Case Study: Skin Care FDA Regulatory Changes

Skin Care FDA Regulatory Changes

FDA regulatory change requires fast response for a $3 Billion+/year skin care business.

The FDA issued regulatory changes to the skin care industry in June of 2011 regarding the terms, “sunblock”, “waterproof” and “sweatproof” requiring the removal of such claims from product labeling and packaging. These changes were initially required to be completed by June of 2012. As a result, our client immediately established a cross functional team and took steps to work with their trade organization to collaborate with competitors to address the changes and meet FDA timelines. WGA was called in to assist the teams and work to assess the impact and efforts needed to successfully achieve the changes.

Approach: Identify size and cost of the impact, build action plans and form program management office

WGA worked with the client’s supply chain, skin care research & development, quality, finance, sales and skin care manufacturing teams to determine the number of current and future skin care products impacted by the label and packaging changes. Once identified, WGA worked with the client to determine the financial impact and evaluate if the client should cease making certain skin care products or continue with the necessary changes. WGA worked with client’s team to establish a strategy for addressing the skin care product changes, communicating status and coordination.

Solution: Classify Skin Care product changes by magnitude, develop action plans, assign resources and execute

Once a PMO was established, WGA worked with the client’s Program and Project Managers to classify the skin care product changes based upon the magnitude of the change (e.g. reformulation needed, packaging change only). Once the skin care product changes were classified, action plans were developed for each classification and skin care product changes were assigned to project managers. WGA assisted the PMO with continuous monitoring of the cross-functional teams and provided executive status reporting on the progress of the project, FDA updates, financial reporting and the escalation of problems for the duration of the project.

Results: Deadlines and necessary product changes achieved with limited supply impact

The client was able to collaborate on several key elements of the regulatory changes with the FDA which allowed for additional time to deploy the changes.

  • Various changes to over 300 skin care products achieved
  • Some limited skin care product supply reliability impacts realized