FDA WARNING_LETTER - Eli Lilly And Company

**FDA Warning Letter Summary**

**Company:** Eli Lilly and Company **Inspection Dates:** Not applicable (review of promotional content) **Main Violations/Issues:** The FDA identified a misleading promotional video featuring Eli Lilly representatives discussing ZEPBOUND® (tirzepatide) injection, which was posted on dayton247now.com. The video failed to communicate critical risk information associated with Zepbound, including its serious, potentially life-threatening risks like thyroid C-cell tumors, as highlighted in the drug"s boxed warning. Additionally, the video did not disclose the drug"s limitations of use, creating a misleading impression about its safety and effectiveness. Furthermore, the promotional materials were not submitted to the FDA at the time of initial dissemination, violating regulatory requirements.

**Regulatory Framework:** The violations pertain to the Federal Food, Drug, and Cosmetic Act (FD&C Act), specifically sections 21 U.S.C. 352(a), (n); 321(n); 331(a), and the Code of Federal Regulations (CFR) 21 CFR 202.1 (e)(3)(i); (e)(5), and 21 CFR 314.81(b)(3)(i).

**Required Actions:** Eli Lilly is required to take immediate corrective actions, including ceasing the dissemination of misleading promotional communications. The company must ensure future promotional materials accurately convey risk information and comply with submission requirements. Failure to address these violations may result in further regulatory action by the FDA.