FDA Launches New Post-Market Chemical Review Program

The U.S. Food and Drug Administration (FDA) announced that it will increase transparency and ensure the safety of chemicals in food with the launch of a stronger, more systematic review process for food chemicals already on the market, with an emphasis on those that concern consumers most.

Kyle Diamantas, acting deputy commissioner for human foods at FDA, announced the post-market chemical review program at Food Safety Summit’s May 15 Town Hall at the Donald E. Stephens Convention Center in Rosemont, Ill.

“That plan will include the creation and rolling out of a modernized, evidence-based prioritization scheme for reviewing chemicals presently in the food supply,” said Diamantas. “That will be made available for public comment later this month.”

The FDA said it will roll out several actions over the coming months:

• A modernized, evidence-based prioritization scheme for reviewing existing chemicals. A draft will be released for public comment soon, the agency said.
• A final, systematic post-market review process shaped by stakeholder input.
• An updated list of chemicals under review, including BHT, BHA and ADA. The agency will also take steps to expedite its review of chemicals currently under review like phthalates, propylparaben and titanium dioxide. FDA will continue to share information about the status of this work on its public website as part of its push for greater transparency.

Until now, the FDA has conducted post-market reviews on a case-by-case basis, said the agency, often in response to citizen petitions or new scientific evidence. This new framework aims to be proactive, science-based and built for long-term impact, said FDA.

“We are prioritizing our resources and leveraging gold standard science to create, for the first time, a systematic post-market review program that consumers can trust and rely on,” said FDA Commissioner Martin A. Makary, M.D., M.P.H. “Only by improving the safety and transparency of the food supply and ensuring consumers can make healthful food choices will we overcome the long-standing trajectory of chronic diseases.”

The post-market review effort is part of a larger initiative to improve food chemical oversight. Last month, the FDA announced plans to phase out petroleum-based synthetic dyes from the U.S. food supply. Earlier this year, the agency also began exploring rulemaking to eliminate the process that allows companies to self-affirm substances as “generally recognized as safe” (GRAS) without FDA oversight.