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FDA Implementing FSMA: Program Realignment Building a Firm Foundation

By John Johnson III   |   

FDA is full-speed ahead with rolling out the Food Safety Modernization Act (commonly referred to as “FSMA”). With FSMA, FDA seeks to overhaul the U.S. regime for food safety – from a regime that reacted to safety outbreaks to one that seeks to prevent them. A key pillar in this preventive model is the Hazard Analysis and Risk-based Preventive Controls Rule (HARPC or PCR). This rule requires food facilities to develop and implement Food Safety Plans that control for food safety hazards. FDA staggered the compliance dates for this regulation; however, the “large” companies had to start complying almost a year ago (August 2016).

Since the first compliance date for HARPC, FDA has been silent about any enforcement activities.

This is not surprising – notably the first Warning Letter for Dietary Supplement cGMPs did not occur until almost two years after the first compliance date. However, FDA’s silence should not be interpreted as non-action by the Agency.



FDA’s Program Realignment

Rather, FDA has been hard at work implementing Program Realignment, which took effect in May 2017. FDA’s Program Realignment is larger than FSMA and concerns reorganizing FDA’s field operations (frontline inspection and enforcement staff) from generalists who handle all FDA commodities into specialist groups that handle just one commodity (such as just foods). This allows the FDA staff to become more familiar with the unique aspects of the commodity.

This specialist expertise is essential for implementing FSMA. First, HARPC requires the industry to conduct hazard analyses and then implement appropriate controls for those hazards. FDA must have the knowledge and expertise to analyze and critique a facility’s decisions. Second, FDA intends to enforce FSMA through more real-time compliance decisions – as compared to conducting an inspection and not raising issues until weeks or months later. Under the new FSMA approach, FDA desires to make certain compliance decisions during the inspection and/or issue a “deficiency letter” within days of the inspection.

Thus, to accomplish FDA’s goals for FSMA compliance and enforcement, FDA needs a highly trained front-line staff that specializes in the food regulations, policies, and science. FDA’s Program Realignment provides a firm foundation for FDA to build this new inspection and compliance corps for enforcing FSMA.




* Note: this blog was originally posted on and has been re-posted here with the author’s permission. 


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About the Author

John Johnson III practices FDA and Customs law with a focus on integration of the two agencies’ regulatory compliance requirements, and has extensive experience with representing FDA-regulated clients before FDA, USDA, Customs and other regulatory agencies. Mr. Johnson aptly deals with FDA Compliance Officers, Headquarters Officials, Customs officials, laboratories, warehouses, and brokers to remove obstacles at every step along the way. This routinely includes developing individualized import and export operating procedures to smooth and expedite the movement of highly-regulated goods, and to minimize the impact of import alerts, detentions, product recalls, and market withdrawals. To minimize the risk of FDA scrutiny and enforcement actions, Mr. Johnson advises firms on regulatory compliance. This work includes assisting firms with labeling, marketing, and formulation compliance. Additionally, he assists firms with current Good Manufacturing Practices and HACCP obligations, and with developing and implementing Standard Operating Procedures to strengthen internal programs and ensure compliance.

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