Before the Fact

Abstract:Comprehensive regulatory guidance exists for U.S. Food and Drug Administration (FDA) product safety oversight of suppliers of food and of dietary supplements. This guidance includes the Food Safety Modernization Act, enacted in 2011. However, Warning letters and product recalls since 2011 have been on the increase. In many instances, the FDA's enforcement activity is rooted in a supplier's failure to adhere to the regulatory requirements. One of the potential barriers to taking a proactive approach to product safety is the FDA's punitive approach for regulatory oversight, premised on an inspection-driven process. Because of ongoing concerns associated with product safety issues surrounding the food and dietary supplement industries, the FDA is compelled to continue its current approach. Regulatory oversight to drive improvements in product safety, however, must be augmented by other tools that already exist, such as science-based practices and risk management …

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