Tony Pavel Quoted in Green Queen Article on Self-GRAS Uncertainty

Keller and Heckman Partner Tony Pavel was quoted in the Green Queen article, “Self-GRAS Uncertainty Looms Over Food Tech Leaders As FDA Spotlights ‘Transparency.’” The article discusses the likely implications behind the U.S. Health Secretary’s direction to the U.S. Food and Drug Administration (FDA) to explore the potential elimination of self-GRAS determinations.

According to Tony, the impact of the GRAS overhaul will depend on how the HHS and FDA evolve. “As of today, the GRAS programme at the FDA appears likely to remain in operation,” he explained. “If there is a significant increase in GRAS notifications submitted to the FDA by mandate, without increasing funding and resources, review timelines will likely suffer.”

He added, “Currently, manufacturers may assess certain manufacturing changes or improvements without necessitating a filing with the FDA. If this flexibility is lost, there will potentially be significant additional burdens on the industry, as it iterates products through continuous improvement processes.”

To read the full article, please click here.