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Supplement Adverse Event Reports Grow, But FDA Says 'Serious' Intel Is Short

 
• By Eileen Francis

Serious AERs submitted to FDA have plateaued since 2010, though reports the agency receives from consumers steadily increased. While FDA suspects supplement firms are not providing all serious AERs as required, stakeholders say the agency overestimates the number of serious AERs.

FDA entrance sign 2016

Dietary supplement firms are sitting on serious adverse event reports about their products that they are required to submit to FDA, according to the agency's Center for Food Safety and Applied Nutrition.

“We’ve had a few companies call up and say, ‘I have 400 or 500 case reports I’d like to submit...

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More from Policy & Regulation

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• By David Ridley

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