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Index/Topics/Unregulated Consumer Products

Unregulated Consumer Products

Unregulated consumer products, including novelty pumps and sexual-enhancement products, that evade FDA standards and promote unsupported claims.

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Jan 6, 2026

How do FDA‑approved medical penis pumps differ in safety and instructions from unregulated consumer devices?

FDA‑regulated external penile rigidity devices — commonly called medical penis pumps or vacuum erection devices (VEDs) — are governed by Class II special controls that prescribe specific safety featur...