A retrospective analysis of every warning letter posted by the U.S. Food and Drug Administration between January 1, 2022, and September 28, 2026, found that just 7 of 3,011 letters, or 0.23 percent, referred to artificial intelligence in any form, according to the study published in Discover Pharmaceutical Sciences. The analysis searched the full text of all letters in FDA’s public warning letter database for terms including “artificial intelligence,” “AI,” “machine learning,” “large language model,” “neural network,” “deep learning,” and “chatbot.” Eleven letters contained a term, but four were excluded on review: in two, “AI” meant adequate intake, and in two others the abbreviation appeared only in a document title or an action-item number. By year, none of 689 letters mentioned AI in 2022; one of 608 did so in 2023, two of 569 in 2024, three of 736 in 2025, and one of 409 in 2026 through the September 28 search date. The authors note that with only seven letters, no trend can be established, and the analysis is descriptive rather than explanatory. The seven letters split across three FDA programs: three from the device program, three from the Center for Tobacco Products, and one from the Center for Drug Evaluation and Research. Together they cited 36 violations, ranging from 2 to 9 per letter,