Rules
Aboutfair balancerisk disclosureindication on labelsubstantiationcomparativemisleading presentationname ingredientsubmissionpre approvalscientific exchangedisclosure
Naturepromotional
Document typeadvertisement
Risk info placementdistinct-part
Communication typeadvertisement
Regulatory classprescription-drug
Drug classprescription
Rx statusprescription
Advertising typeprescription-drug-advertisement
Populationhuman-use
Content triggerliterature-or-study-effectiveness-claim
Materialadvertisement
Content typeadvertisement
Active ingredient counttwo-or-more
Proprietary name basismixture-designation
Established name statusnone-for-mixture-designation
Drug classificationprescription
Labeling scenariosingle-proprietary-name-multiple-preparations-no-established-name
Prescription statusprescription-drug
Ad formattelevision
Intended specieshuman
Exemption statusnon-exempt
Approval pathwayaccelerated
43 of 251 rules — including rules the source does not limit to any one scope
US-MIS-001·21 CFR 202.1(e)(3)(i)AI-verified
Untrue information in one part of an ad cannot be cured by truth elsewhere
blockerneeds human judgment
US-MIS-002·21 CFR 202.1(e)(3)(i)Disputed
Misleading omissions in prescription drug ads require added qualification within that part/theme
blockerneeds human judgment
US-MIS-003·21 CFR 202.1(e)(5)(iii)AI-verified
Ad must not omit facts material to its representations or to use consequences
blockerneeds human judgment
US-MIS-004·21 CFR 202.1(e)(6)(iii)AI-verified
No presenting since-invalidated favorable information as current
blockerneeds human judgment
US-MIS-005·21 CFR 202.1(e)(6)(iii)AI-verified
No literature/quotations more favorable than the evidence supports
blockerneeds human judgment
US-MIS-006·21 CFR 202.1(e)(6)(iv)AI-verified
No selective presentation of information to suggest greater safety than demonstrated
blockerneeds human judgment
US-MIS-007·21 CFR 202.1(e)(6)(v)AI-verified
No overstating the generalizability of a single study's experience
blockerneeds human judgment
US-MIS-008·21 CFR 202.1(e)(6)(vi)AI-verified
Disclose when effectiveness claims may reflect concomitant therapy
blockerneeds human judgment
US-MIS-009·21 CFR 202.1(e)(6)(vi)AI-verified
Disclose placebo-effect info when citing studies for human drug effectiveness
blockerneeds human judgment
US-MIS-010·21 CFR 202.1(e)(6)(viii)AI-verified
No favorable authority quote without disclosing later or concurrent unfavorable data
blockerneeds human judgment
US-MIS-011·21 CFR 202.1(e)(6)(ix)AI-verified
No quoting or paraphrasing out of context to mislead
blockerneeds human judgment
US-MIS-013·21 CFR 202.1(e)(6)(xiv)Disputed
No misleading pooled statistics in prescription drug advertising
blockerneeds human judgment
US-MIS-014·21 CFR 202.1(e)(6)(xv)AI-verified
No Erroneous Use of "No Significant Difference" to Claim Equivalence
blockerneeds human judgment
US-MIS-015·21 CFR 202.1(e)(6)(xviii)AI-verified
No misleading headlines, subheadlines, or graphics in prescription drug ads
blockerneeds human judgment
US-MIS-016·21 CFR 202.1(e)(7)(ii)AI-verified
Statistical significance should not be used to imply unproven clinical significance
warningneeds human judgment
US-MIS-017·21 CFR 202.1(e)(7)(ii)AI-verified
Average results should disclose the range of variation
warningneeds human judgment
US-MIS-018·21 CFR 202.1(e)(7)(iii)AI-verified
Retrospective statistical mining to find unsupported findings may mislead
warningneeds human judgment
US-MIS-019·21 CFR 202.1(e)(7)(iii)AI-verified
Don't use retrospective stats to imply rigor for unsuited study designs
warningneeds human judgment
US-MIS-020·21 CFR 202.1(e)(7)(iv)AI-verified
Tables and graphs must not distort study relationships or trends
warningneeds human judgment
