is pinned to this date, so it shows the text as it stood then
Retrieved: 2026-09-21 from www.ecfr.gov
Fingerprint: fda613253bfbb24458871266…

Applies when

Launch stagepre-approval

Naturepromotional

How this rule was checked

Citation proven by script and passed an independent verifier running on a different model. Not yet confirmed by a human.

Drafted
claude-sonnet-5 · 2026-09-21
Independent verification — pass
claude-opus-5 · 2026-09-21
Reviewer's reasons
- The quote is the operative mandatory clause of 21 CFR 312.7(a) ('shall not represent in a promotional context...'), not an example, definition, or preamble summary. The rule statement reproduces the actor scope (sponsor, investigator, persons acting on their behalf) and the object (safe/effective for the use under investigation) faithfully.
- Not overstated: the rule is narrower than the source, omitting the 'or otherwise promote the drug' limb. Reading 'represent' to cover express or implied claims is consistent with the provision's stated intent to restrict 'promotional claims of safety or effectiveness.'
- The escalate clause correctly preserves the regulation's own carve-out that the provision 'is not intended to restrict the full exchange of scientific information... including dissemination of scientific findings in scientific or lay media,' routing ambiguous scientific-reporting cases to human judgment instead of auto-flagging them.
- Atomic: 'safe or effective' is a single disjunctive prohibition within one sentence, not two independently checkable obligations. The rule does not reach into 312.7(b) commercial distribution or (c) prolonging an investigation.
- Determinism 'judgment' is correct: whether a communication is 'in a promotional context' and whether data presentation implies a safety/efficacy claim turn on impression and framing, not literal match.
- Authority 'binding' is correct: this is codified federal regulation.
- Severity 'blocker' is defensible; the conduct is flatly prohibited with no compliant presentation, and violation exposes the IND to FDA action. Locator 21 CFR 312.7(a) matches the subsection containing the quote.
- Minor, non-disqualifying: the applies_when gate 'launch-stage: pre-approval' may under-trigger for a marketed product studied for a new indication under an IND, which the source still covers. The check text ('unapproved drug or unapproved use') captures this correctly, so the substance is sound.

Nearby rules

US-PRE-002 US-SCI-001