This week, the U.S. Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) posted a warning letter (the “Letter”)[1], issued on May 29, 2025, to Sprout Pharmaceuticals, Inc. (“Sprout”) and its CEO, Cindy Eckert (“Eckert”), regarding a social media post promoting ADDYI® (flibanserin) (“Addyi”). According to FDA, the now-flagged Instagram post, shared by Eckert, touted Addyi’s benefits but left out crucial safety information and important details on for the indicated population. There is a lot to unpack with this Letter and FDA’s manner of issuance, but as previewed in our prior blog posts this year, we believe this to be yet another example of FDA’s enhanced focus on drug advertising and promotion. Expect to see more warning letters—especially via social media advertising and promotion, actions directed at executives or personal social media accounts, and other creative ways the agency can push its mandate—in lieu of written regulation—to police the pharmaceutical industry.
Promotional Content
Addyi is the first FDA-approved medication for premenopausal women struggling with acquired, generalized hypoactive sexual desire disorder (HSDD). However, its use is highly specific—including a limitation of use—and comes with serious safety warnings, including a boxed warning for severe low blood pressure and fainting, especially when combined with alcohol or certain medications.
The Instagram post at the heart of the Letter (the “Post”) was shared on Eckert’s personal account, and included both content from a People Magazine article (the “Article”) and Eckert’s commentary about the Article. FDA made it a point to clarify that it considers a screenshot and user-generated text as one “post,” which is both important for contextualizing this Letter and for understanding how FDA thinks about these increasingly common types of social media posts. FDA found that the Post underscored Addyi’s benefits and big-picture messaging (e.g., “the sex pill for women”) but skipped over critical risks and omitted limitation of use language that Addyi isn’t approved for postmenopausal women, men, or to boost sexual performance in general. FDA’s principal concern, though, was doing this via a high-profile social media platform.
In short, FDA determined that the Post promoted Addyi in broad strokes for women’s sexual health, left out required safety and usage details, and created the impression that the product is safe and effective for a broader group than what FDA has actually approved.
Prior Warning to Sprout
This isn’t FDA’s first warning to Sprout; a previous warning letter in 2020[2] focused on a radio ad for Addyi that, in FDA’s eyes, touted Addyi’s benefits for women affected by HSDD but skipped over many of the drug's risks and key limitations. For instance, FDA found that the advertisement only briefly mentioned low blood pressure and fainting, but didn't explain what FDA views as bigger risks—like how drinking alcohol close in time to taking Addyi makes these dangers much worse. Also, according to FDA, the ad left out the fact that certain prescription meds or liver problems can seriously increase the risk, and didn’t mention some other risks entirely. In short, FDA viewed the presentation of information to be false and misleading with respect to risk and scope of Addyi’s approved uses.
FDA called out nearly identical issues in this year’s Letter, providing even more reason for FDA to be concerned, and suggesting that FDA feels the company hasn’t learned from past missteps.
Takeaways
Risk Presentation and Social Media Platforms
Failure to present risk information has historically been, and remains low-hanging fruit for FDA enforcement. As we covered towards the end of 2024,[3] social media is a platform for promotional content that is of growing concern for FDA. All told, it is unsurprising that an Instagram post promoting an FDA-regulated product, but providing no risk information, was the subject of FDA scrutiny. However, there is more nuance here than meets the eye.
The Post from Eckert’s personal account includes a screenshot of the Article about Addyi which makes some of the claims that FDA takes issue with, including, “the sex pill for women” and “Addyi is the first FDA-approved treatment for women’s sexual dysfunction.” The Post also includes Eckert’s commentary to the Article that makes an additional claim that FDA takes issue with: “[t]he first articles on @addyi a decade ago questioned the women struggling, told them it was normal, debated how many more satisfying sexual events were enough for them to deserve a pill…” Of course, there are two forms of content at issue here: the Article and Eckert’s own commentary, but FDA views them as one. FDA makes this clear in a footnote, but the concept is historically well-understood among advertising and promotional committees. In short, reposting/endorsing/liking third-party communications about a product, and in some cases (like here) providing commentary about the product and reposted content, will be viewed as one communication by FDA, so explicit and implied claims related thereto should be considered.
In examining the Post and FDA’s analysis, a few major points stand out regarding risk and omission of material information.
Fair Balance
The Post, on its surface, is clearly well-intentioned—aimed at breaking the stigma around HSDD and encouraging open conversation about an often-overlooked issue. The Post, particularly through Eckert’s commentary, spotlights the value of personal storytelling from women living with HSDD, and praises the efforts of the couple highlighted in the Article. However, under FDA regulations, any communication that mentions a drug by name (in this case, Addyi) and makes reference to its use (sexual dysfunction), either explicitly (such as “sex pill for women”) or implicitly (for example, by discussing how the product affected a couple’s marriage), triggers specific promotional requirements. In particular, FDA rules require a fair balance between information about the drug’s benefits and its risks.
In this instance, FDA noted a complete absence of fair balance. The post fails to mention any of Addyi’s safety risks or provide the full FDA-approved indications. This omission is especially concerning to FDA given that Addyi carries a boxed warning for risks such as severe hypotension and loss of consciousness, particularly when used with alcohol. The Letter specifically called out the lack of this critical safety information. Had Addyi not been a boxed warning product, the absence of safety information might have resulted in a less severe FDA response if there had at least been a brief mention or link to the product’s safety profile.
Limitations of Use
FDA highlights that according to the indications of usage section of the FDA-approved product labeling (“PI”), Addyi is indicated for the “treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD), as characterized by low sexual desire that causes marked distress or interpersonal difficulty,” and is not due to: (1) a co-existing medical or psychiatric condition; (2) problems within the relationship; or (3) the effects of a medication or other drug substance. Further, FDA noted that Addyi is not indicated for postmenopausal women, men, or to enhance sexual performance.
There are two key omissions noted by FDA with respect to the PI. First, according to FDA, the post failed to disclose Addyi’s limitations of use. Second, and perhaps more subtle, is that, in FDA’s eyes, the broad claim “sex pill for women” suggests that Addyi enhances sexual performance and may be used by “women” in general, as opposed to premenopausal women, as indicated in the PI. FDA’s concern stems from the same principle discussed earlier: once a drug and its use are mentioned, promotional rules apply, requiring that the content accurately present the drug’s approved indications and not mislead consumers. In this instance, FDA may believe the post creates the impression that Addyi is suitable for all women seeking sexual enhancement, regardless of age or underlying conditions, when in reality, its approval is limited to a specific patient population.
Ultimately, this case serves as a cautionary example: even content intended to reduce stigma or advocate for patients on social media is subject to FDA rules on drug promotion. Any mention of a prescription product’s name, plus its use or benefits, requires the communicator to provide balanced disclosure of safety risks and approved indications.
FOOTNOTES
[1] Warning Letter available here: Sprout Pharmaceuticals, Inc. - 709942 - 05/29/2025 | FDA
[2] 2020 Warning Letter available here: Sprout Pharmaceuticals, Inc - 610569 - 08/31/2020 | FDA
[3] 2024 article available here: Key Takeaways From FDA's Latest Social Media Warnings - Law360