Eli Lilly and Company
FDA issued a warning letter to Eli Lilly and Company (CEO David A. Ricks) on September 9, 2025, regarding a sponsored direct-to-consumer online video promoting ZEPBOUND® (tirzepatide) that aired on okcfox.com. The video featured Eli Lilly representatives making claims about Zepbound's safety and effectiveness while entirely omitting required risk information — including the boxed warning for thyroid C-cell tumors — and failing to disclose the drug's limitations of use. The video was also never submitted to FDA under Form FDA-2253 at the time of initial publication as required by regulation. FDA determined the video misbrands Zepbound in violation of the FD&C Act and demanded a written response within 15 working days, a corrective communication plan, and cessation of the misleading promotional materials, warning that failure to comply may result in seizure or injunction.
Flagged claims (2)
look out for FDA-approved safe and authentic medicines if they are already on treatment for obesity and to avoid those unapproved ones. . . .
We at Lilly are providing options. One of the options for treatment is Zepbound, which is now available at LillyDirect which is our self-pay pharmacy solution. This provides an option to patients to get access to safe and effective authentic medicine. . . .
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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