The Food and Drug Administration’s (“FDA”) Office of Prescription Drug Promotion (“OPDP”) has issued its fifth Untitled Letter of the year, matching last year’s total number of enforcement letters. As a reminder, OPDP issued four Untitled Letters and one Warning Letter in 2023. So far this year, FDA has not issued any Warning Letters. With only about three weeks left in the year, it is likely that we will again see a low number of letters from OPDP. Interestingly enough, three of the five letters involved celebrity influencers, which is not surprising given their visibility and reach.
The latest Untitled Letter was issued to a pharmaceutical company over a social media post for its botulinum toxin injectable product used to temporarily improve the appearance of glabellar lines, commonly known as frown lines. The post, which featured a paid partnership with social media influencer Nate Berkus and appeared on his personal Instagram account, was flagged for presenting misleading claims about the drug’s risks and benefits, in violation of the Federal Food, Drug, and Cosmetic Act.
Misleading Risk Presentation
OPDP found the post, an Instagram reel (short-form video content), to be misleading as it failed to give adequate prominence or readability to the drug’s risk information, making it less likely that viewers would notice or fully comprehend the potential side effects and contradictions associated with the drug.
In the reel, Berkus is seen dancing to music while getting “ready for a big night out” as he promotes the drug as a “smart tox” that smooths out frown lines and further implies that it will keep him “looking fresh.” The reel displays the indication and use statement for the drug as static, onscreen text at the bottom of the reel throughout the entirety of Berkus’ 40-second presentation. In contrast, the risks associated with the drug are presented only at the end of the reel after Berkus says, “See you guys at the next big event,” and walks toward the door. At this point, the entire screen goes black for several seconds—an action that typically signals the conclusion of a promotional piece. Only then is the drug’s risk information presented, but using a fast-moving, small scrolling font that was difficult to read, making it unlikely to draw the viewer’s attention. Additionally, the reel did not present any signal to alert the viewers that the important risk information was included at the end of Nate Berkus’s presentation.
OPDP found that the risk information was not given the same prominence as the benefits, which undermines its importance and misleads viewers about the safety of the drug. Additionally, OPDP highlighted that limited risk information was included in the caption for the post, but it required users to manually scroll down past additional benefit claims and other unrelated information. As such, the “limited risk information [did not] mitigate the post’s overall misleading minimization of the risk.” OPDP found this to be “especially problematic” given the serious risks associated with the drug.”
Exaggerated Benefit Claims
OPDP also found that the reel exaggerated the speed of the drug’s effectiveness. In the reel, Berkus suggests that the treatment is a “secret weapon” for quickly smoothing frown lines “when those lines might decide to make a surprise appearance,” implying that the drug offers immediate or rapid results. However, OPDP found that clinical studies on the drug have not demonstrated such fast-acting results. The efficacy of the drug for the temporary improvement in the appearance of moderate to severe glabellar lines was evaluated based on a composite endpoint where treatment success was defined as a 2-grade improvement for both the investigator and patient assessment per the 4-point Facial Wrinkle Scale compared to the baseline on day 30. While efficacy data was also collected at other time points besides the primary endpoint at day 30, composite endpoint treatment success was not evaluated before day seven. As such, OPDP concluded that there is no data supporting the idea that the drug can provide significant improvements in such a short time frame.
Furthermore, the reel highlighted the drug’s formulation as a “double-filtered smart tox,” which misleadingly suggests that the drug’s manufacturing process offers superior benefits over other botulinum toxin products. In fact, no clinical evidence supports this claim, as the drug is one of several FDA-approved botulinum toxin products, and there have been no studies comparing it directly to other treatments to suggest a clear advantage.
Practical Takeaways
- Social media and influencer marketing is a “hot topic” at OPDP and will likely continue to be as we go into 2025. Pharmaceutical companies should be particularly careful when engaging in social media marketing campaigns using celebrity influencers given their visibility and reach.
- Companies are responsible for ensuring that any claims made by third-party endorsers, like celebrity influencers, are accurate and compliant with FDA’s requirements. If an influencer makes misleading claims about the product’s effectiveness or safety, the company will be held accountable for the misleading content, even if it was posted by the influencer on his or her personal social media account.
- It is essential to ensure that risk information is prominently displayed and easy for consumers to read, particularly when posting on social media platforms that may have limitations on how information is presented to the viewers. Risk information should not be buried in captions or presented in small, hard-to-read text, or appear “below the fold” requiring consumers to scroll down to read it.
- As highlighted in the letter, this company received advisory comments from OPDP in 2010 and 2012 related to risk and benefits presentation. The issuance of this Untitled Letter is a reminder that companies must take into account comments previously provided by OPDP no matter how old when developing marketing campaigns.
- As we go into 2025 and usher in a new administration, it will be interesting to see whether OPDP will issue new guidance to address some of the regulatory gaps raised by Congress in their February 2024 letter to the agency. In that letter, Congress urged FDA to, among other things, “take swift action to update its enforcement tools to reflect the current platforms and methods used to promote prescription drugs and biologics…”
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- Carolina Wirth at (202) 780-2989 or cwirth@hallrender.com;
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- Your primary Hall Render contact.
Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot—outside of an attorney-client relationship—answer specific questions that would be legal advice.
