Instagram Post that Sparked FDA Warning Letter

DarshanTalks Podcast

In this episode, Darshan Kulkarni unpacks the May 29, 2025 FDA Warning Letter issued to Sprout Pharmaceuticals. The trigger? A promotional Instagram post from the company's CEO calling Addyi “the sex pill for women,” highlighting benefits but completely omitting the serious risks—like hypotension, syncope, alcohol interactions, and contraindications. To make matters worse, the post wasn’t submitted to the FDA via Form 2253 as required. This isn’t Sprout’s first offense; the FDA previously cited them in 2020, and repeat misbranding is now considered a public health risk.

Darshan emphasizes that for pharma marketing teams and legal departments, this is more than a one-off mistake—it's a compliance wake-up call. He outlines the FDA’s expectations for corrective action, including a written response within 15 business days and a plan to distribute truthful, non-promotional messages via the same platforms used for the original content. He also urges companies to ask themselves: Do we have a working SOP for executive social media posts? Are our review teams empowered to flag risky content before it goes live?

Beyond this case, Darshan offers a practical compliance checklist: have a formal social media review policy, use a centralized submission tracking system, train marketing teams on risk messaging, and audit past posts regularly. He warns that many companies underestimate the regulatory scrutiny on digital and user-generated content, making them vulnerable to enforcement action.

Bottom Line:
In the FDA's eyes, social media is advertising—and it must follow all the same rules. Even casual executive posts can result in million-dollar mistakes. Darshan and the Kulkarni Law Firm stand ready to help companies strengthen their review systems, respond to enforcement, and avoid the reputational damage that comes with noncompliance.

Support the show