How well a company manages a food product recall situation, especially when there is human health impact, affects the future viability of the product and the company’s reputation and “brand equity.”
Reaching a decision to voluntarily withdraw or recall a product, and conducting the recall, requires careful evaluation, including analysis of adverse-event reports, identification of the specific products and product lots to be recalled, execution of a health hazard evaluation, and implementation of a root-cause analysis and corrective and preventive action plan. A firm’s success in interacting with the U.S. Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA), or state agencies, and communicating with health-care professionals, the media, the public, and its own employees, can have a major impact on future perceptions of the company, and on possible liability. In addition, identifying and correcting an ingredient or finished-product failure that might have occurred is key to return a product back to the market after a recall.
A well-managed recall is the result of extensive advanced preparation. As the situation develops, the company must perform a health hazard evaluation, decide if a recall is necessary, and generate a recall plan. This includes forming a “recall team” with the right capabilities and experience. Exponent has extensive medical, engineering, scientific, and regulatory expertise to assist ingredient, food, and beverage companies to determine if a recall is necessary, prepare for the recall, and to assist in the decision-making involved in managing and terminating a recalls providing support for interactions with regulatory and public health agencies. Furthermore, Exponent can assist with performing a root-cause analysis, evaluate a company’s food safety system, and assist with the development a corrective and preventive action plan.
We have a wide variety of experience and expertise in areas including:
- Regulatory Support
- Human Factors
- Materials Science
- Mechanical Engineering
Exponent’s team brings a multidisciplinary approach to address a wide range of food and beverage recall issues, applying the expertise described below:
Health Hazard Evaluations and Recall Decision Advice
Our staff of former FDA and USDA officials, physicians, and scientists—including nutritionists, toxicologists, epidemiologists, microbiologists, biostatisticians, and regulatory specialists—have broad expertise in risk and exposure assessment, conducting health hazard evaluations, and providing recall decision advice to companies.
Exponent's food and beverage specialists have many years of experience evaluating the safety of finished products, as well as ingredients, food production, processing, distribution, and food service and retail. Our multidisciplinary teams have developed and conducted farm and factory investigations, generated sampling and analytical plans, and performed root-cause analyses to address numerous situations across the entire food chain.
Corrective and Preventive Actions
Exponent’s food safety and regulatory experts have extensive experience in recommending, developing, and evaluating corrective and preventive action plans.
Exponent can assist companies in developing or managing a recall plan to ensure maximum effectiveness and efficiency.
Exponent’s experienced food, health, scientific, and engineering experts can help companies with their written or face-to-face communications with a wide variety of audiences.
Exponent’s staff of former senior regulators can advise companies on best strategies to interact with federal and state regulatory officials.