In the future, we might look back at 2013 as the year the Food Safety Modernization Act (FSMA) finally got some teeth. In January, the Food & Drug Administration (FDA) released two long awaited proposed rules, one aimed at food manufacturers and the other at farmers. A third rule is still in the drafting process and will require food importers to comply with United States standards through a stringent verification process.
It has been two years since President Obama signed FSMA into law, but these new rules proposed in January would be the first which actually give the FDA enhanced authority in its efforts to prevent food-borne illness. A major motive behind FSMA and the new rules is to allow the FDA to be proactive, rather than reactive, which, in turn, should lead to a tangible decrease in the number of food-related illnesses. Presently, one in every six Americans suffers from a food-borne illness annually, with 130,000 requiring hospitalization and 3,000 dying each year. As a result of these eye popping numbers, and increased media coverage, outbreak awareness and food litigation have exploded in recent years. From the perspective of attorneys involved in food litigation, there are likely several ways which these new rules will impact current and future client. Let’s take a closer look:
Rule #1, Manufacturers:
This rule will require food manufacturers to formulate a plan to prevent its food products from causing food-borne illness, as well as a plan to deal with any contamination or outbreak. The rule also requires that the plan include a detailed strategy related to recall procedures. Manufacturers will be required to document the plan and keep records to verify that their preventive steps are working. Furthermore, each plan will be evaluated by the FDA, and it will use the plan as a key factor in determining “high risk” facilities, which will be subject to increased inspections. The new rule also grants audit power to FDA inspectors to confirm compliance with safety standards established in a plan. Additional scrutiny by the FDA means more opportunity for a problem to be found, which could lead to increased future litigation. As such, compliance with the new rule is of paramount importance to any of your clients who manufacture a food product (which includes products originally manufactured in a foreign country). Your clients must be advised that a well-crafted, detailed plan is essential to both minimize risk of a contamination event, and to reduce the possibility of FDA scrutiny through audits and inspections.
Also, it may sound obvious, but your clients must be instructed that going forward, they must comply with the plan at all times. Having a plan is the first step, but that plan must be followed. It is almost worse for your client to have a plan, if they do not comply with it. After the rule is formally enacted, it is easy to envision how a plaintiff could exploit any inconsistencies or failure to comply with the plan that your