Navigating FDA Promotional Compliance: TEVIMBRA and Digital Brand Assets

By Darya Lucas

Background

In December 2025, the U.S. Food and Drug Administration (FDA) sent an Untitled Letter to BeOne Medicines USA, Inc., raising concerns about the company’s use of branded Microsoft Teams backgrounds to promote TEVIMBRA injection. While FDA enforcement has historically focused on television ads or social media campaigns, this action highlights a growing emphasis on nontraditional digital marketing tools used to convey promotional messaging. Importantly, it also demonstrates that even seemingly innocuous digital materials can be subject to FDA scrutiny.

“The FDA’s recent enforcement activity reinforces that when digital material communicates a claim, it is treated as promotional and subject to the same standards as traditional advertising.”
—Darya Lucas, Associate Attorney

According to the FDA’s Office of Prescription Drug Promotion (OPDP), which viewed the Teams backgrounds as promotional materials rather than merely internal communications, BeOne’s Teams backgrounds were false or misleading because they highlighted potential benefits without including risk information or specifying the drug’s FDA-approved indications. Notably, the promotional materials posted by OPDP did not indicate any audience limitation (e.g., “internal only”), which underscores the Agency’s position that audience labeling alone does not determine whether a piece is promotional. 

The backgrounds implied TEVIMBRA could be used broadly for “upper GI cancers,” when in reality, its approval is more narrowly defined. 

TEVIMBRA is approved to treat certain types of advanced stomach and esophagus cancers in adults. For esophageal squamous cell carcinoma (ESCC), it can be used as a first treatment along with platinum-based chemotherapy for tumors that have a protein called PD-L1. It is also approved as a single-agent therapy for ESCC after prior chemotherapy, but only if that prior treatment did not include a PD-L1 inhibitor. For gastric or gastroesophageal junction adenocarcinoma, TEVIMBRA can be used as a first treatment along with platinum and fluoropyrimidine chemotherapy for HER2-negative tumors that express PD-L1. 

The Teams backgrounds did not explain these details, potentially giving the impression that TEVIMBRA is approved for a broader range of “upper GI cancers” than it actually is, or that it is safer than the official information indicates. Even if the Teams backgrounds were intended primarily for internal use, FDA’s position suggests that the inclusion of product claims to even the most limited of external audiences is sufficient to trigger promotional requirements.

Concerns and Implications

This Untitled Letter serves as a clear warning to pharmaceutical and medical device companies. It reinforces a simple but crucial point, that any material that makes a claim about a drug, no matter how informal, must comply with FDA regulations. This includes digital assets like Teams or Zoom backgrounds, email signatures, and presentation slides, in addition to more traditional marketing materials. The distinction between the intended audience and actual exposure does not necessarily insulate a material from regulatory scrutiny.

The implications of this Untitled Letter are significant. Marketing teams should be aware that internal communications with any external exposure or subtle digital branding may be scrutinized. Even an asset as seemingly innocuous as a virtual background can be interpreted as promotional material, and failing to include risk information or clarify indications may expose a company to regulatory action. The risk is heightened by the practical reality that digital materials may be displayed during external-facing meetings. In companies with broad product portfolios, employees may be routinely exposed to promotional materials for products outside of their direct responsibilities. In this context, employees may be exposed to marketing claims in a manner similar to external audiences, which may highlight the importance of including balanced risk information in materials seen by a broader group of employees. 

For BeOne, the issue was not only the omission of safety details, but also the suggestion of a broader applicability than what is supported by TEVIMBRA’s FDA-approved labeling.

More broadly, this letter signals the FDA’s increasing attention to various forms of digital promotional materials. As healthcare interactions move online, regulators are clearly prepared to hold companies accountable for accuracy and transparency across all channels, not just conventional promotional campaigns. Materials originally designed for internal use may reach external audiences, which further emphasizes the importance of accuracy and risk disclosure. For marketers and advertising and promotional reviewers, the message is clear that precision, clarity, and compliance cannot be an afterthought in the digital age.

Recommendations

To minimize risk and maintain compliance, companies should consider the following actions:

• Audit all promotional materials, emails, and internal presentations for alignment with FDA standards, taking into account the audiences that materials could, in practice, reach.
• Include risk information whenever benefits are communicated to ensure audiences have a clear understanding of potential side effects.
• Clarify approved indications and avoid language that might imply off-label or broader use.
• Implement proactive review processes for all marketing content incorporating cross-functional oversight from regulatory, legal, and medical affairs teams.
• Establish rapid response plans to address any FDA inquiries, including proactive documentation of corrective measures and rationale for any disputed or high-risk claims.

The Untitled Letter to BeOne highlights a broader shift in regulatory expectations. In today’s digital-first environment, companies must recognize that even subtle or internal-focused digital assets may be scrutinized with the same rigor as traditional ads. Materials that may be viewed by employees outside the scope of their product responsibilities, as well as by external audiences, may trigger regulatory concern. Materials that were originally created for internal use only may unintentionally reach external audiences, increasing the risk of regulatory concern. By auditing all materials, emphasizing transparency, and building robust review processes, companies can not only avoid enforcement actions, but also foster trust with healthcare professionals, patients, and the public.

How Gardner Law Can Help

Ensure your company remains prepared, proactive, and compliant with FDA promotional regulations. Reach out to Gardner Law for expert assistance in assessing and mitigating risks by establishing and maintaining a robust review and compliance program for all marketing assets, including digital and nontraditional channels.