Eli Lilly and Company
FDA issued a warning letter to Eli Lilly and Company (CEO David A. Ricks) regarding a direct-to-consumer online video promoting ZEPBOUND® (tirzepatide) that was posted on dayton247now.com on July 9, 2025. The video featured Eli Lilly representatives making claims about Zepbound's safety and effectiveness while entirely omitting all risk information — including the boxed warning for thyroid C-cell tumors — and failing to disclose the drug's limitations of use. FDA determined the video misbrands Zepbound in violation of the FD&C Act and also cited Eli Lilly for failing to submit the promotional material under Form FDA-2253 at the time of initial dissemination; Lilly was directed to respond within 15 working days, cease misleading communications, and disseminate corrective communications to the same audience.
Flagged claims (3)
make sure they have access to the FDA-approved, authentic and safe medicines
what are the options for people who want to access the safe and effective obesity medicines?
We at Lilly are providing options. We know different patients have different needs and we have access to Zepbound on Lilly Direct. You can go to Lilly Direct, it's our self-pay option. . . . This is the option for patients living with obesity that have a way to get that access to that safe and authentic medication
Required actions (4)
You should take immediate action to address any violations (including, for example, ceasing and desisting promotional communications that are misleading as described above).
Please submit a written response to this letter within 15 working days from the date of receipt, addressing the concerns described in this letter, listing all other promotional communications (with the 2253 submission date) for Zepbound that contain representations such as those described above, and explaining your plan for discontinuation of such communications, or for ceasing distribution of Zepbound.
Additionally, we request that your submission include a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective communication(s) about the concern(s) discussed in this letter. The corrective communication(s) should be disseminated to the audience(s) that received the promotional communication(s) identified in the opening paragraph of this letter.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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