The Food and Drug Administration (FDA) has recently brought the Office of Regulatory Affairs (ORA) into better alignment with current food safety regulations by restructuring the organization from a geographical arrangement to having whole reporting chains based on subject matter expertise. Rather than having inspectors in specific geographic locations handle all the compliance issues in that area; now, inspection and compliance personnel within the ORA will be focused on one area of specialization, including biological products, bio research, human and animal food, medical device and radiological monitoring, pharmaceuticals, and tobacco.
What this means to the dietary supplement industry is that field investigators with industry experience and expertise specializing in food and dietary supplements will be better attuned when they inspect facilities. This will allow for more uniform application policies and processes, better consistency, and regulatory confidence.
Larisa Pavlick, vice president of Global Regulatory & Compliance for the Salt Lake City, Utah- based United Natural Products Alliance (UNPA), says that before, FDA placed investigators where they were needed, and not necessarily in their area of expertise. While they did receive training for their assigned area, investigators were not necessarily specialized in one program area, and sometimes had secondary specialties in other program areas. This often gave rise to regulations from other disciplines such as pharmaceuticals and medical devices being imposed upon dietary supplement manufacturers, and some discontinuity from investigator to investigator as they were investigating across multiple commodities.
Just as process consistency and specialization is key in maintaining manufacturing excellence – consistency and specialization with inspections and compliance issues will lead to more consistent quality as well.
Members of the UNPA, along with the Grocery Manufacturers Association (GMA), which represents such big names as General Mills, Inc. and PepsiCo Inc., are largely in support of this initiative, although a few maintain that there is a need for both specialists and generalists to enable more uniform application of the regulations across all players, including those who are considerably out of compliance with FDA regulations. The new organization platform will allow for greater consumer protection for the amount of resources that are available.
Daisy Herpin, VP of Quality