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misbranding is still a thing despite First Amendment, court rules

United States v. Vascular Solutions, Inc., No. SA-14-CR-926, --- F.Supp.3d ----, 2016 WL 5475999 (W.D. Tex. Jan. 27, 2016) Defendants sell a medical device which permanently closes varicose veins using a laser, allowing healthier veins to move blood. The device is approved for treatment of superficial veins only, not perferator veins. The government indicted defendants for misbranding: they failed to provide the FDA with required notification of a new intended use, and the devices’ labeling lacked adequate directions for that new intended use.
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