Todd Harrison and Alexander Rubel examine how the Dietary Supplement Innovation Act illustrates the importance of precise statutory drafting following the Supreme Court’s Loper Bright decision in their Law360 article, “FDA Bill Shows Risk of Inexact Statute Text, Post-Loper Bright.” The following is an excerpt:
H.R. 10336, the Dietary Supplement Innovation Act, addresses a genuine problem in the Federal Food, Drug and Cosmetic Act's drug preclusion framework. Its clinical investigation trigger, however, shows why textual precision matters when Congress replaces an open-ended standard with a seemingly clearer regulatory marker.
The stakes are higher now because the U.S. Supreme Court's 2024 decision in Loper Bright Enterprises v. Raimondo requires courts to independently determine a statute's best reading rather than merely ask whether the agency's reading is reasonable. Obtaining legislation is not enough. The enacted text must be drafted with that reviewing-court role in mind.
This creates both opportunity and risk: Industry can now seek durable statutory rules rather than depend on shifting administrative interpretations, but imprecise drafting can harden an unintended result into law.
Changes to the Rule via a Clearer Trigger
Current Section 301(ll) of the FDCA permits investigational-drug preclusion when "substantial clinical investigations" have been instituted and made public. The term "substantial" is undefined and has generated understandable uncertainty. H.R. 10336, introduced Sept. 10 by Rep. Diana Harshbarger, R-Tenn., would replace that phrase with a categorical reference to publicly disclosed phase 2 or phase 3 investigations.
That change could narrow current law in one respect. The existing Section 301(ll) does not identify a particular phase of clinical development, while H.R. 10336 would generally exclude phase 1 activity from the investigational trigger. The bill carries that same limitation into the prior-marketing exception in proposed paragraph (2)(C), which is likewise keyed to phase 2 or phase 3 rather than to substantial clinical investigations.
Those are real improvements. But the same amendment may broaden the rule within phase 2, because it eliminates the separate requirement that the investigation be substantial.
For the full article, click here. .