United States of America,plaintiff-Counter-Defendant-Appellee v. Snoring Relief Labs Inc.,defendant-Counter-Claimant-Appellant

D.W. NELSON, Circuit Judge:

Snoring Relief manufactures SnorBan, an anti-snoring mouthpiece that it seeks to sell without a prescription. The government brought this in rem seizure action, claiming that SnorBan cannot be sold without a prescription because it is a Class III adulterated device under the Federal Food, Drug, and Cosmetic Act (FDC Act), 21 U.S.C. § 351(f)(1)(B); SnorBan lacked pre-market approval; and it was “mis-branded” under 21 U.S.C. § 352(f)(1). The district court granted the Food and Drug Administration’s (FDA’s) summary judgment motion and denied Snoring Relief’s…