The recent Supreme Court decision to overturn Chevron deference has sent shockwaves through the regulatory world, with the U.S. Food and Drug Administration (FDA) facing significant potential impacts. The decision emphasizes that courts, not agencies, will interpret the reasonable scope of authority that any given law provides. The full ruling is available here: https://www.supremecourt.gov/opinions/23pdf/22-451_7m58.pdf
Chevron Doctrine: What is it?
The Chevron Doctrine, established in 1984, previously instructed courts to defer to an agency’s interpretation of the statutes it’s tasked with enforcing. In other words, whenever a law is not explicit, an agency can bend it to best meet its desired outcome. This doctrine provided significant leeway for agencies like the FDA to issue regulations, even in the absence of explicit congressional authorization.
The Supreme Court’s Ruling
The Supreme Court’s ruling in Loper Bright Enterprises v. Raimondo significantly curtails Chevron deference. The ruling says that courts should not simply rubber-stamp an agency’s interpretation of a statute unless it is a “reasonable” one. It instructs courts to apply a more stringent standard of review based on the text of the law, ensuring that an agency’s interpretation is truly consistent with Congress’s action and intent.
Future of Cigar and Pipe Tobacco Regulation
This decision greatly strengthens PCA’s frequent assertion that the FDA regularly exceeds its Congressionally authorized mandates to achieve political ends. It provides a new framework to challenge onerous regulations and enforcement actions.
In response, the FDA is likely to begin examining past regulations in an attempt to shore up its authority and avoid legal challenges. Congress will also come under pressure to write laws clarifying how the FDA should proceed with regulating cigars and pipe tobacco.
It will take some time to see the full impact of this ruling. But one thing is sure: the landscape upon which FDA develops future regulations is now steeper.
– This article was contributed by the PCA Government Affairs team.