- Massachusetts Sen. Edward Markey called on the FDA to respond to his questions challenging the conflicts of interest and other concerns when leaving voluntary reporting of generally recognized as safe (GRAS) ingredients up to companies.
- His letter to FDA Commissioner Robert Califf, M.D. shared several concerns, such as the fact that the Pew Charitable Trust found the loopholes in GRAS have allowed 1,000 chemicals to enter the food supply without being reviewed by the FDA.
- One of Markey's three questions asks if the FDA has the authority to require a label on food or beverages that contain ingredients determined to be GRAS without an FDA review. The suggestion for the label is: "The safety of some ingredients in this product has not been evaluated by the Food and Drug Administration."
"The public assumes the FDA plays a pivotal role in assessing the safety of new food ingredients by ensuring that any ingredient used in food has been thoroughly vetted and determined safe by the agency," Markey wrote. "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."
Markey's letter comes on the heels of a large transparency push from the industry through GMA's SmartLabel program, not to mention the FSMA implementation process. FDA's impending response — which Markey asked for by May 17 — will indicate its priority of these claims. The FDA is expected to issue a final rule about the GRAS process in August.
If the FDA honors the May 17 deadline, it will more than likely address its progress regarding the GRAS final rule. But if it wants to quiet the concerns, the agency will have to give concrete details on its efforts. Ingredient manufacturers have a vested interest in the status quo, so this will be a key issue to track.