US-MIS-021·21 CFR 202.1(e)(7)(xiii)AI-verified
No falsely presenting reports/opinions as authentic or authoritative
warningneeds human judgment
US-MIS-022·Q.6/A.6AI-verified
Communications should not overstate study findings
warningneeds human judgment
US-MIS-023·Q.6/A.6AI-verified
Do not imply statistical rigor (e.g., via p-values) that the analysis lacks
warningneeds human judgment
US-MIS-024·Q.6/A.6AI-verified
Disclosing limitations does not cure a claim based on an inadequate study
warningneeds human judgment
US-MIS-025·Q.6/A.6AI-verified
Claims should not rest on speculation, belief, or a poorly designed or conducted study
blockerneeds human judgment
US-MIS-027·Section V, Recommendation 4AI-verified
Keep unsolicited-request response material scientific in tone, not promotional
warningneeds human judgment
US-MIS-028·Section V, Recommendation 4AI-verified
Do not bundle the off-label response with promotional material
warningneeds human judgment
US-MIS-029·Section VI, Recommendation 4AI-verified
Public responses should not be promotional in nature or tone
warningneeds human judgment
US-MIS-041·Section II.B, Policy OverviewAI-verified
A deceptive net impression can be misleading even when individual claims are not
warningneeds human judgment
US-MIS-042·Section III.A.1, Consistent Use of LanguageAI-verified
Use risk language comprehensible to the same audience as benefit language
warningneeds human judgment
US-MIS-043·Section III.A.2, Use of SignalsAI-verified
Use headlines/signals for risk information whenever benefit information is signaled
warningneeds human judgment
US-MIS-044·Section III.A.2, Use of SignalsDisputed
Risk information should be preceded by a signal indicating risk information follows
warningneeds human judgment
US-MIS-045·Section III.A.3, Framing Risk InformationAI-verified
Match specificity of risk statements to benefit statements
warningneeds human judgment
US-MIS-046·Section III.A.3, Framing Risk InformationAI-verified
Risk wording should not minimize the severity of a risk event
warningneeds human judgment
US-MIS-047·Section III.A.4, Hierarchy of Risk InformationAI-verified
Risk ordering should not falsely suggest a risk applies only to certain populations or conditions
warningneeds human judgment
US-MIS-048·Section III.C.2, Non-Print Promotion, Textual ElementsAI-verified
Vocalize, visualize, or place concurrent SUPERs for required claim qualifiers
warningneeds human judgment
US-MIS-049·Section III.C.2, Non-Print Promotion, Textual ElementsDraft
Qualifying SUPERs should appear close enough to the claim they qualify
warningneeds human judgment
US-MIS-050·Section III.C.2, Non-Print Promotion, Textual ElementsAI-verified
Do not rely on a single line of text for complex qualifying information
noteneeds human judgment
US-MIS-051·Section III.C.2, Non-Print Promotion, Textual ElementsAI-verified
Make SUPERs reasonably visible under typical viewing conditions
warningneeds human judgment
US-MIS-052·Section III.C.2, Non-Print Promotion, Textual ElementsAI-verified
SUPERs should remain on screen long enough to be read and understood
warningneeds human judgment
US-MIS-053·Section III.C.2, Non-Print Promotion, Textual ElementsAI-verified
Distracting graphics during risk presentations should be avoided
warningneeds human judgment
US-MIS-054·Section III.C.2, Non-Print Promotion, Textual ElementsDraft
Risk-related SUPERs should not compete with unrelated SUPERs on screen
warningneeds human judgment
US-MIS-056·Q.6/A.6AI-verified
Material study limitations should be disclosed
warningneeds human judgment
US-MIS-057·Section III.A.2, Use of SignalsAI-verified
A risk-information presentation should not open with unrelated content
warningneeds human judgment