Genus Triumphs Over FDA In Barium Sulfate Product Classification Suit

The decision limits US FDA discretion in determining how to regulate products that seem to meet both drug and device standards.

Periodic symbol for barium on a silver square
• Source: Shutterstock

A contrast agent used during radiology scans is legally a device and not a drug, the DC Circuit Court of Appeals determined on 16 April in a rebuke to the US Food and Drug Administration.

The ruling marked a victory for Genus Medical Technologies, who sued the FDA in 2019 after the agency determined that its barium sulfate products, which are sold under the brand name Vanilla SilQ, should be regulated as drugs

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