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Cory Trio

Cory Trio is an associate in the firm’s Washington, DC office where he is a member of the Food, Drug, and Device Practice Group. He advises food, device, pharmaceutical, and biotechnology companies on a variety of regulatory and compliance issues.

August 21, 2024, Covington Alert

On August 15, 2024, the Food and Drug Administration’s (FDA’s) Center for Food Safety and Nutrition (CFSAN) took another important step in its sodium reduction efforts by issuing a Draft Guidance that contains new voluntary targets for sodium reduction in foods. The Draft Guidance builds on FDA’s October 2021 Final Guidance on Voluntary Sodium Reduction Goals, which established short-term voluntary targets for reducing sodium in commercially processed, packaged and prepared food. The Draft Guidance proposes new three-year sodium reduction targets for 16 overarching food categories and 163 subcategories that are commercially processed and packaged, or prepared in food service establishments such as restaurants. 

Background

Average sodium intake in the United States is currently almost 50% more than the recommended limit.[1]  To help reduce sodium across the food supply, FDA has taken an iterative, step-wise approach that includes establishing voluntary sodium targets for industry, monitoring and evaluating progress, and engaging with stakeholders.

FDA’s sodium reduction efforts began in 2016, when it released draft guidance on the agency’s short-term and long-term goals for sodium reduction in a variety of commercially processed, packaged, or prepared foods. FDA issued final guidance on this topic in October 2021 (Final Guidance), in which it set a goal of reducing average sodium intake from over 3,400 mg/day to 3,000 mg/day. As of 2022, about 40% of the targets set for foods in the Final Guidance had been reached.[2]  FDA has deemed the Final Guidance “Phase I” of its sodium reduction efforts.Continue Reading FDA Issues Draft Guidance on New Voluntary Targets for Sodium Reduction in Foods

Drug manufacturers have responded to the COVID-19 pandemic by adopting measures to ensure continuity in their operations—continuity that is vital to safeguarding the global drug supply. In doing so, some have faced unprecedented challenges with regard to ensuring the health of their employees, preventing COVID-19 transmission at their facilities, and


Continue Reading FDA Releases Guidance on Resuming Normal Drug and Biologics Manufacturing Operations During COVID-19