Orton Motor, Inc. v. HHS

The FDA counted both the sale to a minor and the failure to verify age as two separate violations on Orton's second failed inspection and assessed the maximum penalty of $500 for three violations within a 24-month period under the civil money penalty schedule. The DC Circuit denied Orton's petition for review, finding no merit in Orton's contention that the Tobacco Control Act precludes the FDA's methodology of charging multiple violations in a single inspection, and that the FDA violates the law by failing to provide a process for retailers to challenge first violations before the issuance of a warning letter. The court held that the statute was easily understood to permit multiple violations where multiple regulations were breached, and the FDA interpreted the statute consistently. The court also held that the FDA's adjudication of the subsequent violation provided a meaningful opportunity for a retailer to be heard regarding the underlying first violation, at the time that the first violation carried legally significant effects. In this case, due process required nothing more. View "Orton Motor, Inc. v. HHS" on Justia Law