For US FDA, ‘History Is Again Repeating’ With International Diethylene Glycol Poisoning Outbreak

CDER manufacturing quality director notes origin of Food, Drug and Cosmetic Act in 1938 is linked to DEG/EG poisoning. FDA says current outbreak in at least seven countries “one of the largest epidemics of DEG and EG poisoning in history.”

Recent US Food and Drug Administration warnings to foreign and domestic OTC drug firms about failing to test ingredients for diethylene glycol and ethylene glycol substitution are the latest indications that, as an agency official says, ‘“sadly, FDA has a long history with DEG/EG poisonings.”

In a presentation prepared for a recent pharmaceutical manufacturing regulatory conference, Francis Godwin, manufacturing quality director in the FDA Center...