FDA loses power to block unapproved drugs sold as supplements
H.R. 10336 — Dietary Supplement Innovation Act · Filed by Diana Harshbarger (R-TN) · Introduced Sep 10, 2026 · Referred to committee
Your members of Congress
Enter a ZIP to see where your representative and both senators stood on this bill.
Looked up on this device — your ZIP is never stored on our servers.
What it does
This bill amends the Federal Food, Drug, and Cosmetic Act to clarify when a drug ingredient can be added to dietary supplements without triggering FDA drug-approval requirements. It creates new exceptions allowing drugs in clinical trials (Phase 2/3) to be added to supplements if the trials have been inactive for 7+ years, or if the drug was marketed as a supplement before clinical testing began. It also shifts the burden of proof to the FDA to demonstrate a violation, and makes FDA warning letters immediately challengeable in court.
Why we flagged it
The bill's operative mechanism is to create exceptions to FDA's drug-preclusion rule, allowing pharmaceutical ingredients to be marketed as dietary supplements under conditions that bypass traditional drug-approval pathways. This is a regulatory carve-out favoring the supplement industry over FDA enforcement authority.
What the text implies
- The 7-year inactive-trial exception may allow sponsors to deliberately pause clinical trials to reset the clock, converting failed or stalled drug development into supplement ingredients without FDA approval.
- Shifting burden of proof to FDA in court challenges means the agency must affirmatively prove harm or violation, rather than requiring supplement makers to prove safety—a reversal of the traditional FDA enforcement model.
The full analysis lists 4 implications of this text.
Who stands to gain
dietary supplement manufacturers; supplement ingredient suppliers; contract research organizations (CROs) managing clinical trials