Novo Nordisk Inc.

Warning LetterOpen

Maziar Mike Doustdar President and Chief Executive Officer Novo Nordisk Inc. 800 Scudders Mill Road Plainsboro , NJ 08536 United StatesFEI 2244771Issued Sep 9, 2025Center for Drug Evaluation and Research (CDER)

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 2244771.

Violations2

Issue DateSep 9, 2025

Product TypeDrugs

StatusOpen

Letter Details

Firm: Novo Nordisk Inc.
Location: Maziar Mike Doustdar President and Chief Executive Officer Novo Nordisk Inc. 800 Scudders Mill Road Plainsboro , NJ 08536 United States
FEI Number: 2244771
Country: United States
Issue Date: September 09, 2025
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

Novo Nordisk was cited for false and misleading promotional claims in a direct-to-consumer video titled "An Oprah Special: Shame, Blame, and the Weight Loss Revolution" that promoted Wegovy, Ozempic, and Victoza without adequately communicating serious safety risks, including a boxed warning for thyroid C-cell tumors. The company violated FDA regulations by failing to submit the promotional materials for review prior to dissemination, as required by 21 CFR 314.81(b)(3)(i), and the video created a misleading impression regarding drug safety in a vulnerable patient population. The violations were deemed particularly concerning because obesity, excessive weight, and type 2 diabetes are significant public health issues affecting millions of Americans and vulnerable populations including children.

Novo Nordisk Inc. FDA Warning Letter, September 9, 2025