Compliance in Influencer Marketing: Klick's Approach to FDA Standards

What you’ll learn:

Star Power And FDA Scrutiny: Influencer Pharma Partnerships

Brittany Mahomes and Nate Berkus have something in common. They aren’t just recognizable names but celebrities who have worked with pharmaceutical companies to promote prescription medications. Their social media posts caught the attention of the FDA, who issued Untitled letters addressing this promotional content. The subject of these letters focused on Instagram posts that either failed to include appropriate risk information, even when the Important Safety Information (ISI) was present, made misleading efficacy claims, or failed to provide a balanced presentation of risks and benefits. Another celebrity influencer was issued an Untitled letter, which cited a TV commercial for making false or misleading representations and suggestions about efficacy.

These advertisements featured high-profile ambassadors, which, as noted by the FDA, amplifies the impact of the misleading content. The use of celebrities the agency highlighted, may also add an undue layer of credibility, making the promotional messaging appear more believable and increasing the potential for consumer misunderstanding. 

The Importance of Consumer Comprehension in Celebrity and Influencer Ads

The FDA has highlighted that consumer comprehension is top of mind when evaluating promotional material. The gold standard of having accurate and non-misleading promotional communications appropriately balanced for benefit-risk information has been a hot topic recently, with five Untitled letters issued by the FDA in 2024 (compared to four letters in 2023 and three letters in 2022). 

Ads featuring influencers and celebrities representing pharmaceutical companies are not only subject to the same rules and regulations as any other promotional ad but may be under increased scrutiny. In today’s digital media ecosystem, influencers and celebrities have greater reach to a larger and broader audience with a higher level of trust. Therefore, such ads may be at an increased risk of hurting their audience due to the perceived credibility of the source. 

With these letters, it is clear that the FDA is concerned with how efficacy data is interpreted and presented and how risk information is communicated to consumers in celebrity and influencer-endorsed ads.  

Transparency in Influencer Marketing: Klick Health’s Proactive Compliance Measures

Summary: The FTC has clear guidelines on influencer promotions and disclosure requirements, but the FDA has yet to provide comparable guidance for influencer marketing despite offering various social media compliance resources. However, recent FDA enforcement actions signal evolving scrutiny, and Klick actively tracks these updates to help clients stay compliant.

The FTC has issued guidelines regarding the types of content influencers can promote and the use of proper, prominent disclosures of their advertising relationships. In contrast, the FDA has not yet provided comparable guidance for influencer marketing. While the FDA has provided consolidated resources for social media compliance on its website and issued guidance for internet and social media marketing—specifically addressing efficacy and risk presentations on platforms with character-space limitations—their formal guidance has not been updated in over a decade (since June 2014). Social media marketing has evolved substantially during this period, with influencers, particularly celebrity influencers, emerging as trusted advisors. However, not all these influencers are qualified to provide medically accurate information. 

In 2024, the FDA issued three Untitled letters related to influencer and social media ads, accounting for 60% (3 of 5) of all letters issued to firms this year. These letters offer valuable insights into the latest perspectives and positions of the FDA on the topic and are useful tools for the industry to evaluate compliance. At Klick, we closely monitor, document, and share FDA-issued letters with our clients to ensure that relevant changes and updates are integrated into current and future projects.

The FDA’s Primary Concerns and How to Address Them

Summary: The FDA’s recent Untitled letters highlight key concerns in influencer marketing, including inadequate risk disclosures, unclear risk presentation, unsupported efficacy claims, and overpromised treatment benefits. To maintain compliance, brands should ensure balanced risk and efficacy messaging, present risk information clearly and at a readable pace, and align influencer claims with clinical trial data.

The FDA highlighted several key focus areas in the three Untitled letters involving influencers. These are listed below, along with our recommended best practices to maintain compliance:

FDA’s concern: Risk information to balance efficacy presentations is not appropriately presented by the influencer.

