Strategic Revisions Lead to Successful GRAS Submission

PROJECT BACKGROUND

A leading beverage manufacturer was in the process of creating the first sports drink that included natural ingredients to boost performance for fitness and elite athletes worldwide. Unlike past products that followed standard manufacturing and marketing plans, the addition of a nutraceutical (food ingredients with health benefits) in the new beverage complicated the production process. In order to comply with FDA and other regulatory guidelines requiring proof of product efficacy and safety, various strategies and milestones were necessary and had already prohibited a quick product launch. IPM stepped in to coordinate and communicate with all involved constituents, ensuring adherence to development timelines and FDA approval requirements.

THE CHALLENGE

When the company hired IPM to manage this project, numerous crucial milestones had passed without success, preventing the company from achieving the original product launch date. Several factors contributed to company delays, complicating the project and its timeline.

In order to achieve GRAS status (the FDA’s designation meaning Generally Regarded As Safe), the company needed clinical data using human subjects. Two clinical studies were initiated by a Clinical Research Organization (CRO) to evaluate safety and potential benefits, which were then used to support efficiency claims in packaging and advertising. After months of testing, the company’s functional areas still had differing perceptions of safety study deliverables and had not properly communicated with the CRO. Further complicating the process, data generated by the study completed abroad did not accurately represent the target consumers and was therefore obsolete.

In addition to managing FDA approval guidelines including product efficacy, the product faced technical challenges – it needed to taste good and be visually appealing to the consumer. IPM was challenged with coordinating the numerous functional areas in order to complete the necessary steps to effectively manufacture and market the new product.

IPM’S SOLUTION

With years of pharmaceutical experience, IPM was familiar with FDA requirements and the processes necessary to submit documentation for government approval. IPM used this knowledge, blending the methods, ideologies, and processes used in a pharmaceutical setting and applied it to a food and beverage product launch. This experience helped the company organize GRAS documents for submission, track case study progress, and stay on top of project requirements and timelines.

IPM provided crisis management services throughout the CRO debacle; determining proper case study deliverables, promoting communication between parties, and facilitating a contract with a new CRO in order to minimize the delay in acquiring efficiency results. IPM led the company in creating a contingency plan and proposed a new timeline.

To combat poor communication between company departments, IPM assessed resources and corresponding responsibilities and became the liaison between functional areas. The project manager created a documentation e-room to provide a central repository for all relevant discussions and decisions. This forum facilitated communication across departments throughout the US and included important third party experts.

PROJECT RESULTS

Although IPM joined the project as it was failing to meet product launch expectations, reasonable and attainable timelines were implemented in order to expedite the production process of the company’s first nutraceutical-enhanced sports drink. IPM successfully maneuvered the company through the FDA documentation process and prepared it for GRAS submission. IPM’s crisis management addressed issues with the company’s CRO and provided sound suggestions for proving the new product’s efficacy.

IPM’s systematic approach to gathering evidence to support nutraceutical health benefits saved the company significant time and money. The company is currently waiting to hear whether the FDA has acknowledged that its nutraceutical is safe, allowing for its use in future foods and beverages.