WASHINGTON, D.C. — Last Friday, Center for Food Safety (CFS) endorsed the Toxi
For years, FDA has allowed food manufacturers to designate various chemicals as ‘generally recognized as safe’ (GRAS), without FDA review or public notice. The Toxic Free Food Act would require FDA to close the so-called GRAS loophole and make the industry’s chemical food additives subject to FDA approval.
“For years, FDA has allowed food and chemical companies to decide whether long-lasting toxic
Under the Federal Food, Drug, and Cosmetic Act (FFDCA), FDA is required to review and confirm the safety of any food additives before they enter the food supply. Under FDA’s GRAS rule, however, the agency allowed food manufacturers to bypass these reviews and instead make safety determinations in secret.
Congress initially created the GRAS exemption to cover ingredients that are widely known to be safe, such as vegetable oil, but the rule has been applied in recent years to cover novel chemicals and is now a de facto loophole that has swallowed the law.
CFS filed suit in 2014 to challenge an interim rule that initially established the GRAS loophole. That successful challenge forced FDA to finally stop regulating under a proposed rule and finalize the GRAS rule. The finalized rule, however, codified the secret GRAS system, depriving the public from knowing what chemicals are in their food.
In 2017, CFS and Environmental Defense Fund filed suit challenging the final rule, co-represented by CFS and Earthjustice. The case is currently under review in federal court. The Toxic Free Food Act would mandate FDA to thoroughly review chemical additives in food and prevent companies from using the extremely weak GRAS process to self-approve these toxic additives. Had the proposed act become law years ago, many of the problems CFS’s lawsuit is seeking to solve could have been avoided.
Independent watchdogs have criticized the GRAS system for being rife with industry conflicts of interest because the vast majority of GRAS determinations are made by either the manufacturers themselves or their hired consultants. Moreover, the current system that allows secret GRAS determinations makes it nearly impossible for FDA or manufacturers to assess the cumulative effect of all similar chemicals on consumers—as required by law.
As a result, the GRAS exception is overwhelming the food safety system. An independent study by the Pew Charitable Trusts found that from 2003-2013, almost all new chemicals added to were deemed by manufacturers to be GRAS. Today an estimated 3,000 chemicals that have never been scrutinized by the FDA are in use.