Klick’s recommendation: Ensure efficacy and ease-of-use claims are balanced by appropriate risk information. This approach includes incorporating the full Important Safety Information and a link to the Prescribing Information in branded ads with claims. Particularly true for space-limited ads, this approach means that the depth of risk and efficacy information must be suitable for the platform’s limitations. 

FDA’s concern: Risk presentation is inadequate for effective consumer comprehension.

Klick’s recommendation: The presentation of risk information should be evaluated for clarity, considering font color, font size, possible visual distractions (e.g., animations occurring in the background), and the speed of the presentation. Adequate time must be given for the risk information to be read and comprehended by a consumer. Research cited by the FDA indicates that the average silent reading speed for adults reading non-fiction in English is 238 words per minute (wpm), with most adults reading between 175 and 300 wpm. Therefore, it is recommended that risk presentations, including the scroll speed for ISI content, align with this range to ensure readability and comprehension. 

In addition, ensure that risk presentations come before any signals indicating the ad is ending (i.e., transitioning to a black screen before the ISI is presented).

FDA’s concern: Claims made by influencers are not supported by appropriate data or are too expansive. 

Klick’s recommendation: Ensure efficacy claims are well-supported by the drug’s pivotal trials (or align with recommended best practices for CFL data), carefully evaluating any subjective or comparative language. Additionally, visuals in the ad that may imply specific efficacy claims should be assessed.

FDA’s concern: The influencer overpromises efficacy results or quality-of-life claims.

Klick's recommendation: Avoid the implication that all patients will benefit from a drug. Instead, efficacy presentations should be limited to the appropriate patient population. The use of specific imagery elements and carefully positioned supers and voice-overs should not overstate efficacy above what’s described in the label.

Klick Health’s Expertise in Creator Marketing and Social Compliance

Summary: Influencer marketing in pharma requires a balance between authenticity and compliance, achieved through deep collaboration between brands, agencies, and MLR teams. By working closely with creators and regulatory experts, brands can develop impactful FDA-compliant content that resonates with audiences while maintaining clarity, accuracy, and trust.

“While working with social media creators and influencers may be a newer tactic within a marketing mix, the strategy of using influential people to endorse a product or service is not. Precedence within the industry does exist! Deep collaboration between the trifecta of agency, brand, and MLR teams is crucial to ensuring authentic and compliant content that will connect with communities to achieve your business objective” – Jessica Botting, VP Group Director, Strategy, Klick Health

At Klick Health, our Creator and SciReg teams are experts in managing celebrity and influencer engagements while ensuring compliance with pharmaceutical regulations. Klick’s Creator team understands the nuances of working with content creators in the pharma space, leveraging their power of authenticity to create meaningful connections with audiences. In addition, our SciReg team balances regulatory requirements with the authentic, relatable tone that makes influencer-driven content so impactful.

Content creators, like influencers, bring authenticity and trust to their messaging, but their ability to deeply engage communities offers an additional layer of impact. Klick’s team collaborates with content creators to ensure that all content—whether for patients, caregivers, or HCPs—meets FDA standards for clarity, balance, and accuracy. By working directly with creators to co-develop content, Klick ensures that promotional messaging remains compliant without losing the human, relatable tone that makes creator-driven campaigns so effective. In addition, our SciReg team plays a vital role in familiarizing MLR teams with the concept of creator marketing, helping them understand its unique value and ensuring all parties are comfortable with the approach. Through close collaboration and education, we guide influencer content through the review process, addressing concerns and aligning on compliant, impactful messaging. This approach addresses the FDA’s top concerns, such as misleading claims or unbalanced risk presentations, and maximizes the potential of creator marketing to amplify a brand’s reach and trust.

“The seamless management of influencer partners by our dedicated influencer team allows for productive conversations with the creators that do not stifle their authentic content creation. Our influencer team fosters relationships with influencers that allows our SciReg team to provide meaningful compliance feedback while ensuring influencers feel they can collaborate with the Klick team on content solutions. This leads to engaging content that our MLR teams feel confident in.” – Katie Belgrave, Director, SciReg, Klick Health

Stay up-to-date with FDA guidelines and build a compliant influencer strategy with our experts. Get in touch now.