Rinvoq – Compliance Alert

Caution

This ad has compliance risks that should be reviewed.

Analysis of this 60s ad identified 4 enforcement patterns, primarily Visual Distraction. Patterns span Visual Distraction, Fair Balance — “Outdoor & Physical Activity” identified at 13.1s, previously cited in BRUKINSA, COBENFY, Fasenra (x3).

Recommended action: Flag for next MLR cycle: Visual content during safety information window (31s–53s) may distract from risk disclosure. Schedule creative revision to use static or neutral visuals during major statement.

Video Timeline

Risk disclosure: 31.4s – 53.4s (22.1s of 60.1s total — 36.7% of ad)

Risk Window

0s15s30s45s60s

Daily Activities?Outdoor & Physical?Family & Social?Risk Window?

Patterns Detected (4)

Each pattern below is a known FDA enforcement concern, identified by matching this ad against 14 violation types from 34 FDA warning letters

Pattern	Dimension	Score	Evidence	CFR
Outdoor & Physical Activity Upbeat outdoor imagery shown while safety warnings are being read	Visual Distraction	38	3 clips	21 CFR 202.1(e)(1)	▶
FDA Concern: Risk information must be presented in a clear, conspicuous, and neutral manner without distracting visuals Previously cited: BRUKINSA, COBENFY, Fasenra (x3), Velsipity, Calquence
Family & Social Scenes Warm family scenes that emotionally minimize risk information	Visual Distraction	38	2 clips	21 CFR 202.1(e)(1)	▶
FDA Concern: Risk information must be presented in a clear, conspicuous, and neutral manner without distracting visuals Previously cited: Jardiance (x3), Contrave, Qulipta, Calquence, Austedo (x2)
Daily Activities Relatable lifestyle visuals that divert attention from safety disclosures	Visual Distraction	38	2 clips	21 CFR 202.1(e)(1)	▶
FDA Concern: Risk information must be presented in a clear, conspicuous, and neutral manner without distracting visuals Previously cited: Contrave, Velsipity, Qulipta, Fasenra (salsa)
Benefit vs. Risk Time Imbalance Significantly more time spent on benefits than on risks	Fair Balance	73	1 metric	21 CFR 202.1(e)(3)(iii)	▶
FDA Concern: Risk and benefit information must be presented with equal prominence Previously cited: FABHALTA, Vyvgart Hytrulo (x2), Wegovy, Vonjo Benefit:Risk Ratio: 1.73:1

Compliance Alert: Rinvoq

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