> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Preemption in FDA Monograph OTC Cases Explained
- URL: https://www.fdaweb.com/preemption-in-fda-monograph-otc-cases-explained/
- Published: 2022-07-11T12:00:00.000Z
- Updated: 2026-09-14T17:51:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152229

Two Covington & Burling attorneys say the Federal Food, Drug, and Cosmetic Act preemption provision for over-the-counter medications is “expansive. Although there are a few outlier cases in the food labeling context, courts have interpreted the preemption provision for OTC medications to mean what it says: state law claims are preempted if they seek to impose any requirements that differ in any way from an FDA monograph.”

Writing in an online [post](https://www.lexology.com/library/detail.aspx?g=5bb8a1e7-b318-497c-83ee-23d3b146f4f6&utm%5Fsource=lexology+daily+newsfeed&utm%5Fmedium=html+email+-+body+-+general+section&utm%5Fcampaign=lexology+subscriber+daily+feed&utm%5Fcontent=lexology+daily+newsfeed+2022-07-07&utm%5Fterm=), the attorneys review major preemption decisions involving OTC drug monographs and the minority of decisions that declined to find preemption, particularly involving food labeling.