It’s a U.S. Food and Drug Administration rule that most Americans know little about, yet gives corporations the license to add potentially harmful ingredients to foods without regulatory oversight or public notice. For decades, the FDA’s “generally recognized as safe,” or GRAS, designation has allowed food makers to decide for themselves whether certain novel ingredients are safe or not — even without providing evidence to agency scientists.
Yet after reviewing all 155 pages of the PharmaGABA notice, FDA scientists raised concerns about the product's purity, its risk for causing low blood pressure and electrolyte imbalances, and the lack of data on how PharmaGABA is metabolized, among other problems. Pharma Foods withdrew its notice, and the FDA ended its evaluation.