The Impact of the Supreme Court Striking Down Chevron on FDA Regulation

As has been widely reported today, the United States Supreme Court overturned a 40-year old precdent known as the Chevron Doctrine. There are excellent write-ups of the Court’s opinion here and here. At it’s simpliest the Chevron Doctrine required courts to give deference to federal agencies, like the U.S. Food and Drug Administration, when creating regulations based on an ambiguous law (Chevron U.S. A. Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 842—843 (1984)).

The application of the Chevron Doctrine to the FDA illustrates both the power and the limitations of the agency in interpreting and enforcing its regulatory mandate. The limitations of this power were seen in FDA v. Brown & Williamson Tobacco Corp. 529 U.S. 120 (2000). In this case, the FDA attempted to promuglated regulations governing tobacco products on the basis that the FDCA granted the agency the authority to regulate, among other items, “drugs” and “devices.” In 1996, the FDA asserted jurisdiction to regulate tobacco products, concluding that, under the FDCA, nicotine is a “drug” and cigarettes and smokeless tobacco are “devices” that deliver nicotine to the body. The Supreme Court held that despite the required deference under the Chevron Doctrine, “Congress has clearly precluded the FDA from asserting jurisdiction to regulate tobacco products.”

As is more often the case, courts defer to the FDA’s expertise in ambiguous cases, granting the agency significant leeway in shaping public health policy through its interpretations of the FCDA and other related laws (See, Amarin Pharma, Inc. v. FDA, United States District Court for the Southern District of New York 119 F. Supp. 3d 196 (2015). However, this deference is not absolute and is contingent on the reasonableness of the FDA’s interpretations and the clarity of congressional intent. The doctrine thus ensures a balance between agency expertise and judicial oversight, shaping the landscape of administrative law and public health regulation.

What will be interesting and possibly troubling to watch is how courts respond to challenges of FDA regulation going forward now that deference to the agency’s expertise is not required. The agency is typically driven by data, science, and various subject matter experts. It would be impossible for a single judge or panel of judges to replicate the approach to regulatory decisions employed by the FDA. In part, it’s because it’s often the case that no single expert’s opinion is relied upon but a team of experts in various fields. Possibly, the first test of this new framework will be Triton, a vape case currently pending on the Supreme Court’s docket.

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Marc Sanchez

Marc Sanchez

Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

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