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CriticalPre-pubOpenFIND-1902

AstaRx DTC unit omits required risk information

Source: AstaRx — landing page draft

“AstaRx is the only treatment that works. Start living again.”

Why this is a finding

Prescription advertising must present a true statement of side effects, contraindications, and effectiveness — fair balance under 21 CFR § 202.1. Benefit-only copy that skips the boxed warning is also misbranding under 21 U.S.C. § 352(n).

Suggested fix

Add major risks with comparable prominence, or run a reminder ad that actually meets the reminder conditions. Do not ship this unit.

A draft for the officer. RuleCites does not clear copy.

First seen
Sep 2, 2026, 8:18 AM EDT
Last scan
Sep 2, 2026, 8:18 AM EDT