In letter to the FDA, lawmaker seeks information about how agency plans to strengthen standards for ingredients that bypass FDA approval


Washington (April 26, 2016) – Senator Edward J. Markey (D-Mass.) today sent a letter to the Food and Drug Administration (FDA) asking about the agency’s strategy to ensure the safety of ingredients self-determined to be safe by food and beverage companies. These ingredients, known as “Generally Recognized as Safe”, or GRAS” substances, can be self-designated by the company intending to use the substance without FDA review. There also is no requirement that the company notify the FDA that the company intends to use this self-designated “GRAS” ingredient. It is estimated that 1,000 chemicals have entered the food supply without ever undergoing a review by the FDA. The letter also highlights potential conflicts of interest among those who determine if a substance is GRAS and the very companies pursuing this designation.


“The public assumes the FDA plays a pivotal role in assessing the safety of new food ingredients,” writes Senator Markey in the letter to FDA Commissioner Dr. Robert Califf. “Many would be shocked to learn that numerous ingredients are used in foods without ever being evaluated by the FDA, and furthermore, in many circumstances the FDA is not even aware such chemicals are being used unless a company voluntarily discloses that information.”  


In the letter, Senator Markey asks FDA if a warning label could be required to inform consumers about products containing a self-determined GRAS substance that has not been evaluated by the FDA, whether rules can be promulgated to reduce conflicts and set requirements for those determining if an ingredient is safe, and whether the agency needs greater authority to ensure the safety of the food supply.  


A copy of Senator Markey's letter can be found HERE.


In Congress, Senator Markey has successfully petitioned the FDA to abandon the use of bisphenol-A (BPA) in infant formula packaging, introduced legislation to prohibit the use of BPA in all food and beverage containers, encouraged companies that produce major energy drinks to voluntary takemeasures that will better protect young consumers and prevent misuse, and called for banning the use of the chemical triclosan in consumer soaps and hand-washes, products intended for use by children, and products intended to come into contact with food.