Protecting national retail relationships and consumer trust during first of its kind women’s health clinical trial 

Situation
As women’s trust and use of boric acid (BA) grows, clinically validating product safety and efficacy is important. A leading women’s health CPG brand, recognized as a category leader, has initiated its first FDA-cleared Phase 3 clinical trial for boric acid suppositories.

The category’s first clinical trial of its kind, this effort sets a precedent for validating how boric acid as a potential approved drug, could demonstrate safety.

Research from this trial could provide an opportunity to reinforce consumer confidence and secure long-term retail partnerships by demonstrating clinical validation.

In the boric acid suppository retail category one company’s products are sold every fifteen seconds in more than 50,000 U.S. locations. The brand’s continued shelf presence helps ensure accessibility to women’s health products, especially women in rural areas who do not have routine access to providers, particularly OB-GYNs.

Complications
Without ingredient classification or a trial validating BA’s safety and efficacy, the company and its retailers faced challenges from regulatory ambiguity. Even minor perceived risks can lead to months of planning by retailers to reduce shelf space or worse, removal for a CPG company.

Activists and policymakers who monitor women’s health products can add complexity to the equation. Activist groups increased scrutiny of certain products, heightening the urgency for shaping clear, science-backed messaging. Despite BA’s century-long use and published scientific support, misinformation and regulatory uncertainty create challenges. Lack of a clear, reassuring narrative and operational plan could jeopardize retailer confidence, provider trust and public use.

Solution
Our reputation management approach included the development of a strategic positioning framework complete with three initiatives aligned with business and research goals. It addressed anticipated stakeholder concerns by retailers, regulators, politicians, providers, employees and consumers:

  • Positioning document: the emphasis of our narrative on established boric acid use, educated and reassured retail partners without triggering alarm. Existing research and the brand’s commitment to transparency and protecting women’s access stood out to these partners. It also noted expert perspectives by the American College of Obstetricians and Gynecologists (ACOG) which recognizes boric acid as a second-line option in its clinical guidelines for managing vaginitis in non-pregnant women; and the Centers for Disease Control and Prevention (CDC) which supports boric acid efficacy in managing recurrent Vulvovaginal candidiasis (VVC).
  • Crisis preparedness: development of comprehensive FAQs addressing anticipated concerns of a variety of stakeholders, boric acid’s long-standing safety profile, the ingredient’s history of use, and the FDA and proper usage guidelines
  • Legislative advocacy: crafted talking points and responses for physicians to use, and equipped the CEO with scientific and evidence-based information to use during interviews

Our narrative shifted a once-dormant conversation from clinical ambiguity to industry and consumer leadership, highlighting how retail cosmetic products like BA suppositories are vital to women’s health. The complexity of this project was driven by finely walking a very thin line between retail product success and not promoting pre-approval of a product in regulatory review as boric acid is being clinically investigated.

Results
The rollout of the strategy and materials safeguarded the brand’s coveted retail relationships, FDA-cleared trial and critical legislative priorities. The company maintained its position as an industry leader. Retailers maintained confidence in the brand, products and leaders as legislators received fact-based advocacy points as the clinical trial proceeded nationwide without disruption to consumer trust.

  • Earned media value of news coverage $91,000:
    • Nearly two-page feature in The Tennessean that ran on three different days:
      • Friday afternoon digital edition: ROI of $23,972
      • Monday morning edition of “The Daily Briefing” newsletter reaching about 99K subscribers
      • Wednesday print edition: ROI of $67,000

By aligning communications for the clinical trial with fact-based science, business priorities for access to care that minimizes healthcare deserts, we reinforced the brand’s reputation and trust with its loyal customer base as women choose boric acid suppositories off major retail shelves every :15 seconds nationwide.