FDA’s Rules are FDA’s to Enforce

Lexology October 10, 2023
Reed Smith LLP

We can sum up the claim in Telebrands Corp. v. Luminas Int’l LLC, like this—hey court, it’s not fair that I’m following the FDA’s rules and my competitors are not, so you should force them to do so to even the playing field. 2023 U.S. Dist. LEXIS 179285 (S.D. Cal. Jul. 12, 2023). To which the court appropriately said—you’ve come to the wrong place; FDA rules are the FDA’s to enforce. In other words, all your claims are impliedly preempted and so they are dismissed without leave to amend.

Plaintiff is an online seller of over-the-counter analgesic patches used for pain relief. Plaintiff has listed its patches on the FDA’s National Drug Code (“NDC”) database. Id. at *2. Doing so...

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