(Saint Petersburg, FL - January 11, 2011)

On the evening of January 4th, 2011, President Obama signed an act that has a potential sweeping effect on manufacturers of FDA regulated products, the Food Safety and Modernization Act (FSMA).

While this law is specific to food manufacturers/processors, the law clearly sets a precedence for FDA to adopt similar actions for pharmaceutical, device, dietary supplement, and other FDA regulated manufacturers. The new law itself can be broken down into five (5) areas and is briefly discussed below:

Preventive Controls



For the first time ever, FDA has been given the mandate to require food manufacturers/processors to implement preventive measures and controls versus standard corrective actions to issues discovered.

Inspection and Compliance



The law specifies how often the agency should inspect food manufacturers. While it is expected that FDA will employ a risk-based approach to inspections, a mandate on inspection schedules for food producers will inevitably mean that FDA will hire significantly more resources dedicated to regulated industry site inspections. In fact, in Section 401 of the act, FDA is directed to direct funding to safety and enforcement and significantly increase field staff over the next five (5) years.

Importation



Similar to recent focuses on medical device and pharmaceutical companies, FDA is now focusing on supplier qualification for food companies. For example, food companies will now for the first time be required to verify and document that their foreign suppliers have adequate controls to ensure safety of their products. In addition, FDA plans to accredit qualified 3rd parties to certify that foreign food facilities can and do comply with current US food safety standards and practices.

Recall Authority



For the first time, FDA will have mandatory recall authority for all food products. The previous system of voluntary recalls is still in place except that FDA will no longer only be able to "suggest" a recall and will instead mandate a recall should the food product be of questionable quality or safety.

Partnerships



The new law discusses the strengthening of relationships and establishment of new relationships to help achieve public health goals. For example, the legislation directs FDA to improve training of state, local, territorial and tribal food safety officials to assist with monitoring and enforcement activities.

Of specific interest to all FDA regulated industries is the fact that FDA is now given the ability to charge fees for non-compliance and recall efforts. This will undoubtedly increase enforcement, will most likely cross over into other FDA regulated industries, and will in turn add to the significant burden associated with complicated product recalls. The activities, recommended steps, and costs of recalls for FDA regulated manufacturers are discussed in detail in a recently published article in Pharmaceutical Technology magazine and authored by expert FDA and state regulated consulting firm, Advanced Biomedical Consulting (ABC), LLC.

Saint Petersburg, FL - January 11, 2011)