The production or distribution of a contaminated product is every food manufacturer’s worst nightmare. In spite of state-of-the-art technology and best practices, no one is immune to the possibility of contamination resulting in adulterated food. The consequences can conclude with a possible FDA recall, damage to the company’s brand, and if someone is injured as a result of the contamination, multiple individual or class action lawsuits. Advance preparation for a possible contamination puts a food manufacturer in the best position to get ahead of harm to consumers and defend any potential liability.
For purposes of this article, assume the food manufacturer is following all steps possible to avoid contamination, including the requirements of the Food Safety Modernization Act and all best industry practices. Despite these efforts, what steps should be taken in anticipation of a possible recall or litigation and what steps should be taken when either occurs?
Being able to quickly respond to a possible contamination is critical. In the event of a Class I recall, action is required within 24 hours. In possible litigation, the question will always be raised whether the company acted as quickly and efficiently as possible to minimize danger to consumers.
Before anything goes wrong, identify a crisis management team. The team should be trained on how to respond to a scenario of a contaminated product and should hold drills to practice their response. Internally, the team should include key members of management, quality control, production and distribution. The team should also include outside individuals including a regulatory attorney, litigation attorney, and possibly a public relations firm. A regulatory attorney can assist in determining whether a recall is necessary and help coordinate with the FDA. A litigation attorney is a risk manager who will help to ensure that what the company does or says to address the crisis in the short term has limited ramifications on longer-term liabilities. A public relations firm helps to protect the company’s brand through the process. Each of these team members brings a unique perspective and a base of knowledge that in combination should be able to address the current crisis and minimize the risk of the crisis growing.
Meaningful recordkeeping procedures and maintenance of particular data will also shorten response time. Once a determination is made to issue a recall, the FDA will want to see a Recall Submission. The data sought in this submission is used to track where the contamination may have originated and where the contaminated products may have ended up. Regularly maintaining records in a way that parallels the data will allow for quicker response to the FDA and hasten the manufacturer to get its arms around the scope of the problem. A Recall Submission will ask for product information such as brand and generic names, model and catalog numbers, order numbers, product and packaging physical descriptions, intended uses, self-life, copies of all labeling, inserts, and directions. Submissions must also include various product codes such as lot or unit numbers, expiration dates, use-by dates and universal product codes. Information regarding the volume of the recalled product must be provided including the total quantity produced, dates produced, quantity distributed, and dates distributed. Additionally, information must be provided relating to distribution patterns such as the number of direct accounts sold to, geographic areas of distribution, a detailed list of consignees (including names, addresses, contact names, and phone numbers), and information on both “ship to” customers and “bill to” customers. While this list is not everything that must be submitted to FDA in a Recall Submission, it does include data and information that could be a part of regular recordkeeping procedures.