Consumer Information for Medical Devices Update: The FDA warns against using unapproved versions of Juvederm

On Thursday, June 8, the FDA updated its Dermal Fillers (Soft Tissue Fillers) website to warn the public about unapproved versions of Juvederm, such as Juvederm Ultra 2, 3, or 4, which are being sold and distributed illegally in the U.S.

Juvederm is a prescription device that should only be injected and sold by or on the prescription of a licensed health care provider. Consumers should not buy Juvederm online because the products available to buy without a medical license may not be safe or work as promised. Health care providers and consumers should avoid products labeled as Juvederm Ultra 2, 3 or 4, because these products are not approved by the FDA for use in the U.S., and their safety and effectiveness cannot be assured.

A list of Juvederm products approved for use in the U.S. can be found on the manufacturer’s website at juvederm.com. The FDA’s Dermal Fillers Approved by the Center for Devices and Radiological Health page also provides a list of products approved for use i