Simply put, when Congress explicitly states that federal law is the exclusive law, then states cannot interfere with that federal law. Preemption can be either express or implied. This is the type of inconsistency that the FDCA’s express preemption provisions were designed to prevent. Examples of such laws would include, but are not limited to such language as, “exclusive regulatory authority,” Implied preemption presents more difficult issues. (You can see some of our prior posts on OTC express preemption with clever titles like “Express Preemption OTC” and “Preemption Without Prescription” here and here) Take for example Bailey v. Rite Aid Corp. We have long wondered whether such federal requirements are “requirements” sufficient to carry the preemption day. The preemption doctrine comes from the “Supremacy Clause” in Article VI of the Constitution, which makes the Constitution and laws passed under it the “supreme Law of the Land.” When Congress passes a law explicitly stating that it preempts state laws on a certain subject, such “express preemption” is easy to spot and to apply. For example, a plaintiff could argue that a manufacturer failed to use the specific design or labeling approved by the FDA or otherwise violated FDA regulations. Furthermore, Kansas argues that the DOJ also rejected express preemption in its Ninth Circuit amicus brief in Puente Arizona. 1. Preemption is a doctrine in law which states that if there is a conflict between laws in a lower level of government and laws in a higher level of government, the higher laws win. Two Kinds of Preemption: Express and Implied Preemption would not apply in some circumstances, however. However, the court DID find preemption, it was conflict preemption .. "allowing state liability for cars made in complacence with federal laws would conflict with federal rule.' Whether express or implied, federal law will almost always prevail when it interferes or conflicts with state law, except in circumstances where the federal law is deemed unconstitutional, or where the Supremacy Clause does not apply. Therefore, it is critical that manufacturers are able to identify the competing federal and state requirements implicated by a consumer protection action when evaluating the viability of an express preemption defense. Express preemption cases tend to be simpler than implied preemption cases. When Congress chooses to expressly preempt state law, the only question for courts becomes determining whether the challenged state law is one that the federal law is intended to preempt. Preemption can be either express or implied. ... Pennsylvania v Nelson is an example of implied preemption challenge. However, there are plenty of examples where tension between state and federal law remains unresolved. Fundamentals of Preemption changelabsolutions.org 2 Types of Preemption There are several forms of preemption, but at its most basic preemption is either express or implied.2 Express Preemption: When Preemptive Intent Is Stated Outright “Express preemption” occurs when a law explicitly states whether it is meant to preempt a lower-level When Congress chooses to expressly preempt state law, the only question for courts becomes determining whether the challenged state law is one that the federal law is intended to preempt. Just because there is a saving clause for expression preemption, there can still be implied preemption. EXPRESS PREEMPTION: When the state law explicitly (or expressly) conveys its intent to limit or entirely restrict lower levels of government from regulating a particular policy area. Express preemption occurs when Congress explicitly states within a statute that the state law will be preempted.